(WASHINGTON, D.C) — This week, the four leading trade associations representing the U.S. dietary supplement industry joined forces to urge Congress to take action to ensure consumer safety and provide legal clarity in the cannabidiol (CBD) product marketplace. In a letter, the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and United Natural Products Alliance (UNPA) called on Congress “to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria.”
The letter from industry stated that the lengthy time FDA has projected for completion of a rulemaking in the face of the rapidly growing CBD marketplace should compel Congress to take quick action now on several fronts. “While FDA has been working to craft its policy on hemp-derived products…it could take three to five years for even an expedited rule-making process,” according to the industry letter, and “Given the rapidly growing marketplace of products…it is crucial that Congress take quick action to clarify the legal status of hemp-derived CBD dietary supplements…[and]…essential for FDA to have the resources it needs to protect the public from unsafe CBD products.” It urges Congress to provide “a limited waiver of §201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FDCA), [21 U.S.C. § 321(ff)(3)(B)], which governs articles used in both drugs and dietary supplements,” to allow lawful marketing of supplements containing hemp-derived CBD.
Industry further urged Congress to provide FDA with statutory authority and substantial additional resources to set a clear regulatory framework for the marketplace and to better assure consumer protection. The letter expresses appreciation for the additional $2 million included in the Senate bill which would help FDA to enforce existing laws governing the safety, manufacturing, and labeling of dietary supplements containing CBD.
The industry letter made clear that such new lawful ingredients would also need to meet other critical standards and regulations for dietary supplement consumer protections. “Importantly, these products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims,” according to the letter.
Read the full industry letter here.
