Natural Products insider write…
FDA’s recent batch of warning letters to marketers of delta-8 THC is unlikely to cool the sale of these products in the U.S., some legal experts said, citing the agency’s lack of follow-up enforcement actions in cases involving CBD and other ingredients.
State legislatures and regulatory agencies, however, are expected to continue to clamp down on delta-8 THC in the wake of FDA’s letters.
“I largely suspect there will be little chilling effect, if any, toward the sale of delta-8 products,” said Garrett Graff, a partner in Denver with Moye White LLP. “FDA’s rhetoric in writing but lack of actual enforcement activity does not particularly threaten or cause fear for those in the hemp industry.”
Graff suggested marketers of delta-8 THC products are accustomed to taking risks. “Many companies that are engaging in the sale of these products recognize that there’s a lot of regulatory uncertainties at the federal level but also then at the state level,” he said.
In the warning letters, FDA asserted the companies are marketing their delta-8 THC products as unapproved treatments for medical conditions or for other therapeutic uses. In addition, FDA identified drug misbranding violations since labels failed to include adequate directions for use as a drug.
Also, FDA said delta-8 THC was improperly added to such food as caramels, chewing gum, chocolate, gummies and peanut brittle. The agency contends CBD and delta-8 THC are unapproved food additives for use in any animal or human food product.