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Five companies targeted in first FDA warnings over delta-8 THC products

Janet Woodcock, FDA Principal Deputy Commissioner
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The U.S. Food and Drug Administration (FDA) today warned five companies over what it calls the illegal sale of products containing delta-8 THC.

Companies receiving warning letters were ATLRx Inc., Alpharetta, Georgia; Bio MD Plus LLC, Marietta, Georgia; Delta 8 Hemp, Los Angeles; Kingdom Harvest LLC, Hendersonville, North Carolina; and M Six Labs Inc., Saukville, Wisconsin.

FDA Principal Deputy Commissioner Janet Woodcock said the agency “is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide.”

Appealing to kids

“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,” Woodcock said, adding: “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children.”

FDA also warned all five companies to stop health-based marketing claims for CBD. The agency started sending out CBD warnings in 2019 and since that time has cited a number of companies over such claims.

FDA and CBD

FDA rules bar the marketing of cannabis derivatives in food products, with both CBD and delta-8 THC unapproved for human and animal consumption. Despite repeated calls for regulations from CBD stakeholders, the agency has yet to comprehensively address the compound’s legality, saying more research is needed.

Some stakeholders have said CBD may only find a legal path to market through legislation after the FDA last August rejected two food safety applications by a pair of major U.S. sellers, citing a clause in the Food, Drug & Cosmetic Act that prohibits supplements from containing pharmaceutical ingredients. CBD is the active ingredient in Epidiolex, which is approved by the FDA, but as a drug. CBD is otherwise unapproved.

Grappling with delta-8

States all over the USA are meanwhile grappling with delta-8 THC, which is unregulated by the U.S. Drug Enforcement Administration and falls into a legal gray area. Some states have outlawed the compound altogether while others are treating it under rules guiding products that carry delta-9 THC, the more common form of THC derived from marijuana plants.

Proponents of delta-8 THC have argued that the compound is a legal derivative of hemp, which was legalized federally under the 2018 Farm Bill. But regulators have pushed back because delta-8 THC is not derived from the hemp plant in a natural manner.

Gummies to pet treats

Products containing delta-8 THC that were cited in the letters issued today included gummies, chocolates, caramels, capsules, chewing gum, peanut brittle, sugar, candy, syrup and vape cartridges.

CBD products mentioned in the warning letters included capsules, gummies, coffee, tea, CBD oils and treats for pets, hand sanitizer and a range of topicals.

The letters urged the companies to ensure they comply with federal law and FDA regulations, and warned they could face “legal action including, without limitation, seizure and injunction” for failing to do so. The companies have 15 days to reply.

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