The U.S. Food and Drug Administration (FDA) issued warning letters to five companies selling products with Delta-8 tetrahydrocannabinol (THC) as health products.
This is the first time the FDA has issued warning letters for products containing Delta-8 THC. They say 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.
Delta-8 THC products claiming to have health benefits are considered an unapproved new drugs. The FDA has not evaluated whether these unapproved drug products are effective, what an appropriate dose is, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.
Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant. Concentrated amounts of Delta-8 THC are manufactured from hemp-derived Cannabidiol (CBD) and have psychoactive and intoxicating effects.
Products containing Delta-8 are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, and smokable hemp sprayed with Delta-8-THC extract, distillate, tinctures, and infused beverages.
The warning letters address the illegal marketing of unapproved Delta-8 THC products as producing health benefits.
The letters also cite violations related to drug misbranding where products lack dosage instructions and the addition of Delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.
“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.
“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,” she added.
The FDA has published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. They have received adverse reports involving products containing Delta-8 THC from consumers, healthcare practitioners, and law enforcement.
Some of them resulted in the need for hospitalization or emergency room treatment.
Violations related to FDA-regulated products containing Delta-8 THC, several of the warning letters outline additional violations of the Federal Food, Drug, and Cosmetic Act (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.
They said CBD and delta-8 THC are unapproved food additives for use in human or animal food products, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe
One of the letters expressed concerns regarding giving CBD to animals raised to produce food since they said there is little data on safe CBD residue levels.
The FDA issued warning letters to:
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, violating the FD&C Act. In some cases, there were further violations because CBD was added to food products. 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.
There has been a rising concern about Delta-8 for some time.