The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on July 16, 2024, to five companies for illegally selling and introducing into the market copycat food products containing delta-8 tetrahydrocannabinol (THC). This action marks a continuation of the joint efforts by FDA and FTC to protect consumers from unregulated, intoxicating delta-8 THC products that have “[i]nadequate or confusing labeling,” according to FDA Principal Deputy Commissioner Namandjé Bumpus, Ph.D. In these new warning letters, FDA noted that these companies have 15 business days to respond regarding how they will address the violations and prevent their recurrence. Failure to address these violations may result in additional enforcement activity, including product seizures and injunctions.

In the agency’s announcement of the new warning letters, FDA cites that, from January 1, 2021, to December 31, 2023, FDA received more than 300 adverse event reports involving children and adults who consumed delta-8 THC products. Approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products, such as candy or brownies. These adverse reports have resulted in FDA and FTC jointly warning six different companies in July 2023 for selling unregulated, intoxicating food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.