Lawyers skeptical FDA warning letters will chill delta-8 THC market
Given FDA’s track record of enforcement on CBD, marketers of delta-8 THC may not have much to worry about. But states likely pose a graver threat to their business.
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.
Mark Hubbard, chief science officer of M Six Labs Inc., said he faces a quandary after his company received a letter from FDA that identified improper marketing claims and other issues related to delta-8 THC and CBD, two substances from cannabis that are intertwined since delta-8 THC is typically made from hemp-based CBD through a process of chemical synthesis.
“We have a conundrum on how … we function as a business without being able to market our business,” Hubbard told Natural Products Insider. “This is a big problem. Now, I’m being handicapped versus everybody else.”
The companies who received the letters could be subject to legal action, including an injunction and/or a seizure of their products, if they fail to address the purported violations of law identified by FDA, the agency said. FDA requested written responses from the companies within 15 working days, disclosing how they will address the infractions and prevent them from reoccurring.
Ideally, from regulators’ perspective, a batch of warning letters would cause not only the recipients to change their behavior but also the broader industry to come into greater compliance with the Federal Food, Drug and Cosmetic Act.
Attorney Marc Ullman counsels businesses on FDA regulations, with a focus on the natural products industry. Asked whether the warning letters will chill the delta-8 THC market, he responded, “Zero. Not at all.”
Ullman, who is of counsel to Rivkin Radler LLP and based in Uniondale, New York, described the letters as “enforcement theater.” He referenced FDA warning letters to CBD companies to highlight why letters—like those sent to marketers of delta-8 THC—“have zero impact.”
He described the CBD market as being in a state of "purgatory" since FDA asserts it's illegal in food and supplements, yet doesn't follow up with a court action that would give industry stakeholders standing to challenge the agency's position.
FDA's lack of follow-up is "a disservice to the public health," especially if it believes certain ingredients are unsafe, as is the case with CBD, Ullman said.
FDA's history with CBD doesn’t mean states won’t continue to impose restrictions or regulations on the sale of delta-8 THC.