FDA and FTC Issue Warning Letters Over Misleading Delta-8 THC Products Resembling Popular Snack Brands

FDA and FTC Issue Warning Letters Over Misleading Delta-8 THC Products Resembling Popular Snack Brands

The market for delta-8 THC and other novel cannabinoids has grown rapidly since the legalization of hemp and its derivatives under the 2018 Farm Bill. While the FDA and FTC have generally exercised discretion in enforcing regulations against businesses selling CBD or delta-8 products, they are targeting those that engage in misleading packaging or make false medical claims.

The warning letters address two aspects of federal law. First, they allege violations of the Federal Food, Drug and Cosmetic Act (FDCA) due to the presence of unapproved "additive" delta-8 tetrahydrocannabinol. Secondly, the letters highlight the packaging of these products, which mimic popular food brands and can be easily mistaken for regular snacks, potentially leading to accidental ingestion by children. The FDA emphasizes that children are more susceptible to the effects of THC and cites cases of illness and hospitalization resulting from the consumption of edibles containing THC.

The FDA Principal Deputy Commissioner, Janet Woodcock, expressed concern about the dangers these products pose, stating that young children could inadvertently ingest them in high doses without realizing the consequences. The FDA is committed to taking action against companies illegally selling regulated products that could harm public health.

The warning letters were sent to Delta Munchies, Dr. Smoke LLC, Exclusive Hemp Farms/Oshipt, Nikte's Wholesale LLC, North Carolina Hemp Exchange LLC, and The Haunted Vapor Room. The FDA reports receiving reports of "serious adverse events" related to delta-8 product consumption and expresses concern about potential harmful contaminants in the production process.

By issuing these warning letters, the FDA and FTC aim to address both the unapproved use of delta-8 THC as an additive and the marketing practices that could lead to unintentional consumption by children. The companies that received the letters must respond within 15 days, either contesting the claims or outlining steps they are taking to comply with regulations and cease sales of the specific products. Failure to address the violations may result in legal action, such as product seizure or injunction.

While the FDA has taken action against a limited number of businesses, it continues to face criticism for its decision not to establish regulations allowing for the lawful marketing of CBD in food or as dietary supplements. The agency states that such rulemaking requires congressional attention. There have been efforts by lawmakers to bridge this regulatory gap, including the reintroduction of bills by Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN) aimed at providing a pathway for the regulation of hemp derivatives as dietary supplements and food additives.

In addition to the delta-8 THC warning letters, the FDA has faced pressure to address CBD regulations. Rep. James Comer (R-KY) initiated an investigation into the agency's lack of action on CBD regulations, while Rep. Andy Harris (R-MD) criticized the FDA for disrupting public confidence through its inaction.

The FDA has previously sent warning letters to companies selling CBD-infused foods and beverages, focusing on products that could be easily confused with traditional foods or beverages, leading to unintended or excessive CBD consumption.

As the FDA conducts a scientific review of marijuana, directed by President Joe Biden, to assess its federal scheduling, the agency released draft guidance on studying psychedelics as potential therapies. The DEA is also expected to propose new rules prohibiting synthetically manufactured cannabinoids like delta-8 THC, although natural constituents found in cannabis are currently uncontrolled. Overall, the FDA and FTC's joint effort to issue warning letters aims to address

the unlawful sale of "copycat" delta-8 THC products resembling popular food brands. The agencies are concerned about misleading packaging and potential risks, especially to children, and have urged the companies to respond and take appropriate action to comply with regulations.