JULY 7, 2023
WASHINGTON — The Council for Responsible Nutrition (CRN), the leading association representing the dietary supplement and functional food industry, sounded alarm today over recently-released details of the Food and Drug Administration’s (FDA) previously-announced restructuring of the agency’s Human Foods program.
After a careful assessment of a stakeholder relations call held by the FDA on June 28, 2023, in which top agency officials offered an explanation of the Human Foods Program restructuring introduced back in January, CRN has determined that the supplements industry should be actively concerned about the proposed changes. The proposal, as revealed by an organizational chart released by the agency on June 27, would eliminate the Office of Dietary Supplement Programs (ODSP) under the current Center for Food Safety and Applied Nutrition (CFSAN). FDA proposes the regulation of dietary supplements will fall under a new combined office that will be called the Office of Food Chemical Safety, Dietary Supplements and Innovation.
UPDATE: CRN writes to FDA Commissioner Califf regarding the agency's 'Reorganization of the Human Foods Program - Office of Dietary Supplement Programs'
“Last fall, FDA asked the Reagan-Udall Foundation to conduct an evaluation of FDA’s Foods program, but, unfortunately, they intentionally left out a review of the dietary supplement piece of CFSAN, despite the fact that supplements are regulated as food,” said CRN President and CEO, Steve Mister. “So, when the recommendations came back, there was no mention of dietary supplements. It appears now FDA has just inserted supplement oversight into another Office. For our industry, this means that the attention and priorities given to dietary supplements, even as little as it was before, will be even less in this new structure.”
CRN questioned why the agency is pulling back on its responsibility to effectively regulate dietary supplements, when these products have grown into a nearly $60 billion industry, and at a time when supplement use is higher than ever before. “Seventy-five percent of Americans use a dietary supplement1; they deserve to have an agency overseeing this market that acknowledges their health benefits and devotes adequate resources to effectively regulate the market,” Mister continued.
Despite widespread confidence in dietary supplements by consumers, issues related to labeling, misleading claims, manufacturing quality and counterfeit products still persist that demand FDA oversight and enforcement. In 2016, CRN strongly supported the elevation of the former Division of Dietary Supplements into an Office, a designation that brought more priority to FDA’s oversight. Since then, the industry has successfully lobbied Congress to more than double annual funding to the Office to assure increasing attention and enforcement. The proposed reorganization jeopardizes those advances that reinforce consumer trust in these products.
“Be assured that CRN is working here in Washington to try to change FDA's mind about the reorganization and we've already reached out to members of Congress,” added Mister. CRN Members are encouraged to identify their members of Congress and let them know that supplement company operations in their districts are responsible for jobs and for the contribution to the tax base, and that FDA’s proposed reorganization means a downgrade in the prioritization of supplements by the agency.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing more than 200 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. Follow us on Twitter @CRN_Supplements and LinkedIn.
1According to the 2022 CRN/Ipsos Consumer Survey on Dietary Supplements, trust in the dietary supplement industry is also high. More than three-quarters of Americans (77%) find the industry trustworthy. That number is even higher among supplement users, at 84%.