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E-Cigarettes: Vapin’ in the Boys’ Room

Regan Metteauer

Program Attorney, TMCEC

Prosecutors Conference

San Marcos, 2014

Session Outline

I. What are electronic cigarettes?

A. No standard definition of e-cigarettes exists, but generally they resemble traditional

cigarettes and heat nicotine into a vapor instead of burning tobacco.

B. History

a. First patented in 1963

b. Current form entered the market in 2007

C. Terminology

a. Vaping

b. Cartridge

c. Atomizer

d. Cartomizer

e. Juice

f. PG (Propylene Glycol)

g. VG (Vegetable Glycerin)

h. EGO

i. MOD

j. Hookah pens, vape pens

II. The State of the Law

A. Federal

a. What the FDA has done (wrong)

i. Attempted to ban bringing e-cigarettes into the country

ii. Attempted to regulate e-cigarettes as medical devices

1. Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010).

iii. Testing (criticized as not exactly scientific)

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iv. Proposed rules to regulate as tobacco under the Family Smoking

Prevention and Tobacco Control Act (currently under review)

B. State Law

a. Texas

i. Section 161.081(1) and (5), Health and Safety Code.

ii. Section 154.001(2), Tax Code.

iii. Section 155.001(15)(E), Tax. Code.

b. Other States

i. Almost half the states have banned the sale of e-cigarettes to minors.

ii. New York raised the legal age for tobacco sales, including e-cigarettes, to

21.

iii. Four states have added e-cigarettes to current indoor smoking bans: New

Jersey, Arkansas (its ban only covers school campuses), Utah, and North

Dakota.

iv. Oklahoma recently banned e-cigarettes on all state owned and leased

property, in state buildings, and in state vehicles.

c. Local Ordinances

i. Banning Sale to Minors

1. Murphy

2. Rockwall (January 2014)

3. Frisco (February 2014)

ii. Banning in public places (where smoking is banned)

1. Lufkin

2. Frisco

iii. Restrictions on new “vape shops”

1. Mansfield – six month moratorium

2. Richardson – requires a special permit for e-cigarette businesses

iv. Exempting e-cigarettes from public smoking bans

1. San Marcos

2. San Antonio

3. Richardson

C. Regulation and Preemption

a. Savings Clause in the Family Smoking Prevention and Tobacco Control Act

b. U.S. Smokeless Tobacco Mfg. Co. LLC et al. v. City of New York, 708 F.3d 428 (2nd

Cir. 2013).

c. Tobacco Control Legal Consortium recommendations

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III. What the Law Should Be: Policy Considerations

A. Minors

a. Targeting minors?

i. Flavors: Captain Crunch, Fruit Loops, Bubble Gum, Gummy Bears

ii. Bright colors

iii. Cases and kits

iv. #vapelife

b. Percentage of middle school and high school vapers doubled between 2011 and

2012.

c. Gateway to cigarettes or nicotine addiction

i. One in five middle school students who have tried one say they have

never smoked a “real” cigarette.

d. Glamorized bong

i. Edcouch man arrested for e-cigarettes with liquid THC

B. Caffeine v. Nicotine

a. Non-scientific reasons I know Nicotine is more harmful than Caffeine

i. Pregnancy

ii. Chocolate

b. Scientific reasons

i. Bean stimulant v. potent natural insecticide

ii. It takes 50 to 60 mg of nicotine to kill a 160 lb person, while it would take

10,000 mg of caffeine to do so (166 times more deadly).

1. That makes nicotine more toxic drop for drop than the lethal dose

of strychnine (75 mg), diamondback rattlesnake venom (100 mg),

arsenic (200 mg), or cyanide (500 mg).

iii. Cancer

1. Nicotine is transformed into the chemical NNK, concerned to

cause lung cancer.

2. Nicotine adds to cancer risks by preventing apoptosis (normal

programmed cell death) and by inducing angiogenesis (the

creation of new blood vessels), which accelerates existing tumor

growth rates.

iv. Nicotine is linked to hardening of arteries and cardiovascular disease,

memory impairment, dementia, and chronic depression.

C. Side Effects

a. PG allergies

b. Cramps

c. Nicotine Overdose

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d. Headaches

e. Nausea

f. The FDA and other health experts are concerned that the side effects of inhaling

pure nicotine have yet to be adequately studied.

D. What We Don’t Know Can Hurt Us

a. FDA testing

b. Lack of regulation

c. Quality control

d. Disclosure of ingredients

e. THC

E. A Safer Cigarette?

a. Compare to nicotine patch and gum

b. The CDC fears they could lead smokers who have quit to become addicted again

or take longer to quit.

c. “The industry can’t be trusted to provide safer products. The historical mistake

was not the pursuit of a safer cigarette, but championing that cause with

dishonest partners.” –New York Times, December 2013

F. Stigmatized by tobacco

a. Are we being unfair?

b. Efforts to re-brand

i. Hookah

ii. Vape pen

IV. The RUB

Recognize the law concerning electronic cigarettes as uncharted territory.

Understand the options and policy considerations for regulation.

Be on the lookout for future legislation.

http://www.ecigology.com/e-cig-glossary/

E-Cig Glossary

On this page you’ll find an extensive glossary of terms used in the e-cigarette world along with

their meanings. For easiest searching and best results we recommend you use the “Find” feature

of your browser to find a specific term you are looking for.

We are constantly adding to this, so check back often. If you have a question about an

abbreviation or term you don’t see on this page, leave us a comment and we’ll get right on it for

you!

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306 – One of many styles of electronic cigarettes available. Many users of the 510 e-cigs are

using the 306 atomizers on their batteries, as they feel it gives a better experience.

401, 402, and 403 – Also referred to as m401, m402, and m403. One of many styles of electronic

cigarettes available. These are all essentially the same unit (same threading on batteries and

atomizers) but with different length batteries. The 401 model is the longest in physical length and

battery life of the three while the 403 is the shortest in length and battery life.

510 – Arguably the most common and popular style of electronic cigarettes available.

808 or KR808 - One of many styles of electronic cigarettes available.

901 – One of many styles of electronic cigarettes available.

A

Adapter – Used to allow a specific style of atomizer or cartomizer to fit onto a different style of

battery. Many users prefer the vapor production of one style of atty but prefer the battery life of

another style battery. This allows them to have access to both simultaneously.

Analog or Analogue – Slang term for a traditional cigarette.

Atomizer (Abbreviated as Atty) - The part of an e-cigarette that actually heats the juice to the

point of vaporization.

http://www.ecigology.com/e-cig-glossary/

Atty – Abbreviation for Atomizer.

Automatic – A style of electronic cigarette battery that does not have a button to activate the

heating element. Rather, when the user draws on the device a switch is activated and the

atomizer is activated. This style of e-cig is most like smoking a traditional cigarette.

B

Batt – Abbreviation for Battery.

Battery (Abbreviated as Batt) – The battery piece of an electronic cigarette is the part that

provides power to the heating element. This allows the heating element to heat the Juice and

produce vapor.

Bridge – A small U-shaped covering inside of the atomizer. This is used to absorb liquid and

help wick it towards the heating element.

C

Cartridge (Abbreviated as Cart) – A plastic tube-like piece that is usually stuffed with some

sort of absorbent filler material that holds the juice.

Cart – Abbreviation for Cartridge.

Carto – Abbreviation for Cartomizer.

Cartomizer (Abbreviated as Carto) – A cartridge and atomizer in a single unit. These generally

are disposable, inexpensive and hold more juice than a regular cartridge/atomizer combination.

Charger – A battery charger. This is used to recharge your e-cig battery once it has been

depleted.

D

Drip Tip – An accessory that can be used in conjunction with an atomizer or cartomizer. These

have a larger opening than the original equipment and allows a user to drip Juice directly onto

the atomizer. Some people use a drip tip on their Cartomizers simply for looks and/or comfort.

Dripping – A method of adding juice to the atomizer. A user will drip a few drop directly onto

the bridge before vaping. Many users feel this method produces the best vapor production and

taste, since there is no filler material involved with the process.

E

E-Cig – Abbreviation for Electronic Cigarette.

http://www.ecigology.com/e-cig-glossary/

E-Juice – Also referred to as E-Liquid, Juice, or Smoke Juice. This is the liquid that is

vaporized when using an electronic cigarette.

E-Liquid – Also referred to as E-Juice, Juice, or Smoke Juice. This is the liquid that is

vaporized when using an electronic cigarette.

ECF - Abbreviation for E-Cigarette-Forum.

eCigology – The science of e-cigs. Also the greatest e-cig blog of all time.

eGo - A style of electronic cigarette that utilizes the 510 threads and allows one to use 510

components but with a much larger battery. Many people feel this is one of the superior models

of e-cigs that are available.

Electronic Cigarette (Abbreviated as E-Cig) – A device that heats up a liquid solution

consisting of nicotine, propylene glycol and/or vegetable glycol, and flavorings to a point where

it actually turns into a vapor which can be inhaled. For more detailed information, click here:

Understanding E-Cigs: A Beginner’s Guide

F

FDA - Abbreviation for the (United States) Food and Drug Administration.

Filler Material (Abbreviated as Filler) - Material placed inside of a Cartridge that is absorbent.

It is used to help keep the juice inside of the cartridge and deliver it to the atomizer at an optimal

pace (so as to not flood the device). Most cartridges come with PolyFill being used as the Filler

Material, but there are many modifications available that may help enhance your e-cig

experience (such as the Pyramid Tea Bag mod or Blue Foam mod – check our Modifications

section for more information).

Flooding – Something that can occur when too much Juice is applied to the atomizer. Since

atomizers require some air to properly vaporize Liquid, adding too much Juice to an atomizer

will cause a decrease in Vapor Production and flavor.

Food and Drug Administration (Abbreviated as FDA) – An administrative branch of the

United States government that oversees rules and regulations pertaining to the safety of food and

drug products sold in the USA. There is currently a very controversial lawsuit involving the FDA

and the importation and distribution of electronic cigarettes.

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H

Hot Cigarette – A slang term for a traditional cigarette.

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http://www.ecigology.com/e-cig-glossary/

J

Juice – Also referred to as E-Liquid, E-Juice, or Smoke Juice. This is the liquid that is vaporized

when using an electronic cigarette.

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L

Leaking – This can happen when too much Juice is added to an atomizer or cartomizer. Juice

can leak out of the bottom of the heating element and onto the battery, which in some cases can

cause damage to the device (as is the case with Automatic Batteries).

LED - Abbreviation for Light Emitting Diode.

Light Emitting Diode (Abbreviated as LED) – A diode that converts applied voltage to light.

These are commonly used in electronic cigarette devices to indicate that the device is actively

being used.

Liquid – Also referred to as E-Liquid, E-Juice, Smoke Juice, or Juice. This is the liquid that is

vaporized when using an electronic cigarette.

Low Resistance (Abbreviated as LR) – An atomizer or cartomizer with a lower Ohm rating than

the standard equipment. This generally causes the heating element to get hotter faster and

produces vapor more quickly. In many cases it produces more vapor than an atty or carto that has

a standard resistance rating.

LR - Abbreviation for Low Resistance.

M

m401, m402, and m403 – Also referred to as 401, 402, and 403. One of many styles of

electronic cigarettes available. These are all essentially the same unit (same threading on

batteries and atomizers) but with different length batteries. The m401 model is the longest in

physical length and battery life of the three while the m403 is the shortest in length and battery

life.

Manual – A style of electronic cigarette battery that has a button (usually on the top or side of

the battery) that activates the heating element. When the user wishes to use the device, the button

must first be depressed in order to produce vapor from the atomizer. This style of e-cig is less

like a traditional cigarette than the Automatic, but is preferred by many due to the fact that it is

sealed and can not be adversely affected by Leaking.

mg – Abbreviation for Milligrams.

http://www.ecigology.com/e-cig-glossary/

Milligrams (Abbreviated as mg) – The amount of nicotine found in a Juice. Typical levels

include 0mg, 6mg, 8mg, 12mg, 16mg, 18mg, 24mg, 30mg, 36mg and 48mg. Generally speaking,

a medium level of nicotine is around 18mg. Those who use Juice with a higher nicotine content

than that are generally people who were heavy smokers or have been vaping for quite some time.

Milliliters (Abbreviated as mL) – The amount of Juice in a given container.

Mini – One of many styles of electronic cigarettes available. These generally are about the same

size as a traditional cigarette and have the shortest battery life of any style.

mL - Abbreviation for Milliliters.

Mod – Dual usage – Can be used to describe modifications to a device or accessory (such as

getting more vapor production out of your cartridges) or a design variation of a commonly

manufactured electronic cigarette. In the latter context, mods typically use larger rechargeable

Lithium Ion batteries and allow the user longer battery life and increased vapor production but at

the cost of the device looking like a traditional cigarette. Many mods will also allow the user to

increase or decrease the voltage of their device to achieve optimal performance.

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O

Ohm - A measure of electrical resistance. A lower number indicates lower resistance and

therefore faster heating.

P

Passthrough – A device that plugs directly into the USB port of a computer or charger and

allows the user to vape without having to worry about battery life. Some users report better vapor

production and/or flavor while using a Passthrough compared to their regular batteries.

PCC - Abbreviation for Personal Charging Case.

Pen Style – One of many styles of electronic cigarettes available. Slightly resembles a ball point

pen in appearance.

Personal Charging Case – A portable charger that can be taken with a user on the go to charge

electronic cigarette batteries when away from a power outlet. Particularly useful when using an

e-cig that has less than a 2 hour battery life per charge. Take a look at this post for battery life

information for many common e-cig batteries.

Personal Vaporizor (Abbreviated as PV) – Another name for an Electronic Cigarette. Usually

used in reference to the more untraditional style e-cigs (also known as Mods).

PG – Abbreviation for Propylene Glycol.

http://www.ecigology.com/e-cig-glossary/

Propylene Glycol (Abbreviated as PG) – An ingredient found in many brands of E-Juice. Some

users have reported an allergic reaction to it and must therefore use 100% VG Juice instead. This

is one of the ingredients used that when heated will produce vapor that can be inhaled. Typically,

PG produces less vapor than it’s VG counterpart but provides more flavor and Throat Hit. This

substance has been used as a primary ingredient in medical inhalers for years.

PV - Abbreviation for Personal Vaporizor.

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R

S

Smoke Juice – Also referred to as E-Liquid, Liquid, Juice, or E-Juice. This is the liquid that is

vaporized when using an electronic cigarette.

Smokeless Cigarette – A term used to refer to an electronic cigarette. This term is used

commonly due to the fact that no actual smoke is inhaled or exhaled while using an e-cig.

Starter Kit – A kit that includes basic e-cigarette equipment. Typically includes everything

needed to begin vaping. Most starter kits come with 1 or more atomizers, 1 or more batteries, a

charger and 5 cartridges pre-filled with Juice.

T

TH - Abbreviation for Throat Hit.

Throat Hit (Abbreviated as TH) - The tingling feeling one feels in the back of the throat when

vaporizing juice that contains nicotine. Typically, since nicotine is a large contributing factor in

throat hit, when a juice that contains zero nicotine is vaporized, there is no throat hit.

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V

Vape – The action of “smoking” an electronic cigarette. Since e-cigs actually produce vapor

(rather than smoke) people refer to this as “Vaping”.

Vapor Cigarette – A term used to refer to an electronic cigarette. This term is used commonly

due to the water vapor that is exhaled when using an e-cig.

Vapor Production – Typically associated with Juices. Indicates how much vapor is produced

using an average inhale of an e-cigarette.

http://www.ecigology.com/e-cig-glossary/

Vegetable Glycerol or Vegetable Glycerin (Abbreviated as VG) – An ingredient found in many

brands of E-Juice. This is one of the ingredients used that when heated will produce vapor that

can be inhaled. Typically, VG produces more vapor than it’s PG counterpart but provides less

flavor and Throat Hit. Some users who are allergic to Propylene Glycol must use 100% VG

Juices.

VG - Abbreviation for Vegetable Glycerol or Vegetable Glycerin.

W

Wick – A narrow piece of poly string that is inside of many styles of atomizers that allows easier

delivery of Juice to the heating element.

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3,200,819 Aug. 17, 1965

‘H. A. GILBERT

SMOKELESS NON-TOBACCO CIGARETTE

Filed April 17, 1965

6.2m

INVENTOR

Herbert A. Gilbert

.12... 5.

Q t!( M ATTORNEYS

United States Patent 0 l

3 209,819 SMOKELESS NON’JTOIBACCO CIGARETTE

Herbert A. Gilbert, 278 McKinley Road, Beaver Falls, Pa. Filed Apr. 17, 1963, Ser. No. 273,624

10 Claims. (Cl. 128—208)

The present invention relates to a smokeless non tobacco cigarette and has for an object to provide a safe and harmless means for and method of smoking by re placing burning tobacco and paper with heated, moist, ?avored air; or by inhaling warm medication into the lungs in case of a respiratory ailment under direction of a physician.

‘ Another object of the invention is to provide an article of manufacture resembling a cigarette ‘by which air may be drawn through a porous substance of a cartridge which has been moistened with a chemically harmless ?avoring preparation, combining moisture and taste ‘fol lowing which the moist and ?avored air passes through a section of the device heated by a suitable heating ele ment so that warm, moist and flavored air is drawn into the ‘mouth and if desired into the lungs of the user. A vfurther object of the invention is to provide a smoke

less non-tobacco cigarette in which provision is made for circulating the ?uid around the heating element in a tur bulent manner to suitably raise the temperature of the inhalent mixture, with the purpose that the temperature of the ?avored air may approximate that of ‘cigarette smoke. A further object is to insulate the heat source so that

the “cigarette” may be held in the ?ngers without dis comfort to the user’s hand. With the foregoing and other objects in View, the in

vention will ‘be more fully described hereinafter, and will be more particularly pointed out in the claims appended hereto.

In the drawings, wherein like symbols refer to like or corresponding parts throughout the several views: FIGURE 1 is a side elevational view of the completed

article constructed in accordance with the invention in simulation of a cigarette. lFIGURE 2 is a longitudinal section taken through the

same with all interior parts assembled. FIGURE 3 is a cross-sectional view taken on the line

3-3 in FIGURE 2. FIGURE 4 is a side elevational view of a form of ?a

vor cartridge employed. FIGURE 5 is a transverse sectional view taken on the

line 5—-5 in FIGURE 2. ‘FIGURE 6 is a similar View taken on the line 6——6 in

FIGURE 2. FIGURE 7 is a longitudinal sectional view of a form

of outer tube.

FIGURE 8 is a similar view of a form of insulating liner. ‘FIGURE 9 is a longitudinal sectional view of a form

of mouthpiece that may be employed. FIGURE 10 is a side elevational view of a form of

heating element or vacuum tube ‘or bulb that may be employed.

Referring more particularly to the drawings, 15 desig nates an external tube made preferably the size, color and ‘form of a cigarette, such tube having an outer end portion 16 and an inner end portion 17.

subdividing the interior space of the external tube is an internal shoulder 18 which is preferably closer to the outer end portion 16 than to the opposite inner end por tion 17, thus dividing the tube into relatively short and substantially longer chambers. The tube 15 is supplied at the inner end portion 117

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3,290,819 Patented Aug. 17, 1965

2 with internal threads 19 or some other means of connec tion for a mouthpiece as later described.

In the outer end portion 16 is detachably ?tted a ?avor cartridge 26 of some suitable absorbent material, pref erably having longitudinal spaced passages 21 there through of a small diameter. The cartridge 20 is abutted against the outer edge of the internal shoulder 18 and is of an external diameter to ?t snugly into the outer end portion 16 so that it will be held therein by ‘friction or other suitable means. Within the more forward chamber of the outer tube 15

is received a tubular liner 22 preferably of insulating ma terial and having an internal wall 23 of a form and character to tumble the air or create turbulence therein. This internal Wall may be spiralled or ri?ed as indicated. A mouthpiece 24 is a?ixed to the inner end portion 17

of the tube .15 in any appropriate manner, preferably ldetachably as by external threads 25 on the hollow shank 25 of the mouthpiece which mate with the internal threads 19 in the inner end portion of the outer tube 15. As shown in FIGURE 2, the free outer end of the

hollow shank 25, when ?tted home in the outer tube, will encounter and push the insert 22 against the inner wall of the internal shoulder 18 thus holding the insert 22 im movably in place. The hollow shank 25 will preferably have an outstand~

ing shoulder 27 ‘forwardly of the threads 26 to engage the inner end of the tube 15 in the completely assembled position of the mouthpiece 24 relatively to the outer tube 15.

As best seen in FIGURE 6 showing a ‘cross-section through the hollow shank portion 25 of the mouthpiece, a spider formation is shown providing air draft spaces 28 bet-Ween the hollow shank 25 and an inner ring 29 spaced inwardly from the hollow shank 25 and con nected therewith by radial arms 39. The air draft spaces 23 communicate with the suction ori?ce 40 of the mouth piece at the inner end and at the outer end with the space circumscribed by the inner wall 23 of the tubular in sert 22.

