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.
That said, multiple states, including New York, California, and Colorado, have passed legislation legalizing the sale of CBD food products – a position that directly contradicts the FDA’s position. Until the latest batch of warning letters, the FDA stayed mostly silent in enforcing its prohibition of CBD food products, instead focusing on health claims and products that might be considered appealing to children.
However, the latest warning letters explicitly state that CBD food products are prohibited by the FDA and “that people may confuse [them] for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.” The letters also state that “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.”
There are a number of key takeaways from the FDA’s latest warning letters:
1. This is an expansion in scope from the FDA’s prior warning letters, which focused primarily on health claims and not the form of the product. The FDA now sees CBD food products as an enforcement priority.
2. The FDA is hyper vigilant of the sale and marketing of three categories of products:
a. Delta-8 THC products
b. CBD pet products
c. CBD OTC drugs (supplements sold with health claims on the packaging, for example, “Elixicure Pain Relief”).
3. The FDA takes issue with CBD- and Delta-8-THC-infused foods that appeal to children such as candies, lollipops, and gummies.
4. The FDA expects companies to list CBD and THC as ingredients if the product contains any trace amounts.
This round of letters suggests that the FDA intends to make the sale and marketing of CBD products an enforcement priority and may be more aggressive in enforcing that priority going forward. Adding to the confusion is the fact that some of the recent FDA warning letters were sent to companies operating in states that have expressly legalized CBD food products. While the legal landscape remains murky at best, companies can help ensure that they do not become a target of the FDA by selling only products that clearly identify CBD as an ingredient, are not sold in a form/packaging that would be attractive to children, and do not make any health/medical claims.
Client Alert 2022-401