The Dietary Supplement Regulatory Uniformity Act reflects a shared desire to bring greater clarity and consistency to dietary supplement regulation. As an industry, we have long purported to support strong, uniform federal standards administered by the FDA. Clear national rules promote consumer confidence, support responsible innovation, and reduce the friction of navigating a patchwork of overlapping requirements.

At the same time, this bill also illustrates a broader problem: piecemeal legislation is rarely a durable substitute for comprehensive reform. Broad preemption language, when added incrementally, can create unintended consequences, particularly in areas of traditional state authority that Congress may not seek to displace.

These tensions reinforce my continued advocacy for a comprehensive update to the Dietary Supplement Health and Education Act (DSHEA) — often described as “DSHEA 2.0” — rather than relying on one-off statutory fixes. My concerns with this bill, however, can be addressed through a narrow, targeted clarification that strengthens the legislation without losing sight of the need for broader modernization.

The Promise and the Risk of Broad Preemption

The preemption bill would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to prohibit state or local requirements “concerning a dietary supplement” that differ from, supplement, or are not identical to federal requirements. This framework uses familiar legislative language, similar to other parts of the FDCA, and reflects a legitimate desire to avoid inconsistent state product standards and labeling rules.

The challenge lies in how this language may be interpreted when the FDA has not established specific requirements. Courts have sometimes treated federal silence as a limit on state action when broad “not identical” preemption language is used. This interpretive approach can create uncertainty for state laws that have traditionally operated alongside federal regulation, particularly those focused on retail practices or consumer protection.

This concern is not hypothetical. State age-of-sale laws, ingredient-specific sales restrictions, and supplemental warning requirements could be challenged as “additional” requirements in areas where federal law is silent. While reasonable arguments exist on both sides as to whether age-based restrictions should be treated that way, the better question for industry is whether this issue should be litigated at all — or resolved through a narrow statutory clarification that delivers uniformity without controversy.

Protecting Minors Is a Shared Responsibility

Protecting minors warrants special attention. States have long exercised their authority to safeguard vulnerable populations, including by imposing reasonable age-based restrictions on certain products.

In the dietary supplement context, some states have considered or adopted age restrictions for products marketed for weight loss or muscle building. These measures do not regulate product formulation, labeling, or manufacturing. Instead, they address who may purchase certain products and under what conditions — a traditional and well-recognized area of state authority.

The industry should not shy away from this issue or attempt to obscure it. Recognizing that protecting minors is a shared responsibility is not inconsistent with national uniformity; to the contrary, acknowledging a limited role for state age-of-sale measures strengthens the case for responsible federal preemption.

The Limits of the FDA Exemption Process

The bill allows for state variation through an FDA exemption process that permits states to petition to exceed federal standards. While well-intentioned, this approach may undermine the uniformity the Act is intended to achieve.

First, the exemption process places significant discretion in the FDA’s hands, discretion that may be exercised differently across administrations. And the FDA, receptive to state experimentation, may grant exemptions more readily, while a future administration may take a narrower view or reverse prior decisions. These dynamic risks reintroduce uncertainty rather than resolving it.

Second, the exemption process may turn the FDA’s silence into an indirect form of regulation. Faced with state petitions, the FDA could grant or deny exemptions to signal its views on ingredients or product categories without undertaking nationwide rulemaking. Conversely, the agency could, based on a single state petition, determine that an issue warrants broader application, effectively nationalizing a policy choice that originated at the state level.

In either case, outcomes may reflect shifting policy priorities rather than scientific consensus. This instability underscores the need for clear statutory guidance rather than reliance on discretionary exemptions to achieve durable, predictable uniformity.

A Targeted Savings Clause Is the Solution

A narrow savings clause can address these concerns by preserving reasonable state authority over age-of-sale restrictions without creating broader regulatory fragmentation.

Congress could consider adding language along the following lines:

“Nothing in this subsection shall be construed to preempt or otherwise limit the authority of a State or political subdivision thereof to impose reasonable age-based restrictions on the retail sale, including online sale, of dietary supplements to minors, including restrictions related to products marketed for weight loss or muscle building, provided that such restrictions do not impose requirements concerning the formulation, labeling, or manufacturing of dietary supplements. Reasonable age-based restrictions may include good-faith age-assurance measures at the point of sale, but shall not be construed to require parental or adult signatures or similar verification measures at the point of delivery.”

This language is intentionally limited. It preserves the bill’s core objective of uniform federal product standards while clarifying that states retain a narrow, appropriate role in regulating youth access at the retail level.

Why Industry Should Support This Clarification

For industry, this approach provides certainty. Without clarification, companies could face years of litigation over the scope of state youth-protection measures, with inconsistent outcomes across jurisdictions. A clear savings clause allows Congress to resolve this issue directly and reduces unnecessary legal risk.

It also avoids making the exemption process the sole pathway for state action. Reliance on exemptions alone would perpetuate a patchwork of rules and undermine the predictability and stability the bill is intended to provide.

Why Consumers Benefit

Consumers benefit from transparent, coherent, and credible regulation. Protecting minors through reasonable age-of-sale measures, while maintaining uniform national standards for product safety and labeling, enhances consumer confidence and avoids imposing unnecessary burdens on adult consumers.

Why the FDA Should Welcome It

This clarification also supports the FDA’s institutional role. It preserves the agency’s authority over product standards, safety, and labeling, while avoiding pressure to oversee retail logistics or age-verification practices through exemptions or informal guidance.

Age assurance at the point of sale is fundamentally different from federal product regulation. The FDA should not be placed in the position of adjudicating such matters indirectly when Congress can draw that line expressly.

Conclusion

The Dietary Supplement Regulatory Uniformity Act represents a meaningful step toward clearer federal preemption and a more predictable regulatory environment. By including a narrow savings clause addressing age-of-sale restrictions, Congress can advance the bill’s uniformity goals without unintended effects on traditional state authority.

This approach benefits industry, consumers, and the FDA alike. It strengthens the legislation by directly addressing a real and foreseeable issue, rather than leaving it to be resolved through litigation.