FDA is targeting products containing cannabidiol (CBD) based on certain priorities, but it hasn’t adopted a formal policy of “enforcement discretion,” the agency’s top dietary supplement official said this week, according to some people who heard him speak.
Sources present during the official’s May 14 remarks said they were intended to clarify statements that FDA’s then-Commissioner, Scott Gottlieb, M.D., made before members of Congress in April. During a Senate appropriations subcommittee hearing, Gottlieb said his agency was using its “enforcement discretion” and “will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims."
Steven Tave is director of FDA’s Office of Dietary Supplement Programs. On Tuesday, during a regulatory summit in Washington focused on dietary supplements, he addressed the issue of enforcement discretion.
Tave flatly rejected that his agency has a policy of enforcement discretion related to CBD and reported FDA was focusing its limited enforcement resources on CBD products that present a higher risk to the public health, according to a Tweet from a government affairs representative of The Pew Charitable Trusts, a nonprofit organization.
Asked for this article to comment on Tave's remarks, Michael Felberbaum, an FDA spokesman, said "some companies are marketing products containing cannabis or cannabis-derived compounds in ways that violate the law.
"Our biggest concern is the marketing of products that put the health and safety of consumers at greatest risk, such as those claiming to prevent, diagnose, treat or cure serious diseases, such as cancer," he added in an email. "That being said, the agency does not have a policy of enforcement discretion with respect to any of these products."
Gottlieb—now a resident fellow at the American Enterprise Institute—did not immediately comment for this article in response to a request.
“Companies who are marketing these products should not take comfort from Dr. Gottlieb’s remarks and think that they’re getting a free pass,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in an interview. “It just means that FDA has other priorities, and they are looking at the ones that are the most egregious for now.”
For at least five years, FDA has asserted CBD cannot be lawfully marketed in a dietary supplement or added to conventional food. In 2018, FDA approved the compound as a drug to treat seizures associated with rare forms of epilepsy.
But the U.S. market has been inundated with launches of CBD products and brands. According to an assessment in 2018 by Colorado-based brand Functional Remedies, an estimated 750 brands in the hemp-derived CBD business are on the market.
“The agency continues to fail to provide a consistent and clear approach to regulating CBD,” said Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), in a statement. “The biggest losers in this are American consumers who are interested in this product.”
Ricardo Carvajal is a director with the law firm, Hyman, Phelps & McNamara P.C., who consults manufacturers and marketers of dietary supplements on regulatory issues.
Carvajal said he interpreted Gottlieb’s statements as describing the agency’s routine exercise of determining, based on priorities, which products to target. He said he isn’t aware FDA has flagged any CBD products other than those that make claims of treating a disease—what the lawyer characterized as “therapeutic claims.” Federal law prohibits dietary supplement products from making claims to diagnose, mitigate, treat, cure or prevent a specific disease.
“Even though FDA hasn’t said that’s how it’s running this program, its actions … could reasonably be interpreted as an indication that, for whatever reason, FDA does not view CBD products that don’t make therapeutic claims as a high priority,” Carvajal said in an interview.
Mister said CRN and other trade groups have been urging the agency to take enforcement action against companies that market their CBD products as dietary supplements, but flout the rules that govern such products—such as the legal obligations to report serious adverse events to FDA, register their facilities with the agency and follow FDA labeling requirements.
“We are pressuring the agency very hard to start going after products that are labeled as supplements and basically ignoring all of the framework of regulation that’s around these products,” he said.
As a former FDA lawyer, Carvajal said he understood Gottlieb’s remarks didn’t signify how FDA typically announces a decision to exercise its enforcement discretion.
For example, in exercising its enforcement discretion regarding certain categories of CBD products, the agency might publish a guidance document or other written manual, former FDA officials said, although FDA hasn’t issued such a document.
However, FDA has issued an updated Q&A on its regulation of cannabis-derived products, reiterating its stance that CBD can’t be sold in a dietary supplement. The Q&A explained FDA’s decision to commence an enforcement action for a violation of law is based on many considerations, including its “resources and the threat to the public health.”
Fabricant, who previously led what was then known as FDA’s Division of Dietary Supplement Programs, urged the agency to exercise enforcement discretion by disclosing the thresholds at which CBD is safe in a food and dietary supplement, and the levels at which the intended use is a drug.
He said the agency has exercised such discretion with regard to red yeast rice products marketed as dietary supplements. Red yeast rice contains monacolin K, the chemical equivalent to lovastatin—the active ingredient in the pharmaceutical cholesterol-lowering drug known as Mevacor. In warning letters, FDA has cautioned companies that their red yeast rice supplements contain significant levels of lovastatin, rendering the products unapproved new drugs.
“It’s not unprecedented, and that’s really where people’s mindset should be in terms of what enforcement discretion looks like,” Fabricant said in an interview.
But Carvajal noted FDA may not have gathered the science on CBD to issue a formal policy of enforcement discretion.
“It depends on their policy objectives and priorities,” he said. “It may be that they don’t want to give a green light or … give any comfort to this marketplace until they have a much better understanding of the potential safety risks.”
The lawyer added FDA may not have obtained the data to justify taking action that could be interpreted as sanctioning the marketing of CBD products.
Tave’s remarks likely reinforced FDA’s long-held view that CBD can’t be marketed lawfully in dietary supplements, and even if marketers avoid the types of “over-the-line” claims described by Gottlieb, they face risks of intervention by the government. But industry lawyers, trade groups and others will be looking to future FDA enforcement actions against CBD products to ascertain the true meaning of his comments.
“If six months from now, FDA still has not acted against any CBD products that don’t make therapeutic claims, what are people supposed to think?” Carvajal asked. “It almost doesn’t matter whether FDA’s made a conscious, high-level, programmatic decision, or it’s just making these individual enforcement decisions day by day. Either way, they’re ending up in the same place. They’re not acting against CBD products that don’t make therapeutic claims.”