Within the inner ring 2-9 is a threaded electric socket 3b and forwardly thereof a battery cavity 31 for detach ably receiving a battery 3-2 having an inner contact 33 and an outer contact 34 with a contact strip 35 between the inner contact 33 and the socket 30. The heating element is preferably a vacuum tube or

bulb 36 having a screw plug 37 for detachable engage ment with the socket 30. The screw plug 3-7 has an end contact 38 adapted to close against the outer battery con tact ‘3d. The bulb or tube 36, similar to a light bulb, is preferably elongated and of 1a diameter to ?t within the lnsert 22 in such manner '

heating passage throughout the length of the bulb and around the complete circumference of the bulb 36.

in assembly, the ?avor cartridge 2'0 can be introduced and removed without regard to the other units of the device.

Before the mouthpiece 24 is assembled to the external tube 15, the liner 22 is slid through the open inner end portion of the tube until the outer end of the liner 22 encounters the internal shoulder 18. The bulb 36 will be mounted to the socket 30 while the mouthpiece 24 is detached from the tube 15 whereupon the bulb 36 may be introduced into the insert 22 as the mouthpiece 24 is put into place and rotated to effect attachment of the mouthpiece to the outer tube 15. The ?nal home posi tion of the parts is indicated in FIGURE 2 in which the hollow shank 25 engages the inner end of the insert 22 while the outer end of the insert is abutted against the internal shoulder 13. When the bulb 36 is assembled to the socket 30 its tip

end 33 will engage the inner battery contact 313 and com—

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3,200,819 5»

plete the circuit through the ?lament of the bulb 36 by the contact strip 35. Thus the bulb 3d will be illuminated or energized before assembly to the external tube 15. 4 The battery 32 is ‘removable so that when exhausted, a fresh dry battery may be substituted, access to the same being had by ?rst unscrewing the mouthpiece Z4 and withdrawing the bulb 36 and subsequently removing the bulb 36 from its socket 30. The insert 22 is preferably of a ceramic material. By

the act of inhalation through the mouthpiece 24, air from the ambient atmosphere is drawn in through the passages 21 of the cartridge 20 which has been impregnated with suitable ?avoring material which is picked up by the in haled air and such air then passes into the heating cham ber and is caused to ?ow around the heating bulb 36, the heated and ?avored air ?nally passing through the mouth piece 24 into the mouth and also, if desired, into the lungs.

The tumbling of the air around the heat source provides for uniformity of heat transfer while the insert 22 also serves to insulate the basic tube 15 so that it does not become hot to the hand of the user. The cartridge 2@ may be composed of a porous, mois

ture-holding substance such as felt or plastic sponge al though there are many other materials which will serve the purpose. The impregnation will be by a harmless ?avored chemi

cal compound. As suggested, such compounds may be solutions ranging from slightly mentholated water to a solution which would simulate arti?cially the ?avor of Scotch whisky. Many other solutions and ?avors may be employed. The outer tube may be of plastic, ?ber glass or any

other appropriate material. The member 24 as shown in the drawings is shaped in

the fashion of a mouthpiece but it is not necessary that it be so shaped. The tubular shape of the outer tube 15 may be continued to the right hand end of the mouthpiece if desired to further the illusion of a cigarette. Some of the advantages of the invention are: (at) There is no open ?ame or ?re and ?re hazard is

therefore eliminated. (b) Nothing is consumed so that there is no smoke,

ashes or dirt. (c) Since the air which enters the lungs of the user comes into contact with only inert materials, there is nothing of an injurious nature being placed into the respiratory system of the user.

(d) Heated medication for respiratory ailments may be induced into the lungs of a user of this invention should a physician feel the same desirable.

(e) Persons who wish to smoke but have been ad vised against such a practice by their doctor may use this invention to maintain the satisfaction of smoking without any of its disadvantages.

(f) By changing the liquid employed to moisten the

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cartridge 20, a variety of tastes may be imparted _ > to the warm moist air which serves to duplicate the

. smoking sensation. (g) The size and shape of the device according to this

invention may approximate the size and shape of a cigarette; therefore its use will not call undue at tention to the user. A white coloration of the basic tube 15 and mouthpiece will further add to this illusion.

It is to be understood that various details of the ex emplary structures chosen to illustrate the invention are capable of being modified and in some cases omitted without departing from the broad principles of the in vention as de?ned by the more broadly worded of the appended claims. What is claimed is: 1. A smokeless non-tobacco cigarette comprising .(a) an external tube having inner and outer end

portions,

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ll (b) a ?avor cartridge in the outer end portion, (c) heating means in the tube, (d) a tubular liner also in the tube at least partially

surrounding and spaced from the heating means and having .

(e) an internal wall shaped to produce turbulence in the air stream drawn through the space between the heating means and tubular liner,

(f) a mouthpiece on the inner end portion of the tube for drawing atmosphere air by inhaling through the outer end portion of the tube including the cartridge and through the space between the heating means and liner and into the mouth of the user, and said cartridge having air passages therethrough com municating at the outer end of the tube with the at mosphere and at the inner end of the tube with said space and ultimately with the mouthpiece for per mitting air to be drawn past the ?avor cartridge for inhalation by the user at the mouthpiece.

2. A smokeless non-tobacco cigarette as claimed in claim 1 in which the internal wall (e) of the tubular liner is ri?ed to produce the turbulent eifect recited.

3. A smokeless non-tobacco cigarette as claimed in claim l in which the tubular liner (d) is of heat insulat ing material and in which the internal wall (e) is spir ally grooved to tumble the air around the heating means.

4. A smokeless non-tobacco cigarette as claimed in claim 1 in which the ?avor cartridge (b) comprises

(h) a porous substance moistened with (i) a chemically harmless ?avoring material. 5. A smokeless non-tobacco cigarette as claimed in

1cjlairn 4 in which the porous substance (h) is traversed

(j) air passages running lengthwise of the tube open ing at the outer end to atmosphere and at the inner lend to'the space between the heating means'and the men

6. A smokeless non-tobacco cigarette as claimed in claim 1 in which the tube has

(h) an inwardly projecting division shoulder consti tuting a stop against the rear edge of which the ?avor cartridge is abutted and against the forward edge of which the rear end of the liner is abutted.

‘7. A- smokeless non-tobacco cigarette as claimed in claim 1 in which the mouthpiece (f) includes

(h) a hollow shank detachably interlocked with the external tube andv abutted against the inner end por tion of the liner.

8. A smokeless non-tobacco cigarette comprising (a) on external tube having inner and outer end por

tions, .

(b) a ?avor cartridge in the outer end portion, (0) heating means in the tube, (d) a tubular liner also in the tube at least partially

surrounding and spaced from the heating means and having

(e) an internal wall shaped to produce the air stream drawn through the space between the heating means and tubular liner, >

(f) a mouthpiece on the inner end portion of the tube for drawing atmospheric air by inhaling through the outer end portion of the tube including the cartridge and through the space between the heating means and liner and into the mouth of the user,

(g) said cartridge having air passages therethrough communicating at the outer end of the tube with the atmosphere and at the inner end of the tube with said space and ultimately with the mouthpiece for permitting air to be drawn past the ?avor car tridge for inhalation by the user at the mouthpiece,

(h) an electric socket in the mouthpiece, said heating means ‘being an electric bulb having

(i) a plug entered‘into the socket, and V (j) a battery also in the mouthpiece having electric ‘

turbulence in ,

3,200,819 5 6

connection to the socket and exposed in the socket (in) a battery cavity in the inner ring inwardly of to the plug for energizing the electric bulb. the socket,

9. A smokeless non-tobacco cigarette as claimed in (n) a battery in the cavity electrically connected to claim 8 further comprising the socket, said heating means having a screw plug

(k) a battery receiving cavity in the mouthpiece in- 5 adapted to be entered into the socket and elec Wardly of the socket, trically connected to the battery.

(1) a battery rernovably mounted through the socket _ ' into the cavity and having References Cited by the Examiner

(In) inner and outer contacts, said plug having UNITED STATES PATENTS (11) an inner end contact for closing against said 10 726,037 4/03 Perm _____________ __ 128_20O outer contact, and -

- - - 962,617 6/10 Bucceri ____________ __ 128—201 (0) a contact strip connecting the inner battery con - , 2,204,312 6/40 Huxter ____________ __ 128~192 tact with the socket. , -

. . . 2,696,382 12/54 Gelardin. 19. A smokeless non-tobacco cigarette as claimed 1n . . . . . . 2,702,033 2/55 Pardernan __________ __ 128——201 clalm 1 in which said mouthpiece (f) comprises 15 2721551 10/55 Lobl 128 208 (h) a spider internal construction having 2’860’6q8 11/58 Bartolg‘f “““““““““ “ 128-201 (i) spaced internal and external concentric rings ’ ’ J ' mes “““““ " __

having FOREIGN PATENTS (j) air draft spaces therebetween, 566,647 4/53 Belgium‘ (k) radiating angularly spaced arms connecting the 20 960,469 10/49 France, rings, (1) a threaded socket in the inner ring, RICHARD A’ GAUDET, Primary Examine?‘

October 23, 2013 The Honorable Margaret Hamburg, Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: FDA Regulation of E-Cigarettes Dear Commissioner Hamburg, The undersigned Attorneys General write to urge the Food and Drug Administration (FDA) to take all available measures to meet the FDA’s stated deadline of October 31, 2013, to issue proposed regulations that will address the advertising, ingredients, and sale to minors of electronic cigarettes (also known as e-cigarettes). State Attorneys General have long fought to protect their States’ citizens, particularly youth, from the dangers of tobacco products. For example, every State Attorney General sued the major cigarette companies for the harm their products caused. With the protection of our States’ citizens again in mind, the undersigned Attorneys General write to highlight the need for immediate regulatory oversight of e-cigarettes, an increasingly widespread, addictive product. As you know, e-cigarettes are battery-operated products designed to deliver nicotine to the user by heating liquid nicotine, derived from tobacco plants, along with flavors and other chemicals, into a vapor that the user inhales. The nicotine found in e-cigarettes is highly addictive, has immediate bio-chemical effects on the brain and body at any dosage, and is toxic in high doses.1 E-Cigarette Sales are Growing Exponentially Using Marketing that Includes Television Sales of e-cigarettes have grown rapidly in the United States, and after doubling every year since 2008, sales in 2013 are now accelerating even faster and projected to reach $1.7 billion.2 The cost of e-cigarettes has fallen

1 U.S. Surgeon General, U.S. Department of Health and Human Services, The Health Consequences of Smoking: Nicotine Addiction (1988); Emergency Response Safety and Health Database, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, http://www.cdc.gov/niosh/ershdb/EmergencyResponseCard_29750028.html 2 Compare Josh Sanburn, Can Electronic Cigarettes Challenge Big Tobacco?, Time.com, Jan. 8, 2013, available at http://business.time.com/2013/01/08/can-electronic-cigarettes-challenge-big-tobacco/, (estimating 2013 sales at $1 billion), with Stuart Elliot, E-Cigarette Makers’ Ads Echo Tobacco’s Heyday, New York Times, Aug. 29, 2013, available at http://www.nytimes.com/2013/08/30/business/media/e-cigarette-makers-ads-echo-tobaccos-heyday.html, (estimating 2013 sales at $1.7 billion).

2

dramatically, as well, making them more affordable, and thus more attractive to young people. Unlike traditional tobacco products, there are no federal age restrictions that would prevent children from obtaining e-cigarettes, nor are there any advertising restrictions. Along with the growth of e-cigarette sales, there has also been a growth of e-cigarette advertising over the past year. For example, in this year’s Super Bowl broadcast, NJOY e-cigarettes purchased a 30-second television advertisement slot which reached at least 10 million viewers in certain markets and reportedly translated into a dramatic 30-40% increase in sales.3 The advertisement depicted an attractive man smoking an e-cigarette that looked just like a real cigarette. Since then, advertisements for e-cigarettes have regularly appeared on primetime television, making it easier for those advertisements to reach children. Moreover, e-cigarettes are not being marketed as smoking cessation devices, but rather as recreational alternatives to real cigarettes. Consumers are led to believe that e-cigarettes are a safe alternative to cigarettes, despite the fact that they are addictive, and there is no regulatory oversight ensuring the safety of the ingredients in e-cigarettes. E-Cigarettes Appeal to Youth E-cigarettes contain fruit and candy flavors -- such as cherry, chocolate, gummy bear, and bubble gum -- that are appealing to youth. The FDA has banned such flavors from cigarettes and should take the same action regarding e-cigarettes. E-cigarettes and refills of the liquid nicotine solution used with e-cigarettes can easily be ordered online without age verification. By intentional use or mistaken ingestion from the non-child resistant containers, e-cigarettes and liquid nicotine refills can deliver dangerously high doses of liquid nicotine to youth. In addition to flavors, e-cigarette manufacturers, such as eJuiceMonkeys.com and Magic Puff City E-cigarettes, use cartoon monkeys to sell e-cigarettes,4 even though for many years, the major manufacturers of traditional cigarettes have been banned from using cartoons to advertise. Finally, e-cigarette manufacturers, such as White Cloud Cigarettes, offer reusable e-cigarette “skins” -- known as Vapor Jackets -- that are intended to make the e-cigarette desirable or fashionable and are available in a variety of patterns that appeal to children, one of which uses images from the popular video game, Angry Birds.5 Further, data from the 2011 and 2012 National Youth Tobacco Surveys (conducted by the Centers for Disease Control and Prevention) show that e-cigarette use among students doubled in the last year. Specifically, one in 10 high school students reported that they had tried an e-cigarette in the last year -- up from one in 20 in 2011, and 1.8 million middle and high school students said they had tried e-cigarettes in 2012.6 The increased usage among young people

3 Benjamin Wallace, Smoke Without Fire, New York Magazine, April 28, 2013, available at http://nymag.com/news/features/e-cigarettes-2013-5/. 4 See http://ejuicemonkeys.com/ and http://cityecigarettes.com/ 5 See http://www.whitecloudelectroniccigarettes.com/accessories/vapor-jackets/ 6 Catherine Corey, Notes from the Field: Electronic Cigarette Use Among Middle and High School Students – United States, 2011-2012, Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report,September 6, 2013, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm?s_cid=mm6235a6_w

3

echoes the growth among adult users, and researchers indicated that aggressive marketing campaigns, in part, drove the increase.7 The FDA has Authority to Regulate E-cigarettes and Protect the Public In the Tobacco Control Act, Congress recognized that nicotine is an addictive drug, and virtually all new users of tobacco products are under the age of eighteen and are therefore too young to legally purchase such products. Congress further found that tobacco advertising and marketing contributes significantly to the teenage use of nicotine-containing tobacco products. To help prevent children from using tobacco products, the Tobacco Control Act imposed restrictions on advertising and marketing to youth. These restrictions should be applied to e-cigarettes, as well, to safeguard children from nicotine addiction and other potential health effects of e-cigarettes. The FDA has authority to regulate electronic cigarettes as “tobacco products” under the Tobacco Control Act, as they are products “made or derived from tobacco” that are not a “drug,” “device,” or combination product. Case law, such as Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), further supports the contention that e-cigarettes are “made or derived from tobacco” and can be regulated as “tobacco products” under the Tobacco Control Act. We ask the FDA to move quickly to ensure that all tobacco products are tested and regulated to ensure that companies do not continue to sell or advertise to our nation’s youth. Very respectfully yours, Martha Coakley Mike DeWine Massachusetts Attorney General Ohio Attorney General Michael Geraghty Tom Horne Alaska Attorney General Arizona Attorney General Dustin McDaniel Kamala Harris Arkansas Attorney General California Attorney General

7 Sabrina Tavernise, Rise Is Seen in Students Who Use E-Cigarettes, New York Times, September 5, 2013, available at http://www.nytimes.com/2013/09/06/health/e-cigarette-use-doubles-among-students-survey-shows.html

4

John Suthers George Jepsen Colorado Attorney General Connecticut Attorney General Joseph R. “Beau” Biden III Pamela Jo Bondi Delaware Attorney General Florida Attorney General Lenny Rapadas David Louie Guam Attorney General Hawaii Attorney General Lawrence Wasden Lisa Madigan Idaho Attorney General Illinois Attorney General Greg Zoeller Tom Miller Indiana Attorney General Iowa Attorney General Jack Conway James “Buddy” Caldwell Kentucky Attorney General Louisiana Attorney General Janet Mills Douglas F. Gansler Maine Attorney General Maryland Attorney General Bill Schuette Lori Swanson Michigan Attorney General Minnesota Attorney General Jim Hood Chris Koster Mississippi Attorney General Missouri Attorney General

5

Tim Fox Catherine Cortez Masto Montana Attorney General Nevada Attorney General

Gary King p y ral New Mexico Attorney General

Eric T. Schneiderman Roy Cooper New York Attorney General North Carolina Attorney General Ellen Rosenblum Kathleen Kane Oregon Attorney General Pennsylvania Attorney General Luis Sánchez Betances Peter Kilmartin Puerto Rico Attorney General Rhode Island Attorney General Marty J. Jackley Robert E. Cooper, Jr.

neral Tennessee Attorney General

William H. Sorrell Vermont Attorney General

Vincent Frazer Robert W. Ferguson Virgin Islands Attorney General Washington Attorney General Peter K. Michael Bruce B. Kim Wyoming Attorney General Hawaii Office of Consumer Protection Executive Director

Page 1

SOTTERA, INC., DOING BUSINESS AS NJOY, APPELLEE v. FOOD & DRUG

ADMINISTRATION, ET AL., APPELLANTS

No. 10-5032

UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA

CIRCUIT

627 F.3d 891; 393 U.S. App. D.C. 257

September 23, 2010, Argued

December 7, 2010, Decided

SUBSEQUENT HISTORY: Rehearing, en banc, denied

by, Motion granted by Sottera, Inc. v. FDA, 2011 U.S.

App. LEXIS 26339 (D.C. Cir., Jan. 24, 2011)

Related proceeding at Thompson Hine LLP v. Smoking

Everywhere, Inc., 840 F. Supp. 2d 138, 2012 U.S. Dist.

LEXIS 1676 (D.D.C., Jan. 6, 2012)

PRIOR HISTORY: Appeal from the United States District Court for the

District of Columbia. (No. 1:09-cv-00771-RJL).

Smoking Everywhere, Inc. v. United States FDA, 680 F.

Supp. 2d 62, 2010 U.S. Dist. LEXIS 2836 (D.D.C., 2010)

COUNSEL: Alisa B. Klein, Attorney, U.S. Department

of Justice, argued the cause for appellants. With her on

the briefs were Ronald C. Machen, Jr., U.S. Attorney,

Mark B. Stern and Samantha L. Chaifetz, Attorneys,

Ralph S. Tyler, Chief Counsel, United States Department

of Health and Human Services, Eric M. Blumberg, Dep-

uty Chief Counsel, and Karen E. Schifter, Associate

Chief Counsel. Drake S. Cutini, Attorney, U.S. Depart-

ment of Justice, entered an appearance.

William B. Schultz was on the brief for amici curiae

American Academy of Pediatrics, et al. in support of

appellants.

Gregory G. Garre argued the cause for appellee Sottera,

Inc. With him on the brief were Richard P. Bress, John

R. Manthei, and Jessica E. Phillips.

Deborah M. Shelton and Christopher M. Loveland were

on the brief for amici curiae Smokefree Pennsylvania, et

al. in support of appellee.

Daniel J. Popeo, Richard A. Samp, Coleen E. Klasmeier,

and Rebecca K. Wood were on the brief for amicus curi-

ae Washington Legal Foundation in support of appellee.

JUDGES: Before: GARLAND and KAVANAUGH,

Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge

WILLIAMS. Opinion concurring in the judgment filed

by Circuit Judge GARLAND.

OPINION BY: WILLIAMS

OPINION

[*892] [**258] WILLIAMS, Senior Circuit

Judge: Sottera, Inc., which does business as NJOY, is an

importer and distributor of "electronic cigarettes" or

"e-cigarettes," a product that enables users to inhale va-

porized nicotine. The question before us is whether Con-

gress has authorized the Food and Drug Administration

("FDA") to regulate e-cigarettes under the drug/device

provisions of the Federal Food, Drug, and Cosmetic Act

("FDCA"), 21 U.S.C. § 351 et seq., or under the Family

Smoking Prevention and Tobacco Control Act of 2009

(the "Tobacco Act"), Pub. L. 111-31, 123 Stat. 1776. We

think that the statutes, properly read in light of the Su-

preme Court's decision in FDA v. Brown & Williamson,

529 U.S. 120, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000),

locate the product under the Tobacco Act.

* * *

[*893] [**259] Electronic cigarettes are bat-

tery-powered products that allow users to inhale nicotine

vapor without fire, smoke, ash, or carbon monoxide.

NJOY Compl. at 2. Designed to look like a traditional

cigarette, each e-cigarette consists of three parts: the nic-

otine cartridge, the atomizer or heating element, and the

battery and electronics. The plastic cartridge serves as

the mouthpiece and contains liquid nicotine, water, pro-

pylene glycol, and glycerol. Id. at 5. The atomizer va-

porizes the liquid nicotine, and the battery and electron-

ics power the atomizer and monitor air flow. Id. When

the user inhales, the electronics detect the air flow and

activate the atomizer; the liquid nicotine is vaporized,

and the user inhales the vapor. Id.

NJOY has imported and distributed e-cigarettes

since 2007. Id. at 2, 4. The liquid nicotine in each

e-cigarette is derived from natural tobacco plants, Decl.

Page 2

of John Leadbeater at 2, and NJOY claims that its prod-

uct is marketed and labeled for "smoking pleasure," ra-

ther than as a therapeutic or smoking cessation product.

