The U.S. Food and Drug Administration has issued warnings to five companies selling products that contain a powerful cannabis compound, claiming that the companies are marketing unapproved new drugs and making unsupported claims about the health benefits involved.
The compound, Delta-8 THC, is one of more than 100 cannabinoids produced in cannabis plants, but it is not found naturally in significant amounts. Concentrated versions of Delta-8 THC are typically manufactured from hemp-derived cannabidiol, known as CBD. Many CBD-infused food, drink, and beauty products are available online and contain only trace amounts of THC, the psychoactive ingredient in marijuana. But the FDA is concerned that the Delta-8 products, which range from candy, cookies, gummies and chocolate to vape cartridges, lotions, and infused beverages, can have psychoactive and intoxicating effects.
The FDA has received “adverse event reports” from consumers who have used products containing Delta-8, as well as from healthcare providers, law enforcement, and poison control centers. Some of the cases have resulted in hospitalization or emergency room treatment.
“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, in a statement announcing the warning letters. “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.”
In addition to citing concerns about unapproved Delta-8 products, several of the warning letters outline additional violations of the federal Food, Drug, and Cosmetic Act involving the marketing of CBD products as dietary supplements, food additives, or to treat medical conditions in humans and animals. The FDA has previously sent warning letters to other companies for illegally selling unapproved CBD products that claimed to diagnose, cure, prevent or treat various diseases. The FDA has not approved any CBD product other than one prescription human drug product used to treat rare forms of epilepsy.
The companies targeted by the latest warning letters have 15 days to respond. Failure to address the violations could result in legal action, including product seizure or an injunction against further sales.
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