Delia Deschaine Quoted in “Federal Regulators Issue Warnings About Delta-8”

This week the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention delivered a one-two punch in separate missives on the cannabinoid Delta-8, Delta-9 THC's less-potent sibling.

"It is important for consumers to be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context," the FDA said in a Sept. 14 posting on its website. "They may be marketed in ways that put the public health at risk and should especially be kept out of reach of children and pets."

The FDA said it had recorded "an uptick in adverse event reports" tied to exposure to or consumption of Delta-8.

Also on Sept. 14, the CDC issued a health advisory echoing similar concerns, warning that some consumers had mistaken an intoxicating Delta-8 product for low-THC-containing CBD.

So what's going on with these notices?

"I believe the FDA and the CDC warnings this week are intended to be a shot across the bow of persons that are marketing delta-8 THC under the auspices of it being legal 'hemp' and safe as a human consumable product," Epstein Becker Green partner Delia Ann Deschaine said in an email.

"One inference that can be drawn, here, is that FDA does not consider delta-8 THC to be GRAS (Generally Recognized as Safe) and, therefore, it cannot be included as an ingredient in food absent FDA approving it as a food additive," Deschaine said. "FDA also warns that making therapeutic claims about delta-8 products render those products unapproved new drugs, and, therefore, unlawful."

And we know that making unsubstantiated health claims about any cannabis-related product is the fastest way to get a nasty-gram from federal regulators.

"I would also expect plaintiffs’ lawyers to pick up on these notices quickly, and for us to see them in future state consumer product liability cases," Deschaine said.