Cannabinoid Water Page 1 of 6 Attorney Client Label Opinion Letter Confidential Communication

COMPLIANCE ADVISOR

A LAW FIRM P.O. Box 8451

Mission Hills CA, 91346 TELEPHONE: (681) 238 – 4737 WWW.CALF.LEGAL EMAIL: Satinder@Calf.Legal

20 November 2016

Cannabinoid Water, LLC.

2893 Executive Park Drive Suite 203

Weston, Florida 33331

Re: Labelling Compliance of Cannabinoid Water.

(NOTE: CONFIDENTIAL ATTORNEY-CLIENT COMMUNICATION AND PROPRIETARY TRADE SECRETS

CONTAINED HEREIN)

To whom it may concern:

I am a licensed attorney in California. I focus on life sciences matters relating to the Food and Drug

Administration (“FDA”) of the United States of America. I advise clients on matters relating to complying

with regulatory matters.

I have been asked to prepare this legal analysis letter reviewing the Cannabinoid Water labels against

the applicable

regulations. Enclosed in this letter are the labels that create the basis for this letter.

I will address the following matters in this letter,

Applicable agency regulations,

Applicable bottled water regulations,

FDA and the CBD, and

The enclosed Cannabinoid Water labels.

Applicable Agency Regulations

Bottled water products such as Cannabinoid Water are subject to multiple state and federal

regulations. This letter will focus on the federal regulations, specifically the FDA and the Environmental

Protection Agency (“EPA”).

The FDA’s authority over Cannabinoid Water.

The FDA regulates how most food is processed, packaged, and labeled. Per Title 21, Chapter 9

Food, Drug, and Cosmetics Act, Subchapter II – Definitions (21 U.S.C 321: Definitions; Generally):

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“(f) The term "food" means:

(1) articles used for food or drink for man or other animals,

(2) chewing gum, and

(3) articles used for components of any such article.”

A review of the enclosed Cannabinoid Water label implies that Cannabinoid Water is for

consumption by humans. Under subsection f(1) as identified above, Cannabinoid Water will be regulated

according to FDA’s food regulations.

The EPA’s regulations are inapplicable to Cannabinoid Water’s labels.

The EPA focuses on the regulation of the source of drinking water, while the FDA focuses on the

consumer portions such as bottled water. The EPA derives the authority to regulate drinking water from the

Safe Drinking Water Act (“SDWA”), 42 U.S.C. §300f et seq. (1974). SDWA protects the quality of

drinking water in the U.S. This law focuses on all waters actually or potentially designed for drinking use,

whether from above ground or underground sources.

For the purpose of this letter, the source of Cannabinoid Water is not in question. The EPA does

not regulate food labels and therefore, for this letter, the FDA regulations will govern the label of

Cannabinoid Water.

FDA bottled water regulations

The FDA has established specific regulations for bottled water in Title 21 of the Code of Federal

Regulations (“21 CFR”) which are as follows:

including standard of identity regulations (21 CFR § 165.110[a]) that define different types of

bottled water, such as spring water and mineral water, and

standard of quality regulations (21 CFR §165.110[b]) that establish allowable levels of

contaminants (chemical, physical, microbial and radiological) in bottled water.

FDA also has established Current Good Manufacturing Practice (CGMP) regulations for the

processing and bottling of bottled drinking water (21 CFR part 129).

Labeling regulations (21 CFR part 101) and

CGMP regulations (21 CFR part 110) for foods in general also apply to bottled water. It is worth

noting that bottled water is one of the few foods for which FDA has developed specific CGMP

regulations or such a detailed standard of quality.

The FDA regulates food labels as part of the FDA’s authority over foods. Specifically, TITLE 21-

-FOOD AND DRUGS CHAPTER I - PART 101 FOOD LABELING SUBPART A, lists the requirements

applicable to food labels. In the interest of time, this letter will focus on the Cannabinoid Water label’s

Nutrient Content Claims – General Principles (Section 101.13) and Health Claims: General Requirements

of section (Section 101.14) because of the potential for regulatory action:

Nutrient content claims are not present on the Cannabinoid Water labels

The FDA has general provisions against health and nutrition claims for food that are not

pre-approved or substantiated by significant amounts of data. TITLE 21 FOOD AND DRUGS

CHAPTER I SUBCHAPTER B-FOOD FOR HUMAN CONSUMPTION PART 101-FOOD

LABELING Subpart A General Provisions Sec. 101.13 Nutrient content claims states that:

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“(b) A claim that expressly or implicitly characterizes the level of a nutrient of the type

required to be in nutrition labeling under 101.9 or under 101.36 (that is, a nutrient content

claim) may not be made on the label or in labeling of foods unless the claim is made in

accordance with this regulation and with the applicable regulations in subpart D of this

part or in part 105 or part 107 of this chapter.”

