FDA Issues First Batch of Warning Letters to Delta-8 THC Product Manufacturers

Friday, May 6, 2022

Source: Cannabis Business Times

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters over the past several years to CBD companies, most recently calling out a group of businesses for claiming that their products can cure, treat or prevent COVID-19.

Now, the federal agency is setting its sights on the delta-8 THC space.

The FDA issued warning letters to five companies May 4 “for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act),” according to a press release.

The warning letters, issued to ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC and M Six Labs Inc., also cite CBD-related violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting them as dietary supplements, and adding CBD to human and animal foods.

“FDA’s announcement … that it had issued warning letters to five marketers of delta-8 THC is significant, although not all that unexpected,” Jonathan Havens, co-chair of the Cannabis Law Practice and the Food and Beverage Practice at Saul Ewing Arnstein & Lehr, told Cannabis Business Times. “However, the five warning letters represent the first enforcement actions taken by FDA against delta-8 marketers.”

The agency stated in its announcement that there are no FDA-approved drugs containing delta-8 THC, and that it considers any delta-8 product that claims to diagnose, cure, mitigate, treat or prevent diseases an unapproved new drug.

“The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns,” the release stated.

In addition to addressing the illegal marketing of delta-8 THC products as unapproved treatments for medical conditions or other therapeutic uses, FDA officials said in the release that the warning letters also cite violations related to the misbranding of drugs—such as not including adequate directions for use—and the addition of delta-8 in food products.

“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 public statement. “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. 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.”

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The FDA published a consumer update about delta-8 THC in September 2021 to express concerns about the potential health effects of delta-8 products.

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