The US Food and Drug Administration (FDA) is considering a controversial regulatory shift that could significantly alter how health warnings appear on dietary supplements. The proposed change would reduce the frequency of key disclaimers mandated on product packaging, a move that has alarmed public health experts.
The Proposed Regulatory Shift
Under longstanding federal law, manufacturers must include a prominent, boldface disclaimer whenever their products make specific health claims, such as 'supports immune health' or 'promotes heart health'. This disclaimer clearly states: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." This serves as a crucial reminder that, unlike pharmaceuticals, supplements are not assessed for safety or efficacy before they reach shop shelves.
In a letter to manufacturers dated last week, Kyle Diamantas, head of the FDA's food division, indicated the agency is now looking to relax this rule. The new policy would require the disclaimer to appear only once on a label, rather than being repeated each time a health benefit is mentioned. Diamantas argued that the FDA has seldom enforced the current rule and that easing it would reduce label clutter and lower costs for companies.
He added that no firm timeline for the change has been established, but the agency will not enforce the existing requirement while the policy is under review. "If FDA does not identify significant concerns as we continue our review of the available data and information regarding this request, we are likely to propose a rule to amend this requirement," Diamantas wrote.
Expert Warnings and Political Backdrop
The potential change has drawn sharp criticism from medical professionals. Dr. Pieter Cohen of Harvard Medical School warned that this move could further weaken what are already limited warnings on dietary supplements. "Then you start saying things like, 'We only need it on the actual bottle,'" Cohen told NBC News. "Then you say, 'It only needs to be on the back.' Then you let the print get smaller."
The debate occurs within a specific political context. Dietary supplements have gained notable prominence among figures linked to the "Make America Healthy Again" movement, drawing renewed scrutiny from health experts and lawmakers. For instance, Dr. Mehmet Oz, now administrator of the Centers for Medicare and Medicaid Services, faced criticism during his March confirmation hearing for previously promoting supplements he called a "magic weight loss cure" and a "miracle in a bottle."
Furthermore, Health Secretary Robert F. Kennedy Jr., who has said he personally takes many supplements, has advocated for the Trump administration to loosen oversight. He argues this would free Americans from what he describes as the FDA's "aggressive suppression" of vitamins and dietary supplements.
Potential Impact on Consumers
The scale of the supplement market makes this a significant issue for public health. According to the FDA, approximately 75 percent of Americans use at least one supplement, with up to 100,000 different products on sale across the United States.
In defence of the proposed change, Department of Health and Human Services spokesperson Andrew Nixon reportedly stated that the adjustment would not make warnings harder to notice. He claimed that "a growing number of Americans are paying closer attention to product labels." The Independent has contacted the White House and HHS for further comment.
Critics, however, fear that diluting these clear, repeated warnings risks misleading consumers who may already struggle to distinguish between rigorously tested medicines and unregulated supplements. The outcome of the FDA's review could have profound implications for how millions of Americans understand the products they consume daily for their health and wellbeing.
