Earlier today, the Food & Drug Administration (FDA) posted 8 warning letters issued to marketers of products containing cannabidiol (CBD). Two of the companies receiving the letters were criticized for claims they made about products manufactured by CV Sciences, formerly CannaVest (OTC: CANV). Stuart Tomc, Vice President Of Human Nutrition, responded to the news, saying “CV Sciences did not receive a warning letter from the FDA and never has.” The company strongly condemns distributors of its products making health claims.
“FDA routinely sends out warning letters for drug claims, however this issue originated from an FDA Q and A online post about marijuana, not dietary supplements. Notwithstanding the FDA’s Q&A posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, thereby rendering the IND preclusion inapplicable,” said Tomc.
The FDA first raised issues about marketing CBD products when it published FDA and Marijuana: Questions and Answers last year with an update on September 30th. The memo included 21 questions, but the applicable ones to this discussion were these:
12. Can products that contain cannabidiol be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.
13. How did the FDA determine that cannabidiol products are excluded from the dietary supplement definition?
Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if an article (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.
The existence of substantial clinical investigations regarding cannabidiol has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
14. Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements?
A. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
Below is CV Sciences official response to the FDA Q&A:
In response to a question and answer page (“Q&A Posting”) posted in mid-May 2015 on the U.S. Food and Drug Administration’s (“FDA”) website relating to marijuana products, CV Sciences firmly believes that hemp-derived cannabidiol (“CBD”) falls under the definition of a dietary supplement, according to Dietary Supplement Health and Education Act 1994. In our opinion, CBD meets the definition of a supplement, as it is an extract of a botanical, and for its use by man to supplement the diet by increasing the total dietary intake.
The Q&A Posting comments that CBD cannot be sold as a dietary supplement based on “available evidence” gathered by the FDA. The “available evidence” was not made public by the FDA. Based on the FDA’s non-public evaluation, they concluded that CBD is subject to the Investigational New Drug (“IND”) preclusion regulations under the Federal Food, Drug, and Cosmetic (“FD&C”) Act.
The IND preclusion includes several requirements that must render true for a certain ingredient to be precluded from the definition of dietary supplement. First, the article must be authorized by the FDA for investigation of a new drug. Next, substantial clinical investigations must be instituted. Third, the existence of such substantial clinical investigations must be made public. Lastly, all of the above must have occurred prior to marketing the substance as a dietary supplement or food. From our investigations, all requirements to consider CBD under the IND preclusion regulations have not been adequately conducted; thus furthering our opinion that CBD is not precluded from the definition of “dietary supplement” (under Section 201 (ff)(3)(B)(ii)) of the FD&C Act).
Furthermore, the IND preclusion isn’t a new conversation with dietary supplements. In fact, Red Yeast Rice, Trans-Resveratrol, P5P, NAC, and DHEA have been subject to the same scrutiny, and continue to be sold as dietary supplements.
It is important to note that statements published on the FDA’s website may be considered one of the following: position, guideline, or policy. The Q&A Posting is not official action by the FDA; it is simply a position within a subsector to a much larger conversation. The nature of the position on CBD was published under the umbrella of Marijuana Questions and Answers, subsequently inviting solicitation and confusion from the industry. This may be considered prejudicial based on the controversial nature of the issue (marijuana cannabis vs. hemp cannabis) at hand.
Based on global demand for hemp-derived CBD, a compromise will eventually be reached, with artisanal hemp extracts sold in co-existence with pharmaceuticals, as is the case with prescription omega-3 fish oils and commercially available omega-3 offerings.
In fact, CV Sciences has committed itself to pursuing both:
1) hemp-derived CBD for use in a wide range of consumer products including nutritional supplements, specialty foods and beauty products; and,
2) proprietary therapeutics, using CBD as the active pharmaceutical ingredient, across multiple medical indications. Our development pipeline currently includes two preclinical programs.
Notwithstanding the FDA’s Q&A Posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, as the investigations that were publicized were not substantial, due to being limited in number and preliminary in nature, thereby rendering the IND preclusion inapplicable.
