Introduction to Tobacco and Nicotine Regulation: Pathways ... Tobacco... · This presentation provides information about the law. Legal information is not the same as legal advice,

Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 1Copyright © 2017 | www.khlaw.com 1Keller and Heckman LLPCopyright © 2019 | www.khlaw.com 1Keller and Heckman LLP

Introduction to Tobacco and Nicotine Regulation: Pathways to Market

Azim ChowdhuryKeller and Heckman LLP

[email protected]

October 23, 2019

Kathryn SkaggsKeller and Heckman LLP

[email protected]

Benjamin WolfKeller and Heckman LLP

[email protected]


Preliminary Statement

▪ This presentation provides information about the law. Legal information is not the same as legal advice, which involves the application of law to an individual’s specific circumstances. The interpretation and application of the law to an individual’s specific circumstance depend on many factors. This presentation is not intended to provide legal advice.

▪ The information provided in this presentation is drawn entirely from public information. The views expressed in this presentation are ours alone and not those of the our clients.


Agenda – Pathways to Market

▪ Grandfathered products

▪ FDA’s Compliance Policy for Deemed Products

▪ Substantial Equivalence (SE) Reports

▪ SE Exemption Requests

▪ Premarket Tobacco Applications (PMTA)

▪ Modified Risk Tobacco Product Applications (MRTPA)


Premarket Review

▪ All new tobacco products must be authorized by FDA before marketing.

▪ A “new tobacco product” is one that was either (1) introduced to the U.S. market after February 15, 2007, or (2) if it was on the market, modified in any way after that date, other than to its label or labeling.

▪ New tobacco products includes any changes to the design, components, parts, constituents, including a smoke constituent, or in the content, delivery, or form of nicotine, any other additive or ingredient, or product quantity packaged, etc.


The Grandfather Date

▪ A grandfathered product marketed as of February 15, 2007 does not require prior authorization to be legally marketed

▪ FDA interprets “as of” to mean “on”

▪ Companies can voluntarily submit Standalone Grandfather Submissions:• FDA Database of standalone submissions:

https://www.accessdata.fda.gov/scripts/ctpGnd/



▪ To establish grandfathered status, need dated documentation of commercial marketing in U.S. on February 15, 2007

▪ Can instead provide dated documentation of commercial marketing for a reasonable period of time before and after February 15, 2007


▪ FDA Guidance: https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf



▪ Proposed Rule on “Premarket Tobacco Product Applications and Recordkeeping Requirements” (Docket No. FDA-2019-N-2854) includes requirements for manufacturers to maintain records regarding the legal marketing of grandfathered tobacco products and products that are exempt from the requirements of demonstrating substantial equivalence

▪ Comments due by November 25, 2019.


Compliance Policy for Deemed Products

▪ All deemed products (e.g., e-cigarettes, cigars, hookah) that were not on the market as of February 15, 2007 (not grandfathered) must go through premarket review• In other words, such products are “new” tobacco products

▪ But new deemed products on the market on August 8, 2016 (effective date of Deeming Rule) are permitted to remain on the market without premarket authorization for a certain period of time pursuant to FDA’s “compliance policy” before premarket applications become due



▪ Initial compliance policy deadlines in the Deeming Rule for deemed products on the market on 8/8/16• SE Exemption Requests: August 8, 2017• SE Reports: February 8, 2018• PMTAs: August 8, 2018• Accepted applications subject to 12-month continued

compliance (sunset) period

▪ July 2017 – FDA published final guidance, changing compliance policy deadlines based on product type: • Any application for combustible product: August 8, 2021• Any application for non-combustible product: August 8, 2022• Eliminated sunset period for accepted applications



▪ March 2019 – FDA published draft guidance proposing to modify the compliance policy for certain deemed flavored tobacco products, as follows: • Flavored ENDS (other than tobacco, mint, menthol) have until

August 8, 2021, except that if such products are (a) targeted to minors or likely to promote ENDS use by minors, or (b) offered for sale in ways that pose a greater risk of minor access, they will be subject to immediate enforcement (i.e., no compliance policy).

• Deadline for tobacco, mint, menthol and unflavored ENDS would remain August 8, 2022.

• Eliminates the compliance policy for deemed flavored cigars –subject to immediate enforcement (unless grandfathered).

• Keeps in place the existing compliance policy for other deemed tobacco products whether or not flavored, i.e., August 8, 2021 for combustibles (i.e., waterpipe/hookah and pipe tobacco) and August 8, 2022 for non-combustibles (i.e., dissolvable tobacco).



