FDA issues first warning letters for delta-8 THC products

According to FDA, the products violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) by making unapproved claims to diagnose, cure, mitigate, treat, or prevent diseases.

FDA (Washington) issued warning letters to five companies for selling products containing delta-8 tetrahydrocannabinol (delta-8 THC). According to FDA, the products violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) by making unapproved claims to diagnose, cure, mitigate, treat, or prevent diseases. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods.This makes them unapproved drugs under the law. FDA has also received reports from patients who experienced adverse events after consumingproduct containing delta-8 THC, raising concerns about the ingredient’s safety. These are the first warning letters FDA has issues against delta-8 THC products.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA principal deputy commissioner Janet Woodcock, MD, in a press release. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”