FDA May Relax Dietary Supplement Warning Label Rules: Implications for Public Health

Dietary supplements are among the most widely used health products in the United States, with roughly three-quarters of Americans reporting regular use of at least 1 supplement and an estimated 80,000 to 100,000 products on the market.¹ While most consumers view vitamins, minerals, and herbal products as safe and helpful to their health, the FDA’s recent moves are indicating changes in regulations that could significantly change the way users are informed about these products' restrictions and possibly increase the public health risks.

Under current law, dietary supplement manufacturers must include a conspicuous disclaimer on product labels whenever they make health-related claims. That disclaimer states that the claim "has not been evaluated by the [FDA]" and that the product "is not intended to diagnose, treat, cure, or prevent any disease."¹ These warnings are designed to remind consumers that supplements are not approved for safety or efficacy before sale, unlike prescription medications or over-the-counter drugs.¹

Proposed Relaxation of Warning Label Requirements

In a recent letter to industry, the FDA’s food division head indicated that the agency is thinking of loosening the old regulation that requires the repeated display of such disclaimers on supplement packaging. Instead, companies will only have to put the necessary FDA disclosure once on the label rather than next to each individual health claim. The agency indicates that this change would lessen "label clutter," save money, and reflect that the current rule has been rarely enforced.

However, the FDA has not established a timeline for formal rulemaking, and the existing requirements will remain unenforced during the review period. The announcement—despite this temporary status—has already ignited a discussion among medical professionals and advocates.

Concerns From Public Health Experts

Critics of the proposal, including Pieter Cohen, MD, a physician at Harvard Medical School, warn that reducing the frequency of disclaimers could weaken consumers' understanding of the products they are buying.¹ As Cohen told NBC News, shifting disclaimers from prominent placement could lead to smaller, less noticeable warnings—or ultimately, to consumers overlooking them entirely.¹ This concern resonates with long-standing criticisms that supplement labeling already provides insufficient context on product limitations and risks.

Consumer confusion about dietary supplements is not new. By law, supplements are regulated more like foods than drugs and are not subject to premarket approval for safety or effectiveness.^2,3 Manufacturers are responsible for ensuring safety and accurate labeling before marketing, but they are not required to provide evidence of efficacy to the FDA prior to sale.³ Consequently, products often reach the marketplace with limited or uneven clinical support for their purported benefits, and adverse events may only emerge through voluntary reporting after widespread use.³

A 2022 review highlights how those statutory limitations in the current regulatory framework hinder the FDA's ability to assure consumer safety.² The Dietary Supplement Health and Education Act of 1994 explicitly defines supplements as a unique category of products distinct from conventional food and drug items, limiting FDA's premarket authority and placing much of the compliance burden on manufacturers.²

Implications for Consumer Safety and Trust

The proposed change in labeling rules comes at a time when use of dietary supplements is deeply ingrained in US health practices. With millions relying on these products for perceived immune support, cardiovascular health, energy enhancement, or digestive wellness, the need for clear and accurate information has never been greater.¹ Yet, the nature of supplement marketing, where broad claims often go unverified by rigorous clinical trials, means that labeling plays a critical role in guiding consumer expectations and safety.¹

Reducing the visibility of disclaimers may increase the likelihood that consumers assume regulatory endorsement of supplement claims. Public health advocates argue that this could erode informed decision-making, particularly among vulnerable populations such as older adults, pregnant people, or those with chronic disease who may be more likely to use multiple supplements concurrently with prescription medications.

Furthermore, critics note that relaxing warning label requirements does not address deeper issues in supplement oversight, such as inconsistent product quality, variable ingredient concentrations, and the presence of undeclared components in some formulations.² Without stronger safety nets, the regulatory landscape risks favoring industry convenience over consumer protection.

Conclusion

As the FDA evaluates potential regulatory changes, health care professionals, especially pharmacists, must remain vigilant in educating patients about the limitations and risks of dietary supplements. Clinicians should encourage open dialogue about all products patients are taking and emphasize that "natural" does not always equate to "safe."³ Patients should be advised to consult qualified health care professionals before adding new supplements, especially when managing chronic conditions or taking prescription medications.

Ultimately, the pending regulatory shift serves as a reminder that, in the realm of dietary supplements, consumer literacy and clinical guidance are as critical as any government requirement.

REFERENCES

1. Keller E. FDA could relax regulations on dietary supplements, and it could have a big impact on your health. The Independent. Published December 16, 2025. Accessed December 23, 2025. https://www.the-independent.com/news/health/fda-dietary-supplements-label-regulations-b2885821.html

2. Richardson E. Akkas F. Cadwallader A. What Should Dietary Supplement Oversight Look Like in the United States? AMA Journal of Ethics. Published May 2022. Accessed December 23, 2025. https://journalofethics.ama-assn.org/article/what-should-dietary-supplement-oversight-look-us/2022-05

3. U.S. Food and Drug Administration. Dietary Supplements. Updated Oct 1, 2024. Accessed December 23, 2025. https://www.fda.gov/food/dietary-supplements