(Silver Spring, Maryland) Today, the Food and Drug Administration (FDA) issued several warning letters to CBD and THC companies who are illegally selling and marketing products for human and animal use containing Delta-8 tetrahydrocannabinol, also known as Delta-8 THC, and infusing them in gummi bears and other candies, pet products, oils, and other foods.
Dr. Kevin Sabet, President and CEO of Smart Approaches to Marijuana, issued the following statement in response to the FDA’s actions:
“We commend the FDA for taking this swift and decisive action.
No one should be shocked at the unethical and illegal practices of the marijuana industry and its quest for profits. By promoting and selling harmful and unsafe products, the marijuana industry continues pushing outlandish health and wellness cures and claims with zero evidence.
“This is the same story that we saw a decade ago when high-potency THC products became more common in the market. High-potency THC products don’t exist in nature—they were created in a lab by profit-seeking corporations and can be engineered to contain up to 99% THC. These products have no benefit; in fact, we know these products actively harm users, especially young users with developing brains.
“These dangerous products contain Delta-8 and Delta-9 THC for one reason: because there is money to be made. I am grateful to the FDA Office of Compliance for their attention to this issue. I ask that the FDA continue this work holding these companies accountable.”
Delta-8 THC is an isomer of Delta-9––the two are practically the same, with only slight molecular differences. Most Delta-8 products are not extracted from a marijuana plant. Instead, producers of Delta-8 convert plant-derived CBD into Delta-8 using a chemical process called isomerization. Delta-8, an addictive and psychoactive substance, was inadvertently federally legalized through a loophole in the 2018 Farm Bill. This mistake can be remedied next year when Congress passes a new Farm Bill.
Delta-8 is restricted or banned in 20 states, including New York, Washington, and Colorado. Products that contain Delta-8 are unregulated and according to the FDA, “have not been evaluated or approved by the FDA for safe use in any context.” There are no FDA-approved drugs containing Delta-8 THC. FDA Issues Warning Letters on Delta-8 THC