The U.S. Food and Drug Administration (FDA) has sent warning letters to five companies that have been selling products containing the substance delta-8 tetrahydrocannabinol (delta-8 THC) marketed for medical use. The announcement, issued May 4, marks the first time that the FDA has ever had to address products containing delta-8 THC.
According to the FDA, letters were sent to ATLRx Inc., BioMD Plus LLC., Delta 8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc., for violating the Federal Food, Drug, and Cosmetic Act with their inclusion of delta-8 THC. “Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” the agency stated in the warning letter.
Delta-8 THC is one of over 100 compounds known as cannabinoids, which are produced in the Cannabis sativa L. plant in sparse amounts. More concentrated amounts of delta-8 THC can be manufactured from hemp-derived cannabidiol (CBD). This concentrated form of delta-8 THC can have psychoactive and intoxicating effects. Due to the varying legality of THC and other cannabinoids in the U.S., there are some legal products containing delta-8-THC that are available in some states in varying forms. These forms include candies, cookies, breakfast cereals, chocolates, gummies, e-cigarette cartridges, smokable hemp sprayed with delta-8-THC extract, distillates, tinctures, and infused beverages.
While it is legal in some states to sell these products as consumer goods, manufacturers and vendors are not allowed to sell delta-8 THC products as medicine. According to the FDA, “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug.”
The reason that the FDA is so adamant about approving delta-8 THC products is that the agency needs to evaluate this new drug for a myriad of criteria including:
- Appropriate dosage
- Effectiveness
- Interaction with other approved drugs
- Interactions with substances such as alcohol
- Safety concerns
- Side effects
Until these delta-8 THC products have passed FDA muster on these fronts, the drugs remain unapproved and illegal to sell as medicine. In the warning letters, the FDA discusses the illegal marketing of these delta-8 THC products as treatments for medical conditions or for therapeutic use.
FDA Principal Deputy Commissioner, Dr. Janet Woodcock, M.D., spoke about the risk of using these products, stating, “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.”
These companies have also received warning letters for their inclusion of delta-8 THC in food products, the other major domain of the FDA. According to the warning letters, delta-8 THC is an unapproved food additive that may not be used in “any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS).” Some of the foods that have had delta-8 THC added include gummies, chocolates, caramels, gum and peanut brittle.
Deputy Commissioner Woodcock noted that the addition of delta-8 THC into food by companies is “extremely troubling” because “some of the food products are packaged and labeled in ways that may appeal to children.”