AHPA responds to request for information regarding FDA regulation of CBD
Existing statutes and regulations are sufficient for FDA to effectively regulate CBD dietary supplements
August 21, 2023
Last week, the American Herbal Products Association (AHPA) -- together with the Consumer Healthcare Products Association and United Natural Products Alliance -- submitted comments in response to the congressional Request for Information (RFI) regarding the U.S. Food and Drug Administration's (FDA's) regulation of cannabidiol (CBD). These comments outline how existing statutes and regulations are sufficient for FDA to effectively regulate CBD dietary supplements, thus making the congressional development of a new regulatory pathway for CBD dietary supplements, as sought by FDA, unnecessary.
Since the 2018 Farm Bill was enacted, FDA has proven unwilling to use its existing authorities to regulate CBD dietary supplements. Despite how the regulatory status of CBD products has remained unresolved, the market for CBD dietary supplements has proliferated. FDA's delay in action has poorly served consumers, the medical community, and responsible industry.
“FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance,” said AHPA President Michael McGuffin. “AHPA remains committed to advocating for FDA's prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA) issued the bipartisan RFI. In the comments submitted, AHPA and its co-signatories thanked the committee leaders for their work to resolve the regulatory status of CBD products and urged them to encourage FDA to “get to a yes” and establish the procedures by which CBD-containing dietary supplements can be marketed under current law.