Reed Smith Client Alerts

In late November, the U.S. Food and Drug Administration (FDA) sent a new round of warning letters to companies manufacturing and marketing cannabidiol (CBD) products. While the FDA has been sending warning letters to CBD companies for the last few years, those letters focus primarily on unwarranted health claims. The new round of warning letters sets its sights on CBD food products and also involves entities selling products in states that have legalized CBD food products. Is this FDA’s way of signaling a shift in or expansion of its enforcement priorities? Likely so.

Prior to 2018, industrial hemp and industrial hemp-derived compounds, such as CBD, were considered “marihuana” under federal law. Until that time, marihuana compounds were identified as Schedule 1 substances under the Controlled Substances Act of 1970, 21 U.S.C. §§ 801–971 (Ch. 13 Drug Abuse Prevention and Control) (CSA).

The Agricultural Improvement Act of 2018 (2018 Farm Bill), which became U.S. law in December 2018, expressly removed “hemp” from the definition of “marihuana” under the CSA, thereby legalizing industrial hemp and industrial hemp-derived compounds. Under the 2018 Farm Bill, hemp is defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis.”

While the 2018 Farm Bill provided the U.S. Department of Agriculture with oversight of hemp production, it also left intact the FDA’s authority over certain hemp and hemp-derived products (cosmetics, dietary supplements, food, and drugs). Since the passage of the 2018 Farm Bill, the FDA has repeatedly and explicitly stated that CBD may not be added to food and dietary supplements because under the Federal Food, Drug, and Cosmetic Act (FDCA), a food or dietary supplement may not contain ingredients that are also active ingredients in an FDA-approved drug product. The FDA has also concluded that tetrahydrocannabinol (THC) and CBD products are excluded from the dietary supplement definition under the FDCA.