▪ In March 2018, several public health groups sued FDA in federal district court in Maryland, challenging FDA’s ability to modify the Deeming Rule’s compliance policy deadlines without going through notice and comment rulemaking. See Amer. Acad. of Pediatrics v. FDA, No. PWG-18-883 (D. Md. 2019).

▪ In July 2019, the court ruled for the plaintiffs and vacated the FDA’s compliance policy guidance. After briefing on potential remedies, the court set the premarket application deadline (for all application types) for any new (non-grandfathered) deemed products on the market on 8/8/16 to May 11, 2020 (industry appeal pending).


UPDATE for Flavored ENDS coming?

▪ FDA recently indicated that, in light of rising underage use, FDA would be publishing the final compliance policy Guidance that may eliminate the compliance policy altogether for non-tobacco flavored ENDS.

▪ If so, this would mean all such products on the market without PMTA authorization would be subject to immediate enforcement, and would have to come off the market before the guidance becomes effective.

▪ FDA says this is not a “ban” since flavored ENDS could still earn marketing authorization through the PMTA process. But given the complexity of the PMTA process and rapidly approaching deadlines, this may be tantamount to a national ENDS flavor ban.


Premarket Pathways

▪ Three distinct premarket authorization pathways established in the Tobacco Control Act:• Substantial Equivalence (SE) Report under Section

905(j)

• Premarket Tobacco Product Application (PMTA) under Section 910

• Request for minor modification exemption from SE requirements under Section 910(a)(2)(A)(ii) and 905(j)(3)


SE Reports

▪ An SE Report must show that a new tobacco product is “substantially equivalent” to a predicate product• “Predicate” product – a grandfathered product or a

product that FDA has previously authorized for sale through the SE process

• FDA’s guidance indicates that only a single predicate can be compared against in an SE Report for a new product

‒ Being challenged in federal court by U.S. Smokeless Tobacco, Inc.


SE Reports

▪ “Substantial equivalence” means that FDA has found that the new product:• Has the same characteristics as the predicate tobacco product; or

• Has different characteristics than the predicate product, but information has been submitted to show that the new product does not raise different questions of public health

▪ “Characteristics” are the materials, ingredients, design, composition, heating source, or other features of a tobacco product


SE Reports

▪ Must include:• Comparison of characteristics (quantitative and qualitative) of

new and predicate products‒ Design features‒ Ingredients‒ Materials‒ Heating source‒ Composition‒ HPHCs

• Adequate summary of health information (with adverse health effects)

• Additional public health data, upon request• Environmental Assessment


SE Reports

▪ Label and Product Quantity Changes• Changes to label or labeling (e.g., name, brand, logo, colors,

graphics, etc.) do not alone trigger premarket review.

• Changes to quantity of product packaged (e.g., number of cigarettes in a pack) do trigger premarket review (must submit streamlined “Product Quantity Change SE Report).

• See Philip Morris USA Inc. et al. v. FDA et al. (D.D.C. Aug. 16, 2016) and FDA’s Guidance for Industry: https://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM436468.pdf.


Proposed Rule on SE Reports

▪ Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports published April 2, 2019

▪ 84 FR 12740

▪ Proposed rule would establish • The information an SE Report must include

• General procedures FDA will follow when evaluating SE Reports

▪ Deadline for comments was July 17, 2019 (extended)


Provisional SE Reports

▪ For non-grandfathered tobacco products first marketed between February 15, 2007 and March 22, 2011, Tobacco Control Act allowed manufacturers to submit Provisional SE Reports prior to March 23, 2011

▪ Products subject to timely Provisional SE Reports were allowed to stay on the market unless/until FDA issues an order finding that the tobacco product is Not Substantially Equivalent (NSE) to its predicate


Provisional SE Reports

▪ FDA received 3,589 Provisional SE Reports by March 22, 2011– almost all of which were submitted in the final days before the deadline

▪ FDA triaged the review of Provisional SE Reports based on a public health impact assessment in 2013


Remove From Review (RFR)

▪ In July 2017, FDA Commissioner Gottlieb announced that CTP would reevaluate approach to the ~2,500 remaining Provisional SE Reports

▪ In April 2018, FDA announced that it would proceed to review ~1,000 Provisional SE Reports that have the greatest potential to raise different questions of public health • Agency has begun review for at least 675

