The U.S. Food and Drug Administration issued warning letters to five companies for selling products containing delta-8 THC in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.
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.
Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived CBD and have psychoactive and intoxicating effects for some consumers.
Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges, dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.
"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, M.D.
"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."
The FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The FDA 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 hospitalization or emergency room treatment.
In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods. CBD and delta-8 THC are unapproved food additives for use 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 or otherwise exempt from food additive requirements.
One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.
The FDA issued warning letters to:
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.
The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
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.
Photo: Courtesy of PRNewsfoto/FDA
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