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WASHINGTON– The Council for Responsible Nutrition (CRN) has strongly refuted recent comments by FDA Commissioner Robert Califf during the NIH-FDA Nutrition Regulatory Workshop, describing his views on dietary supplements as dismissive and misinformed.
Califf's call for premarket evaluation of dietary supplements and the assertion that "very little evidence" supports their effectiveness reveals a misunderstanding of the Dietary Supplement Health and Education Act of 1994 (DSHEA), CRN argued. They pointed out that the industry has invested billions in scientific research, clinical trials, and peer-reviewed studies to back the safety and efficacy of its products.
"DSHEA already grants the FDA extensive regulatory authority," CRN emphasized, listing safety evaluations for new ingredients, precise labeling requirements, Good Manufacturing Practices, adverse event monitoring, and facility registrations. "Dietary supplements aren't pharmaceuticals, and comparing the two ignores critical regulatory distinctions established by Congress."
CRN underscored the industry's scientific credibility, pointing to thousands of research studies accessible through platforms like the National Library of Medicine's PubMed and the Office of Dietary Supplements' Fact Sheets. "Commissioner Califf's remarks overlook a wealth of scientific evidence supporting dietary supplements," the organization stated.
The group also highlighted gaps in regulatory enforcement, noting that the FDA already has tools to address unsafe products and penalize non-compliant companies but has not consistently applied them. CRN proposed establishing a mandatory supplement label registry to increase transparency and accountability while avoiding burdensome premarket approval processes.
With Commissioner Califf's pending departure, CRN urged new FDA leadership to adopt a science-driven approach that respects the industry's contributions, reinforces consumer trust, and aligns with Congress's vision of a regulated yet innovative marketplace that ensures product safety and availability.
"It's time to move past baseless criticisms," CRN concluded, "and build a regulatory framework that promotes safety, transparency, and scientific advancement within the dietary supplement industry."