NJOY Compl. at 2; Decl. of John Leadbeater at 2. On

April 15, 2009 the FDA ordered that a shipment of

NJOY's e-cigarettes be denied entry into the United

States, asserting that the e-cigarettes appeared to be

adulterated, misbranded, or unapproved drug-device

combinations under the FDCA. April 20, 2009 Notice of

FDA Action.

Also in April 2009, another importer and distributor

of e-cigarettes, Smoking Everywhere, Inc., sought a pre-

liminary injunction barring the FDA and various officials

from denying their products entry into the United States

and from regulating e-cigarettes under the drug/device

provisions of the FDCA. Smoking Everywhere Compl. at

1-2, 7. NJOY joined as an intervenor-plaintiff and filed

its own complaint and request for a preliminary injunc-

tion. NJOY Compl. at 3; Mem. Op. at 7.

Smoking Everywhere and NJOY argued that the

FDA can regulate electronic cigarettes, as they propose

to market them, only under the Tobacco Act, claiming

that the Supreme Court's opinion in Brown & Williamson

foreclosed FDCA drug/device jurisdiction over tobacco

products marketed without claims of therapeutic effect.

The district court agreed and granted the injunction.

While this appeal was pending, Smoking Everywhere

voluntarily dismissed its complaint against the FDA,

leaving NJOY as the sole appellee. See NJOY Br. at 4.

When deciding whether to grant a preliminary in-

junction, a district court must consider four familiar fac-

tors: whether "(1) the plaintiff has a substantial likeli-

hood of success on the merits; (2) the plaintiff would

suffer irreparable injury were an injunction not granted;

(3) an injunction would substantially injure other inter-

ested parties; and (4) the grant of an injunction would

further the public interest." Ark. Dairy Co-op Ass'n, Inc.

v. U.S. Dep't of Agric., 573 F.3d 815, 821, 387 U.S. App.

D.C. 346 (D.C. Cir. 2009) (citing Serono Labs., Inc. v.

Shalala, 158 F.3d 1313, 1317-18, 332 U.S. App. D.C.

407 (D.C. Cir. 1998)). We review the district court's

weighing of these factors under an abuse of discretion

standard, but review questions of law de novo. Id.; see

also Davis v. Pension Benefit Guarantee Corp., 571 F.3d

1288, 1291, 387 U.S. App. D.C. 205 (D.C. Cir. 2009).

* * *

Under the FDCA, the FDA has authority to regulate

articles that are "drugs," "devices," or drug/device com-

binations. 21 U.S.C. § 321(g)(1) defines drugs to include

(B) articles intended for use in the di-

agnosis, cure, mitigation, treatment, or

prevention of disease in man or other an-

imals; and (C) articles (other than [*894]

[**260] food) intended to affect the

structure or any function of the body of

man or other animals.

21 U.S.C. § 321(g)(1)(B) & (C). The statute defines de-

vices similarly, see 21 U.S.C. § 321(h)(2) & (3); products

that are "combination[s] of a drug, device, or biological

product" are regulated as combination products, see 21

U.S.C. § 353(g)(1).

Until 1996, the FDA had never attempted to regulate

tobacco products under the FDCA (with one exception,

irrelevant for reasons discussed below) unless they were

sold for therapeutic uses, that is, for use in the "diagno-

sis, cure, mitigation, treatment, or prevention of disease"

under § 321(g)(1)(B). Cf. Action on Smoking and Health

v. Harris, 655 F.2d 236, 210 U.S. App. D.C. 123 (D.C.

Cir. 1980). But in that year, the FDA changed its

long-held position, promulgating regulations affecting

tobacco products as customarily marketed, i.e., ones sold

without therapeutic claims. See Regulations Restricting

the Sale and Distribution of Cigarettes and Smokeless

Tobacco to Protect Children and Adolescents, 61 Fed.

Reg. 44,396 (Aug. 28, 1996). The agency asserted that

nicotine is a drug that affects the structure or function of

the body under § 321(g)(1)(C) and that cigarettes and

smokeless tobacco were therefore drug/device combina-

tions falling under the FDA's regulatory purview, even

absent therapeutic claims. See 61 Fed. Reg. at 44,397,

44,400.

In FDA v. Brown & Williamson, the Supreme Court

rejected the FDA's claimed FDCA authority to regulate

tobacco products as customarily marketed. Looking to

the FDCA's "overall regulatory scheme," the "tobac-

co-specific legislation" enacted since the FDCA, and the

FDA's own frequently asserted position, it held that

Congress had "ratified . . . the FDA's plain and resolute

position that the FDCA gives the agency no authority to

regulate tobacco products as customarily marketed." 529

U.S. at 126, 159.

To fill the regulatory gap identified in Brown & Wil-

liamson, Congress in 2009 passed the Tobacco Act, Pub.

L. No. 111-31, 123 Stat. 1776, 21 U.S.C. §§ 387 et seq.,

providing the FDA with authority to regulate tobacco

products. The act defines tobacco products so as to in-

clude all consumption products derived from tobacco

except articles that qualify as drugs, devices, or

drug-device combinations under the FDCA:

(rr) (1) The term "tobacco product"

means any product made or derived from

tobacco that is intended for human con-

Page 3

sumption, including any component, part,

or accessory of a tobacco product . . .

(2) The term "tobacco product" does

not mean an article that is a drug under

[the FDCA's drug provision], a device

under [the FDCA's device provision], or a

combination product described in [the

FDCA's combination product provision].

21 U.S.C. § 321(rr).

The Tobacco Act itself states that it does not "affect,

expand, or limit" the FDA's jurisdiction to regulate

products under the drug/device provisions of the FDCA,

21 U.S.C. § 387a(c)(1), and the district court and parties

themselves appear to agree that the Tobacco Act did not

expand the category of drugs, devices, and combination

products subject to FDCA jurisdiction in the wake of

Brown & Williamson. See Mem Op. 9 n.4. The question

before us, therefore, is whether the FDA can regulate

electronic cigarettes under the FDCA's drug/device pro-

visions or whether it can regulate them only under the

Tobacco Act's provisions.

The FDA at one point argues that its decision to

regulate electronic cigarettes under the FDCA's

drug/device provisions [*895] [**261] is entitled to

Chevron deference. See Chevron U.S.A. Inc. v. Nat. Res.

Def. Council, Inc., 467 U.S. 837, 104 S. Ct. 2778, 81 L.

Ed. 2d 694 (1984). FDA Br. at 20. But in fact the case

does not turn on matters of statutory interpretation. Ra-

ther, as the FDA itself argues, the Tobacco Act did not

alter the FDA's authority under the FDCA. FDA Br. at

19; FDA Reply Br. at 21. And with respect to tobacco

products, the breadth of that authority is governed by the

Supreme Court's decision in Brown & Williamson. We

therefore turn to that case.

* * *

In Brown & Williamson the Supreme Court ad-

dressed the FDA's regulation of cigarettes and smokeless

tobacco products under the FDCA. It began by noting

that the FDCA seeks to ensure that the FDA will approve

products only if they are safe and effective for their in-

tended use. 529 U.S. at 133. Yet the FDA had itself

found that tobacco products are "unsafe," "dangerous,"

and "cause great pain and suffering from illness." Id. at

134 (quoting 61 Fed. Reg. 44,412). If tobacco products

were drug/device combinations under the FDCA, the

FDA would have no choice but to ban them. Id. at 135.

Clearly that could not be the case, the Court rea-

soned. After all, Congress had declared, in a provision of

the U.S. Code then in force, that tobacco was "one of the

greatest basic industries of the United States," id. at 137

(quoting 7 U.S.C. § 1311(a)), and it had also passed six

separate statutes relating to tobacco since 1965. Id. at

137-38. See Federal Cigarette Labeling and Advertising

Act, Pub. L. 89-92, 79 Stat. 282; Public Health Cigarette

Smoking Act of 1969, Pub. L. 91-222, 84 Stat. 87; Al-

cohol and Drug Abuse Amendments of 1983, Pub. L.

98-24, 97 Stat. 175; Comprehensive Smoking Education

Act, Pub. L. 98-474, 98 Stat. 2200; Comprehensive

Smokeless Tobacco Health Education Act of 1986, Pub.

L. 99-252, 100 Stat. 30; Alcohol, Drug Abuse, and Men-

tal Health Administration Reorganization Act, Pub. L.

102-321, § 202, 106 Stat. 394. Finally, citing its decision

in MCI Telecommunications Corp. v. AT&T Co., 512

U.S. 218, 114 S. Ct. 2223, 129 L. Ed. 2d 182 (1994), the

Court noted that "Congress could not have intended to

delegate a decision of such economic and political sig-

nificance to an agency in so cryptic a fashion." Brown &

Williamson, 529 U.S. at 160. So the Court held that the

FDA's claim of FDCA jurisdiction failed.

For our purposes, the central question is whether

Brown & Williamson's reading of the FDA's authority

under the drug/device provisions of the FDCA applies

only to tobacco products for which Congress has passed

specific regulatory statutes or whether it extends to all

tobacco products as customarily marketed. The FDA

argues that Brown & Williamson takes a statute-specific

approach, excluding the FDA from regulating only those

tobacco products that at the time of Brown & Williamson

had been the subject of specific federal legislation. FDA

Br. at 14. Though Brown & Williamson is not crystal

clear, we think the better reading is that the FDA lacks

FDCA drug/device authority to regulate all tobacco

products marketed without claims of therapeutic effect,

i.e., as customarily marketed.

Brown & Williamson's focus was not on the particu-

lar products that the six statutes cover or even on the six

statutes themselves; at no point did it quote the precise

language in which the six statutes identified covered

products. Rather, Brown & Williamson considered the

context of each statute to show that Congress was ac-

tively thinking about "the tobacco [*896] [**262]

problem. " 529 U.S. at 145. In situating the statutes,

Brown & Williamson found that "[i]n adopting each stat-

ute, Congress has acted against the backdrop of the

FDA's consistent and repeated statements that it lacked

authority under the FDCA to regulate tobacco absent

claims of therapeutic benefit by the manufacturer." Id. at

144.

Brown & Williamson concentrated overwhelmingly

on the unifying theme of historic FDA policy towards

tobacco products--a policy that it saw as undifferentiated

except with regard to the presence or absence of claims

of therapeutic effect. See, e.g., id. at 145 ("[T]obacco

marketed for chewing or smoking without accompanying

Page 4

therapeutic claims, does not meet the definitions in the

Food, Drug, and Cosmetic Act..." (citing Letter to Di-

rectors of Bureaus, Divisions and Directors of Districts

from FDA Bureau of Enforcement (May 24, 1963))); id.

at 146 ("In the 73 years since the enactment of the origi-

nal Food and Drug Act, and in the 41 years since the

promulgation of the modern Food, Drug, and Cosmetic

Act, the FDA has repeatedly informed Congress that

cigarettes are beyond the scope of the statute absent

health claims establishing a therapeutic intent on behalf

of the manufacturer or vendor" (citing Brief for Appellee

(FDA) in Action on Smoking and Health v. Harris, 655

F.2d 236, 210 U.S. App. D.C. 123 (D.C. Cir. 1980))); id.

at 146 (noting that the FDA's predecessor agency, the

Bureau of Chemistry, stated it lacked authority to regu-

late tobacco products absent therapeutic claims); id. at

155 (quoting the FDA's General Counsel as defining

regulatory scope over tobacco products based on thera-

peutic purpose); id. at 158 (citing the FDA Deputy

Commissioner stating that FDA's jurisdiction was limited

to tobacco products bearing "drug claims"); id. at 158

(citing the Commissioner of the FDA stating that FDA's

jurisdiction was limited to tobacco products bearing

"health claims").

Moreover, discussing the record before Congress in

the period when it passed these six statutes, Brown &

Williamson noted that Congress knew of both "the ad-

verse health consequences of tobacco use" and of "nico-

tine's pharmacological effects." Id. at 138. Nonetheless,

Congress "considered and rejected bills that would have

granted the FDA" jurisdiction over tobacco products. Id.

at 144.

In this light, Brown & Williamson interprets the six

statutes not as a particular carve-out from the FDCA for

cigarettes and smokeless tobacco (plus any additional

products covered in the six statutes, which the FDA

briefs make no effort to itemize), but rather as "a distinct

regulatory scheme to address the problem of tobacco and

health"--one that Congress intended would "preclude[]

any role for the FDA" with respect to "tobacco absent

claims of therapeutic benefit by the manufacturer." Id. In

doing so, Congress also "persistently acted to preclude a

meaningful role for any administrative agency in making

policy on the subject of tobacco and health." Id. at 156.

As customarily marketed, tobacco products were to re-

main the province of Congress.

Reflecting on the history and structure of tobacco

regulation, Brown & Williamson concluded,

Congress has affirmatively acted to

address the issue of tobacco and health,

relying on the representations of the FDA

that it had no authority to regulate tobac-

co. It has created a distinct scheme to reg-

ulate the sale of tobacco products, focused

on labeling and advertising, and premised

on the belief that the FDA lacks such ju-

risdiction under [*897] [**263] the

FDCA. As a result, Congress' tobac-

co-specific statutes preclude the FDA

from regulating tobacco products as cus-

tomarily marketed.

Id. at 156.

Brown & Williamson therefore did not preclude the

FDA from regulating only those products for which

Congress had passed specific statutes. Rather, it recog-

nized that Congress had consciously developed a statu-

tory scheme for tobacco and health that distinguished

tobacco products as customarily marketed from ones

marketed for therapeutic purposes. "Thus, what Congress

ratified was the FDA's plain and resolute position that the

FDCA gives the agency no authority to regulate tobacco

products as customarily marketed." Id. at 159.

At oral argument the FDA observed with some jus-

tice that the regulatory scheme before the Court in Brown

& Williamson addressed only cigarettes and smokeless

tobacco; it would have us infer that the Court used the

incessantly repeated phrase "tobacco products" as a

shorthand, confined to the products before the Court

(supplemented by whatever additional products were

reached by the six statutes). We find no evidence of any

such restrictive intent; certainly the Court did not use the

familiar economizing form: "cigarettes and smokeless

tobacco ('tobacco products')."

The Tobacco Act is wholly consistent with this

reading of Brown & Williamson. Written to address the

regulatory gap that the case identified, the Tobacco Act

provides the FDA with regulatory authority over tobacco

products without requiring therapeutic claims. Besides

leaving the FDA's authority under the drug/device provi-

sions of the FDCA undisturbed, see 21 U.S.C. §

321(rr)(2) & § 387a(c)(1), the act broadly defines to-

bacco products as extending to "any product made or

derived from tobacco," 21 U.S.C. § 321(rr)(1) (emphasis

added). To be sure, this definition could align with a va-

riety of interpretations of Brown & Williamson's scope

(including the one FDA proffers here), but our reading is

squarely within that range.

The FDA responds that its treatment of the Favor

Smokeless Cigarette in 1987 supports its reading of

Brown & Williamson. FDA Br. at 14-15. We think not.

Favor was a small tube containing a nicotine solution,

enabling the user to inhale nicotine vapor without smoke.

Id. at 14. Though the Smokeless Cigarette was marketed

without therapeutic claims, the FDA warned Favor that it

Page 5

was an unapproved new drug. Id. at 14-15. The FDA's

claimed authority over Favor was, however, never chal-

lenged or adjudicated in court. Nor did Brown & Wil-

liamson address the Smokeless Cigarette, perhaps be-

cause neither side brought it before the Court (perhaps in

turn because the individuals litigating the case were un-

aware of it). In its argument in Brown & Williamson, the

FDA stated that "the only instances in which the agency

had found that tobacco products were drugs involved

cases in which there were express market claims of ther-

apeutic value." Pet'rs' Br., FDA v. Brown & Williamson,

529 U.S. 120, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000)

(No. 98-1152), 1999 WL 503874 at *37 (emphasis add-

ed). In fact, one of the FDA's arguments in Brown &

Williamson was that the agency was "free to change its

position" as long as it provided a reasoned justification

for the change. 529 U.S. 120, Id. at *38 (emphasis add-

ed). And that would likely have been true--but for the

Court's conclusion that Congress had ratified what the

Court understood as the FDA's invariable exclusion of

tobacco products made without claims of therapeutic

effect.

[*898] [**264] The FDA has also offered a

consequentialist argument, namely, that understanding

Brown & Williamson in this fashion leaves the FDA se-

verely thwarted in any effort to nudge e-cigarettes to-

ward relatively healthful forms (or at least away from

relatively unhealthful ones). Whether such a consequen-

tialist argument should play any role in our interpretation

of Brown & Williamson is questionable, but no matter. In

fact the Tobacco Act gives the FDA broad regulatory

authority over tobacco products, including, for instance,

authority to impose restrictions on their sale, and on the

advertising and promotion of such products, see 21

U.S.C. § 387f(d), to regulate the mode of manufacture of

tobacco products, see id. § 387f(e), and to establish

standards for tobacco products, see id. § 387g. To the

extent that Congress believed Brown & Williamson left

an insufficiently regulative environment for cigarettes,

smokeless tobacco, cigars, and other tobacco products, it

found the Tobacco Act an adequate remedy.

Together, Brown & Williamson and the Tobacco Act

establish that the FDA cannot regulate customarily mar-

keted [*899] tobacco products under the FDCA's

drug/device provisions, that it can regulate tobacco

products marketed for therapeutic purposes under those

provisions, and that it can regulate customarily marketed

tobacco products under the Tobacco Act.

* * *

As to NJOY's likelihood of success on the merits,

the firm claims that its electronic cigarettes use a liquid

nicotine mixture derived from tobacco and that its prod-

ucts are not marketed for therapeutic uses, NJOY Compl.

at 5; Decl. of John Leadbeater at 2; the FDA appears not

to challenge either claim. Still, the district court noted

that the factual record on NJOY is meager and that the

FDA may establish that NJOY does in fact make thera-

peutic claims regarding its electronic cigarettes. Mem.

Op. at 25 n. 17. Until such time, the definitional line laid

down in Brown & Williamson (as we understand it)

leaves the FDA without jurisdiction over these products

under the FDCA's drug/device provisions. On the merits,

then, NJOY is likely to succeed.

We also find that the district court did not abuse its

discretion in finding that the balance of harms tips to-

ward NJOY. In showing irreparable harm, the injury to

the party must "be both certain and great; it must be ac-

tual and not theoretical." Wisconsin Gas Co. v. FERC,

758 F.2d 669, 674, 244 U.S. App. D.C. 349 (D.C. Cir.

1985). The FDA's refusal to admit NJOY's products into

the United States obviously destroyed the firm's ability in

the United States to cover its costs for purchase or pro-

duction of e-cigarettes. The district court's finding that

this loss would be irreparable absent an injunction ap-

pears entirely reasonable. Mem. Op. at 29. Regarding

harm to third parties and to the public interest, the district

court observed that the FDA had cited no evidence to

show that electronic cigarettes harmed anyone. Id. at 30.

More significantly, the court rightly found that the FDA

has authority under the Tobacco Act to regulate elec-

tronic cigarettes, enabling it to mitigate or perhaps ex-

tinguish any harm to public health. Id. at 31. Given the

likelihood of NJOY's success on the merits, the irrepara-

ble harm to NJOY's business, and the FDA's unques-

tioned Tobacco Act authority to mitigate any public

harm, the district court did not abuse its discretion in

granting the preliminary injunction.

* * *

As we have already noted, the FDA has authority to

regulate customarily marketed tobacco prod-

ucts--including e-cigarettes--under the Tobacco Act. It

has authority to regulate therapeutically marketed

[**265] tobacco products under the FDCA's

drug/device provisions. And, as this decision is limited to

tobacco products, it does not affect the FDA's ability to

regulate other products under the "structure or any func-

tion" prong defining drugs and devices in 21 U.S.C.§ 321

(g) and (h), as to the scope of which--tobacco products

aside--we express no opinion. Of course, in the event that

Congress prefers that the FDA regulate e-cigarettes un-

der the FDCA's drug/device provisions, it can always so

decree.

The judgment of the district court is

Affirmed.

CONCUR BY: GARLAND

Page 6

CONCUR

GARLAND, Circuit Judge, concurring in the judg-

ment: Although I join my colleagues in the disposition of

this case, I do so based on different reasoning. I do not

read FDA v. Brown & Williamson, 529 U.S. 120, 120 S.

Ct. 1291, 146 L. Ed. 2d 121 (2000), as barring the FDA

from regulating "electronic cigarettes" under the Food,

Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et

seq., because I do not believe the Supreme Court intend-

ed its use of the term "tobacco products" to extend to

products that do not contain tobacco. The Tobacco Con-

trol Act of 2009, Pub. L. No. 111-31, 123 Stat. 1776,

however, expressly extends to products that are merely

"derived from" tobacco. Accordingly, at least in the ab-

sence of a contrary agency interpretation entitled to

Chevron deference, I read the Tobacco Control Act as

requiring the FDA to regulate products like electronic

cigarettes under that Act, rather than under the FDCA.

I

In Brown & Williamson, the Supreme Court held

that the FDA lacks authority to regulate "tobacco prod-

ucts" under the drug/device provisions of the FDCA,

unless those products are marketed with therapeutic

claims. 529 U.S. at 144, 158-59. On its face, the natural

meaning of the term "tobacco product" is a product --

like cigarettes or chewing tobacco -- that contains to-

bacco. Although it is true that the liquid nicotine in

NJOY's electronic cigarettes is derived from tobacco, it

seems less natural to regard that fact as sufficient to

transform NJOY's plastic cartridges -- which contain no

tobacco -- into a tobacco product. As NJOY acknowl-

edges, its reading leads to the counterintuitive conclusion

that a syringe filled with injectable nicotine is a tobacco

product as well. Oral Argument Tr. 40-41.

