FDA sends alert to Delta-8 THC companies

Earlier today, U.S. Food and Drug Administration (FDA) officials issued warning letters to the heads of five companies that manufacture delta-8 THC products. The letters primarily concerned the marketing of health claims for the products in question.

In recent years, the booming popularity of delta-8 THC products has raised questions about the legality of THC products derived from federally legal hemp. Today’s FDA letters do not address the legal status of Delta-8 or other hemp-derived cannabinoid products.

Instead, the warnings continue a consistent pattern in which FDA officials defend their turf against the marketing of health claims. Similar warnings have been issued to companies that manufacture CBD products over the years.

Unapproved products may not be advertised as medicinal products

“The warning letters address the illegal marketing by companies of unapproved delta-8-THC products as unapproved treatments for various medical conditions or for other therapeutic purposes,” FDA officials said in a news release today.

Essentially, these letters are telling the delta-8 THC companies: Stop making medical claims about your products. Under FDA regulations, only products that pass the agency’s testing requirements may be marketed with certain health claims.

The five companies named in the FDA letters are:

FDA ‘very concerned’ about D-8 products

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” said Janet Woodcock, FDA’s Principal Deputy Commissioner. “These products often include claims that they treat or alleviate the side effects of a variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety.”

“It is extremely worrying,” added Woodcock, “that some of the food is packaged and labeled in a way that is appealing to children. We will continue to protect the health and safety of Americans by monitoring the marketplace and taking action when companies are illegally selling products that pose a risk to public health.”

Woodcock’s reference to products that “might appeal to children” was not supported by any evidence in the current round of warning letters. The concern could be based on a general belief that products presented as gummy bears could potentially appeal to children. Gummies have been marketed as candies for generations, but they’ve also been used as a delivery method for adult vitamins for at least a decade.

Related

The FDA is concerned about CBD. Should you be concerned?

Learn more about Delta-8-THC

Bruce Barcott

Leafly senior editor Bruce Barcott oversees news, investigations and feature projects. He is a Guggenheim Fellow and the author of Weed the People: The Future of Legal Marijuana in America.

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