The Food and Drug Administration has dropped a bombshell on a dangerous sector of America’s addiction industry.
How?
The agency recently signaled a major turn in its enforcement policies around Delta-8 THC—expanding its previous focus on going after extremely harmful kid-aimed packages of edibles onto hitting what’s inside those packages.
THE BACKGROUND
Delta-8 THC is a chemical derived from hemp that has powerful intoxicating effects. Just like Delta-9 THC (the psychoactive component in marijuana), its chemical cousin. Delta-8 was only ever available for commercial sale thanks to a loophole in the 2018 Farm Bill, which legalized hemp but failed to outlaw this chemical produced from it. That was a legislative oversight, one that had bad consequences.
The result? A dangerous gray market in which Delta-8 was added to various consumables, many of them packaged in a way to be attractive to kids (think Stony Patch Kids instead of Sour Patch Kids).
THE STORY
The agency pulled back the curtain on this welcome turn by making public a warning letter sent to THC marketplace Puredozo. Here’s some stark language from the letter itself:
FDA has determined that your Dozo D9 Smashers Peach Mango Delta-8 product is adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. It is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. 331(a).
Just so we’re clear, the agency’s position here is that Delta-8 is an adulterant under federal law, an unsafe food additive.
This is a big, key step in the fight against the commercialization of THC. The FDA has put the whole industry on notice.
And the law cited by the FDA mandates penalties including fines and even prison time for violations like the one the letter outlines.
This is not a fire drill.
SOME CONTEXT
The fact that this warning letter dates from March but was publicized the same week that the U.S. House with much greater media visibility advanced a ban aimed at closing the Delta-8 loophole—long a priority of SAM—seems far from coincidental.
Is there a significant regulatory turn on the way around dangerous hemp-based intoxicants? That’s a thread to keep a close eye on.
WHAT’S NEXT
Check out this further language in the FDA letter:
We note that your firm sells food products that contain cannabinoids other than Delta-8 THC. We know of no basis to conclude that any use in food of a cannabinoid, plant derived or otherwise, would be safe and lawful. For some cannabinoids, such as Delta-8 THC, the available data raise serious concerns about potential harm. For other cannabinoids, there is little or no available information concerning the safety of their use in food. No cannabinoid, plant derived or otherwise, is approved for any use in food as a food additive.
That is . . . pretty unambiguous. Not only is Delta-8 verboten, but no other cannabinoids are OK’d for food (which includes for the FDA’s purposes beverages as well).
It’s also unambiguously good news for every parent in America worried about dangerous drugs and their easy availability, for every kid bombarded with pro-THC messaging, and for everyone else concerned about our public health.
To follow this story, and make sure you have the resources to arm yourself in the fight for public health, stay tuned to The Drug Report and visit our parent organizations Smart Approaches to Marijuana and The Foundation for Drug Policy Solutions.