Legislative Push for FDA Preemptive Authority Over Dietary Supplement Regulation

A newly introduced House Bill, H.R. 7366, titled the Dietary Supplement Regulatory Uniformity Act, would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to expressly clarify and affirm the Food and Drug Administration’s (“FDA”) preemptive authority over dietary supplement regulation.

The bill would prohibit states from establishing or maintaining dietary supplement requirements that are different from or in addition to federal requirements, unless a state successfully applies for a specific exemption from FDA preemptive authority. Such exemptions would be limited to circumstances where a state requirement is more stringent than federal law or addresses a compelling local condition without placing a product out of compliance with federal standards. In effect, the proposed legislation reinforces a uniform national regulatory framework for dietary supplements, while preserving a narrow pathway for state involvement under FDA oversight.

The bill is significant because it responds directly to an increasingly fragmented regulatory environment driven by state-level initiatives that prohibit the sale of dietary supplements in various ways. For instance, in recent years, several states have considered or enacted laws restricting the sale of certain dietary supplements—which are often broadly defined—to minors, including proposals affecting products such as amino acids and muscle-building or weight-management supplements.[1] Industry groups, including the Natural Products Association, have raised concerns that these laws are frequently based on limited evidence, sweep far beyond their stated public health goals, and create inconsistent compliance obligations across jurisdictions. By clarifying federal preemption, H.R. 7366 aims to prevent a patchwork of state rules from undermining FDA’s role as the primary regulator of dietary supplements and from creating confusion for both consumers and regulated companies.

For the dietary supplement industry, this proposed legislation goes to the heart of regulatory predictability and market access. A uniform federal standard would allow companies to formulate, label, market, and distribute products nationwide without redesigning compliance strategies on a state-by-state basis. Without clear preemption, manufacturers and retailers face heightened enforcement risk, supply-chain disruptions, and increased costs—particularly when state laws target categories of products rather than specific safety concerns. H.R. 7366 signals congressional recognition that dietary supplements are already subject to a comprehensive federal framework and that deviations from that framework should be carefully controlled. As state activity in this area continues to accelerate, the bill represents a meaningful effort to protect regulatory consistency and ensure that dietary supplement policy remains grounded in science-based federal oversight rather than reactive local bans.

Endnotes

[1] See N.Y. A.B. 5610D, N.Y. S.B. 5823C, N.J. A.B. 1848, N.J. S.B. 3987, and Ill. H.B. 3027.