On May 4, 2022, FDA announced that it had issued warning letters to five companies selling products (including gummies, capsules, tinctures, lotions, vaping products, pet products, and hand sanitizers) labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), as well as cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first time that FDA has issued warning letters for products labeled as containing delta-8 THC.

Delta-8 THC is an isomer of Delta-9 THC and is known to cause similar psychoactive and intoxicating effects. The warning letters follow reports of adverse events from consumers. The warning letters note the illegal marketing of delta-8 THC and CBD as unapproved treatments for medical conditions and therapeutic uses. The letters also cite to violations regarding drug misbranding, and the addition of delta-8 THC and CBD in foods.

The warning letters follow a consumer update from FDA in which the agency expressed its concerns regarding the potential health effects of delta-8 THC products. They also follow previous warning letters that were sent to CBD companies whose products claimed to cure, mitigate, treat or prevent various diseases.