The US Food and Drug Administration (FDA) has issued another round of warning letters involving numerous products for human and animal use containing cannabidiol (CBD) and delta-8 tetrahydrocannabinol (THC). And, in a sign that it is also focusing on cannabis products with significant risk of youth appeal, it has released a consumer warning about the accidental ingestion by children of food products containing THC – including edible products with “copycat” packaging simulating the look of popular, well-recognized kids’ cereals and snacks.
While FDA’s enforcement activity against CBD-containing products largely began in 2015, the agency more recently began taking enforcement action against delta-8 THC products.
Overall, FDA appears to have adopted a more aggressive enforcement strategy toward delta-8 THC products than it has for CBD products, given the psychoactive effects of delta-8 THC, and FDA enforcement against both CBD and delta-8 THC products is expected to continue, as is activity against products that carry significant risk of youth appeal.
Legal/regulatory status of cannabis, CBD, and delta-8 THC
Marijuana, and its derivatives, is a Schedule I drug under the Controlled Substances Act (“CSA”) and is illegal to possess or distribute under US federal law. This classification extends essentially to “all parts of the plant Cannabis sativa L,” as well as synthetic equivalents and extracts. THC and CBD are two among of many cannabis extracts.
The Agricultural Improvement Act of 2018 (the 2018 Farm Bill) removed “hemp”(defined as any cannabis plant or extract with a delta-9 THC “concentration of not more than 0.3 percent on a dry weight basis”) from Schedule I of the CSA. At the time the Farm Bill was passed, there were generally two versions of cannabis in the US: (1) marijuana (cannabis with a delta-9 THC concentration greater than 0.3 percent) and (2) hemp (cannabis with a delta-9 THC concentration of 0.3 percent or less).
While the 2018 Farm Bill focused on hemp, and related delta-9 THC levels, it did not expressly address delta-8 THC. In 2019, delta-8 THC products began proliferating, due to a perception that it potentially falls within the 2018 Farm Bill CSA exclusion.
Delta-8 THC, like delta-9 THC, is a psychoactive substance found in the Cannabis sativa plant. Unlike delta-9 THC, delta-8 THC is not found in significant amounts in the cannabis plant (including hemp), and delta-8 THC products are usually manufactured from concentrated amounts of delta-8 THC that are manufactured from hemp-derived CBD.
The status of delta-8 THC under the CSA is unclear. On one hand, some have argued that the manufacture and distribution of any hemp-derived products with a concentration of delta-9 THC no more than 0.3 percent – including products with high concentrations of delta-8 THC – are exempt from the CSA because they fall under the 2018 Farm Bill’s exclusion of hemp from Schedule I. On the other hand, it is possible that because delta-8 THC is converted from CBD through the use of a catalyst, it is a synthetically derived THC, and therefore is a Schedule I controlled substance. Further, and despite the lack of federal regulation or enforcement, several states have restricted or banned delta-8 THC.
Regardless of the status of CBD or delta-8 THC under the CSA, the 2018 Farm Bill explicitly preserved FDA’s authority to regulate products with cannabis or cannabis derived products under the Federal Food, Drug and Cosmetic Act (FD&C Act). As FDA’s recent enforcement activity has made clear, FDA has elected to exercise that authority, particularly where products and associated benefit statement claims are aggressively touting disease, treatment, or curing claims, and is expected to continue to do so. Also, FDA has issued public advisories expressing its concern about serious health risks associated with delta-8 THC.
FDA’s recent warning letters
FDA issued five warning letters to five different companies for marketing products with such names as Delta 8 Chocolate, CBD Sleep Gummies, CBD Pain Relief Cream, CBD Fair-Trade Coffee, CBD Pet Treats, and Magnolia Botanicals CBD Canna Rocks Popping Candy. In the letters, FDA identified several violations of the FD&C Act, including:
- Unapproved new human drugs: A product can become an unapproved new drug when a claim made in marketing shows the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure or any function of the body. Pulling from its investigation of product websites and company social media websites, FDA called out several claims that rendered products new drugs (that were not permitted to be marketed as such):
- “Whether you have a hectic mind or suffer from an anxiety disorder, Delta 8 THC gummies can provide relief to calm down the mind.”
- “Delta-8-THC has also been shown to be effective at killing cancer cells, making it doubly effective for cancer patients.”
- “High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”
- “CBD Reduces Need for Opioid Use in Pain Treatment.”
- Use of CBD in conventional foods and dietary supplements: Under what is known as the “exclusionary rule,” food, including animal food, cannot be introduced into interstate commerce where (1) an approved drug under Section 505 of the FD&C Act has been added to the food or (2) the food contains a substance for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. The same applies for dietary supplements. Because CBD is the active ingredient in the approved drug product Epidiolex® (in addition to substantial, public clinical investigations involving CBD), FDA found that the use of CBD in conventional foods and dietary supplements adulterated these products.
- No recognition of safety for delta-8 THC nor for CBD in food: For food additives, the FD&C Act requires premarket approval based on data demonstrating safety, and the inclusion of an additive without approval for its intended use in food renders the product unsafe and causes the food to be adulterated. FDA explained that the use of delta-8 THC and CBD qualifies as a food additive, and currently no food additive regulation has authorized the use of CBD or delta-8 THC, nor is there sufficient information available about CBD or Delta-8 THC that would qualify either for generally recognized as safe (GRAS) status.
- Unapproved new animal drugs: As with human drugs, a product can become an unapproved new animal drug where a claim made in marketing shows the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or is intended to affect the structure or any function of the body if an animal.
- Risk of youth appeal: FDA also noted its concern with products that may appeal to children, such as gummies and candies. In other public statements, FDA has noted that “[t]hese products may be purchased online, as well as a variety of retailers, including convenience stores and gas stations, where there may not be age limits on who can purchase these products.” FDA has also found that “there have been numerous poison control center alerts involving pediatric patients who were exposed to delta-8 THC-containing products.”
FDA’s enforcement activity against CBD and delta-8 THC products is expected to continue. Overall, with respect to CBD and delta-8 THC, FDA’s enforcement has consistently focused on several primary areas: (1) the use of CBD in food and dietary supplement products (and the applicability of the “exclusionary rule”); (2) unsubstantiated health claims; (3) and the potential appeal of these products to youth. FDA’s actions against delta-8 THC products with high risk of youth appeal will likely become more aggressive.
FDA also continues to gather knowledge about the safety profile of CBD and other cannabis-derived compounds to inform the Agency’s decision-making and enforcement discretion.
This is an evolving area of law. To learn more about these developments and their implications for your business, please contact any of the authors.
 See 21 U.S.C. § 802(16).
 See 21 C.F.R. § 1308.11(d)(31), (d)(58).
 See 7 C.F.R. § 990.1.
 Agricultural Improvement Act of 2018, Pub. L. 115-334 (enacted Dec. 20, 2018).
 See Drug Enforcement Admin., Implementation of the Agriculture Improvement Act of 2018, 85 Fed. Reg. 51,639 51,641 (Aug. 21, 2020).
 Warning Letter to ATLRx, Inc. (May 4, 2022); Warning Letter to BioMD Plus LLC (May 4, 2022); Warning Letter to Delta 8 Hemp (May 4, 2022); Warning Letter to Kingdom Harvest (May 4, 2022); Warning Letter to M Six Labs, Inc. (May 4, 2022).