The FDA has warned five companies for marketing products containing delta-8 tetrahydrocannabinol (delta-8 THC) as therapies for various medical conditions and other purposes, the agency announced on Wednesday.
Delta-8 THC is a psychoactive substance, typically manufactured from hemp-derived cannabidiol (CBD), which carries intoxicating effects, according to the FDA, and there are no approved drugs containing the ingredient.
The warnings mark the first ever for sales of delta-8 THC products, which the agency said violate the Federal Food, Drug, and Cosmetic Act. The move follows multiple reports of patients experiencing adverse events after consuming such products, some of which required hospitalization or treatment at the emergency department.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” Janet Woodcock, MD, the agency’s principal deputy commissioner, said in a statement. “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.”
For example, of the five companies in question — ATLRx, BioMD Plus, Delta 8 Hemp, Kingdom Harvest, M Six Labs — one promoted delta-8 THC’s “antitumor” properties and marketed its use as an antiemetic for children undergoing chemotherapy. Some of the companies’ products containing delta-8 THC included candy, cereal, chocolate, cookies, gummies, infused beverages, and vaping cartridges, among others.
“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children,” added Woodcock. “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.”
In addition to the delta-8 THC warnings, several of the companies were warned for marketing CBD as a dietary supplement, and for adding CBD to food for humans and food-producing animals. Neither CBD nor delta-8 THC are approved as food additives for use in any human or animal foods.
Only one CBD-derived drug, Epidiolex, is approved by the FDA for treating seizures from Lennox-Gastaut or Dravet syndromes and tuberous sclerosis complex.