▪ For the remaining ~1500 Provisional SE Reports, FDA gave the applicants the option to remove the reports from the SE review process, while permitting them to remain on the market


Remove from Review (RFR)

▪ To request a provisional be removed from review, applicants were asked to provide a certified statement as to the exact date the product was introduced to the market after February 15, 2007 and before March 22, 2011

▪ RFR letters have been issued to responding companies

▪ The catch: RFR products can remain on the market, but may never serve as predicates in future SE Reports


SE Exemption Request

▪ The SE Exemption request for minor modifications is only available for tobacco products that are modified by

• Adding or deleting a tobacco additive, or

• Increasing or decreasing the quantity of an existing additive

▪ An additive is defined broadly as:

• Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring 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.



▪ FDA takes the position that an SE Exemption request can only be made with respect to modifications of a manufacturer’s own product.

▪ FDA will grant the exemption request if it finds that:• Modification is minor

• An SE Report is not necessary to ensure that marketing the product would be appropriate for the protection of the public health, and

• The exemption is otherwise appropriate



▪ Example: Exemption Requests granted for cigarettes:• Changes to cigarette paper (FSC)

• Ink on cigarette barrel

• Color and other changes to tipping paper

• Changes to casing additives

• Changes in filter tow


Premarket Tobacco Product Application

▪ Applies to all new tobacco products not eligible for the SE Report pathway• ALL vapor products (no known grandfathered products)

▪ Review process in a nutshell:


Premarket Tobacco Product Application (PMTA)

▪ Basis for evaluation • PMTA standard: “appropriate for the protection of the public

health”‒ FDA must evaluate risks and benefits to the population as a whole, including

users and nonusers of tobacco products, and taking into account:

• Increased or decreased likelihood of cessation by users

• Increased or decreased likelihood of initiation by nonusers

• Conformance with any manufacturing practice requirements (FDCA 906(e)) which apply (if any)

• Proposed labeling must not be false or misleading • Product must conform to product standards under section 907 which

apply (if any), or must contain an adequate justification for such deviations


PMTA Requirements – FDCA § 910

1. Full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products

2. A full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product

3. A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product

4. An identifying reference to any tobacco product standard under section 907 which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard

5. Such samples of such tobacco product and of components thereof as the Secretary may reasonably require

6. Specimens of the labeling proposed to be used for such tobacco product

7. Such other information relevant to the subject matter of the application as the Secretary may require


PMTA Final Guidance

▪ PMTA Final Guidance for ENDS (June 2019): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-systems-ends

▪ Substantially similar to the draft guidance published in May 2016• New information on HPHCs, “valid scientific evidence”, clinical

assessments, literature reviews, bridging, and need for pre-submission meetings, among other things


Proposed Rule on PMTAs and Recordkeeping

• New 21 C.F.R. Part 1114‒ Subpart A – Scope and Definitions

‒ Subpart B – PMTA

• § 1114.7 – Content and format requirements

• § 1114.9 – Amendments

• § 1114.11 – Withdrawal by applicant

• § 1114.13 – Change in ownership of

an application

• § 1114.15 – Supplemental applications

• § 1114.17 – Resubmissions

‒ Subpart C – FDA Review

• § 1114.29 – FDA action on application

• § 1114.31 – Issuance of a marketing order

• § 1114.33 – Issuance of no marketing order

• § 1114.35 – Withdrawal of a marketing order

• § 1114.37– Temporary suspension of a marketing order

‒ Subpart D – Post-market requirements

• Periodic reports to CTP

• Marketing plans and surveillance

‒ Subpart E – Miscellaneous

• Record retention, confidentiality, electronic submission

FDA’s long-awaited “rules of the road” rulemaking announced in July 2017 provides details on the “threshold”

requirements for PMTA acceptance for filing (i.e., substantive review)


Proposed § 1114.7 – Content and format requirements

▪ Required PMTA sections• General information• Descriptive information• Product samples• Labeling• Statement of compliance with 21 CFR Part 25• Summary • Product formulation• Manufacturing• Health risk investigations• Effect of population as a whole• Certification statement


Health Risk Investigations

To be accepted for filing, PMTAs should contain information on:

(A) The health risks of the new tobacco product (as described in § 1114.7(k)(1)(i)(A) through (C));

(B) The health risks of the new tobacco product compared to the health risks generally presented by both products in the same product category and products in at least one different category that are used by the consumers an applicant expects will use its new tobacco product (as set forth in a portion of § 1114.7(k)(1)(i)(D)).

