By Megan Robertson and Gail H. Javitt
Gummies, brownies, sodas, cookies . . . consumers have been developing a growing taste for food and dietary supplement products containing cannabidiol (“CBD”) over the last few years as states have moved to legalize cannabis for medical or limited recreational use. With the passage of the 2018 Farm Bill on December 20, 2018, which legalized the cultivation of hemp for certain purposes, the CBD “edibles” industry appeared poised for further expansion.
However, developments at both the federal and state level during 2019 may put the “edibles” industry on a diet. At the state level, regulators have struggled to reconcile public health concerns and FDA policy, on the one hand, with consumer demand and industry investment on the other. The actions by Maine, Ohio, and New York City reflect the tension between these competing priorities.
- In February, 2019, Maine Department of Health and Human Services officials ordered the removal of any consumable CBD-containing product from store shelves, including conventional foods and supplement-type products (e.g., tinctures, capsules). Subsequent emergency legislation passed in March, however, limited the banned products to those containing more than 0.3% tetrahydrocannabinol (“THC”), the psychoactive component of cannabis and/or that made therapeutic or health claims.
- The Ohio Department of Agriculture similarly sought to embargo CBD-containing products, but legislation passed by that state’s legislature in July 2019 legalized hemp products, including dietary supplements and food containing hemp-derived CBD.
- Most recently, New York City’s Department of Mental Health and Hygiene ordered businesses in that jurisdiction to stop selling any foods or drinks with CBD as a food additive; the ban went into effect over the summer, and as of October 1, 2019 violations are subject to fines ranging from $200 to $600.
Actions by the FDA could take a bigger bite out of the edibles industry, depending on the agency’s appetite for enforcement. Concurrent with the passage of the Farm Bill, FDA Commissioner Scott Gottlieb released a statement cautioning that the new law did not alter the agency’s position that the addition of CBD to food or dietary supplements is unlawful. According to the statement, it is unlawful under the Federal Food, Drug, and Cosmetic (“FD&C”) Act “to introduce food containing added CBD . . . into interstate commerce, or to market CBD . . . products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as food or dietary supplements.” A newly-added FDA webpage, “FDA and Marijuana: Questions and Answers,” similarly asserts this view.
FDA’s position is rooted in two provisions of the FD&C Act, namely 21 U.S.C. §§ 331(ll) and 321(ff)(3)(B). These provisions prohibit the sale of any food or dietary supplement, respectively, that contains an ingredient that was the subject of clinical investigations or approved as a drug by FDA before the ingredient was marketed in the food or dietary supplement. FDA maintains that CBD was approved as a drug ingredient by the agency (i.e., the anti-epilepsy drug Epidiolex®) before it was marketed in food or dietary supplements, and therefore “it is a prohibited act to introduce or deliver for introduction into interstate commerce any food . . . to which . . . CBD has been added.”
FDA has sent a number of Warning Letters to manufacturers of a wide range of CBD products including dietary supplements, lotions, patches, and vape pens. One such Warning Letter was sent in March 2019 to a manufacturer of “gummies”, stating that such products are unapproved new drugs based on the claims made. Another company received a letter in September 2019 warning against its ingestible CBD-containing products, stating again that CBD products are excluded from the dietary supplement definition because CBD is an active ingredient in an approved drug product. Warning Letters issued to date have focused on products making therapeutic claims, e.g., related to treatment of arthritis, Alzheimer disease, and cancer.
FDA has acknowledged that its current policy could be changed through rulemaking. At a public hearing convened by FDA on May 31, 2019, “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds,” some stakeholders urged the Agency to develop pathways to market for CBD dietary supplements and food products, and FDA officials expressed a desire to receive detailed clinical study or testing data from companies that have already conducted research in this arena.
In addition to rulemaking, a change in FDA policy could also be mandated by Congress. In September 2019 Senate Majority Leader Mitch McConnell, who led the effort to include the hemp legalization provision in the 2018 Farm Bill, proposed language for inclusion in the appropriations bill that would require FDA to develop a temporary policy under which the agency would exercise enforcement discretion (i.e., not take enforcement action) with respect to CBD products. Draft amendment language is still under consideration by the Senate. Additionally, in June, the House approved an amendment to its appropriations bill directing FDA to establish safe CBD consumption levels and allocating funding for such purpose.
Given the uncertain and quickly changing regulatory landscape for CBD edibles, stakeholders with an interest in consumer-based CBD products—as well as in developing other hemp-derived cannabinoid compounds for the consumer market—should anticipate continued uncertainty and may want to consider engagement at the federal and state level with both regulators and legislative bodies.
Megan Robertson is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She focuses her practice on health care compliance, fraud and abuse issues, health regulatory due diligence, and medical device product marketing. Megan can be reached at [email protected].
Gail H. Javitt is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, human cellular, and tissue-based products (HCT/Ps), and dietary supplement companies throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. Gail can be reached at [email protected].