The U.S. Food and Drug Administration issued warnings to companies for selling products labeled as containing Delta-8 Tetrahydrocannabinol (Delta-8 THC) in ways that violate the federal law. These are the first warning letters the FDA has issued for products containing Delta-8 THC; the psychoactive effects may be dangerous to consumers.
There are no FDA-approved drugs containing Delta-8 THC.
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Delta-8 THC is one of over 100 manmade cannabinoids, not found naturally in significant amounts.
Products containing Delta-8 THC are available in multiple forms, including candy, cookies, gummies and vape cartridges.
The warning letters were for illegal marketing of the products as unapproved treatments for various medical conditions. They also address violations related to drug misbranding and the addition of Delta-8 THC in foods, such as gummies, chewing gum and peanut brittle.
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“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.”
The FDA has serious concerns about the potential health effects of Delta-8 THC products and has received reports from consumers, health care practitioners and law enforcement of products which resulted in hospitalization or emergency room treatment.
The FDA also issued warnings about CBD products claiming to treat medical conditions in humans and animals.
The FDA issued warning letters to:
• ATLRx Inc.
• BioMD Plus LLC;
• Delta 8 Hemp;
• Kingdom Harvest LLC;
• M Six Labs Inc.
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations.
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