The U.S. Food and Drug Administration for the first time sent warning letters to five companies on Wednesday that are producing Delta-8 THC products from hemp in “ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
These products, which cause a high but are derived from hemp, which is now federally legal, have created a sizable regulatory gray area as they’ve hit shelves from coast-to-coast.
“There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug,” the FDA said in an announcement about the warning letters.
These companies, the FDA noted, are advertising and selling a wide range of delta-8 THC products, including “candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.”
The five companies are ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. 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,” FDA Principal Deputy Commissioner Janet Woodcock said in a statement. “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.”
The 2018 Farm Bill legalized hemp, defined as cannabis plants containing .3% THC or less. But, it turns out that even the CBD from hemp can be turned into what are called THC isomers, like delta-8 and delta-10, and, unlike CBD, these produce a high. And, the Administration has received reports of adverse events and potential for children to find these products appealing for consumption.
“The FDA has been discussing concerns about delta-8-THC with other federal agencies, as well as our state, local, territorial, and tribal partners,” FDA spokesperson Shannon P. Hatch told Cannabis Wire.
States have taken widely different regulatory approaches to these products, from outright banning them to taking a hands-off approach, leading to a patchwork of rules and regulations from state to state. Meanwhile, the FDA continues to collect data on CBD as they craft rules to guide the CBD industry.
The FDA is unequivocal that delta-8 THC products are “unapproved new drugs sold in violation” of parts of the Federal Food, Drug, and Cosmetic Act, and that companies “introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.”
The FDA also published a consumer update last September on the Administration’s “serious concerns about the potential health effects of delta-8 THC products.” The FDA’s consumer update came in tandem with the Centers for Disease Control and Prevention’s first health advisory on the unregulated and therefore potentially harmful nature of delta-8 THC products.
Meanwhile, New York regulators issued a reminder letter to Cannabinoid Hemp license holders and applicants this week regarding delta-8 THC and delta-10 THC products.
“New York State will continue to enforce product safety standards in our state’s hemp program even if the federal government does not,” Office of Cannabis Management spokesperson Aaron Ghitelman told Cannabis Wire.
“If unlicensed growth and sales of these products don’t stop, they will face consequences from fines to losing existing licenses to running the risk of not getting adult-use licenses to join the market when it opens.”
Editor’s note: This story has been updated with comment from the FDA.