On many, although not all, occasions on which

Brown & Williamson used the term "tobacco products,"

the Court coupled it with an express reference to tobacco

or to products that plainly contain tobacco. 1 At [*900]

[**266] no point did the Court state that the FDA was

barred from regulating "nicotine" (or a product contain-

ing nicotine but not tobacco) under the FDCA. Thus, the

most straightforward reading of the term "tobacco prod-

ucts" is as short-hand for products that contain tobacco.

Compare 529 U.S. at 155 (describing several congres-

sional statutes as "creating a distinct regulatory scheme

for cigarettes and smokeless tobacco"), with id. at 159

(describing the same statutes as "creat[ing] a distinct

regulatory scheme for tobacco products") (emphases

added).

1 See, e.g., 529 U.S. at 126, 127, 128, 129 (us-

ing the term "tobacco products" in reference to

the FDA's rule concerning the sale of "cigarettes

and smokeless tobacco"); id. at 129 (describing

that rule -- which was limited to cigarettes and

smokeless tobacco -- as requiring that a specified

statement appear on "all tobacco product packag-

es"); id. at 134 (noting that the FDA had found

"tobacco products" to cause "tobacco-related ill-

nesses, such as cancer, respiratory illnesses, and

heart disease" -- illnesses that the FDA associated

with tobacco, not nicotine); id. at 142 (noting that

"tobacco products" cannot "be safe within the

meaning of the FDCA" because, "[a]s the FDA

has documented in great detail, cigarettes and

smokeless tobacco are an unsafe means to ob-

taining any pharmacological effect"); id. at 145

(describing the FDA's 1964 testimony that it

lacked authority to label cigarette packages as

testimony that it lacked jurisdiction to regulate

"tobacco products"); id. at 146 (citing, in support

of the proposition that the FDA had never before

"asserted authority to regulate tobacco products

as customarily marketed," the fact that the "FDA

has repeatedly informed Congress that cigarettes

are beyond the scope of the statute absent health

claims").

This reading is consistent with the context in which

the Court decided Brown & Williamson. In that case, the

Court upheld a challenge to a 1996 FDA rule asserting

authority to regulate the sale of cigarettes and smokeless

tobacco under the FDCA. 529 U.S. at 126-30 (citing

Regulations Restricting the Sale and Distribution of

Cigarettes and Smokeless Tobacco to Protect Children

and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996)).

Because all of the products at issue in the rule contained

tobacco, the Court had no occasion to opine upon the

FDA's authority to regulate a product, like electronic

cigarettes, that does not. Indeed, although a product in-

distinguishable from electronic cigarettes had been in-

troduced some ten years earlier -- the "Favor Smokeless

Cigarette," which consisted of a small tube containing an

inhalable nicotine solution -- there is no indication in

Brown & Williamson that the Court had ever heard of it.

(The FDA had asserted authority to regulate Favor in

1987, notwithstanding that it was marketed without

therapeutic claims. Regulatory Letter from FDA to Ad-

vanced Tobacco Prods. Inc. (Feb. 9, 1987) (J.A.

425-26)).

But the most telling indication that the holding of

Brown & Williamson does not extend to electronic ciga-

rettes is that the Court's reasoning does not apply to

products that do not contain tobacco. The Supreme

Court's chief rationale for its holding had two premises.

First, the Court determined that, "if tobacco products

were 'devices' under the FDCA, the FDA would be re-

Page 7

quired to remove them from the market." 529 U.S. at

135. It reached this conclusion because the FDA may

only approve a product for marketing under the FDCA if

it is safe and effective for its intended use, and the FDA

had "exhaustively documented" that tobacco products are

unsafe for any pharmacological use. Id. at 133-35. Sec-

ond, the Court found that Congress had "foreclosed the

removal of tobacco products from the market" through

"tobacco-specific legislation" passed subsequent to the

FDCA. Id. at 137, 143. Thus, the Court concluded: "If

they cannot be used safely for any therapeutic purpose,

and yet they cannot be banned, they simply do not fit"

within the FDCA's regulatory scheme. Id. at 143.

Neither premise holds true for pure nicotine or for a

tobacco-free product that delivers nicotine. First, unlike

products containing tobacco, which the FDA has found

to be associated with "cancer, respiratory illnesses, and

heart disease," 529 U.S. at 134-35, the FDA has not

found that nicotine or tobacco-free products that deliver

nicotine are inherently unsafe. To the contrary, the FDA

has approved several such products marketed with ther-

apeutic claims, determining that they satisfy the FDCA

safety requirements that Brown & Williamson deter-

mined "tobacco products" could not meet. See FDA Br.

16 (noting that the FDA has [*901] [**267] ap-

proved nicotine gums and transdermal patches). Indeed,

the FDA states that "it may well be possible for a manu-

facturer of 'electronic cigarettes' . . . to satisfy the

FDCA's safety, effectiveness, and labeling requirements

and obtain FDA approval." Id.

Second, the "tobacco-specific legislation" the Court

found dispositive in Brown & Williamson simply does

not address products that deliver nicotine but contain no

tobacco. As the Court explained, Congress had "directly

addressed the problem of tobacco and health through

legislation on six occasions since 1965." 529 U.S. at 137. 2 Those statutes impose labeling and advertising re-

quirements that "create a distinct regulatory scheme for

cigarettes and smokeless tobacco." Id. at 155; see id. at

143-44, 148-49. Moreover, Congress has declared that

"[t]he marketing of tobacco constitutes one of the great-

est basic industries of the United States," id. at 137

(quoting 7 U.S.C. § 1311(a)), making it "highly unlikely"

that the legislature would have subjected the industry to a

regulatory regime that could substantially or entirely shut

it down, id. at 160. "[T]he collective premise of these

statutes," the Court said, is "that cigarettes and smokeless

tobacco will continue to be sold in the United States." Id.

at 139.

2 The Court listed the following six statutes:

"Federal Cigarette Labeling and Advertising Act

(FCLAA), Pub. L. 89-92, 79 Stat. 282; Public

Health Cigarette Smoking Act of 1969, Pub. L.

91-222, 84 Stat. 87; Alcohol and Drug Abuse

Amendments of 1983, Pub. L. 98-24, 97 Stat.

175; Comprehensive Smoking Education Act,

Pub. L. 98-474, 98 Stat. 2200; Comprehensive

Smokeless Tobacco Health Education Act of

1986, Pub. L. 99-252, 100 Stat. 30; Alcohol,

Drug Abuse, and Mental Health Administration

Reorganization Act, Pub. L. 102-321, § 202, 106

Stat. 394." 529 U.S. at 137-38.

This "collective premise" does not extend to prod-

ucts, like electronic cigarettes, that contain only nicotine.

None of the statutes the Court referenced regulate such

products, and the statutory labeling requirements and

advertising restrictions the Court cited do not apply to

electronic cigarettes. See FDA Br. 10, 13-14. Nor can it

be said that FDA regulation of a novel product like elec-

tronic cigarettes would threaten the health of the Ameri-

can tobacco industry. As NJOY avers, it "imports one

hundred percent of its supply of E-cigarettes from over-

seas manufacturers, and, upon information and belief,

there is no domestic manufacturer of E-cigarettes or their

component parts." NJOY Compl. ¶ 18 (J.A. 40).

Finally, the Brown & Williamson Court also noted

that, "[i]n adopting each statute, Congress . . . acted

against the backdrop of the FDA's consistent and repeat-

ed statements that it lacked authority under the FDCA to

regulate tobacco absent claims of therapeutic benefit by

the manufacturer." 529 U.S. at 144 (emphasis added).

"Under these circumstances," the Court concluded, "it is

evident that Congress' tobacco-specific statutes . . . ef-

fectively ratified the FDA's long-held position that it

lacks jurisdiction under the FDCA to regulate tobacco

products." Id. (emphasis added). But the backdrop of

pre-1996 statements to which the Court referred did not

include statements that the FDA lacked authority over a

product like nicotine, which is merely derived from to-

bacco. Rather, as the Court's citations make clear, the

FDA's statements to Congress referred to its lack of ju-

risdiction either over "tobacco," id. at 145, or over spe-

cific products that plainly contain tobacco, like ciga-

rettes, id. at 145-46. See, e.g., id. at 145 (citing FDA

statement that "[t]obacco marketed for [*902]

[**268] chewing or smoking without accompanying

therapeutic claims, does not meet the definitions . . . for

food, drug, device or cosmetic" in the FDCA). And in

fact, as noted above, in 1987 the FDA had asserted au-

thority to regulate a product that is materially indistin-

guishable from electronic cigarettes -- the Favor Smoke-

less Cigarette -- apparently without challenge.

In sum, I see nothing in the words, context, or ra-

tionale of Brown & Williamson that supports interpreting

that case as barring the FDA from regulating electronic

cigarettes under the drug/device provisions of the FDCA.

Although I agree with my colleagues that these consider-

Page 8

ations do not justify reading Brown & Williamson as

merely a "carve-out from the FDCA for cigarettes and

smokeless tobacco," Slip Op. at 10, they do justify read-

ing it as a carve-out only for products that contain to-

bacco. See 529 U.S. at 144 (holding that Congress in-

tended to "preclude[] any role for the FDA" with respect

to "tobacco absent claims of therapeutic benefit" (em-

phasis added)). The Supreme Court had no reason to

opine on the status of a product that contains no tobacco,

and there is no indication in the opinion that it meant to

do so. As my colleagues' opinion rests on the supposition

that it did, I cannot join their rationale.

II

But Brown & Williamson is not the end of the story.

In 2009, Congress passed the Tobacco Control Act,

which states: "Tobacco products . . . shall be regulated

by the Secretary under this [Act] and shall not be subject

to the provisions of [the drug/device subchapter of the

FDCA]." 21 U.S.C. § 387a(a). Moreover, unlike Brown

& Williamson, which used the term "tobacco products"

without defining it, the Tobacco Control Act includes a

definition: "The term 'tobacco product' means any prod-

uct made or derived from tobacco that is intended for

human consumption." 21 U.S.C. § 321(rr)(1) (emphasis

added). Because the nicotine in NJOY's electronic ciga-

rettes is "derived from" natural tobacco, NJOY Compl. ¶

1, it appears that the FDA may regulate it only pursuant

to the provisions of the Tobacco Control Act.

The FDA disagrees with this conclusion, contending

that the Tobacco Control Act does not narrow the FDA's

preexisting authority under the FDCA. In support, agen-

cy counsel cites another definitional provision of the

Tobacco Control Act, which states that "[t]he term 'to-

bacco product' does not mean an article that is a drug . . .,

a device . . ., or a combination product" under the FDCA.

21 U.S.C. § 321(rr)(2). In the FDA's view, this provision

preserves for regulation under the FDCA any product

"made or derived from tobacco" that Brown & William-

son did not carve out of the FDCA's coverage. And be-

cause Brown & Williamson's carve-out did not extend to

nicotine-only products, the agency maintains that such

products are not necessarily "tobacco products" within

the meaning of the Tobacco Control Act. 3

3 Like the FDA, NJOY reads § 321(rr)(2) as

leaving the boundary between tobacco products

and drugs where it was prior to the passage of the

Tobacco Control Act. However, because NJOY

reads Brown & Williamson as having removed

nicotine-only products from the FDCA's

drug/device authority, it concludes that such

products are "tobacco products" under the To-

bacco Control Act and so may not be regulated

under the FDCA.

There is no doubt that § 321(rr)(2) introduces a note

of ambiguity into the analysis. But it is a stretch to con-

clude that, having just used one express statutory subsec-

tion to include products "derived from" tobacco within

the definition of "tobacco product," § 321(rr)(1), Con-

gress [*903] [**269] then immediately employed

the next, ambiguous subsection to carve them out again.

Rather, it is more likely that § 321(rr)(2) is an expression

of Congress' intent to preserve Brown & Williamson's

holding that even a product made from tobacco -- for

example, a cigarette -- remains a drug, device, or

drug/device combination that can be regulated under the

FDCA if it is marketed for therapeutic purposes. Hence,

the better reading is that § 321(rr)(2) simply makes clear

that products made or derived from tobacco that are

marketed for therapeutic purposes are not "tobacco

products" within the meaning of the Tobacco Control

Act, and are therefore subject to regulation under the

drug/device provisions of the FDCA.

In the usual circumstance, of course, a judge's view

of the "better" reading of a statute administered by an

agency is not necessarily dispositive. "If a statute is am-

biguous, and if the implementing agency's construction is

reasonable, Chevron requires a federal court to accept the

agency's construction of the statute, even if the agency's

reading differs from what the court believes is the best

statutory interpretation." Nat'l Cable & Telecomms. Ass'n

v. Brand X Internet Servs., 545 U.S. 967, 980, 125 S. Ct.

2688, 162 L. Ed. 2d 820 (2005) (citing Chevron U.S.A.

Inc. v. NRDC, 467 U.S. 837, 843-44 & n.11, 104 S. Ct.

2778, 81 L. Ed. 2d 694 (1984)). In United States v. Mead

Corp., 533 U.S. 218, 121 S. Ct. 2164, 150 L. Ed. 2d 292

(2001), however, the Supreme Court held Chevron def-

erence appropriate only for statutory interpretations with

the "force of law," id. at 229, and ruled that an agency's

litigation briefs -- unlike, for example, its regulations --

do not warrant such deference, id. at 238 n.19. See also

Bowen v. Georgetown Univ. Hosp., 488 U.S. 204,

212-13, 109 S. Ct. 468, 102 L. Ed. 2d 493 (1988) (de-

clining to accord Chevron deference to "agency litigating

positions"); Landmark Legal Found. v. IRS, 267 F.3d

1132, 1135-36, 347 U.S. App. D.C. 370 (D.C. Cir. 2001)

(denying Chevron deference to an interpretation "devel-

oped in litigation"). 4

4 As the FDA observes, the Court has accorded

deference to briefs in which agencies interpret

their own regulations. See Auer v. Robbins, 519

U.S. 452, 117 S. Ct. 905, 137 L. Ed. 2d 79 (1997).

The Court, however, distinguishes between

agency interpretations of regulations and agency

interpretations of statutes. See Coeur Alaska, Inc.

Page 9

v. Southeast Alaska Conservation Council, 557

U.S. 261, 129 S. Ct. 2458, 2473, 174 L. Ed. 2d

193 (2009) (finding interpretive memo "not sub-

ject to sufficiently formal procedures to merit

Chevron deference" under Mead, but still entitled

to deference under Auer "because it interprets the

agencies' own regulatory scheme"); see also

Mead, 533 U.S. at 246 (Scalia, J., dissenting)

(noting and criticizing the distinction); John F.

Manning, Nonlegislative Rules, 72 Geo. Wash. L.

Rev. 893, 943-44 (2004) (observing that Mead

narrowed the range of agency statutory interpre-

tations that are entitled to Chevron deference,

while leaving "intact the related but freestanding

principle" of Auer deference).

In this case, there is no agency pronouncement that

calls for Chevron deference. Other than its briefs, which

do not qualify, the only expression of the FDA's view

regarding electronic cigarettes is the agency's 2008 de-

tention order barring the importation of NJOY's prod-

ucts. But that order was issued before Congress passed

the Tobacco Control Act in 2009 and hence does not

construe it at all. "Chevron being inapplicable here in

light of Mead, [the court] must decide for [itself] the best

reading" of the Act. Landmark Legal Found., 267 F.3d

at 1136. And the best reading is to give full effect to the

Tobacco Control Act's definition of "tobacco product" as

"any product made or derived from tobacco," 21 U.S.C. §

321(rr)(1), as well as to its injunction that "[t]obacco

products . . . [*904] [**270] shall be regulated"

under that Act and "shall not be subject to the provi-

sions" of the FDCA, 21 U.S.C. § 387a(a).

III

In the absence of an authoritative agency interpreta-

tion, I conclude that, unless a product derived from to-

bacco is marketed for therapeutic purposes, the FDA

may regulate it only under the provisions of the Tobacco

Control Act. Accordingly, because NJOY's electronic

cigarettes are derived from tobacco, I join my colleagues'

disposition. What the result would be were the FDA to

offer a contrary statutory interpretation in the form of a

regulation, I leave for the day the agency decides to take

that step.

21 USCS § 387

TITLE 21. FOOD AND DRUGS

CHAPTER 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT

TOBACCO PRODUCTS

*** Current through PL 113-74, with a gap of PL 113-73, approved 1/16/2014 ***

21 USCS § 387

§ 387. Definitions

In this chapter [21 USCS §§ 387 et seq.]:

(1) Additive. The term "additive" means any substance the intended use of which results or may reasonably be ex-

pected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any to-

bacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing,

packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include

tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.

(2) Brand. The term "brand" means a variety of tobacco product distinguished by the tobacco used, tar content, nico-

tine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of

colors, or any combination of such attributes.

(3) Cigarette. The term "cigarette"--

(A) means a product that--

(i) is a tobacco product; and

(ii) meets the definition of the term "cigarette" in section 3(1) of the Federal Cigarette Labeling and Advertis-

ing Act [15 USCS § 1332(1)]; and

(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of

tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a ciga-

rette or as roll-your-own tobacco.

(4) Cigarette tobacco. The term "cigarette tobacco" means any product that consists of loose tobacco that is intended

for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter

[21 USCS §§ 387 et seq.] shall also apply to cigarette tobacco.

(5) Commerce. The term "commerce" has the meaning given that term by section 3(2) of the Federal Cigarette La-

beling and Advertising Act [15 USCS § 1332(2)].

(6) Counterfeit tobacco product. The term "counterfeit tobacco product" means a tobacco product (or the container or

labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, im-

print, or device, or any likeness thereof, of a tobacco product listed in a registration under section 905(i)(1) [21 USCS §

387e(i)(1)].

(7) Distributor. The term "distributor" as regards a tobacco product means any person who furthers the distribution of

a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who

sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors

for purposes of this chapter [21 USCS §§ 387 et seq.].

(8) Illicit trade. The term "illicit trade" means any practice or conduct prohibited by law which relates to production,

shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct in-

tended to facilitate such activity.

(9) Indian country. The term "Indian country" has the meaning given such term in section 1151 of title 18, United

States Code.

(10) Indian tribe. The term "Indian tribe" has the meaning given such term in section 4(e) of the Indian

Self-Determination and Education Assistance Act [25 USCS § 450b(e)].

(11) Little cigar. The term "little cigar" means a product that--

(A) is a tobacco product; and

(B) meets the definition of the term "little cigar" in section 3(7) of the Federal Cigarette Labeling and Advertising

Act [15 USCS § 1332(7)].

(12) Nicotine. The term "nicotine" means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or

C[10]H[14]N[2], including any salt or complex of nicotine.

21 USCS § 387

(13) Package. The term "package" means a pack, box, carton, or container of any kind or, if no other container, any

wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to con-

sumers.

(14) Retailer. The term "retailer" means any person, government, or entity who sells tobacco products to individuals

for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted.

(15) Roll-your-own tobacco. The term "roll-your-own tobacco" means any tobacco product which, because of its

appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as

tobacco for making cigarettes.

(16) Small tobacco product manufacturer. The term "small tobacco product manufacturer" means a tobacco product

manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a man-

ufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each

entity that controls, is controlled by, or is under common control with such manufacturer.

(17) Smoke constituent. The term "smoke constituent" means any chemical or chemical compound in mainstream or

sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by

the combustion or heating of tobacco, additives, or other component of the tobacco product.

(18) Smokeless tobacco. The term "smokeless tobacco" means any tobacco product that consists of cut, ground,

powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.

(19) State; territory. The terms "State" and "Territory" shall have the meanings given to such terms in section 201 [21

USCS § 321].

(20) Tobacco product manufacturer. The term "tobacco product manufacturer" means any person, including any re-

packer or relabeler, who--

(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or

(B) imports a finished tobacco product for sale or distribution in the United States.

(21) Tobacco warehouse.

(A) Subject to subparagraphs (B) and (C), the term "tobacco warehouse" includes any person--

(i) who--

(I) removes foreign material from tobacco leaf through nothing other than a mechanical process;

(II) humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or

(III) de-stems, dries, and packs tobacco leaf for storage and shipment;

(ii) who performs no other actions with respect to tobacco leaf; and

(iii) who provides to any manufacturer to whom the person sells tobacco all information related to the person's

actions described in clause (i) that is necessary for compliance with this Act [21 USCS §§ 301 et seq.].

(B) The term "tobacco warehouse" excludes any person who--

(i) reconstitutes tobacco leaf;

(ii) is a manufacturer, distributor, or retailer of a tobacco product; or

(iii) applies any chemical, additive, or substance to the tobacco leaf other than potable water in the form of

steam or mist.

(C) The definition of the term "tobacco warehouse" in subparagraph (A) shall not apply to the extent to which the

Secretary determines, through rulemaking, that regulation under this chapter [21 USCS §§ 387 et seq.] of the actions

described in such subparagraph is appropriate for the protection of the public health.

(22) United States. The term "United States" means the 50 States of the United States of America and the District of

Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Is-

lands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the

United States.

