In a citizen petition filed Thursday with FDA, a trade group requested FDA promulgate rules establishing a clear path for manufacturers to market CBD in dietary supplements.
FDA was asked to exercise its authority through a rulemaking to provide a pathway to legally market hemp-derived CBD supplements.
The Consumer Healthcare Products Association (CHPA) proposed FDA require manufacturers of CBD-containing dietary supplements submit a new dietary ingredient (NDI) notification to the agency to establish the compound’s safety in products.
“Intense consumer demand and commercial interest has resulted in a flood of CBD products of uncertain quality and unapproved claims already in the marketplace, and this scenario has created an urgent need for FDA action,” said Scott Melville, president and CEO of CHPA, in a statement. “The request in our petition seeks to have FDA utilize the authority it already has to establish a lawful regulatory pathway for manufacturers to bring dietary supplements containing CBD to market. Only then will consumers be able to purchase CBD-containing dietary supplements in a manner that ensures product quality, safety and a level-playing field for enforcement.”
CHPA requested FDA "act swiftly" and use its discretion to issue an interim final rule, determining CBD is lawful in supplements.
"FDA can issue an interim final rule," lawyers for CHPA stated in the citizen petition, "where it finds that an up-front notice and comment period is impracticle, unnecessary or contrary to the public interest."
Citing "intense consumer and commercial interest in CBD-containing products," CHPA stated "FDA would be acting in the public interest" by finding CBD lawful through an interim final rule.
The petition requested FDA issue "guidance on enforcement discretion for reputable companies that comply with the terms of any proposed rule as well as any other applicable law" if the agency decides to conduct a rulemaking through notice and comment.
The trade group also recommended FDA's exercise of enforcement discretion be conditioned on compliance with other applicable laws, such as obligations to meet cGMPs (current Good Manufacturing Practices), report to FDA serious adverse events linked to supplements and comply with NDI notification requirements.
"Currently, it appears that FDA is taking enforcement action only against the more egregious violators with regard to CBD products," CHPA's attorneys wrote in the petition. "Yet, FDA has failed to articulate the basis for or scope of this discretion."
Asked to comment on CHPA's filing, Michael Felberbaum, an FDA spokesman, said the agency "is reviewing the petition and will respond directly to the petitioner."
Industry sources have become increasingly frustrated with FDA's inaction on CBD and have been looking to Congress for a legislative solution. In a recent speech at a conference hosted by the Council for Responsible Nutrition (CRN), an FDA official, Lowell Schiller, expressed reservations about creating a legal pathway for CBD in supplements without fully understanding the ingredient’s safety profile.
“If we are unable to conclude that CBD is safe for use in foods or dietary supplements, and yet we were to make an exception to allow for such uses, what would that mean for the next substance to come along with similar known safety risks?” asked Schiller, principal associate commissioner for policy in FDA’s Office of Policy, during his Nov. 7 speech.