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FDA could relax regulations on dietary supplements and it could have a big impact on your health

Dietary supplements are increasingly popular among figures linked to the Make America Healthy Again movement

Erin Keller
In Ohio
Tuesday 16 December 2025 15:58 EST
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The U.S. Food and Drug Administration is moving toward a controversial change in how warning labels appear on dietary supplements, which would reduce how often key disclaimers must be displayed on product packaging.

Under long-standing federal law, dietary supplement makers must include a boldface disclaimer when their products make health claims such as “supports immune health” or “promotes heart health.”

That language states that the claim “has not been evaluated by the Food and Drug Administration” and that the product “is not intended to diagnose, treat, cure, or prevent any disease.”

These warnings are intended to remind consumers that supplements are not evaluated for safety or effectiveness before they go on sale.

In a letter to manufacturers last week, the FDA’s food division head, Kyle Diamantas, said the agency is considering relaxing the rule so companies would still be required to include the disclaimer at least once on their labels, but would no longer need to repeat it every time a health benefit is referenced.

The FDA is considering allowing supplement labels to show disclaimers once instead of repeating them
The FDA is considering allowing supplement labels to show disclaimers once instead of repeating them (Getty Images)

Diamantas said the FDA has seldom enforced the current rule and that easing it would reduce label clutter and costs. He added that no timeline has been set for the change and that 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 in the letter.

About 75 percent of Americans use at least one supplement, and up to 100,000 supplement products are sold in the U.S., according to the FDA.

Dr. Pieter Cohen of Harvard Medical School warned that the FDA’s move could further weaken already limited warning labels 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.”

Department of Health and Human Services spokesperson Andrew Nixon told the outlet in a statement that the change would not make warnings harder to notice, claiming that “a growing number of Americans are paying closer attention to product labels.”

The Independent has contacted the White House and HHS for comment.

Dietary supplements have gained prominence among figures associated with the Make America Healthy Again movement.

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 labeled a “magic weight loss cure” and a “miracle in a bottle,” NBC reports.

Health Secretary Robert F. Kennedy Jr., who has said he personally takes many supplements, has also argued the Trump administration should loosen oversight, saying it would free Americans from what he described as the FDA’s “aggressive suppression” of vitamins and dietary supplements.

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