HBW Market News: CHPA Petitions For CBD Reg, PEW Urges Stronger Supplement Oversight

The Consumer Healthcare Products Association submitted a citizen petition on 14 November urging the US Food and Drug Administration to exercise its existing statutory authority to swiftly issue a regulation establishing a clear pathway for manufacturers to lawfully market cannabidiol in dietary supplements. The FDA should require manufacturers of CBD-containing products to submit new dietary ingredient notifications for CBD and comply with other agency regulations, including using appropriate labeling and claims, adhering to good manufacturing practices and reporting serious adverse events, CHPA says. “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,” the association says. CHPA also asks the agency 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 while potentially lengthy notice-and-comment rulemaking is underway.

In July, CHPA submitted comments urging FDA to increase its enforcement of products already on the market and move beyond warning letters to carry out inspections, import reviews and other actions. (Also see "Enforce Immediately In CBD Supplement Market, Industry Groups Suggest To FDA" - HBW Insight, 23 July, 2019.) The association’s push for an interim final rule echoes that of Sen. Ron Wyden D-OR who said in a June letter to the agency that its typical two- to three-year period for a rulemaking would be “fully unacceptable.” (Also see "Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access" - HBW Insight, 26 June, 2019