HISTORY: (June 25, 1938, ch 675, Ch. IX, § 900, as added June 22, 2009, P.L. 111-31, Div A, Title I, § 101(b)(3), 123 Stat.

1784.)

21 USCS § 387

HISTORY; ANCILLARY LAWS AND DIRECTIVES

Other provisions:

Family Smoking Prevention and Tobacco Control Act; findings. Act June 22, 2009, P.L. 111-31, Div A, § 2, 123

Stat. 1776, provides:

"The Congress finds the following:

"(1) The use of tobacco products by the Nation's children is a pediatric disease of considerable proportions that

results in new generations of tobacco-dependent children and adults.

"(2) A consensus exists within the scientific and medical communities that tobacco products are inherently dan-

gerous and cause cancer, heart disease, and other serious adverse health effects.

"(3) Nicotine is an addictive drug.

"(4) Virtually all new users of tobacco products are under the minimum legal age to purchase such products.

"(5) Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products

by adolescents.

"(6) Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb

tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are

needed.

"(7) Federal and State governments have lacked the legal and regulatory authority and resources they need to ad-

dress comprehensively the public health and societal problems caused by the use of tobacco products.

"(8) Federal and State public health officials, the public health community, and the public at large recognize that

the tobacco industry should be subject to ongoing oversight.

"(9) Under article I, section 8 of the Constitution, the Congress is vested with the responsibility for regulating

interstate commerce and commerce with Indian tribes.

"(10) The sale, distribution, marketing, advertising, and use of tobacco products are activities in and substantially

affecting interstate commerce because they are sold, marketed, advertised, and distributed in interstate commerce on a

nationwide basis, and have a substantial effect on the Nation's economy.

"(11) The sale, distribution, marketing, advertising, and use of such products substantially affect interstate com-

merce through the health care and other costs attributable to the use of tobacco products.

"(12) It is in the public interest for Congress to enact legislation that provides the Food and Drug Administration

with the authority to regulate tobacco products and the advertising and promotion of such products. The benefits to the

American people from enacting such legislation would be significant in human and economic terms.

"(13) Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths

in the United States each year, and approximately 8,600,000 Americans have chronic illnesses related to smoking.

"(14) Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today's chil-

dren from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobac-

co-induced disease. Such a reduction in youth smoking would also result in approximately $ 75,000,000,000 in savings

attributable to reduced health care costs.

"(15) Advertising, marketing, and promotion of tobacco products have been especially directed to attract young

persons to use tobacco products, and these efforts have resulted in increased use of such products by youth. Past efforts

to oversee these activities have not been successful in adequately preventing such increased use.

"(16) In 2005, the cigarette manufacturers spent more than $ 13,000,000,000 to attract new users, retain current

users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use.

"(17) Tobacco product advertising often misleadingly portrays the use of tobacco as socially acceptable and

healthful to minors.

"(18) Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of

18 are regularly exposed to tobacco product promotional efforts.

"(19) Through advertisements during and sponsorship of sporting events, tobacco has become strongly associated

with sports and has become portrayed as an integral part of sports and the healthy lifestyle associated with rigorous

sporting activity.

"(20) Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about

tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the num-

ber of young people who begin to use tobacco.

21 USCS § 387

"(21) The use of tobacco products in motion pictures and other mass media glamorizes its use for young people

and encourages them to use tobacco products.

"(22) Tobacco advertising expands the size of the tobacco market by increasing consumption of tobacco products

including tobacco use by young people.

"(23) Children are more influenced by tobacco marketing than adults: more than 80 percent of youth smoke three

heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands.

"(24) Tobacco company documents indicate that young people are an important and often crucial segment of the

tobacco market. Children, who tend to be more price sensitive than adults, are influenced by advertising and promotion

practices that result in drastically reduced cigarette prices.

"(25) Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people.

"(26) Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from undermining leg-

islation prohibiting access to young people and providing for education about tobacco use.

"(27) International experience shows that advertising regulations that are stringent and comprehensive have a

greater impact on overall tobacco use and young people's use than weaker or less comprehensive ones.

"(28) Text only requirements, although not as stringent as a ban, will help reduce underage use of tobacco prod-

ucts while preserving the informational function of advertising.

"(29) It is in the public interest for Congress to adopt legislation to address the public health crisis created by ac-

tions of the tobacco industry.

"(30) The final regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996,

issue of the Federal Register (61 Fed. Reg. 44615-44618) for inclusion as part 897 of title 21, Code of Federal Regula-

tions, are consistent with the first amendment to the United States Constitution and with the standards set forth in the

amendments made by this subtitle for the regulation of tobacco products by the Food and Drug Administration, and the

restriction on the sale and distribution of, including access to and the advertising and promotion of, tobacco products

contained in such regulations are substantially related to accomplishing the public health goals of this division.

"(31) The regulations described in paragraph (30) will directly and materially advance the Federal Government's

substantial interest in reducing the number of children and adolescents who use cigarettes and smokeless tobacco and in

preventing the life-threatening health consequences associated with tobacco use. An overwhelming majority of Ameri-

cans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in

those products before reaching the age of 18. Tobacco advertising and promotion play a crucial role in the decision of

these minors to begin using tobacco products. Less restrictive and less comprehensive approaches have not and will not

be effective in reducing the problems addressed by such regulations. The reasonable restrictions on the advertising and

promotion of tobacco products contained in such regulations will lead to a significant decrease in the number of minors

using and becoming addicted to those products.

"(32) The regulations described in paragraph (30) impose no more extensive restrictions on communication by

tobacco manufacturers and sellers than are necessary to reduce the number of children and adolescents who use ciga-

rettes and smokeless tobacco and to prevent the life-threatening health consequences associated with tobacco use. Such

regulations are narrowly tailored to restrict those advertising and promotional practices which are most likely to be seen

or heard by youth and most likely to entice them into tobacco use, while affording tobacco manufacturers and sellers

ample opportunity to convey information about their products to adult consumers.

"(33) Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve

long-term or permanent abstinence.

"(34) Because the only known safe alternative to smoking is cessation, interventions should target all smokers to

help them quit completely.

"(35) Tobacco products have been used to facilitate and finance criminal activities both domestically and interna-

tionally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups.

"(36) It is essential that the Food and Drug Administration review products sold or distributed for use to reduce

risks or exposures associated with tobacco products and that it be empowered to review any advertising and labeling for

such products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that

such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into

account both users of tobacco products and persons who do not currently use tobacco products.

"(37) Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such

risks, those products can cause substantial harm to the public health to the extent that the individuals, who would other-

wise not consume tobacco products or would consume such products less, use tobacco products purporting to reduce

risk. Those who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than

quitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and

21 USCS § 387

premature death. The costs to society of the widespread use of products sold or distributed as modified risk products

that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and injuries and huge costs

to our health care system.

"(38) As the National Cancer Institute has found, many smokers mistakenly believe that 'low tar' and 'light' ciga-

rettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken be-

liefs about the health consequences of smoking 'low tar' and 'light' cigarettes can reduce the motivation to quit smoking

entirely and thereby lead to disease and death.

"(39) Recent studies have demonstrated that there has been no reduction in risk on a population-wide basis from

'low tar' and 'light' cigarettes, and such products may actually increase the risk of tobacco use.

"(40) The dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk

are so high that there is a compelling governmental interest in ensuring that statements about modified risk tobacco

products are complete, accurate, and relate to the overall disease risk of the product.

"(41) As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one

product is claimed to be less harmful than a comparable product, even in the presence of disclosures and advisories in-

tended to provide clarification.

"(42) Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products,

whether express or implied, even if accompanied by disclaimers would be detrimental to the public health.

"(43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk to-

bacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers

sold or distributed for risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to

support claims be fully verified.

"(44) The Food and Drug Administration is a regulatory agency with the scientific expertise to identify harmful

substances in products to which consumers are exposed, to design standards to limit exposure to those substances, to

evaluate scientific studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling,

and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of

the product on health. In connection with its mandate to promote health and reduce the risk of harm, the Food and Drug

Administration routinely makes decisions about whether and how products may be marketed in the United States.

"(45) The Federal Trade Commission was created to protect consumers from unfair or deceptive acts or practices,

and to regulate unfair methods of competition. Its focus is on those marketplace practices that deceive or mislead con-

sumers, and those that give some competitors an unfair advantage. Its mission is to regulate activities in the market-

place. Neither the Federal Trade Commission nor any other Federal agency except the Food and Drug Administration

possesses the scientific expertise needed to implement effectively all provisions of the Family Smoking Prevention and

Tobacco Control Act [for full classification, consult USCS Tables volumes].

"(46) If manufacturers state or imply in communications directed to consumers through the media or through a

label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or

complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending

upon the particular language used and its context, such a statement could result in consumers being misled into believ-

ing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the

harmfulness of the product because of such regulation, inspection, approval, or compliance.

"(47) In August 2006 a United States district court judge found that the major United States cigarette companies

continue to target and market to youth. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99-2496 (GK), August

17, 2006).

"(48) In August 2006 a United States district court judge found that the major United States cigarette companies

dramatically increased their advertising and promotional spending in ways that encourage youth to start smoking sub-

sequent to the signing of the Master Settlement Agreement in 1998. USA v. Philip Morris, USA, Inc., et al. (Civil Ac-

tion No. 99-2496 (GK), August 17, 2006).

"(49) In August 2006 a United States district court judge found that the major United States cigarette companies

have designed their cigarettes to precisely control nicotine delivery levels and provide doses of nicotine sufficient to

create and sustain addiction while also concealing much of their nicotine-related research. USA v. Philip Morris, USA,

Inc., et al. (Civil Action No. 99-2496 (GK), August 17, 2006).".

Family Smoking Prevention and Tobacco Control Act; purpose. Act June 22, 2009, P.L. 111-31, Div A, § 3, 123

Stat. 1781, provides:

"The purposes of this division [21 USCS §§ 387 et seq. generally; for full classification, consult USCS Tables vol-

umes] are--

21 USCS § 387

"(1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal regulatory authority

with respect to the manufacture, marketing, and distribution of tobacco products as provided for in this division;

"(2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to

public health officials, especially the use of tobacco by young people and dependence on tobacco;

"(3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of to-

bacco products and the identity, public disclosure, and amount of ingredients used in such products;

"(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco

industry's efforts to develop, introduce, and promote less harmful tobacco products;

"(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other

harmful components of tobacco products;

"(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose

research which has not previously been made available, as well as research generated in the future, relating to the health

and dependency effects or safety of tobacco products;

"(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they

are not sold or accessible to underage purchasers;

"(8) to impose appropriate regulatory controls on the tobacco industry;

"(9) to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases; and

"(10) to strengthen legislation against illicit trade in tobacco products.".

Family Smoking Prevention and Tobacco Control Act; scope and effect. Act June 22, 2009, P.L. 111-31, Div A,

§ 4, 123 Stat. 1782, provides:

"(a) Intended effect. Nothing in this division [21 USCS §§ 387 et seq. generally; for full classification, consult USCS

Tables volumes] (or an amendment made by this division) shall be construed to--

"(1) establish a precedent with regard to any other industry, situation, circumstance, or legal action; or

"(2) affect any action pending in Federal, State, or tribal court, or any agreement, consent decree, or contract of

any kind.

"(b) Agricultural activities. The provisions of this division [21 USCS §§ 387 et seq. generally; for full classification,

consult USCS Tables volumes] (or an amendment made by this division) which authorize the Secretary to take certain

actions with regard to tobacco and tobacco products shall not be construed to affect any authority of the Secretary of

Agriculture under existing law regarding the growing, cultivation, or curing of raw tobacco.

"(c) Revenue activities. The provisions of this division [21 USCS §§ 387 et seq. generally; for full classification,

consult USCS Tables volumes] (or an amendment made by this division) which authorize the Secretary to take certain

actions with regard to tobacco products shall not be construed to affect any authority of the Secretary of the Treasury

under chapter 52 of the Internal Revenue Code of 1986 [26 USCS §§ 5701 et seq.].".

Family Smoking Prevention and Tobacco Control Act; severability. Act June 22, 2009, P.L. 111-31, Div A, § 5,

123 Stat. 1782, provides: "If any provision of this division [21 USCS §§ 387 et seq. generally; for full classification,

consult USCS Tables volumes], of the amendments made by this division, or of the regulations promulgated under this

division (or under such amendments), or the application of any such provision to any person or circumstance is held to

be invalid, the remainder of this division, such amendments and such regulations, and the application of such provisions

to any other person or circumstance shall not be affected and shall continue to be enforced to the fullest extent possi-

ble.".

Modifications of deadlines for secretarial action. Act June 22, 2009, P.L. 111-31, Div A, § 6, 123 Stat. 1783, pro-

vides:

"(a) Delayed commencement of dates for secretarial action.

(1) In general. Except as provided in subsection (c), with respect to any time periods specified in this division [21

USCS §§ 387 et seq. generally; for full classification, consult USCS Tables volumes] (or in an amendment made by this

division) that begin on the date of enactment of this Act, within which the Secretary of Health and Human Services is

required to carry out and complete specified activities, the calculation of such time periods shall commence on the date

described in subsection (b).

"(2) Limitation. Subsection (a) shall only apply with respect to obligations of the Secretary of Health and Human

Services that must be completed within a specified time period and shall not apply to the obligations of any other person

or to any other provision of this division [21 USCS §§ 387 et seq. generally; for full classification, consult USCS Tables

volumes] (including the amendments made by this division) that do not create such obligations of the Secretary and are

not contingent on actions by the Secretary.

21 USCS § 387

"(b) Date described. The date described in this subsection is the first day of the first fiscal quarter following the ini-

tial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary of Health and Human Services has collected

fees under section 919 of the Federal Food, Drug, and Cosmetic Act [21 USCS § 387s] (as added by section 101).

"(c) Exception. Subsection (a) shall not apply to any time period (or date) contained-

"(1) in section 102 [21 USCS § 387a-1], except that the reference to '180 days' in subsection (a)(1) of such section

shall be deemed to be '270 days'; and

"(2) in sections 201 through 204 [amending 15 USCS §§ 1333, 1334, and 4402, and appearing in part as notes to

such sections] (or the amendments made by any such sections).

"(d) Adjustment. The Secretary of Health and Human Services may extend or reduce the duration of one or more

time periods to which subsection (a) applies if the Secretary determines appropriate, except that no such period shall be

extended for more than 90 days.".

21 USCS § 387

§ 387a. FDA authority over tobacco products

(a) In general. Tobacco products, including modified risk tobacco products for which an order has been issued in ac-

cordance with section 911 [21 USCS § 387k], shall be regulated by the Secretary under this chapter [21 USCS §§ 387 et

seq.] and shall not be subject to the provisions of chapter V [21 USCS §§ 351 et seq.].

(b) Applicability. This chapter [21 USCS §§ 387 et seq.] shall apply to all cigarettes, cigarette tobacco, roll-your-own

tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject

to this chapter [21 USCS §§ 387 et seq.].

(c) Scope.

(1) In general. Nothing in this chapter [21 USCS §§ 387 et seq.], or any policy issued or regulation promulgated

thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Prevention and Tobac-

co Control Act, shall be construed to affect, expand, or limit the Secretary's authority over (including the authority to

determine whether products may be regulated), or the regulation of, products under this Act [21 USCS §§ 301 et seq.]

that are not tobacco products under chapter V [21 USCS §§ 351 et seq.] or any other chapter.

(2) Limitation of authority.

(A) In general. The provisions of this chapter [21 USCS §§ 387 et seq.] shall not apply to tobacco leaf that is not

in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers,

tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration

have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such pro-

ducer.

(B) Exception. Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manu-

facturer or controlled by a tobacco product manufacturer, the producer shall be subject to this chapter [21 USCS §§ 387

et seq.] in the producer's capacity as a manufacturer. The exception in this subparagraph shall not apply to a producer of

tobacco leaf who grows tobacco under a contract with a tobacco product manufacturer and who is not otherwise en-

gaged in the manufacturing process.

(C) Rule of construction. Nothing in this chapter [21 USCS §§ 387 et seq.] shall be construed to grant the Secre-

tary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof,

other than activities by a manufacturer affecting production.

(d) Rulemaking procedures. Each rulemaking under this chapter [21 USCS §§ 387 et seq.] shall be in accordance with

chapter 5 of title 5, United States Code [5 USCS §§ 500 et seq.]. This subsection shall not be construed to affect the

rulemaking provisions of section 102(a) of the Family Smoking Prevention and Tobacco Control Act [21 USCS §

387a-1(a)].

(e) Center for Tobacco Products. Not later than 90 days after the date of enactment of the Family Smoking Prevention

and Tobacco Control Act [enacted June 22, 2009], the Secretary shall establish within the Food and Drug Administra-

tion the Center for Tobacco Products, which shall report to the Commissioner of Food and Drugs in the same manner as

the other agency centers within the Food and Drug Administration. The Center shall be responsible for the implementa-

tion of this chapter [21 USCS §§ 387 et seq.] and related matters assigned by the Commissioner.

(f) Office to assist small tobacco product manufacturers. The Secretary shall establish within the Food and Drug Ad-

ministration an identifiable office to provide technical and other nonfinancial assistance to small tobacco product man-

ufacturers to assist them in complying with the requirements of this Act [21 USCS §§ 301 et seq.].

(g) Consultation prior to rulemaking. Prior to promulgating rules under this chapter [21 USCS §§ 387 et seq.], the

Secretary shall endeavor to consult with other Federal agencies as appropriate.

HISTORY: (June 25, 1938, ch 675, Ch. IX, § 901, as added June 22, 2009, P.L. 111-31, Div A, Title I, § 101(b)(3), 123 Stat.

1786.)

§ 387p. Preservation of State and local authority

(a) In general.

(1) Preservation. Except as provided in paragraph (2)(A), nothing in this chapter [21 USCS §§ 387 et seq.], or rules

promulgated under this chapter [21 USCS §§ 387 et seq.], shall be construed to limit the authority of a Federal agency

(including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact,

adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in

addition to, or more stringent than, requirements established under this chapter [21 USCS §§ 387 et seq.], including a

law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to,

advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State,

or measures relating to fire safety standards for tobacco products. No provision of this chapter [21 USCS §§ 387 et seq.]

shall limit or otherwise affect any State, tribal, or local taxation of tobacco products.

(2) Preemption of certain State and local requirements.

(A) In general. No State or political subdivision of a State may establish or continue in effect with respect to a

tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this

chapter [21 USCS §§ 387 et seq.] relating to tobacco product standards, premarket review, adulteration, misbranding,

labeling, registration, good manufacturing standards, or modified risk tobacco products.

(B) Exception. Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, in-

formation reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by

individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under

subparagraph (A) that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated

as a trade secret and confidential information by the State.

(b) Rule of construction regarding product liability. No provision of this chapter [21 USCS §§ 387 et seq.] relating to a

tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the

product liability law of any State.

HISTORY: (June 25, 1938, ch 675, Ch. IX, § 916, as added June 22, 2009, P.L. 111-31, Div A, Title I, § 101(b)(3), 123 Stat.

1823.)

E-Cigarettes: Relevant State Law

HEALTH AND SAFETY CODE

TITLE 2. HEALTH

SUBTITLE H. PUBLIC HEALTH PROVISIONS

CHAPTER 161. PUBLIC HEALTH PROVISIONS

SUBCHAPTER H. DISTRIBUTION OF CIGARETTES OR TOBACCO PRODUCTS

Tex. Health & Safety Code § 161.081 (2013)

§ 161.081. Definitions

In this subchapter:

(1) "Cigarette" has the meaning assigned by Section 154.001, Tax Code.

(2) "Permit holder" has the meaning assigned by Section 154.001 or 155.001, Tax Code, as applicable.

(3) "Retail sale" means a transfer of possession from a retailer to a consumer in connection with a purchase, sale,

or exchange for value of cigarettes or tobacco products.

(4) "Retailer" has the meaning assigned by Section 154.001 or 155.001, Tax Code, as applicable.

(5) "Tobacco product" has the meaning assigned by Section 155.001, Tax Code.

(6) "Wholesaler" has the meaning assigned by Section 154.001 or 155.001, Tax Code, as applicable.

TAX CODE

TITLE 2. STATE TAXATION

SUBTITLE E. SALES, EXCISE, AND USE TAXES

CHAPTER 154. CIGARETTE TAX

SUBCHAPTER A. GENERAL PROVISIONS

Tex. Tax Code § 154.001 (2013)

§ 154.001. Definitions

In this chapter:

---

(2) "Cigarette" means a roll for smoking:

(A) that is made of tobacco or tobacco mixed with another ingredient and wrapped or covered with a material

other than tobacco; and

(B) that is not a cigar.

---

E-Cigarettes: Relevant State Law

CHAPTER 155. CIGARS AND TOBACCO PRODUCTS TAX

SUBCHAPTER A. GENERAL PROVISIONS

Tex. Tax Code § 155.001 (2013)

§ 155.001. Definitions

In this chapter:

---

(15) "Tobacco product" means:

(A) a cigar;

(B) smoking tobacco, including granulated, plug-cut, crimp-cut, ready-rubbed, and any form of tobacco suit-

able for smoking in a pipe or as a cigarette;

(C) chewing tobacco, including Cavendish, Twist, plug, scrap, and any kind of tobacco suitable for chewing;

(D) snuff or other preparations of pulverized tobacco; or

(E) an article or product that is made of tobacco or a tobacco substitute and that is not a cigarette.

