On July 5, 2023, six companies that market edible products containing Delta-8 tetrahydrocannabinol (delta-8) received a joint cease and desist order and warning letter from the U.S. Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA or the Agency) emphasizing that the packaging of these “copycat food products” are nearly identical to common snacks that appeal to children. As such, FDA and FTC deemed these products adulterated under section 402 of the Federal Food, Drug and Cosmetic Act (FFDCA) and marketed unfairly and deceptively in violation of the Federal Trade Commission Act (FTC Act).
FDA has continuously expressed concern with products containing delta-8, stating that such products are potentially unsafe, make claims in violation of the FFDCA, and are illegally packaged and labeled in ways that may appeal to children. For example, in 2022, FDA issued a Consumer Update entitled “5 Things to Know About Delta-8 Tetrahydrocannabinol – Delta-8 THC.” In this update, FDA provided the five following statements: 1) delta-8 products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk; 2) FDA has received adverse event reports involving delta-8 THC containing products; 3) delta-8 THC has psychoactive and intoxicating effects; 4) delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace; and 5) delta-8 THC products should be kept out of the reach of children and pets.
Soon after, on May 4, 2022, FDA issued a flurry of warning letters to companies making unapproved drug claims for products containing cannabidiol (CBD) and/or delta-8 stating, in part, that such products “are packaged and labeled in ways that may appeal to children.” Then, in June of 2022, FDA released a consumer advisory regarding the risk of accidental ingestion, especially by children, of edible products that contain THC, including delta-8. More specifically, this consumer advisory spoke on certain edible products that may appeal to children as they were easily mistaken for popular, well-recognized foods and designed to mimic the appearance of well-known foods in brand name, logo, or even packaging.
With respect to these recent warning letters, FDA Principal Deputy Commissioner Janet Woodcock, M.D. again expressed “the products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, that consumers, especially children, may confuse with traditional snack foods.” Similarly, Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, stated “marketing edible THC products that can be easily mistaken by children for regular foods is reckless and illegal,” and “companies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.”
While awaiting a new regulatory pathway, FDA and FTC’s most recent actions show enforcement will continue against products that target children. Consequently, it is crucial for your company to review all marketing and promotional materials to ensure compliance with these prohibitions and avoid any potential violations.
If your company needs help determining how this new FDA development may impact your ability to sell your products, Buchanan’s experienced regulatory team is here to help.