Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant, the FDA says, and it has psychoactive and intoxicating effects.
Delta-8 is legal at the federal level because it falls within an approved amount of hemp-derived products allowed in the 2018 Farm Bill. However, there are no FDA-approved drugs containing delta-8 THC, the agency says.
Products containing delta-8 are sold in varying forms, like candy, cookies, gummies, and tinctures.
The warning letters claim the companies are illegally marketing the drugs with a promise of relief for various medical conditions.
“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.
The companies were also warned about what the FDA says is a lack of adequate direction for use.
These are the companies that were sent letters:
Several of the companies were also warned about CBD marketing.
The companies have 15 working days to file a written response on how they will correct the violations.