The US Food and Drug Administration (FDA) has issued a letter to dietary supplement manufacturers, distributors and retailers indicating it is reviewing potential changes to labelling requirements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Currently, federal law requires that dietary supplements carrying health claims (such as “supports immune health” or “promotes heart health”) display a boldface disclaimer on every label panel where such claims appear.
The disclaimer 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."
In his letter, Kyle Diamantas, FDA Deputy Commissioner for Human Foods, said the agency is considering a regulatory amendment that would remove the requirement for the disclaimer to appear on each panel of a product label.
"Revising this regulation would reduce label clutter and unnecessary costs," Diamantas noted.
He added that the FDA has rarely enforced the existing rule.
While the agency evaluates this potential change, it will exercise enforcement discretion regarding repeated placement of the disclaimer, though products must still carry the statement and link it to each health claim.
Experts caution that reducing the visibility of disclaimers could make it easier for consumers to overlook them, potentially undermining informed decision-making.
Dr Pieter Cohen, associate professor at Harvard Medical School, said: "Then you start saying things such as, ‘We only need it on the actual bottle.’ Then you let the print get smaller."
With more than three-quarters of Americans taking at least one supplement and tens of thousands of products on the market, the FDA’s review highlights the tension between regulatory simplification for industry and the need to maintain clear, consumer-facing safety information.
A formal rule change has not yet been proposed and the timeline for implementation remains uncertain.