A nutrient claim is any form of communication about the nutrient content upon which the

manufacturer or seller rely on to promote the product. If there is a nutrient claim present on the

label of the product, then the presentation of that nutrient claim must be in accordance with the

identified sections above. The sections require that any claims made in connection with nutrients

be either pre-approved by the FDA or from a pre-determined list approved by the FDA.

A review of the enclosed labels shows that there are no statements that may be interpreted

as nutrient claims.

Health claims are not present on the Cannabinoid Water labels.

Health claims are prohibited by the FDA on foods unless pre-approval is obtained to

promote such claims. Generally, health claims require a submission and review process by the

FDA. TITLE 21 FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION

SUBCHAPTER B-FOOD FOR HUMAN CONSUMPTION PART 101-- FOOD LABELING

Subpart A-General Provisions Sec. 101.14 Health claims: general requirements states that:

“(a) Definitions. For purposes of this section, the following definitions apply:

(1) Health claim means any claim made on the label or in labeling of a food,

including a dietary supplement, that expressly or by implication, including "third

party" references, written statements (e.g., a brand name including a term such as

"heart"), symbols (e.g., a heart symbol), or vignettes, characterizes the

relationship of any substance to a disease or health-related condition. Implied

health claims include those statements, symbols, vignettes, or other forms of

communication that suggest, within the context in which they are presented, that a

relationship exists between the presence or level of a substance in the food and a

disease or health-related condition.”

A health claim is any form of communication (including labeling) relied upon by a

manufacturer or a seller of the product that may be interpreted to mean that the product may

mitigate, treat or diagnose a disease state. After a review of the enclosed labels, there are no

statements that may be interpreted to be health claims.

The enclosed labels do not present nutrient or content claim violations of the cited sections above.

Also, the labels to provide all the other requisite information such as the identifying information of

the product, the manufacturer, and the ingredients.

FDA and CBD

Cannabinoids are components of the cannabis plant. There are many types of cannabinoids, of

which the most popular is Tetrahydrocannabinol (“THC”). CBD is another cannabinoid, separate from

THC and possesses a different set of attributes.

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The FDA’s stance on CBD being added to food products is outlined on the “FDA and Marijuana:

Questions and Answers” webpage (http://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm).

The FDA states that:

“Is it legal, in interstate commerce, to sell a food to which cannabidiol has

been added?

A. No. Under Section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for

introduction into interstate commerce any food (including any animal food or feed) to which

has been added a drug for which substantial clinical investigations have been instituted and

for which the existence of such investigations has been made public. There are exceptions,

including when the drug was marketed in food before any substantial clinical investigations

involving the drug had been instituted or, in the case of animal feed, that the drug is a new

animal drug approved for use in feed and used according to the approved labeling. However,

based on available evidence, FDA has concluded that none of these is the case for cannabidiol.

FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction

into interstate commerce any food (including any animal food or feed) to which cannabidiol

has been added. FDA is not aware of any evidence that would call into question this

conclusion. Interested parties may present the agency with any evidence that they think has

bearing on this issue.”

The FDA makes it clear that foods that contain added CBD may not be sold in interstate commerce.

However, the FDA does not refer to CBD that is naturally occurring in a product such as an extract, or oils,

for example, anhydrous hemp oil. Also, a point of interest to note is that the FDA has not prevented the

addition of cannabinoids as an array but rather focused on one cannabinoid. So long as CBD is added to

food products as an array of cannabinoids that do not focus on one cannabinoid such as CBD, a product

such as Cannabinoid Water should be available to avoid regulatory action.

Therefore, Cannabinoid Water appears to be exempt from the above FDA opinion because it does

not contain added CBD but rather contains anhydrous hemp oil which has naturally occurring CBD amongst

other cannabinoids. To ensure that Cannabinoid Water does not run afoul of the above regulations, the

product label must not mention any particular cannabinoid, in particular, CBD. The Cannabinoid Water

label may speak to the product containing cannabinoids without making health or nutrient content claims.

After a review of the enclosed labels, there are no statements that may be linked to CBD and

therefore violate the FDA’s stance as stated above.

There appears to be minimal regulatory risks based on the enclosed labels.

This letter highlights the federal agencies that Cannabinoid Water’s label would be subject to.

Also, this letter analyzes the enclosed Cannabinoid Water labels and the FDA’s stance on added CBD

in foods.

For the reasons set forth herein, it is my analysis that Cannabinoid Water may legally market

and sell product based on a review of the enclosed labels. This opinion is based on my research of the

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above and the enclosed labels.

Sincerely,

Disclaimer

This opinion is for the above addressee. The basis of the letter are the enclosed labels. It should not be taken as legal advice for

any other. If you receive this document, it is for your reference only and should not be considered as legal advice for other than

the addressee. Please consult your attorney for legal advice before you act.

Cannabinoid Water Page 6 of 6 Attorney Client Label Opinion Letter Confidential Communication

Enclosed labels:

Label 1:

Label 2: