“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 proposal suggests that FDA require manufacturers of CBD-containing supplements to submit a new dietary ingredient (NDI) notification for CBD and comply with applicable laws. This includes using appropriate labeling and claims (and not using drug claims), adhering to good manufacturing practices, and reporting serious adverse events. The petition also urges FDA to increase enforcement against those that do not comply with the law.
Related: FDA Discusses Legality CBD at CRN Conference Industry Associations Ask Congress: “Take Quick Action to Clarify the Legal Status of CBD”
CHPA noted in the release that since NDIs must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling, the NDI notifications would give FDA with data on CBD. AsWholeFoodspreviously reported, Lowell Schiller, JD, Principal Associate Commissioner for Policy – Office of Policy at the FDA, stressed the need for data during a talk at the Council for Responsible Nutrition (CRN)'s The Conference in November.CHPA urged 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."