---

PENAL ORDINANCE NO. 429

AN ORDINANCE REPEALING PENAL ORDINANCE 406 OF THE CODE OF ORDINANCES, RELATING TO SMOKING, CONTAINING FINDINGS, ADOPTING COMPREHENSIVE REGULATIONS OF SMOKING IN PUBLIC PLACES, PROVIDING FOR SEVERABILITY, AND PROVIDING FOR AN EFFECTIVE DATE.

SECTION I TITLE This Article shall be known as the City of Lufkin Smoking in Public Places Ordinance of 2013. SECTION II FINDINGS AND INTENT WHEREAS, cumulative scientific data indicates that exposure to second-hand smoke in indoor areas is dangerous to human health; and WHEREAS, according to a 2010 U.S. s Report, even occasional exposure to secondhand smoke is harmful; and WHEREAS, a significant amount of secondhand smoke exposure occurs in the workplace; and WHEREAS, studies undertaken across the country demonstrate that there is no significant adverse economic impact as a result of indoor smoking bans; and WHEREAS, recent efforts to secure a local smoking ban suggest that residents of Lufkin desire an increase in the number of smoke-free areas; and WHEREAS, given these considerations, the City Council finds and determines that increasing the number of smoke-free indoor areas is necessary to protect the public health and welfare.

NOW, THEREFORE, BE IT ORDAINED BY THE CITY COUNCIL OF THE CITY OF LUFKIN, TEXAS: That Title III, Chapter 38 (Penal Ordinance 406) of the Code of Ordinances, Lufkin, Texas, is hereby repealed and the following Ordinance is inserted in its place. SECTION III DEFINITIONS The following words and phrases, whenever used in this Ordinance, shall be construed as defined in this Section: 3.1 consumption by guests on the premises and in which the serving of food is only incidental to the consumption of those beverages, including but not limited to, taverns, nightclubs, cocktail lounges, and cabarets. 3.2 on, or other business entity, either for-profit or not-for-profit, including retail establishments where goods or services are sold; professional corporations and other entities where legal, medical, dental, engineering, architectural, or other professional services are delivered; and private clubs.

3.5 municipal corporation, trust, or non-profit entity that employs the services of one or more individual persons. 3.6 two sides by walls, doorways, or windows, whether open or closed. A wall includes any retractable divider, garage door, or other physical barrier, whether temporary or permanent and whether or not containing openings of any kind. 3.7 eatment of diseases, whether physical, mental, or emotional, or other medical, physiological, or psychological conditions, including but not limited to, hospitals, rehabilitation hospitals or other clinics, including weight control clinics, nursing homes, long-term care facilities, homes for the aging or chronically ill, laboratories, and offices of surgeons, chiropractors, physical therapists, physicians, psychiatrists, dentists, and all specialists within these professions. This definition shall include all waiting rooms, hallways, private rooms, semiprivate rooms, and wards within health care facilities. 3.8 including, but not limited to, work areas, private offices, employee lounges, restrooms, conference rooms, meeting rooms, classrooms, employee cafeterias, hallways, construction sites,

used as a child care, adult day care, or health care facility. 3.9 that has play or sports equipment installed or that has been designated or landscaped for play or sports activities, or any similar facility located on public or private school grounds or on City grounds. 3.10 lessee, or occupant of a building or portion thereof used exclusively for club purposes at all times, which is operated solely for a recreational, fraternal, social, patriotic, political, benevolent, or athletic purpose, but not for pecuniary gain, and which only sells alcoholic beverages incidental to its operation. The affairs and management of the organization are conducted by a board of directors, executive committee, or similar body chosen by the members at an annual meeting. The organization has established bylaws and/or a constitution to govern its activities. The organization has been granted an exemption from the payment of federal income tax as a club under 26 U.S.C. Section 501. 3.11 permitted, including but not limited to, banks, bars, educational facilities, gaming facilities, health care facilities, hotels and motels, laundromats, public transportation vehicles and facilities, reception areas, restaurants, retail food production and marketing establishments, retail service establishments, retail stores, shopping malls, sports arenas, theaters, and waiting rooms. A

as a child care, adult day care, or health care facility. 3.12 ited to, coffee shops, cafeterias, sandwich stands, and private and public school cafeterias, which gives or offers for sale food to the public, guests, or employees, as well as kitchens and catering facilities in which food is prepared on the premises for serving elsewhere. The term area within the restaurant.

3.15 cigarette, or pipe, or any other lighted or heated tobacco or plant product intended for inhalation,

which creates a vapor, in any manner or in any form, or the use of any oral smoking device for the purpose of circumventing the prohibition of smoking in this Ordinance. 3.16 ople assemble to engage in physical exercise, participate in athletic competition, or witness sports or other events, including sports pavilions, stadiums, gymnasiums, health spas, boxing arenas, swimming pools, roller and ice rinks, and bowling alleys. SECTION IV APPLICATION OF ARTICLE TO CITY-OWNED FACILITIES AND PROPERTY All enclosed areas, including buildings and vehicles owned, leased, or operated by the City of Lufkin, as well as all outdoor property adjacent to such buildings and under the control of the City, shall be subject to the provisions of this Ordinance. SECTION V PROHIBITION OF SMOKING IN ENCLOSED PUBLIC PLACES 5.1 Smoking shall be prohibited in all enclosed public places within the City of Lufkin, including but not limited to, the following places: A. Aquariums, galleries, libraries, and museums. B. Areas available to the general public in businesses and non-profit entities patronized by the public, including but not limited to, banks, laundromats, professional offices, and retail service establishments. C. Bars. D. Bingo facilities. E. Child care and adult day care facilities. F. Convention facilities. G. Educational facilities, both public and private. H. Elevators. I. Gaming facilities. J. Health care facilities. K. Lobbies, hallways, and other common areas in apartment buildings, condominiums, trailer parks, retirement facilities, nursing homes, and other multiple-unit residential facilities. L. Polling places. M. Public transportation vehicles, including buses and taxicabs, under the authority of the City, and ticket, boarding, and waiting areas of public transportation facilities, including bus, train, and airport facilities. N. Restaurants. O. Restrooms, lobbies, reception areas, hallways, and other common-use areas. P. Retail stores. Q. Rooms, chambers, places of meeting or public assembly, including school buildings, under the control of an agency, board, commission, committee or council of the City or a political subdivision of the State, to the extent the place is subject to the jurisdiction of the City. R. Service lines. S. Shopping malls. T. Sports arenas, including enclosed places in outdoor arenas. U. Theaters and other facilities primarily used for exhibiting motion pictures, stage

d l t i l it l th i il f

C. A retail tobacco store that is mechanically ventilated to prevent smoke from entering any nonsmoking area. SECTION VII PROHIBITION OF SMOKING IN ENCLOSED PLACES OF EMPLOYMENT 7.1 Smoking shall be prohibited in all enclosed areas of places of employment without exception. This includes, without limitation, common work areas, auditoriums, classrooms, conference and meeting rooms, private offices, elevators, hallways, medical facilities, cafeterias, employee lounges, stairs, restrooms, vehicles, and all other enclosed facilities. 7.2 This prohibition on smoking shall be communicated to all existing employees by the effective date of this Ordinance and to all prospective employees upon their application for employment. SECTION VIII PROHIBITION OF SMOKING IN PRIVATE CLUBS Smoking shall be prohibited in all private clubs. SECTION IX PROHIBITION OF SMOKING IN ENCLOSED RESIDENTIAL FACILITIES Smoking shall be prohibited in all private and semi-private rooms in nursing homes. SECTION X PROHIBITION OF SMOKING IN OUTDOOR PUBLIC PLACES 10.1 Smoking shall be prohibited in the following outdoor places: A. Within a reasonable distance of 25 feet outside entrances, operable windows, and ventilation systems of enclosed areas where smoking is prohibited, so as to prevent tobacco smoke from entering those areas. B. On all outdoor property that is adjacent to buildings owned, leased, or operated by the City of Lufkin and that is under the control of the City. C. In, and within 25 feet of, outdoor seating or serving areas of restaurants and bars. D. In all outdoor arenas, stadiums, and amphitheaters. Smoking shall also be prohibited in, and within 25 feet of, bleachers and grandstands for use by spectators at sporting and other public events. E. In, and within 25 feet of, all outdoor playgrounds. F. In, and within 25 feet of, all outdoor public transportation stations, platforms, and shelters under the authority of the City. G. In all outdoor service lines, including lines in which service is obtained by persons in vehicles, such as service that is provided by bank tellers, parking lot attendants, and toll takers. In lines in which service is obtained by persons in vehicles, smoking is prohibited by both pedestrians and persons in vehicles, but only within 25 feet of the point of service. H. In outdoor common areas of apartment buildings, condominiums, trailer parks, retirement facilities, nursing homes, and other multiple-unit residential facilities, except in designated smoking areas, not to exceed twenty-five percent (25%) of the total outdoor common area, which must be located at least 25 feet outside entrances, operable windows, and ventilation systems of enclosed areas where smoking is prohibited. SECTION XI PROHIBITION OF SMOKING IN OUTDOOR PLACES OF EMPLOYMENT 11.1 Smoking shall be prohibited in all outdoor places of employment where two or more

l i d t b i th f th i l t t h th t h b

SECTION XII DECLARATION OF ESTABLISHMENT OR OUTDOOR AREA AS NONSMOKING Notwithstanding any other provision of this Ordinance, an owner, operator, manager, or other person in control of an establishment, facility, or outdoor area may declare that entire establishment, facility, or outdoor area as a nonsmoking place. Smoking shall be prohibited in any place in which a sign conforming to the requirements of Section 13.1(A) is posted. SECTION XIII POSTING OF SIGNS AND REMOVAL OF ASHTRAYS 13.1 The owner, operator, manager, or other person in control of a public place or place of employment where smoking is prohibited by this Ordinance shall: symbol (consisting of a pictorial representation of a burning cigarette enclosed in a red circle with a red bar across it) in that place. B. Clearly and conspicuously post at every entrance to that place a sign stating that smoking is prohibited. C. Clearly and conspicuously post on every vehicle that constitutes a place of employment under this Ordinance at least one sign, visible from the exterior of the vehicle, stating that smoking is prohibited. D. Remove all ashtrays from any area where smoking is prohibited by this Ordinance, except for ashtrays displayed for sale and not for use on the premises. SECTION XIV NON-WAIVER OF RIGHTS An employee who works in a setting where an employer allows smoking does not waive or otherwise surrender any legal rights the employee may have against the employer or any other party. SECTION XV ENFORCEMENT 15.1 This Ordinance shall be enforced by the City Manager or an authorized designee. 15.2 Notice of the provisions of this Ordinance shall be given to all applicants for a business license in the City of Lufkin. 15.3 Any citizen who desires to register a complaint under this Ordinance may initiate enforcement with the City Manager or an authorized designee. 15.4 The Health Department, Fire Department, or their designees shall, while an establishment is undergoing otherwise mandated inspections, inspect for compliance with this Ordinance. 15.5 An owner, manager, operator, or employee of an area regulated by this Ordinance shall direct a person who is smoking in violation of this Ordinance to extinguish the product being smoked. If the person does not stop smoking, the owner, manager, operator, or employee shall refuse service and shall immediately ask the person to leave the premises. If the person in violation refuses to leave the premises, the owner, manager, operator, or employee shall contact a law enforcement agency. 15.6 Notwithstanding any other provision of this Ordinance, an employee or private citizen may bring legal action to enforce this Ordinance.

16.2 A person who owns, manages, operates, or otherwise controls a public place or place of employment and who fails to comply with the provisions of this Ordinance shall be guilty of an infraction, punishable by a fine not exceeding one hundred dollars ($100). 16.3 Violation of this Ordinance is hereby declared to be a public nuisance, which may be abated by the City Manager by restraining order, preliminary and permanent injunction, or other means provided for by law, and the City may take action to recover the costs of the nuisance abatement. 16.4 Each day on which a violation of this Ordinance occurs shall be considered a separate and distinct violation. SECTION XVII OTHER APPLICABLE LAWS This Ordinance shall not be interpreted or construed to permit smoking where it is otherwise restricted by other applicable laws. SECTION XVIII SEVERABILITY If any provision, clause, sentence, or paragraph of this Ordinance or the application thereof to any person or circumstances shall be held invalid, that invalidity shall not affect the other provisions of this Ordinance that can be given effect without the invalid provision or application, and to this end the provisions of this Ordinance are declared to be severable. SECTION XIX EFFECTIVE DATE This Ordinance shall take effect immediately from and after its passage and publication in accordance with the provisions of the City Charter.

APPROVED on first reading this the 2nd day of April, 2013. CITY OF LUFKIN, TEXAS Bob F. Brown, Mayor ATTEST: Kara Atwood, City Secretary APPROVED on the second and final reading this the 16th day of April, 2013. CITY OF LUFKIN, TEXAS Bob F. Brown, Mayor ATTEST: Kara Atwood, City Secretary

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708 F.3d 428

U.S. SMOKELESS TOBACCO MANUFACTURING COMPANY LLC, U.S.

SMOKELESS TOBACCO BRANDS INC., Plaintiffs-Appellants, - v. - CITY OF

NEW YORK, Defendant-Appellee.

Docket No. 11-5167-cv

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

708 F.3d 428

November 6, 2012, Argued

February 26, 2013, Decided

SUBSEQUENT HISTORY: Corrected: February

26, 2013

PRIOR HISTORY: Plaintiffs U.S. Smokeless Tobacco Manufacturing

Company LLC and U.S. Smokeless Tobacco Brands Inc.

sought an injunction in the Southern District of New

York (Colleen McMahon, Judge) against enforcement of

a New York City ordinance governing the sale of fla-

vored tobacco products, which they argue is preempted

by the Family Smoking Prevention and Tobacco Control

Act. Plaintiffs appeal an award of summary judgment in

favor of the City. We affirm because the ordinance is not

preempted.

U.S. Smokeless Tobacco Mfg. Co., LLC v. City of New

York, 2011 U.S. Dist. LEXIS 133018 (S.D.N.Y., Nov. 15,

2011)

DISPOSITION: AFFIRMED.

COUNSEL: KENNETH J. PARSIGIAN (Abigail K.

Hemani, on the brief), Goodwin Procter LLP, Boston,

Massachusetts, for Plaintiffs-Appellants.

MICHAEL JORDAN PASTOR, Assistant Corporate

Counsel (Michelle Goldberg-Cahn, Sherrill Kurland,

Larry A. Sonnenshein, Sharyn Michele Rootenberg, on

the brief), for Michael A. Cardozo, Corporation Counsel,

New York, New York, for Defendant-Appellee.

JUDGES: Before: RAGGI, NEWMAN, LYNCH, Cir-

cuit Judges.

OPINION BY: GERARD E. LYNCH

OPINION

[*430] GERARD E. LYNCH, Circuit Judge:

Plaintiffs U.S. Smokeless Tobacco Manufacturing

Company LLC and U.S. Smokeless Tobacco Brands Inc.

(collectively, "plaintiffs") manufacture and distribute

smokeless tobacco products, including flavored smoke-

less tobacco. On December 28, 2009, they filed suit in

the United States District Court for the Southern District

of New York (Colleen McMahon, Judge), challenging

the validity of a New York City ordinance governing the

sale of flavored tobacco products. Plaintiffs alleged that

the ordinance, New York City Administrative Code §

17-715, is preempted by the Family Smoking Prevention

and Tobacco Control Act ("FSPTCA" or "Act"), Pub. L.

No. 111-31, 123 Stat. 1776 (2009), codified at 21 U.S.C.

§ 387 et seq., and sought an injunction against its en-

forcement. They now appeal an award of summary

judgment entered on November 15, 2011, in favor of

defendant, the City of New York ("the City"). Because

we conclude that the ordinance is not preempted by the

FSPTCA, we affirm the judgment of the district court.

BACKGROUND

I. The Family Smoking Prevention and Tobacco

Control Act

Congress enacted the FSPTCA in 2009 to grant the

Food and Drug Administration ("FDA") authority to reg-

ulate tobacco products under the Food, Drug, and Cos-

metic Act, 21 U.S.C. § 301 et seq. See 21 U.S.C. §

387a(a). Under the Act, the FDA's authority extends to

the regulation of "all cigarettes, cigarette tobacco,

roll-your-own tobacco, and smokeless tobacco and to

any other tobacco products that the [FDA] by regulation

deems to be subject to [the Act]." Id. § 387a(b).

Of particular relevance to the present action is § 907

of the FSPTCA. Entitled "Tobacco Product Standards," it

sets out a "special rule for cigarettes," which provides

that "a cigarette or any of its component parts . . . shall

not contain, as a constituent . . . or additive, an artificial

or natural flavor (other than tobacco or menthol) or an

herb or spice." Id. § 387g(a)(1)(A). Section 907 further

grants the FDA authority to revise the special rule for

cigarettes, id. § 387g(a)(2), and to adopt additional

product standards if "appropriate for the protection of the

public health," id. § 387g(a)(3)(A). Specifically, the FDA

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708 F.3d 428

is authorized to establish standards "respecting the con-

struction, components, ingredients, additives, constitu-

ents, including smoke constituents, and properties of . . .

tobacco product[s]," id. § 387g(a)(4)(B)(i), and to adopt

provisions restricting their sale and distribution, id. §

387g(a)(4)(B)(v). The FDA may not, [*431] however,

"ban[] all cigarettes, all smokeless tobacco products, all

little cigars, all cigars other than little cigars, all pipe

tobacco, or all roll-your-own tobacco products," or "re-

quir[e] the reduction of nicotine yields of a tobacco

product to zero." Id. § 387g(d)(3).

Before imposing "restrictions on the sale and distri-

bution of a tobacco product," the FDA must determine

"that such regulation would be appropriate for the pro-

tection of the public health." Id. § 387f(d)(1). In deciding

whether a regulation is appropriate, the FDA must con-

sider "the risks and benefits to the population as a whole,

including users and nonusers of the tobacco product." Id.

Specifically, the FDA must take into account "the in-

creased or decreased likelihood that existing users of

tobacco products will stop using such products," as well

as "the increased or decreased likelihood that those who

do not use tobacco products will start using such prod-

ucts." Id. § 387f(d)(1)(A), (B). Finally, the FDA may not

"prohibit the sale of any tobacco product in face-to-face

transactions by a specific category of retail outlets; or . . .

establish a minimum age of sale of tobacco products to

any person older than 18 years of age." Id. §

387f(d)(3)(A).

Also central to this appeal is the Act's preemption

provision, set out in § 916. The section is composed of

three parts. First, a preservation clause states, in relevant

part:

Except as provided in [the preemption

clause], nothing in this subchapter . . .

shall be construed to limit the authority of

. . . a State or political subdivision of a

State . . . to enact, adopt, promulgate, and

enforce any law, rule, regulation, or other

measure with respect to tobacco products

that is in addition to, or more stringent

than, requirements established under this

subchapter, including a law, rule, regula-

tion, or other measure relating to or pro-

hibiting the sale, distribution, possession,

exposure to, access to, advertising and

promotion of, or use of tobacco products

by individuals of any age . . . .

Id. § 387p(a)(1). A preemption clause then establishes an

exception to this broad preservation of states' authority,

providing:

No State or political subdivision of a

State may establish or continue in effect

with respect to a tobacco product any re-

quirement which is different from, or in

addition to, any requirement under the

provisions of this subchapter relating to

tobacco product standards, premarket re-

view, adulteration, misbranding, labeling,

registration, good manufacturing stand-

ards, or modified risk tobacco products.

Id. § 387p(a)(2)(A). Finally, a saving clause carves out

an exception to the exception, stipulating that the

preemption clause "does not apply to requirements relat-

ing to the sale, distribution, possession, information re-

porting to the State, exposure to, access to, the advertis-

ing and promotion of, or use of, tobacco products by

individuals of any age." Id. § 387p(a)(2)(B).

II. The New York City Ordinance

New York City Administrative Code § 17-715 pro-

hibits the sale in New York City of "any flavored tobac-

co product except in a tobacco bar." A flavored tobacco

product is any item, not including cigarettes, that con-

tains both tobacco and "a constituent that imparts a char-

acterizing flavor." Id. § 17-713(e). A characterizing fla-

vor is "a distinguishable taste or aroma, other than the

taste or aroma of tobacco, menthol, mint or wintergreen,

imparted either prior to or during consumption of a to-

bacco product or component part thereof." [*432] Id.

§ 17-713(b). A tobacco product is not deemed to have a

characterizing flavor "solely because of the use of addi-

tives or flavorings or the provision of ingredient infor-

mation," id., but any "public statement or claim made or

disseminated by the manufacturer of a tobacco product . .

. that such tobacco product has or produces a character-

izing flavor shall constitute presumptive evidence that

the tobacco product is a flavored tobacco product," id. §

17-713(e).

Although the City's ordinance applies to all flavored

non-cigarette tobacco products, there is no indication in

the record that flavored cigars or non-cigarette products

other than smokeless tobacco constitute a commercially

significant product category, and in any event plaintiffs

do not seek to challenge the ordinance insofar as it re-

lates to products other than the flavored smokeless to-

bacco products they manufacture and distribute. Smoke-

less tobacco products are, as the term suggests, tobacco

products used by means other than smoking. They in-

clude chewing tobacco, dip, and snuff, and, according to

plaintiffs, they are typically consumed by adults, primar-

ily in the South.

