Overview
The US Food and Drug Administration (FDA) has recently taken significant steps toward establishing a regulatory framework for cannabis and cannabis-derived products. This framework will impact many of the products subject to FDA jurisdiction, but particularly food, including dietary supplements and animal food. Recognizing the widespread interest in the incorporation of cannabis and its derivatives in products under FDA's jurisdiction, Commissioner Scott Gottlieb announced[1] several new FDA actions on April 2, 2019:
- A public hearing on May 31, 2019, and an opportunity for written comment;
- The issuance of warning letters, including joint letters with the Federal Trade Commission (FTC);
- The formation of a high-level internal agency working group; and
- Updates to FDA's website with frequently asked questions.
Commissioner Gottlieb reiterated FDA's current stance that products containing cannabis or cannabis-derived compounds are treated like any other FDA-regulated product. It remains unlawful to introduce food containing added cannabidiol (CBD) or tetrahydrocannabinol (THC) into interstate commerce, to market CBD or THC products as dietary supplements, or to market these products as drugs without FDA prior approval. Even as FDA emphasizes its authority over products containing cannabis and its derivatives, the Agency is moving toward clearer boundaries on bringing new products to market. Please let us know if you would like more information on FDA regulation of consumer products containing cannabis and its derivatives or would like to submit comments to FDA regarding such regulations.
1. Public Hearing and Written Comments
FDA will hold a public hearing[2] on May 31, 2019 to receive input on how FDA can and should regulate consumer products containing cannabis and its derivatives to make marketing these products more predictable and efficient. In addition to the public hearing, electronic or written comments will be accepted until July 2, 2019.
2. Warning Letters
In coordination with the Federal Trade Commission (FTC), FDA has issued Warning Letters to three companies marketing dietary supplements containing CBD with disease claims.[3] The types of claim addressed by these Warning Letters include: CBD may prevent or slow the progression of Alzheimer's or rheumatoid arthritis, or that CBD treats depression, cancer, and schizophrenia. FDA's position has consistently been that such claims are appropriate only for FDA-approved pharmaceutical products and are not appropriate structure/function claims for dietary supplements.
Nevertheless, while these Letters are consistent with long-standing FDA policy, these actions by FDA and FTC underscore that both agencies are prepared to enforce federal laws and regulations against products containing cannabis and cannabis-derived products that the agencies believe represent a potential risk to public health and safety.
3. FDA Working Group
FDA is forming a high-level internal agency working group to explore pathways for the lawful marketing of dietary supplements and/or conventional foods that contain CBD. The working group plans to begin sharing information and/or findings with the public as early as summer 2019.
4. FAQ Website
FDA has updated its website[4] to include frequently asked questions and answers regarding the agency's regulation of cannabis and cannabis-derived products. The website currently contains 26 questions and answers on a variety of issues, such as the 2018 Farm Bill,[5] FDA approval of CBD drug products other than Epidiolex,[6] and the agency's reaction to states allowing the sale of cannabis for medical uses.
In sum, while continuing to reiterate its regulation of products containing cannabis and its derivatives, FDA is taking some steps toward establishing clear boundaries on bringing new products to market. Please let us know if you would be interested in submitting comments on how FDA should regulate consumer products containing cannabis and its derivatives, or would like more information on FDA's regulation of such products.
[1] FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency's continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products (Apr. 2, 2019).
[2] See 84 Fed. Reg. 12,969.
[3] Warning Letter from FDA & FTC to Advanced Spine and Pain, LLC (d/b/a Relievus) (Mar. 28, 2019).
[4] FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers (last updated Apr. 3, 2019).
[5] Agriculture Improvement Act of 2018, Pub. L. No. 115-334 (2018).
[6] In June 2018, Epidiolex became the first FDA-approved drug that contains a purified drug substance derived from marijuana.
