FDA Sets its Sights on Companies Selling Products Containing Delta-8 THC in the Latest Round of Warning Letters

May 5, 2022

Over the last several years, the U.S. Food and Drug Administration (FDA) has issued warning letters to companies selling products containing a hemp compound commonly known as CBD alleging that such products violate various provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). On May 4, 2022, the FDA issued its latest round of warning letters to companies selling products containing Delta-8 tetrahydrocannabinol (Delta-8 THC) as well. Delta-8 THC is an intoxicating compound found in hemp. Products containing hemp-derived Delta-8 THC have gained popularity following the passage of the Agricultural Improvement Act of 2018 (2018 Farm Bill), which legalized hemp. However, the 2018 Farm Bill preserved the FDA’s authority to regulate products containing hemp and their compounds under the FD&C Act. The FDA has now used its authority for the first time to pursue companies marketing and selling Delta-8 THC products.

Since 2015, the FDA has sent warning letters to companies selling CBD products that claimed to prevent, diagnose, treat, or cure medical conditions. According to the FDA, when a product is in violation of the FD&C Act, it considers many factors in deciding whether or not to initiate an enforcement action, including the threat to the public health. The FDA has generally used its finite resources to target companies making claims that their hemp-derived products treat serious health conditions because of the concern that it will discourage consumers from using other therapies with proven benefits. The FDA predominantly scrutinizes online activity of companies selling hemp-derived products to consumers. It reviews claims that companies make on their websites, blog posts, and social media accounts. Amongst hundreds, if not thousands, of companies selling hemp-derived products online, the FDA has sent a limited number of warning letters to those companies making claims that their products treat a variety of conditions ranging from pain to cancer. Once a company is under the FDA’s scrutiny, it learns that unproven health claims are not the only issue associated with selling hemp-derived products for consumption. Indeed, such products are generally in further violation of the FD&C Act and may be considered an unapproved drug, a misbranded drug, and/or an adulterated food.

Recently, the FDA published a consumer alert expressing health and safety concerns it has with products containing Delta-8 THC. The FDA has now followed up the consumer alert with the issuance of warning letters to five companies selling both CBD and Delta-8 THC products allegedly in violation of the FD&C Act. The latest round of warning letters by the FDA are a reminder of the legal challenges and risks associated with the online marketing and sale of hemp-derived products across the country.

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FDA Sets its Sights on Companies Selling Products Containing Delta-8 THC in the Latest Round of Warning Letters

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