(WASHINGTON, D.C) — The Consumer Healthcare Products Association (CHPA) today applauds the U.S. Food and Drug Administration (FDA) for enforcing existing provisions in the Federal Food, Drug, and Cosmetic Act by sending warning letters to 15 companies illegally marketing cannabidiol (CBD) products. Companies that violate the law put public health at risk and FDA should continue to take actions like this to keep consumers safe while also working to establish a proper, data-driven pathway for CBD products to come to market.
On November 14, 2019, CHPA submitted a citizen petition to FDA, urging the Agency to exercise its existing statutory authority to swiftly issue regulations establishing a clear pathway for manufacturers to lawfully market CBD in dietary supplements. Such a pathway would put in place necessary safeguards to protect public health while also providing stakeholders a mechanism to provide much-needed safety data. CHPA’s petition also urges FDA to continue and increase enforcement against manufacturers that fail to comply with the law.
“Yesterday’s FDA actions are a very welcome development that will help protect consumers from fraud or the possibility of a negative health outcome,” said Scott Melville, president and CEO of CHPA. “Intense consumer demand and commercial interest has created an urgent need for FDA to act. While we are pleased to see the Agency take this necessary cautionary step, more needs to be done to adequately protect public health by addressing the egregious, unapproved claims and questionable quality of products already in the marketplace. The request in CHPA’s citizen petition encourages FDA to utilize its existing authority and 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.”
Additional details from CHPA’s citizen petition:
- 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. This includes 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.
- FDA should 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 urges FDA to continue and increase enforcement against manufacturers that fail to comply with the law.