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708 F.3d 428

Plaintiffs represent, and the City does not contest,

that there are only eight tobacco bars in New York City,

all of which are in Manhattan and none of which sells

flavored smokeless tobacco. Accordingly, we assume for

purposes of this decision that such products are unavail-

able for purchase anywhere in the city.

DISCUSSION

I. Legal Standards

"We review de novo a district court's application of

preemption principles." N.Y. SMSA Ltd. P'ship v. Town

of Clarkstown, 612 F.3d 97, 103 (2d Cir. 2010). "To

determine whether a state or local law is preempted by

federal law, we look to Congress's intent." 23-34 94th St.

Grocery Corp. v. N.Y. City Bd. of Health, 685 F.3d 174,

180 (2d Cir. 2012). Where the federal statute contains an

express preemption provision, we begin with the word-

ing of that provision, CSX Transp. Inc. v. Easterwood,

507 U.S. 658, 664, 113 S. Ct. 1732, 123 L. Ed. 2d 387

(1993), but we must also consider the statute as a whole

to determine whether the local ordinance actually con-

flicts with the overall federal regulatory scheme, Altria

Grp., Inc. v. Good, 555 U.S. 70, 76-77, 129 S. Ct. 538,

172 L. Ed. 2d 398 (2008). Where, as here, Congress has

specifically addressed the preemption issue, our task is

primarily one of interpreting what Congress has said on

the subject. See Ass'n of Int'l. Auto. Mfrs., Inc. v.

Abrams, 84 F.3d 602, 607 (2d Cir. 1996) ("Where an

express clause is a reliable indicium of congressional

intent, preemption is restricted to the terms of that provi-

sion.").

Preemption analysis is guided by the presumption

that a federal statute does not displace the local law "un-

less Congress has made such an intention clear and man-

ifest." Bates v. Dow Agrosciences LLC, 544 U.S. 431,

449, 125 S. Ct. 1788, 161 L. Ed. 2d 687 (2005) (internal

quotation marks omitted). This assumption is particularly

strong where, as here, a state or locality seeks to exercise

its police powers to protect the health and safety of its

citizens. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 485,

116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996); see N.Y. State

Restaurant Ass'n v. N.Y. City Bd. of Health, 556 F.3d

114, 123 (2d Cir. 2009) ("The presumption against

preemption is heightened 'where federal law is said to bar

state action in fields of traditional state regulation.'"),

quoting N.Y. State Conference of Blue Cross & Blue

Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655,

115 S. Ct. 1671, [*433] 131 L. Ed. 2d 695 (1995).

Accordingly, if there is any ambiguity as to whether the

local and federal laws can coexist, we must uphold the

ordinance. See Bates, 544 U.S. at 449; N.Y. State Res-

taurant Ass'n, 556 F.3d at 123.

II. Application

The FSPTCA's stated purposes include, on the one

hand, reducing the use of, dependence on, and social

costs associated with tobacco products and, on the other,

allowing the continued sale of such products to adults "in

conjunction with measures to ensure that they are not

sold or accessible to underage purchasers." FSPTCA §

3(7), codified at 21 U.S.C. § 387 note. These potentially

conflicting purposes reflect Congress's desire to reduce

the serious health risks associated with tobacco use, see

H.R. Rep. No. 111-58, pt. 1 at 2-4 (2009) (summarizing

extensive human and financial costs of tobacco use),

coupled with its recognition that there is no national

consensus to abolish tobacco products altogether, partic-

ularly in light of the millions of adults who are addicted

to them, see id. at 38 (noting that "prohibition of a prod-

uct that is used regularly by a large number of heavily

addicted adult users" would pose difficult questions of

public health). Congress therefore prohibited the FDA

from banning entire categories of products such as ciga-

rettes or smokeless tobacco. 21 U.S.C. § 387g(d)(3). But

it also recognized that the purposes of the Act would not

be served by allowing unrestrained production of and

access to all tobacco products. It therefore banned the

use of flavoring additives in cigarettes and authorized the

FDA to prohibit the use of other ingredients in tobacco

products if it deems them particularly harmful to the

public health. Id. § 387g(a).

Plaintiffs infer from Congress's compromise with

respect to federal policy that local governments "may not

make it impossible or impracticable for adults to pur-

chase tobacco products whose contents comply with the

federal standards." (Appellants' Br. 37.) Significantly,

however, no provision explicitly embodying such a re-

striction on state authority can be found in the text of the

statute. While § 907(d)(3) prohibits the FDA from ban-

ning entire categories of tobacco products throughout the

country, 21 U.S.C. § 387g(d)(3), the FSPTCA nowhere

extends that prohibition to state and local governments.1

To the contrary, the preservation clause of § 916 ex-

pressly preserves localities' traditional power to adopt

any "measure relating to or prohibiting the sale" of to-

bacco products. 21 U.S.C. § 387p(a)(1). That authority is

limited only to the extent that a state or local regulation

contravenes one of the specific prohibitions of the

preemption clause. Id. The only prohibition relevant here

forbids local governments to impose "any requirement . .

. relating to tobacco product standards." Id. §

387p(a)(2)(A). Even then, pursuant to the saving clause,

local laws that would otherwise fall within the preemp-

tion clause are exempted if they constitute "requirements

relating to the sale . . . of . . . tobacco products." Id.

[*434] § 387p(a)(2)(B). In other words, § 916 distin-

guishes between manufacturing and the retail sale of

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708 F.3d 428

finished products; it reserves regulation at the manufac-

turing stage exclusively to the federal government, but

allows states and localities to continue to regulate sales

and other consumer-related aspects of the industry in the

absence of conflicting federal regulation.

1 Earlier versions of § 907 would have ex-

pressly reserved to the federal government au-

thority to ban the sale of entire categories of to-

bacco products. E.g., H.R. 2180, 107th Cong. §

907(b)(3) (2001); H.R. 4433, 108th Cong. §

907(b)(3) (2004); S. 2461, 108th Cong. §

907(b)(3) (2004); H.R. 1376, 109th Cong. §

907(b)(3) (2005); S. 666, 109th Cong. §

907(b)(3) (2005). These draft versions of the pro-

vision that ultimately became § 907(d)(3) were

eventually rewritten to deny such power only to

the FDA, and as enacted into law, this provision

of the FSPTCA does not forbid such bans by state

and local governments. See 21 U.S.C. §

387g(d)(3).

Plaintiffs argue that the City's ordinance, on its face

a sales regulation, is in fact a product standards regula-

tion designed to "evade express federal preemption . . .

by artful crafting that elevates form over substance."

(Appellants' Br. 28-29.) Certainly, any purported sales

ban that in fact "functions as a command" to tobacco

manufacturers "to structure their operations" in accord-

ance with locally prescribed standards would not escape

preemption simply because the City "fram[ed] it as a ban

on the sale of [tobacco] produced in whatever way [it]

disapproved." Nat'l Meat Ass'n v. Harris, 132 S. Ct. 965,

972-73, 181 L. Ed. 2d 950 (2012); see Engine Mfrs.

Ass'n v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246,

254, 124 S. Ct. 1756, 158 L. Ed. 2d 529 (2004) ("[A]

standard is a standard even when not enforced through

manufacturer-directed regulation . . . ."). But it does not

follow that every sales ban -- many of which would like-

ly have some effect on manufacturers' production deci-

sions -- should be regarded as a backdoor "requirement .

. . relating to tobacco product standards" that is

preempted by the FSPTCA, 21 U.S.C. § 387p(a)(2)(A).

Such a broad reading of the preemption clause, which

collapses the distinction between sales and product regu-

lations, would render superfluous § 916's three-part

structure, and in particular would vitiate the preservation

clause's instruction that the Act not be "construed to limit

the authority of . . . a State or political subdivision of a

State . . . to enact . . . and enforce any . . . measure . . .

prohibiting the sale . . . of tobacco products," 21 U.S.C. §

387p(a)(1). Because "[s]tatutes should be construed, if

possible, to give effect to every clause and word," Cal.

Pub. Emps.' Ret. Sys. v. WorldCom, Inc., 368 F.3d 86,

106 (2d Cir. 2004), and in light of our presumption that

Congress has not limited the exercise of local police

powers, we adopt a narrower reading of the preemption

clause that also gives effect to the preservation clause.

To constitute a product standard subject to preemp-

tion, a local sales regulation must be "something more

than an incentive or motivator," Nat'l Meat Ass'n, 132 S.

Ct. at 973 (internal quotation marks and brackets omit-

ted); it must require manufacturers to alter "the construc-

tion, components, ingredients, additives, constituents . . .

and properties" of their products, 21 U.S.C. §

387g(a)(4)(B). See Bates, 544 U.S. at 443 (federal law

preempting state "requirements" for labeling of pesticide

products did not preempt state product liability suits that

"might 'induce' a pesticide manufacturer to change its

label"); cf. Nat'l Meat Ass'n, 132 S. Ct. at 974 (noting a

"significant" difference between "[a] ban on butchering

horses for human consumption" and a statute that

"reaches into the slaughterhouse's facilities and affects its

daily activities"). A local sales regulation that does not

clearly infringe on the FDA's authority to determine what

chemicals and processes may be used in making tobacco

products does not fall within this description and is

therefore not preempted.

The line between regulating the sale of a finished

product and establishing product standards will not al-

ways be easy to draw. Any finished product can be de-

scribed in terms of its components or method of manu-

facture. [*435] "Flavored tobacco products" are no

exception, and can arguably be described either as a cat-

egory of finished product or as products that are manu-

factured with ingredients that impart a flavor. We find

the first description more plausible. Whether a product is

governed by Administrative Code § 17-715 depends on

its characteristics as an end product, and not on whether

it was manufactured in a particular way or with particular

ingredients. Unlike the FSPTCA's "special rule for ciga-

rettes," which prohibits manufacturers from producing

cigarettes that contain "an artificial or natural flavor" as a

constituent or additive, 21 U.S.C. § 387g(a)(1)(A), the

city ordinance explicitly does not turn on "the use of ad-

ditives or flavorings," but rather on whether the product

itself imparts "a distinguishable taste or aroma," N.Y.

City Admin. Code § 17-713(b). In other words, the City

does not care what goes into the tobacco or how the fla-

vor is produced, but only whether final tobacco products

are ultimately characterized by -- or marketed as having

-- a flavor. No matter the level of generality used to de-

fine "flavored tobacco products," the ordinance is not

easily read to direct manufacturers as to which ingredi-

ents they may or may not include in their products. We

are therefore not persuaded that the City is infringing on

the role reserved for the federal government, and in par-

ticular the scientifically expert FDA, of assessing the

relative risks of specific ingredients or methods of pro-

duction.2

Page 5

708 F.3d 428

2 The City's regulation is therefore easily dis-

tinguishable from the California statute invali-

dated as a manufacturing standard in National

Meat Association. That law expressly prohibited

the sale of meat that was not produced in accord-

ance with specific rules to be applied at the

slaughterhouse with respect to the kinds of ani-

mals that were, according to the state, fit for

butchering -- rules that were in conflict with more

forgiving federal standards. See Nat'l Meat Ass'n,

132 S. Ct. at 970. To be sold in the state, meat

would have to be processed in a particular way.

The ordinance at issue here does not concern it-

self with the mode of manufacturing, or with the

ingredients that may be included in tobacco

products. Rather, it prohibits the sale of a recog-

nized category of tobacco products, characterized

by their flavor and marketed as a distinct product.

Plaintiffs' effort to characterize the ordinance as a

manufacturing standard is tantamount to describ-

ing a ban on cigarettes as a manufacturing stand-

ard mandating that cigars be manufactured in

minimum sizes and with tobacco-leaf rather than

paper wrappings.

In any event, even if the ordinance were construed

as establishing a product standard that falls within §

916's preemption provision, it would not be preempted,

because it also falls within that section's saving clause.

The saving clause excepts from preemption local laws

that establish "requirements relating to the sale . . . of . . .

tobacco products." 21 U.S.C. § 387p(a)(2)(B). As a reg-

ulation limiting the businesses at which flavored tobacco

may be sold, the city ordinance establishes a "require-

ment[] relating to the sale . . . of . . . tobacco products"

within the plain meaning of the saving clause.

Plaintiffs contend that the ordinance is not rescued

by the saving clause because it effects an outright ban on

the sale of flavored tobacco products, and the saving

clause cannot be read to include sales bans. Plaintiffs

point to the difference in language between the preserva-

tion clause, which refers to "measure[s] relating to or

prohibiting the sale" of tobacco products, id. §

387p(a)(1) (emphasis added), and the saving clause,

which refers only to "requirements relating to the sale" of

tobacco products, id. § 387p(a)(2)(B). We need not de-

termine whether this reading of the saving clause is cor-

rect. While the sales restriction imposed by the City's

ordinance is severe, it does not constitute a complete ban,

as it permits the limited sale of flavored [*436] to-

bacco products within New York City.

We are mindful that the limitations imposed by the

ordinance as described by appellants are very strict; in

another context, their proximity to a ban might concern

us. However, given Congress's explicit decision to pre-

serve for the states a robust role in regulating, and even

banning, sales of tobacco products, we adopt a broad

reading of the saving clause and a limited view of the

kinds of restrictions that would constitute a ban and re-

quire us to address the permissibility of outright prohibi-

tions under the saving clause. This interpretation of §

916 both follows from its plain language and comports

with the FSPTCA's overall objectives. Cf. Geier v. Am.

Honda Motor Co., 529 U.S. 861, 872, 120 S. Ct. 1913,

146 L. Ed. 2d 914 (2000) (declining to interpret a saving

provision to allow state law to directly conflict with the

statute's purposes and so "permit[ the federal law] to de-

feat its own objectives"). The City's restriction on the

sale of flavored tobacco products advances the

FSPTCA's objective of reducing the use and harmfulness

of tobacco products, especially among young people, see

FSPTCA § 3(2), 21 U.S.C. § 387 note, without trenching

on Congress's competing goal of keeping tobacco prod-

ucts generally available to addicted adults. It regulates a

niche product, not a broad category of products such as

cigarettes or smokeless tobacco, and it allows that prod-

uct to be sold within New York City, although to a lim-

ited extent.3

3 Accepting arguendo plaintiffs' representation

that flavored smokeless tobacco is not available

in any of the tobacco bars licensed to sell it does

not undermine our conclusion that the ordinance

does not effect a ban. A decision by owners of

tobacco bars not to sell the product is a commer-

cial choice that does not result from the ordinance

itself. In addition, there is no evidence in the rec-

ord or representation by either party that other

products covered by the ordinance but not manu-

factured or distributed by plaintiffs, such as fla-

vored cigars or pipe tobacco, are not sold in to-

bacco bars.

Accordingly, we conclude that Administrative Code

§ 17-715 is a regulation of sale and not a veiled attempt

to regulate the manufacture of tobacco products. The

ordinance represents an exercise of local police power

that Congress specifically allowed in enacting the

FSPTCA, and thus it is not preempted.

CONCLUSION

The district court correctly found plaintiffs' claim of

preemption without merit and awarded summary judg-

ment in favor of the City. We therefore AFFIRM the

district court's judgment.

Regulatory Options for E-Cigarettes / 1

Fact Sheet

Regulatory Options for Electronic Cigarettes

Background

- nicotine delivery , or

pipes, are designed to deliver nicotine or other substances to users in the form of a vapor. Many public health organizations support regulating e-cigarettes to reduce youth initiation to nicotine and tobacco products, protect the health of their users, and promote enforcement of smoke-free laws. This fact sheet provides a brief overview of e-cigarettes, their potential health risks, gaps in current federal and state regulation, and some approaches that state and local governments might consider to regulate their use, pricing, sale, and marketing. Product Description No standard definition or formulation of an e-cigarette exists: in fact, designs and ingredients vary by manufacturer.1 Generally, however, e-cigarettes consist of battery-powered heating elements and replaceable cartridges that contain nicotine or other chemicals, and an atomizer that, when heated, converts the contents of the cartridge into a vapor that users inhale. Proponents of e-cigarettes, including some in the public health community, view them as less hazardous alternatives to combustible cigarettes. Others see them as gateway products to tobacco use and nicotine addiction and support their restriction, or even removal, from the market. Health Risks The U.S. Food and Drug Administration (FDA) and many leading public health organizations have expressed concern about the lack of clinical studies on the potential health risks posed by e-cigarettes and the way these products are marketed without appropriate health warnings or legal age restrictions.2 cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene

3 In October 2012, the World Medical Association

commercially available e-cigarettes, neither their value as therapeutic aids for smoking cessation

Regulatory Options for E-Cigarettes / 2

nor their safety as cigarette replacements 4 In recent years, litigation between the FDA and e-cigarette manufacturers arising from concerns about their safety and regulatory status resulted in a temporary restriction on the importation of e-cigarettes into the United States.5 As a result of a 2010 ruling by the U.S. Court of Appeals for the D.C. Circuit,6 in April 2011 the FDA announced that it will regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act7 the federal law granting the FDA the authority to regulate tobacco products they are re 8 As of February 2013, however, the FDA has not yet regulated e-cigarettes as tobacco products. For that reason, it has become more of a priority for many state and local governments to consider regulatory options for electronic cigarettes. Regulatory Gaps & Options Taxation

Regulatory Gap: Many state tax laws define the term s in a way that excludes e-cigarettes. Although the FDA has said it will regulate electronic cigarettes as tobacco products, it is not clear whether every product marketed as an e-cigarette contains tobacco, or even nicotine derived from tobacco.9

Regulatory Options: The Family Smoking Prevention and Tobacco Control Act (the

Tobacco Control Act) expressly preserves the authority of state and local governments to levy taxes on tobacco products.10 Since e-cigarettes are a different type of product, containing electronic parts and synthetically-derived ingredients, existing tobacco tax laws may not be well-suited to them.11 Some states have addressed this issue by

ir tax codes so e-cigarettes are considered tobacco products for taxation purposes.12 Unless the FDA determines that e-cigarettes have genuine therapeutic uses, other states might consider, in the meantime, taxing e-cigarettes in a way that complements their existing cigarette and tobacco product taxes.13

Coupons, Discounts, & Rebates

Regulatory Gap: Tobacco manufacturers use coupons and other price-related incentives to make products such as e-cigarettes more attractive to consumers, particularly young people.14 Coupons and other price discounts for electronic cigarettes are utilized in the retail environment and discounted e-cigarettes are extensively promoted online.

Regulatory Options: Local and state governments could consider restricting or

prohibiting the retail redemption of coupons for tobacco products, including e-cigarettes and similar nicotine delivery systems, or restricting other price-related practices in the retail environment, such as payments from e-cigarette manufacturers and distributors to retailers resulting in price discounts; tobacco retailer incentive programs; and retail value-added deals (e.g., buy-one-get-one-free offers).15

Regulatory Options for E-Cigarettes / 3

While legal challenges to such policies can be anticipated in light of the e-cigarette in price-related marketing strategies, a federal district court has

recently upheld a local law prohibiting the sale of discounted tobacco products.16 In early 2012, Providence, Rhode Island enacted an ordinance prohibiting licensed tobacco dealers from selling discounted tobacco products through coupon redemption and multi-pack offers.17 Tobacco industry stakeholders challenged the law on First Amendment and federal and state preemption grounds. In December 2012, a federal district court upheld the pricing ordinance, concluding that its prohibition against certain industry price discounting practices did not violate the First Amendment, and also was not preempted by federal or state law.18 Although this decision has been appealed, and even if upheld, would not be controlling in all jurisdictions, may help support similar state or local laws to prohibit the deeply discounted sale of emerging tobacco products like e-cigarettes.

Free Samples

Regulatory Gap: Under the Tobacco Control Act, tobacco manufacturers are restricted

19 At present, this restriction does not apply to e-cigarettes. Although the FDA has indicated that it intends to regulate electronic cigarettes as tobacco products, the agency has yet to issue regulations asserting jurisdiction over e-cigarettes or extending

20

Regulatory Options: State and local governments could prohibit the distribution of all free samples of tobacco products, including e-cigarettes and other nicotine delivery systems.21

Flavoring

Regulatory Gap: Another disparity exists in the way flavored e-cigarette cartridges are regulated versus flavored cigarettes. Under the Tobacco Control Act, tobacco companies are prohibited from producing cigarettes containing any characterizing flavor other than tobacco or menthol.22 This prohibition is limited to flavored cigarettes, however. E-cigarette manufacturers can continue to market e-cigarette cartridges in a variety of candy-like flavors that appeal to youth (such as bubble gum, chocolate, and mint),23 and sell them at mall kiosks, where young people often congregate, as well as online, where safeguards against youth access can be breached more easily than in face-to-face purchases.

