FDA sends warning to delta-8 THC companies

Published on May 4, 2022
image of delta-8 consumer and vapor
Delta-8 THC offers a milder experience than Delta-9 THC, and it's often legal in places where Delta-9 isn't. (Illustration: Joshua Titus / Leafly)

Officials at the U.S. Food and Drug Administration (FDA) issued warning letters earlier today to the leaders of five companies that manufacture delta-8 THC products. The letters primarily addressed 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 on the marketing of health claims. Similar warnings have been issued over the years to companies making CBD products.

You can’t advertise non-approved products as medicine

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

In essence, these letters tell the delta-8 THC companies: Stop it with the medical claims for your products. Under FDA rules, only products that have passed the agency’s testing requirements may be marketed with specific 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 FDA Principal Deputy Commissioner Janet Woodcock. “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.”

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“It is extremely troubling,” Woodcock added, “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.” 

Woodcock’s reference to products that “may appeal to children” was unsupported by any evidence in the current round of warning letters. The concern may be rooted in a general assumption that products presented as gummies could potentially appeal to children. Gummies have been marketing as candy for generations, but they have also been used as a delivery method for adult vitamins for at least a decade.

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

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