Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced that it has issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA said this is the first time warning letters have been issued for products containing delta-8 THC, which FDA said has psychoactive and intoxicating effects and may be dangerous to consumers.
FDA recently published a consumer update outlining its concerns regarding potential health effects of delta-8 THC products. The agency reported that it has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for medical treatment. The agency also noted that the national poison control centers is receiving increasing number of exposure cases involving products containing delta-8 THC, and that alerts issued by state poison control centers have increased.
Delta-8 THC (one of over 100 cannabinoids produced in the Cannabis sativa L. plant) is not found naturally in significant amounts, FDA stated, and concentrated amounts seen in products such as gummies and vape cartridges are typically manufactured from hemp-derived cannabidiol (CBD).
There are no FDA-approved drugs containing delta-8 THC, the agency explained, and any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug that has not been evaluated by the agency to determine effectiveness for the uses manufacturers claim, nor for appropriate dose, potential interactions, or dangerous side effects and safety concerns.
The warning letters address the illegal marketing of unapproved delta-8 THC products and cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, including those that may appeal to children, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.
Related: FDA Shares “5 Things to Know” about Delta-8 THC U.S. Hemp Authority Won’t Certify “Hemp” Products Marketed for Intoxication
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide," said FDA Principal Deputy Commissioner Janet Woodcock, M.D. "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. 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.”
Violations noted in the letters include:
- marketing CBD products claiming to treat medical conditions in humans and animals
- promoting CBD products as dietary supplements
- adding CBD to human and animal foods. FDA explained that CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, and the agency is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.
Warning letters were issued to: ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc. The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.