Washington, D.C., December 13, 2018 – In response to an announcement made by Scott Gottlieb, M.D., Commissioner, Food & Drug Administration (FDA) at the Food and Drug Law Institute Enforcement, Litigation and Compliance Conference on December 12, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Steve Mister, president & CEO:
“CRN welcomes the announcement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to re-examine its policies and approaches for dietary supplements. He’s correct that the dietary supplement industry has grown tremendously since the enactment of the Dietary Supplement Health & Education Act (DSHEA) in 1994 due to the emerging science that further supports the health benefits of these products and the continued growth in consumers’ interest to take more active roles in their health and wellness. We look forward to learning more about the recommendations of FDA’s Dietary Supplement Working Group and to working with the agency in evaluating these approaches.
Since Dr. Gottlieb’s arrival at FDA, we have seen increased enforcement against bad actors that mismarket drug ingredients as dietary supplements, the implementation of the Program Alignment initiative to make FDA inspectors stronger experts in the product facilities they inspect, and a willingness to work with the industry on Supplement Facts label changes. We applaud these efforts.
It is appropriate that FDA periodically re-evaluate its regulatory tools and procedures. CRN has encouraged FDA to engage in more enforcement and to make use of the Supplement OWL, the dietary supplement industry’s online registry of products that provides the agency with new transparency. CRN will analyze any new proposals from the Working Group through the lens of DSHEA and the critical balance it strikes to protect public health while assuring consumer access to a wide range of healthful and safe products marketed as dietary supplements.”
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 and LinkedIn.