Regulatory Options: Although the Tobacco Control Act prohibits state and local

governments from establishing tobacco product standards relating to the manufacture of tobacco products, it expressly preserves the authority of state and local governments to regulate the sale and distribution of tobacco products.24

Regulatory Options for E-Cigarettes / 4

In 2009, New York City enacted an ordinance prohibiting the sale of flavored non-cigarette tobacco products with a characterizing flavor other than menthol, mint, or

25 Smokeless tobacco companies sued the city, arguing that the ordinance imposed manufacturing standards on their products in conflict with federal law. In 2010, the federal district court for the Southern District of

enforcement of the law.26 The court stated that the Tobacco Control Act gives the federal government exclusive authority over tobacco product manufacturing standards, but preserves state and local authority to regulate the sale and distribution of tobacco products. The court then found that the New York City ordinance was a sales restriction, not a product standard. In 2011, the court affirmed the reasoning of its previous decision and dismissed the complaint.27 In early 2012, Providence, Rhode Island enacted a similar ordinance prohibiting the sale

28 Several tobacco industry stakeholders sued the city, arguing that the ordinance was preempted by the Tobacco Control Act because it attempted to establish a product standard, and also violated the First Amendment because it limited their ability to describe their products. Like the New York court, the federal district court in Rhode Island concluded that the ordinance was a sales restriction, not a product standard, and thus was not preempted under the Tobacco Control Act.29

the sale of a particular product.30 Although both of these decisions are on appeal and, even if upheld, would not be precedential in all jurisdictions, their promising initial results may help support similar state or local laws to prohibit or restrict the sale of flavored tobacco products, including flavored e-cigarettes

Youth Access

Regulatory Gap: 31 As explained above, the

FDA has yet to assert jurisdiction over electronic cigarettes and extend restrictions like this to e-cigarettes. Also, many state and local youth access laws do not include e-cigarettes.32

Regulatory Options: State and local governments could consider passing stronger, more

comprehensive youth access laws to prohibit the sale of e-cigarettes to minors, require these products to be kept behind the counter, allow them to be sold only in places adults are permitted to enter, or raise the minimum legal age to purchase them.33

Use Restrictions

Regulatory Gap: Many smoke-carrying a lighted tobacco or plant product intended for inhalation. E-cigarettes, which

Regulatory Options for E-Cigarettes / 5

-cigarettes in public may lead conventional smokers to assume that smoking is permitted in such locations and nonsmokers to believe that a smoke-free law is being violated. Because of this, several health organizations recommend that the use of electronic cigarettes be prohibited in public places and workplaces.34

Regulatory Options: Local and state governments could include e-cigarettes in their

smoke- and tobacco-free restrictions by revising definitions of e-cigarettes and other electronic nicotine delivery systems.

Point-of-Sale Warnings, Marketing Restrictions, & Broad Sales Prohibitions

Regulatory Gap: The Federal Cigarette Labeling and Advertising Act35 limits the authority of state and local governments to regulate the advertising and promotion of cigarettes; however, no federal statute limits the authority of local or state governments to regulate the advertising and promotion of non-cigarette tobacco products. In addition, as discussed above, the Tobacco Control Act expressly preserves state and local government authority to regulate the sale of tobacco products. Therefore, state and local governments are able to warn consumers of the dangers of using electronic cigarettes, regulate the advertising or promotion of e-cigarettes, and regulate the sale of e-cigarettes without risking federal preemption concerns.

Regulatory Options: To determine the most effective options for regulating the sale and

marketing of e-cigarettes or for warning consumers about the use of these products, state and local governments need to analyze their jurisdiction-specific needs, priorities, and goals. Possible policy options include posting health warnings at the point-of-sale,36 imposing marketing restrictions, and prohibiting the sale of all electronic cigarettes.37 Although federal statutes should not pose a barrier for state and local policies restricting the sale and marketing of e-cigarettes, such laws will most certainly be challenged on the basis that they violate state or federal constitutional provisions related to free speech or interstate commerce.38 Although it is important to work with an attorney when pursuing any policy options, the legal issues surrounding the First Amendment are complicated, and jurisdictions must consult with legal counsel before pursuing these types of policies.

Contact Us Please feel free to contact the Tobacco Control Legal Consortium at (651) 290-7506 or publichealthlaw@wmitchell.edu with any questions about the information included in this fact sheet or to discuss local concerns you may have about implementing these policy options.

The Tobacco Control Legal Consortium provides information and technical assistance on issues related to tobacco and public health. The Consortium does not provide legal representation or advice. This document should not be considered legal advice or a substitute for obtaining legal advice from an attorney who can represent you. We recommend that you consult with local legal counsel before attempting to implement any of these measures.

Regulatory Options for E-Cigarettes / 6

Last Updated: February 2013

Notes

1 Statement on Electronic Cigarettes and Other Electronic Nicotine Delivery Systems (Oct. 2012), available at http://www.wma.net/en/30publications/10policies/e19/. 2 U.S. Food and & Drug Admin., Electronic Cigarettes, http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm (last visited Feb. 8, 2013). 3 U.S. Food & Drug Admin., Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted by the FDA, http://www.fda.gov/newsevents/publichealthfocus/ucm173146.htm (last visited Feb. 8, 2013). 4 See , supra note 1. 5 Sottera v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010). 6 Sottera, 627 F.3d at 893 (holding that e-cigarettes and other nicotine-containing products are not drugs or devices unless they are marketed for therapeutic purposes, but that other nicotine-containing products

the Federal Food, Drug, and Cosmetic Act). 7 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in relevant part at 21 U.S.C. §§ 301, 321, 387), available at www.govtrack.us/congress/bills/111/hr1256/text. 8 See , Regulation of E-Cigarettes and Other Tobacco Products (Apr. 25, 2011), available at http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm. 9 See Michael Freiberg, Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products, 21 ANNALS OF HEALTH LAW 407, 412 (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/phlc-lreview-freiberg-regulating-otp-2012.pdf. 10 21 U.S.C. § 387p(a)(1). 11 See Freiberg, supra note 9, at 421. 12 See, e.g., 2010 Minn. Laws ch. 305 § 2, available at https://www.revisor.mn.gov/data/revisor/law/2010/0/2010-305.pdf. 13 See Freiberg, supra note 9, at 418, 421. 14 Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General, 522-30 (2012), available at http://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/full-report.pdf . 15 See, e.g., Marlo Miura, Tobacco Control Legal Consortium, Regulating Tobacco Product Pricing: Guidelines for State and Local Governments (2010), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricing-2010.pdf; Tobacco Control Legal Consortium, Price-Related Promotions for Tobacco Products: An Introduction to Key Terms and Concepts (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricerelatedpromotions-2011_0.pdf. 16 No. 12 96 ML, 2012 WL 6128707 (D.R.I. Dec. 12, 2012). 17 PROVIDENCE, R.I. CODE §§ 14-300, 14-303.

Regulatory Options for E-Cigarettes / 7

18 2012 WL 6128707 at *5-7, 11. 19 21 C.F.R. § 1140.16(d)(1). 20 The Tobacco Control Act immediately gave the FDA the authority to regulate cigarettes, roll your own, and smokeless tobacco and

The Act includes a broad definition of tobacco products that would appear to include e-cigarettes and any other tobacco product that is currently on the market. However, in order to regulate those products, the FDA has to issue a regulation that deems them subject to the Act. After indicating in 2011 that it intended to issue the regulations later that year, the FDA did not issue the regulations in 2011 or 2012. In January 2013, the U.S. Department of Health and Human Services (HHS) published its Unified Regulatory Agenda, which indicates that the FDA intends to issue a notice of proposed rulemaking regarding its authority to deem other tobacco products subject to its jurisdiction in April 2013.

available at http://www.gpo.gov/fdsys/pkg/FR-2013-01-08/pdf/2012-31671.pdf. 21 See, e.g., Tobacco Control Legal Consortium, Tobacco Coupon Regulations and Sampling Restrictions Tips and Tools (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-

guide-tobcouponregsandsampling-2011.pdf. 22 See U.S. Food & Drug Admin., Flavored Tobacco, http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/default.htm (last visited Feb. 8, 2013) (containing links to resources related to 2009 law prohibiting the manufacture and sale of cigarettes containing certain characterizing flavors). 23 Minutes, U.S. Food & Drug Admin., Ctr. for Tobacco Products, Tobacco Products Scientific Advisory Committee Meeting, Dissolvable Tobacco Products Session, Testimony of Curtis Wright (July 21, 2011), available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM270282.pdf. 24 21 U.S.C. § 387p(a)(1). See Tobacco Control Legal Consortium, Federal Regulation of Tobacco: Impact on State and Local Authority (2009), available at http://www.publichealthlawcenter.org/sites/default/files/fda-1.pdf. 25 N.Y.C. CODE § 17-713, 715 (prohibiting the sale of smokeless tobacco products that have as a component part tastes or aromas relating to "any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice."). 26 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 344-45 (S.D.N.Y. 2010)

their federal preemption claim; concluding that the Tobacco Control Act gives the federal government the exclusive authority to regulate the manufacture of tobacco products, while reserving to the states the power to regulate the sale and distribution of tobacco products). 27 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, No. 09 Civ. 10511, 2011 WL 5569431 (S.D.N.Y. Nov. 15, 2011) (affirming reasoning of preliminary injunction order that the ordinance

defendan -motion for summary judgment, and dismissing the complaint). 28 PROVIDENCE, R.I. CODE §§ 14-308, 14-309, and 14-310. 29 No. 12 96 ML, 2012 WL 6128707 at *12-13 (D.R.I. Dec. 12, 2012). 30 Id. at *8.

Regulatory Options for E-Cigarettes / 8

31 21 C.F.R. § 1140.14(a). 32 Freiberg, supra note 9, at 434. 33 See Tobacco Control Legal Consortium, Regulating E-Cigarettes Tips and Tools (2011) (including select U.S. legislation and policies regulating e-cigarettes), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regecigs-2011.pdf; Tobacco Control Legal Consortium, Raising the Minimum Legal Sale Age for Tobacco and Related Products (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-minimumlegal-saleage-2012_0.pdf. 34 See, e.g., Model Ordinance Prohibiting Smoking in All Workplaces and Public Places 7 (2011), available at http://www.no-smoke.org/pdf/modelordinance.pdf. 35 15 U.S.C. § 1331 et seq. 36 See 23-34 94th St. Grocery Corp. v. New York City Bd. of Health, 685 F.3d 174, 183-85 (2d Cir. 2012) (affirming a district court decision ruling that New York City may not require cigarette retailers to post graphic health warnings next to cash registers or adjacent to cigarette displays, on the grounds that the Federal Cigarette Labeling and Advertising Act prevents state or local governments from adopting laws that affect the content of to

It should be noted that if a jurisdiction adopted graphic point-of-sale warning requirements applying to non-cigarette tobacco products such as electronic cigarettes, the FCLAA would not apply. However, the law would almost certainly be challenged on First Amendment grounds. 37 Freiberg, supra note 9, at 438. 38 For additional information, see Amendment and Commerce Clause issues in the regulation of tobacco products, available at http://publichealthlawcenter.org/topics/special-collections/federal-regulation-tobacco-collection.

E-Cigarettes: Texas Cities Dipping their Toes in the Vapor

Regan Metteauer

Program Attorney, TMCEC

The eyes of lawmakers, whether they sit in the U.S. Capitol or the City Council Chambers in

Murphy, Texas, are on e-cigarettes, a $1.7 billion industry in the United States.1 Such lawmakers are

faced with multiple questions: Who should be able to use them? Where should they be used? What

exactly are they?

The last question creates the biggest obstacle to regulation. No standard definition of “e-cigarette”

exists—in fact, designs and ingredients vary by manufacturer.2 Generally, electronic nicotine delivery

systems (“electronic cigarettes” or “e-cigarettes”) resemble traditional cigarettes and heat nicotine into a

vapor instead of burning tobacco.3 They consist of a 3-6 inch tube containing a battery and an atomizer

cartridge that holds liquid nicotine or other chemicals.4 When the user draws in, a switch turns on a mini-

heating element and produces a vapor, which comes in a variety of flavors.5 The first e-cigarette was

patented in 1963,6 but its current form entered the market in 2007 when a Chinese pharmacist reportedly

invented a device that vaporized nicotine using powerful miniature lithium batteries.7 Users can receive

the amount of nicotine in two packs of traditional cigarettes in just one e-cigarette, costing as little as

$7.99.8 Manufacturers say most e-cigarettes release only the vapor of nicotine and stabilizing chemicals

like propylene glycol, a common food preservative, instead of hundreds of toxic chemicals released by a

traditional tobacco cigarette.9 Users can find e-cigarettes at vapor shops, which sell disposable and

refillable e-cigarettes and the liquid that refills them. There are at least 40 such establishments in Texas.10

Cities in Texas and across the country are wrestling with what to do with e-cigarettes, mainly due to the

lack of action by the federal government.

The gap in federal regulation stems from the lack of classification of e-cigarettes. The Federal

Drug Administration (FDA) first attempted to regulate them as medical devices, but the U.S. Court of

Appeals for the District of Columbia Circuit rejected such an attempt.11

The FDA has since stated its

intention to issue a proposed rule that deems e-cigarettes a “tobacco product,” bringing them under the

Tobacco Control Act.12

As of this writing, proposed regulations to limit sales to minors, marketing

practices, and study health effects of the devices are currently under review at the White House’s Office

of Management and Budget.13

The FDA’s proposed regulations come at the behest of attorneys general

from 42 states (Texas was not one of them).14

Designation as a tobacco product will determine how e-

cigarettes are taxed and whether they are subject to the same indoor bans imposed on traditional smoking

materials. In the interim, if state laws classify e-cigarettes differently (i.e., not a tobacco product), a

problem will arise as such classification will conflict with future tobacco regulation.15

As 2013 came to a close, cities and states throughout the U.S. continued to implement laws

regulating e-cigarettes. Almost half the states have banned the sale of e-cigarettes to minors.16

New York

made recent headlines by raising the legal age for tobacco sales, including e-cigarettes, to 21. Four states

have added e-cigarettes to current indoor smoking bans: New Jersey, Arkansas (its ban only covers school

campuses), Utah, and North Dakota.17

New Jersey was the first state to specifically ban “electronic

vaping” in public places, including bars and restaurants in 2010.18

Utah, North Dakota, and cities across

the nation followed. While Texas’ neighbor to the north, Oklahoma, recently enacted statewide

regulations,19

no Texas law or court case specifically mentions e-cigarettes. Section 161.081 of the Texas

Health and Safety Code defines “cigarette” and “tobacco product” with the meanings respectively

assigned to those terms by the Tax Code.20

Section 154.001 of the Tax Code defines “cigarette” as a roll

for smoking that is made of tobacco or tobacco mixed with another ingredient and wrapped or covered

with a material other than tobacco, and that is not a cigar.21

The relevant part of Section 155.001 of the

Tax Code defines “tobacco product” as an article or product that is made of tobacco or a tobacco

substitute and that is not a cigarette.22

While there may be an argument that e-cigarettes are a tobacco

substitute, manufacturers seem to have pulled back from advertising as a method to quit smoking to avoid

regulation by the FDA as a medical device.23

Some Texas cities have, however, taken action in the

absence of state or federal regulation. The City of Murphy banned the possession and sale of e-cigarettes

to minors in November of 2013.24

Rockwall is considering a similar ban.25

Mansfield adopted a six-month

moratorium on new e-cigarette shops while it considers how e-cigarettes fit into the city's smoking

ordinance.26

Richardson requires a special permit for e-cigarette businesses, but has exempted e-cigarettes

from its smoking ban in public places.27

Likewise, San Marcos and San Antonio have excluded e-

cigarettes from their respective public smoking bans.28

Lufkin’s smoking ordinance, on the other hand,

includes e-cigarettes.29

Nacogdoches officials are currently looking into how e-cigarettes fit into the city’s

smoking ban.30

Efforts to regulate e-cigarettes have been met with counter-efforts to prohibit regulation.

For example, organizations like StopECB.org monitor regulatory efforts in Texas.31

Until the FDA’s proposed regulations are released for public comment, local and state

governments will have to wait and see. However, that process could take up to two years and local

pressure may continue to build. In 2013, there were no efforts by the Texas Legislature to regulate e-

cigarettes. However, as e-cigarettes continue to garnish media attention, it is hard to imagine an absence

of efforts to pass statewide legislation in 2015. State and federal regulatory efforts potentially raise

preemption issues for municipalities.32

Because of the potential for future state and federal regulation,

local governments, particularly cities that choose to regulate e-cigarettes by ordinance, will have to keep a

vigilant eye on the horizon for such developments.

1 Daniel Fisher, Will Taxes and Regulation Rein in the Booming E-Cigarette Market?, Forbes,

http://www.forbes.com/sites/danielfisher/2013/10/02/will-taxes-and-regulation-rein-in-the-booming-e-cigarette-

market (October 2, 2013). The entire e-cigarette market was expected to reach $1.7 billion in the U.S. in 2013.

Compare this to the expected $80 billion for traditional cigarettes. 2 Tobacco Control Legal Consortium, Regulatory Options for Electronic Cigarettes,

http://publichealthlawcenter.org/resources/regulatory-options-electronic-cigarettes-2013 (accessed December 30,

2013). 3 Tobacco Control Legal Consortium, Regulating E-Cigarettes,

http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regecigs-2011.pdf (accessed December 30,

2013). 4 Id. Other chemicals could include liquid marijuana. A man from Edcouch, Texas faces federal charges after

sending e-cigarettes filled with THC, the active chemical ingredient in marijuana, by mail. Sergio Chapa, Valley

Central.com, E-cigarettes filled with liquid marijuana land Edcouch man in jail,

http://www.valleycentral.com/news/story.aspx?id=970705#.UsM-D7R1nMM (November 12, 2013). 5 See, endnote 2.

6 Gilbert, H.A. “Smokeless Non-Tobacco Cigarette.” Patent 3,200,819. 17 August 1965. This patent is available

online at

http://www.google.com/patents?id=RjlUAAAAEBAJ&printsec=abstract&zoom=4&source=gbs_overview_r&cad=

0#v=onepage&q&f=false. 7 See, endnote 1.

8 See, endnote 1.

9 See, endnote 1. For more on the potential health risks of e-cigarettes and the lack of clinical studies, see, endnote 2.

10 Guide to Vaping, Vapor Shops, http://www.guidetovaping.com (accessed December 30, 2013).

11 Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010).

12 U.S. Food and Drug Administration, News & Events, Electronic Cigarettes,

http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm (accessed December 30, 2013). The Family

Smoking Prevention and Tobacco Control Act, commonly referred to as the Tobacco Control Act gives the FDA

authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. For

more information on the Act, visit the FDA website at http://www.fda.gov. 13

See, endnote 1. 14

National Association of Attorneys General, Letter to the FDA urging regulation,

http://www.naag.org/assets/files/pdf/signons/E%20Cigarette%20Final%20Letter%20w%20Florida.pdf (accessed

December 30, 2013). 15

For example, Arizona’s recent ban on e-cigarette sales to minors designates e-cigarettes as a “vapor product.”

Section 13-3622, Arizona Revised Statutes. 16

Jake Grovum, Staff Writer, Stateline, The Daily News Service of the Pew Charitable Trusts, States Move on E-

Cigarettes as Washington Delays, http://www.pewstates.org/projects/stateline/headlines/states-move-on-e-

cigarettes-as-washington-delays-85899525111 (December 9, 2013). 17

Id. 18

Id. 19

E-Cigarette Ban in Oklahome; Not Affecting Texas Sales, http://www.texomashomepage.com/story/e-cigarette-

ban-in-oklahoma-not-affecting-texas-sa/d/story/X8Lhy0ut2k2mcpekYFvbJg (accessed January 17, 2014). 20

Section 161.081(1) and (5), Health and Safety Code. 21

Section 154.001(2), Tax Code. 22

Section 155.001(15)(E), Tax Code. 23

Under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.S. § 301 et seq., the FDA has authority to

regulate articles that are drugs, devices, or drug/device combinations. 21 U.S.C.S. § 321(g)(1) defines drugs to

include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or

other animals. See, Soterra, 627 F.3d at 894. Proponents of e-cigarettes promulgate their use as a method to quit

smoking. 24

Murphy City Council Minutes, http://www.murphytx.org/Archive/ViewFile/Item/662 (accessed December 30,

2013). 25

Andrew Scoggin, Dallas Morning News, Rockwall Considering Ban on E-Cigarette Sales to Minors,

http://www.dallasnews.com/news/community-news/rockwall-rowlett/headlines/20131204-rockwall-considering-

ban-on-e-cigarette-sales-to-minors.ece (December 4, 2013). 26

Julieta Chiquillo, Staff Writer, Dallas Morning News, Dallas-area Cities Wrestle with Regulation of E-Cigarettes,

http://www.dallasnews.com/news/metro/20131217-dallas-area-cities-struggle-with-regulation-of-e-cigarettes.ece

(December 17, 2013). 27

Id. 28

James Carneiro, The University Star, Smoking e-cigarettes to be allowed in vape shops after ordinance

amendment, https://star.txstate.edu/node/1234 (November 20, 2013); Jessica Belasco, San Antonio Express News,

E-cigarettes on rise, but questioned, http://www.expressnews.com/news/local/article/E-cigarettes-on-rise-but-

questioned-4857591.php (October 1, 2013). 29

Lufkin Penal Ordinance No. 429,

http://www.cityoflufkin.com/pdfs/2013/Smoking%20Ordianance%20No.%20429.pdf (accessed December 30,

2013). 30

Donna McCollom, KTRE, Nacogdoches Officials Looking into Banning E-Cigarettes,

http://www.ktre.com/story/23571395/nacogdoches-officials-looking-into-banning-e-cigarettes (September 30,

2013).

31

See, STOPECB.ORG, http://www.electroniccigaretteban.org/State-Texas-ecigs-ban.htm (accessed January 17,

2014). 32

Municipalities seeking to regulate e-cigarettes should consult an attorney. For regulatory options for electronic

cigarettes, see, endnote 2.