“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 chief executive officer of CHPA. “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.”
Under CHPA’s proposal, FDA should require manufacturers of CBD-containing dietary supplements to submit a new dietary ingredient (NDI) notification for CBD and comply with other applicable laws, including using appropriate labeling and claims – importantly, not using drug claims – adhering to good manufacturing practices, and reporting serious adverse events. NDI notifications would provide FDA with much-needed data on CBD since they must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling.
CHPA’s petition also emphasizes the need for FDA to work quickly by either issuing an interim final rule that takes effect right away or by issuing guidance on enforcement discretion for reputable manufacturers that take certain steps to ensure product quality (such as appropriately sourcing and identifying the CBD ingredient) while potentially lengthy notice-and-comment rulemaking is underway. CHPA’s petition also urges FDA to continue and increase enforcement against manufacturers that fail to comply with the law.