The Consumer Health Care Products Association is tired of waiting. On Thursday, the Washington, D.C.-based trade organization presented the Food and Drug Administration with a citizen petition that urges the agency to exercise its statutory authority to issue regulations establishing a clear pathway for the inclusion of CBD in dietary supplements.
“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. “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’s proposed path of action would see the FDA requiring manufacturers of CBD-containing dietary supplements to submit new dietary ingredient notifications for each product and comply with other applicable laws, including labeling and claims, as well as following good manufacturing practices and reporting serious adverse events. The NDI notifications would provide the FDA with necessary data about CBD, particularly given the FDA’s need to include evidence establishing a reasonable expectation of safety when used under the suggested conditions on the product’s label.
CHPA’s petition also noted that there is a need for the FDA to act, issuing either an interim or final rule, or through issuing guidance on enforcement discretion for manufacturers to take certain quality-related steps during the notice-and-comment rulemaking period. The petition also urges the FDA to continue and increase enforcement against manufacturers that don’t comply with the law.