Califf's Closer: A Legacy of Dismissing the Dietary Supplement Industry and Consumer Needs
DECEMBER 19, 2024
Commissioner Califf’s call for premarket evaluation of dietary supplements and his assertion that there is “very little evidence” supporting these products reflect a fundamental misunderstanding of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the extensive scientific investment made by the industry. These remarks undermine billions of dollars spent on rigorous scientific research, clinical trials, and peer-reviewed studies that demonstrate the safety and efficacy of dietary supplements.
DSHEA already provides the FDA with comprehensive regulatory oversight, including safety reviews of new ingredients, labeling requirements, Good Manufacturing Practices, adverse event reporting, and facility registration. Unlike pharmaceuticals, dietary supplements are not intended to treat or cure diseases and have decades of safe consumer use that highlight their exceptional safety profile. Drawing misguided comparisons between supplements and pharmaceuticals ignores their inherent differences and the balanced regulatory framework established by Congress.
The dietary supplement industry is deeply committed to science and innovation. Commissioner Califf’s claim of insufficient evidence disregards the significant body of research and undermines consumer trust in products relied upon by millions to support their health and wellness. A simple review of the National Library of Medicine’s PubMed or the Office of Dietary Supplements’ Fact Sheets would have demonstrated the error in his remarks.
The FDA already has the authority to remove unsafe products and hold bad actors accountable. However, inconsistent enforcement—not a deficiency in DSHEA—has allowed non-compliant companies to persist. FDA needs enforcement tools to more effectively utilize the authority it already has. For example, a mandatory supplement label registry, supported by responsible industry, would give the FDA transparency and accountability without imposing burdensome premarket approval requirements.
Commissioner Califf’s anticipated departure from FDA provides an opportunity for new leadership to embrace a balanced and informed approach to dietary supplement regulation. The industry calls on incoming leadership to recognize the scientific contributions of responsible companies, restore consumer confidence, and align with Congress’s vision of a robust and innovative marketplace that prioritizes safety and transparency. It is time to move beyond unfounded critiques and foster a regulatory environment that supports both consumer access and scientific advancement.
About CRN:
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 180+ 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.