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In a letter this week to FDA Commissioner Dr. Robert Califf, the U.S. Hemp Roundtable requested FDA apply its playbook on NAC (N-acetyl-L-cysteine) to another ingredient widely marketed in dietary supplements—CBD—and exercise “enforcement discretion.”
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, made additional requests to FDA’s commissioner: Consider a rulemaking to make CBD lawful in supplements, create a pathway to include CBD in beverages and food and grant a meeting with FDA’s Cannabis Product Committee to discuss issues he raised in the letter, including results of a safety study completed by Validcare.
Michael Felberbaum, an FDA spokesman, said the agency would respond directly to the letter from the U.S. Hemp Roundtable.
FDA in recently published draft guidance announced its intent to exercise enforcement discretion concerning the distribution and sale of products containing NAC. The agency also is considering commencing a notice-and-comment rulemaking to make NAC lawful in supplements, in response to a citizen petition filed by the Natural Products Association (NPA), which also sued FDA last year regarding NAC.
FDA has concluded NAC and CBD are both excluded from the definition of a dietary supplement under U.S. law because the ingredients were either first approved (NAC) or studied (CBD) as drugs before they were marketed in supplements.
In the May 23 letter, Miller requested Califf “take immediate action to issue an enforcement discretion policy for CBD and other lawful hemp-derived products, similar to your actions on NAC, to help pave a regulatory pathway for these products.”
As Natural Products Insider previously reported, FDA and some lawyers well-versed in FDA policies suggested it’s unlikely the agency would issue an enforcement discretion policy for CBD.
“Regarding other ingredients, any decision to issue an enforcement discretion guidance would be made on a case-by-case basis after careful analysis of the relevant facts and circumstances,” an FDA spokesperson said in an April 22 email to Natural Products Insider.
The agency continues to have safety concerns regarding CBD, which was approved as a drug in 2018 by FDA to treat seizures associated with rare and severe forms of epilepsy. By contrast, FDA has not identified any acute safety concerns related to NAC. The latter ingredient was marketed in nutritional products as early as 1991, based on information submitted to FDA from industry trade organizations. Congress did not legalize hemp from which CBD is derived until 2018.
“Available data raises concerns about potential harm from CBD,” the FDA spokesperson said, after being asked last month in an email whether the agency’s draft guidance for NAC sets a precedent for issuance of an enforcement discretion policy related to CBD. “For example, peer-reviewed literature and studies associated with Epidiolex strongly point to risks when orally consuming CBD.”
On the other hand, Miller maintained a completed safety study addresses FDA’s concerns.
“The Validcare study provides data that addresses FDA’s specific safety concerns regarding CBD, with the results indicating that daily CBD consumption across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels or daytime drowsiness,” Miller wrote to Califf.
Last week, during a hearing before the House Appropriations Committee, Rep. Mark Pocan, D-Wis., asked Califf about possibly regulating CBD as a food and whether there was any timeline for doing so. The agency has asserted for years it’s unlawful to add CBD to food or market it as a dietary supplement.
“The research so far has shown that there are some risks with CBD, and so we’re going to need a different pathway than just the standard food pathway,” Califf responded.
He added, “I’m committed to do something about this, and it’s going to take some work. I hope that you’ll work with me on that because it’s going to take some creativity.”
In the letter, Miller also mentioned his group’s support for several CBD bills pending in Congress to regulate CBD in supplements and/or food and beverages, including HR 841, HR 6134 and S 1698.
“We are open to other creative solutions like you suggest and have been willing for the past three years to sit down with FDA to discuss alternative approaches,” Miller wrote to Califf. “Unfortunately, the agency has been unwilling to meet with us to discuss legislative options. At the same time, we have been told FDA is urging congressional staff not to proceed with existing legislation.”
Miller requested Califf help “break this stalemate,” and he concluded “we stand by to participate in productive negotiations with your staff to come up with solutions that best protect American consumers.”
Jessica Wasserman is a Washington, D.C.-based attorney in the FDA practice of WassermanRowe LLC, who advises cannabis companies on regulatory compliance issues.
She doesn’t believe FDA will issue a formal policy of enforcement discretion. She observed FDA only issued draft guidance on NAC after citizen petitions were filed with the agency and FDA was involved in litigation with NPA.
Unlike NAC, FDA doesn’t have its “back to the wall” on CBD, Wasserman said in an interview. “No litigation has been filed.”
The twist, FDA and other lawyers specializing in FDA regulations said, is the agency has informally used enforcement discretion against CBD-containing products over the years.
FDA hasn’t “seized or taken action against CBD in any way” with the exception of warning letters targeting improper marketing claims, Wasserman noted. “That is in effect enforcement discretion,” she added, but FDA’s failure to “institute it formally is frustrating because it just creates another level of uncertainty or an impression that they don’t view the product as serious or certainty not a priority in any way.”
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