As part of its ongoing enforcement against unlawful cannabis-containing foods and dietary supplements, the U.S. Food and Drug Administration (FDA) has recently posted two new Warning Letters against cannabis marketers:
- Warning Letter to GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR (Hemp XR): and,
- Warning Letter to Discover Health, LLC d/b/a Discover CBD and Strain Snobs (Discover Health).
Both Warning Letters cite the marketers for promoting and distributing human and animal foods and dietary supplements containing (or that purport to contain) the cannabinoids delta-8 tetrahydrocannabinol (THC) and/or cannabidiol (CBD).
Background: Cannabinoids Under Federal Law
Delta-8 THC occupies a conflicting place under federal controlled substances law. The 2018 Farm Bill removed “hemp” and its derivatives from the definition of marijuana – hemp is defined as cannabis sativa containing no more than 0.3% delta THC on a dry weight basis. Cannabis sativa with more than 0.3% delta-9 THC on a dry weight basis is marijuana and illegal under federal law. Delta-8 THC, if derived naturally from hemp, is outside the controls of the federal Controlled Substances Act (CSA), even though it is intoxicating. Though the position of the Drug Enforcement Administration (DEA) is that most delta-8 THC is synthetically derived and therefore unlawful, at least one Court has taken the position that the 2018 Farm Bill legalized all hemp derivatives, including delta-8 THC. The ambiguity has led many States to ban or restrict delta-8 THC.
CBD, if derived from hemp and containing no more than 0.3% delta-9 on a dry weight basis, is lawful under the CSA.
Regardless of the legal status of delta-8 THC and CBD under the 2018 Farm Bill, the CSA, and State laws, FDA has been clear that neither substance is a lawful ingredient in foods or dietary supplements under the federal Food, Drug, and Cosmetic Act (FDC Act).
CBD-containing foods and dietary supplements are frequent targets for FDA enforcement, for example here and here. FDA issued a consumer advisory warning of the health risks of CBD and delta-8 THC: 5 Things to Know about Delta-8 Tetrahydrocannabinol; What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. The Discover Health and Hemp XR Warning Letters follow FDA and the Federal Trade Commission (FTC) enforcement in July 2023 against six marketers of delta-8 THC-containing products that were “copycats” of conventional foods.
The Hemp XR Warning Letter
The Warning Letter identifies numerous Hemp XR products in violation of the FDC Act, including Far Out Candy 500 MG Delta 8 Cookies, Not Ya Son’s Weed Bakedies Delta 8 THC 600 MG Crispy Bites, Hemp XR Delta 8 Stoner Candy Gummies, Lava Rocks 250 MG Delta 8, and others. FDA explains in the Warning Letter that delta-8 THC is an unapproved food additive, with no regulation authorizing its use in food. Substances not approved as food additives may be added to food if generally recognized as safe (GRAS). FDA states that delta-8 THC is not GRAS.
As delta-8 THC is not GRAS, it is an unapproved food additive and is deemed to be unsafe under § 409(a) of the FDC Act. Its inclusion in the Hemp RX foods causes these products to be adulterated under the FDC Act. The introduction of adulterated food into interstate commerce is prohibited under § 301(a) of the FDC Act, with potential enforcement and civil and criminal penalties.
The FDA comes to a similar conclusion with regard to Hemp XR’s CBD-containing product, Hemp XR CBD Honey 500 MG. CBD is neither GRAS nor an approved food additive and therefore, its inclusion in Hemp XR CBD Honey 500 MG causes the product to be adulterated and its introduction into commerce is prohibited under the FDC Act.
Discover Health Warning Letter
The Discover Health Warning Letter includes the same violations found in the Hemp RX Warning Letter. The marketer’s products, including Active CBD Oil Infused Coffee, Active CBD Oil Gummies, and Strain Snobs™ Delta-8 Plant-Based Gummie, contain CBD and delta-8 THC which are unapproved food additives that are not GRAS. The products are therefore adulterated human foods and their introduction into commerce is a violation of the FDC Act. In a similar manner, Discover Health’s CBD-containing pet treats and tincture products were adulterated animal foods under the FDC Act. Their introduction into interstate commerce is similarly prohibited under § 301(a) of the FDC Act.