(C) The abuse liability of the new tobacco product (as set forth in § 1114.7(k)(1)(ii)(A));

(D) How consumers would be expected to actually use the product, including use frequency, use trends over time, and how such use affects the health risks of the product to individual users (as set forth in § 1114.7(k)(1)(ii)(B));

(E) The impact that marketing the new tobacco product would have on the likelihood that current tobacco product users would start using the new tobacco product, use the product in conjunction with other tobacco products, and, after using the product, switch to or switch back to other tobacco products that may present increased risks to individual health (as set forth in § 1114.7(k)(1)(ii)(C) through (F));

(F) The impact that the marketing of the new tobacco product would have on tobacco product use behavior of current nonusers of tobacco products (as described in § 1114.7(k)(1)(iii)); or

(G) The impact of the product and its label, labeling, and advertising on individuals' perception of the product and their use intentions (as described in § 1114.7(k)(1)(iv))


Appropriate for the Protection of the Public Health

Graphic Source: Cardno Chemrisk


PMTAs so far…

See: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-product-marketing-orders#1

• PMTA authorized products are Swedish Match’s General Snus and Phillip

Morris’s IQOS heat-not-burn system.


Modified Risk Tobacco Products (MRTPs)

▪ Prior authorization pathway for certain marketing claims (not products)

▪ Label or advertising that represents “explicitly or implicitly” that:

• The product presents a lower risk of disease than one or more marketed tobacco products

• Tobacco product or its smoke contains a reduced level of a substance of presents a reduced exposure to a substance

• Tobacco product or its smoke does not contain or is free of a substance

▪ Label or advertising that uses “light,” “mild,” low, or similar descriptors

▪ Any statement by manufacturer that would reasonably be expected to result in belief that product/smoke may present lower risk, is less harmful, or presents reduced exposure to/does not contain substance


MRTPA Review

▪ Two types of potential orders1. Risk-modification order (FDCA §

911(g)(1))‒ Standard: significantly reduce harm and

risk of tobacco-related disease to individual tobacco users; and

‒ Benefit health of population as a whole taking into account both users and non-users of tobacco products and persons who do not currently use tobacco products


MRTP Orders

2. Exposure-modification order (FDCA § 911(g)(2))‒ MRTP claims limited to reduced-exposure claims.‒ Cannot make “reduced harm” finding due to need for, but unavailability of, long-term

epidemiological study data.‒ Available data demonstrate that measurable and substantial reduction in morbidity or

mortality among individual tobacco users is reasonably likely to be observed in subsequent studies.

‒ Reduction in exposure is substantial, substance is harmful, and product as actually used exposes consumers to specified reduced level of a substance.

‒ Product as actually used by consumers will not create higher levels of other harmful substances compared to similar types of tobacco products unless increases are minimal and reasonably likely overall impact remains substantial and measurable reduction in overall morbidity and mortality among individual tobacco users.

‒ Testing of actual consumer perception demonstrates consumers will not be misled into believing that the product is or has been demonstrated to be less harmful or presents or ahs been demonstrated to present less risk of disease than one or more other commercially marketed tobacco products.

‒ Order is expected to benefit health of population as a whole taking into account both users and non-users.


MRTPA Review – Public Health Benefit

Benefit to Health of Individuals and of Population as a Whole, FDA will consider (see FDCA § 911(g)(4)):

A. the relative health risks to individuals of the tobacco product

B. the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product

C. the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product

D. the risks and benefits to persons from the use of the tobacco product as compared to the use of products for smoking cessation approved to treat nicotine dependence; and

E. comments, data, and information submitted by interested persons.


Avoid Modified Risk Claims

▪ Prohibited MRTP claims include:• No tar• No ash• Diacetyl-free• Low, light, mild• Less risky• Less harmful• Safer than [x]• Contains reduced levels of [x]• Links to other websites that make modified risk claims

▪ First Amendment appeal pending before DC Circuit. See Nicopure Labs et al. v. FDA, Case No. 15-5196 (D.C. Cir. Sept. 12, 2018)


Pending and Approved MRTPAs

▪ FDA announced on October 22, 2019 that the Swedish Match General Snus MRTPA has been authorized for the claim: “Using General Snus instead of cigarettes puts you at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

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Introduction to Tobacco and Nicotine Regulation: Pathways ... Tobacco... · This presentation provides information about the law. Legal information is not the same as legal advice,