Vitamins, probiotics, minerals, and botanicals are among the many dietary supplements used by approximately 75% of Americans to support their diets and maintain their health. Although often found in the same aisle in stores, the FDA does not regulate supplements in the same way as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as a category of foods regulated by the FDA. The Act furthermore enacted labeling requirements, including rules on the placement and contents of disclaimers and nutrition labels. The disclosures are required to remind consumers that supplements are not FDA-reviewed for safety or effectiveness before they are sold. Recently, the issue has been how much a manufacturer must disclose on a label and specifically how many disclosures are required to appear on each “panel” of a supplement label.
In a class action suit filed against Amazon in 2023, the plaintiffs, a group of consumers, claimed that Amazon promotes and sells products that lack mandatory disclaimers on their labels, making them dangerous, defective, and illegal. The plaintiffs alleged that Amazon advertised purported benefits of certain dietary supplements not approved by the FDA without providing the required disclaimers. While the case remains ongoing, Amazon recently filed a motion to pause the suit, claiming it hinges on a regulation that the FDA announced is under revision.
On December 11, 2025, the FDA released a letter responding to requests to amend label regulation 21 C.F.R. 101.93(d), which governs the placement of disclaimers. The current regulation, added by DSHEA, provides that statements for supplements can be made if they contain a disclaimer in bold type that reads: “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.” The current rules require that the disclaimer appear on each panel of a product label where a claim is made. The FDA’s December letter asserted that, based on its initial review, revising the regulation to remove the requirement that the disclaimer appear on each panel of a supplement would “be consistent with section 403(r)(6)(C) of the FD&C Act while reducing label clutter and unnecessary costs.” The letter also acknowledges that the FDA has rarely enforced this requirement and is therefore likely to propose an amendment. There is no timeline for when the rule change might take effect; however, the letter states the FDA will not enforce the existing rule while it is under review.
The regulations would still require the disclaimer to appear at least once on the bottle, however, many consumers and critics in the medical field believe the amendment would weaken the already deficient warning system. A study done between 2004 and 2013 found that consumers made more than 15,000 reports of health problems linked to supplements to the FDA’s central reporting system. Supplements that claim to help with weight loss, sexual function, energy and muscle building have been among those found to have potentially harmful undisclosed ingredients like prescription pharmaceuticals and steroids. Public health advocacy organizations and consumers have called for reforms to the supplement regulation process including proposals of mandatory product listing, FDA standards, and premarket review.
Some supplement retailers advertise that their supplements are voluntarily self-regulated following industry-wide initiatives which created their own standards that complement or enhance government regulations. Voluntary programs like the Council for Responsible Nutrition and the Consumer Healthcare Products Association can promote enhanced product safety and fill the gaps of government regulation. Although they present certain benefits, these programs remain limited by their lack of enforcement power and voluntary nature.
The letter proposing the relaxation of disclaimer requirements is a step in the wrong direction for advocates who have been fighting for heightened regulation. The plaintiffs in the Amazon case say the letter should not stop their suit, because their claims include many other disclaimer violations beyond the “each panel” rule. If passed, however, many believe the amendment will be the first step toward dangerously weak warnings on supplement labels.