The Discover Health Warning Letter also cited the marketer for making claims that its CBD and delta-8-containing products would treat or cure serious diseases, including cancers, post-traumatic stress disorder, and epilepsy. Only FDA-approved drugs may make such claims and Discover Health’s CBD-containing products did not hold such approvals. Therefore, the products were unapproved drugs in violation of the FDC Act and misbranded under the FDC Act. The introduction of unapproved, misbranded drugs into interstate commerce is prohibited under §§ 301(a) and (d) of the FDC Act.
Additional Observations
FDA and the Department of Health and Human Services have recommended that the Drug Enforcement Administration (DEA) down-schedule marijuana from an unlawful Schedule I controlled substance to a Schedule III controlled substance. Schedule I controlled substances include substances such as heroin and (currently) marijuana that have no accepted medical use and a high potential for abuse. Certain codeine and testosterone-containing prescription drugs are examples of Schedule III controlled substances that are deemed to have a currently accepted medical use, but their abuse may lead to moderate or low physical dependence or high psychological dependence.” See, e.g., Congressional Research Service, HHS Recommendation to Reschedule Marijuana: Implications for Federal Policy (September 13, 2023) here.
However, as discussed above, the status of marijuana, CBD, and delta-8 THC under the CSA is irrelevant to whether these substances may be lawfully added to human and animal foods and dietary supplements under the FDC Act. FDA has concluded that, as to CBD, the existing framework under the FDC Act is insufficient to regulate the ingredient in foods and dietary supplements and the agency has asked Congress for additional authority. In the meantime, FDA continues to assert the authority it does have and has repeatedly demonstrated it will take action against cannabinoid-containing products as agency resources permit.
Marketers who continue to distribute foods and dietary supplements to which CBD, delta-8 THC, and other cannabinoids have been added should take particular note of the Hemp XR Warning Letter. It has long been assumed that marketers could enjoy a “safe harbor” from FDA enforcement if they avoided making “drug-like” claims. Discover Health was cited for such claims in the Warning Letter it received. In contrast, no such claims are cited or referenced in the Hemp RX Warning Letter. FDA pursued Hemp XR solely because its CBD and delta-8 THC-containing products contained unapproved food additives even though the marketer did not claim its products would treat disease.
While all such products are at risk of FDA enforcement, that risk is heightened if the product copies traditional food formats. Hemp XR and Discover Health were marketing products labeled as candy, gummies, coffee, bites, and treats. The labeling suggests that these products are conventional food when, in fact, they contain CBD and intoxicating delta-8 THC.
Lastly, foreign manufacturers and/or importers of foods or food additives containing CBD and delta-8 THC would likely be subject to even more heightened enforcement by FDA when attempting to import a product or raw material into the U.S. This is because a food import is subject to screening by U.S. Customs and Border Protection (CBP) and FDA at the time of importation. FDA will receive a Prior Notice filing before the arrival of the imported food product. FDA then has the opportunity to review the food label and claims to establish the product’s intended use and obtain a sample upon entry to conduct an uncontestable rapid testing at the border. Similar to Discover Health, if the importer product’s claims were drug-like, the product’s intended use would be pushed into the category of an unapproved drug meriting refusal. Undoubtedly, if the sampled food product is found to contain CBD and delta-8 THC, even in legally recognized thresholds, the product is subject to FDA refusal under the FDC Act. A refusal is made publicly available through FDA, which can cause reputational harm similar to a Warning Letter.
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We expect federal cannabis policy and regulation to continue to be very active in 2024. Please contact OFW Law’s Cannabis Team – Tish Pahl (tpahl@ofwlaw.com), Denise Calle (dcalle@ofwlaw.com), or Kyla Kaplan (kkaplan@ofwlaw.com) – if you need assistance.
