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.
###
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry. AHPA is comprised of more than 350 member companies, consisting primarily of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products as foods, dietary supplements, cosmetics, and non-prescription drugs, and also including companies that provide expert services to the herbal trade. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products to ensure that consumers continue to enjoy informed access to a wide variety of herbal goods. More at ahpa.org
The Consumer Healthcare Products Association (CHPA) is the 137-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to promoting the increasingly vital role of over-the-counter medicines and dietary supplements in America’s healthcare system through science, education, and advocacy. Visit www.chpa.org and www.KnowYourOTCs.org.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements, Facebook, and LinkedIn.
The United Natural Products Alliance (UNPA) is an international trade association representing many leading natural products, dietary supplement, functional food, scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com.