Marijuana Regulatory Update: FDA Issues Warning Letters to CBD Dietary Supplement Companies

Feb 29, 2016   

In 2015, the U.S. Food and Drug Administration (“FDA”) took steps to curtail the use of cannabidiol (CBD) in dietary supplements. CBD is a non-narcotic component of Cannabis sativa. As we blogged last year (click here to read our 2015 Marijuana Regulatory Update), FDA published its “FDA and Marijuana Questions and Answers” (“Questions and Answers”) announcing that CBD cannot be marketed as a dietary supplement because CBD is the subject of at least one FDA-regulated clinical investigation. Prior to its “Questions and Answers,” in February of 2015, FDA issued warning letters to six companies marketing products claiming to contain CBD for various violations, primarily related to the claims made about the products on company websites and the intended uses ascribed to the CBD products targeted.

Fast forward to February of 2016 and FDA has issued numerous new warning letters to companies marketing CBD products as dietary supplements. These recent warning letters represent FDA’s first enforcement of the policies announced in the agency’s “Questions and Answers.” A sampling of the warning letters can be viewed here, here, here, and here. All were issued by FDA’s Center for Food Safety and Applied Nutrition, FDA’s food safety and compliance center. One of the letters clearly re-states FDA’s policy on this subject:

You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) 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 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 CBD.

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1]. 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. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act, but you may present the agency with any evidence that has bearing on this issue.

In each of the new warning letters, FDA identifies claims made about the CBD products at issue and cites the claims as evidence that these products are unapproved new drugs. Notably, the claims cited by FDA are claims made not just on the company websites but also on company social media pages such as Pinterest, Etsy, Facebook, and Twitter.

This fresh wave of enforcement action evidences a new enforcement trend, that FDA will focus not only on CBD-containing products but also on social media advertising of these products. Stakeholders in the dietary supplement and marijuana industries must be aware of the high level of regulation surrounding their industries and govern themselves accordingly to protect their businesses.

The regulatory attorneys at FIDJ continue to stay abreast of these developing areas of law. Please contact us with questions or concerns on these topics,