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May 5, 2022

FDA Warns Delta 8 THC Sellers for Illegal Health Claims

The FDA sent warning letters yesterday to five manufacturers of delta 8 THC, accusing the companies of making illegal therapeutic claims for their products. It is the first time the federal drug regulator has warned manufacturers of delta 8, which it says “has psychoactive and intoxicating effects and may be dangerous to consumers.”

“Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug,” the FDA Center for Drug Evaluation and Research (CDER) said in a press release. CDER is the largest FDA office, responsible for drug and medical device approvals.

The FDA doesn’t have regulatory authority over delta 8 or any cannabis product, but the agency has the power to enforce against manufacturers of any kind of product that makes unsubstantiated health claims.

The companies receiving warning letters are:

  • ATLRx Inc.
  • BioMD Plus LLC
  • Delta 8 Hemp
  • Kingdom Harvest LLC
  • M Six Labs Inc.

The FDA issued a “consumer update” last September, warning that more than 100 people have been hospitalized after using delta 8, and claiming that some delta 8 marketing is “appealing to children”—a phrase that should be familiar to both cannabis and nicotine users. The agency has previously issued warning letters to some CBD manufacturers and sellers regarding therapeutic claims made for their products.

Delta 8 THC is produced naturally in cannabis plants, but in very small quantities. Commercial delta 8 THC is made by using a chemical catalyst to convert legal hemp-derived CBD into delta 8. It is generally considered less potent than the traditional delta 9 THC found in marijuana.

Because the 2018 Farm Bill legalized hemp products containing less than 0.3 percent delta 9 THC, and the Drug Enforcement Administration (DEA) has so far chosen not to enforce against delta 8 processors and sellers, many believe the substance is federally legal. Whether it is legal or not, the cannabinoid has created a new unregulated market for intoxicating hemp-derived cannabis compounds, with manufacturers selling delta 8 THC—and delta 10 THC, HHC, THC-O and others—online and in convenience stores, gas stations, head shops and vape shops.

While state-regulated marijuana dispensaries were resigned to some competition from (non-intoxicating) hemp-derived CBD products, they have pushed back hard against the explosive open market for intoxicating hemp-derived cannabinoids, which competes with their licensed marijuana market. Using their newfound political clout, legal cannabis interests have actively supported efforts to regulate or ban delta 8 sales in some state legislatures.

The FDA warning letters are strictly concerned with marketing claims, and not with sales in general, but they probably serve as a preview of the future after marijuana is federally legalized and the FDA is given regulatory authority. It is more likely the agency will treat the cannabis market as it does the tobacco and nicotine market—with skepticism, and requiring strict oversight—than, for example, the dietary supplement market (mostly ignored).

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

The bottom line (for now) for delta 8 manufacturers: don’t make therapeutic claims and keep your advertisements subtle and vanilla.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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