2893 Executive Park Drive Suite 203 - Mr. Checkout
Transcript of 2893 Executive Park Drive Suite 203 - Mr. Checkout
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: [email protected]
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.
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Enclosed labels:
Label 1:
Label 2: