The Dietary Supplement Regulatory Uniformity Act (H.R.7366) would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to "clarify and affirm" the Food and Drug Administration's preemptive authority over dietary supplement regulation. Framed as a uniformity measure, the bill could have implications beyond labeling and formulation, potentially affecting state retail restrictions, age-of-sale laws, and state consumer-protection statutes, including California's Proposition 65.
The bill raises a central legal question: When federal law establishes a regulatory framework but does not regulate a particular risk, may states impose additional requirements, or does federal silence limit state action?
What the Bill Would Do
The bill would amend FDCA §403A to prohibit any state or local requirement "concerning a dietary supplement" that is:
- different from
- in addition to or
- not identical with
a federal requirement, unless the state obtains an exemption from the FDA.
This language mirrors express preemption provisions elsewhere in the FDCA. Its explicit application to dietary supplements, however, represents a notable expansion in an area historically governed by both federal standards and state public-health regulation.
Federal Framework and State Regulation
The FDCA establishes a comprehensive federal framework for dietary supplements by defining the product category, prohibiting adulteration and misbranding, setting labeling and manufacturing standards, and authorizing the FDA to regulate safety and claims.
At the same time, the FDA has not regulated every aspect of dietary supplement commerce. Federal law is largely silent on retail sales conditions, and the FDA has not established quantitative exposure thresholds for many potential contaminants, often relying instead on enforcement discretion. Instead, states have traditionally regulated these areas through retail restrictions, age-of-sale laws, and consumer-protection statutes.
The bill's preemption language would renew focus on whether those state laws are permissible complements to federal regulation or impermissible additions.
Interpreting "in Addition to"
Courts interpreting express preemption provisions often apply a functional analysis, asking whether a state law imposes obligations beyond those imposed by federal law. Under that approach, the absence of a federal requirement does not necessarily preserve state authority; a state rule addressing an unregulated subject may be characterized as an additional requirement rather than a complementary one. The bill's emphasis on "identical" requirements reinforces this framework and could influence how courts evaluate state laws that operate where the FDA has not adopted specific regulations.
Exemption Process
The bill allows states to seek FDA's approval to impose more stringent or locally tailored requirements. Courts have sometimes viewed such mechanisms as evidence that Congress intended federal regulators to define the permissible scope of state regulation, which could also factor into future preemption analyses.
Implications for State Laws
Retail and age-of-sale laws
States generally view age-of-sale and retail restrictions as regulating purchasers, rather than the product itself. However, such laws could be challenged as requirements "concerning a dietary supplement" if they restrict the sale of supplements to certain consumers.
State ingredient restrictions, prohibitions and bans
States have at times restricted or prohibited specific dietary ingredients in dietary supplements based on local safety concerns, emerging science, or enforcement priorities, even when FDA has not acted at the federal level. Under the bill, such state restrictions or prohibitions could face increased preemption risk if they are characterized as additional requirements imposed without a federal determination that the ingredient is unsafe. As a result, the exemption process may become the primary avenue for states seeking to maintain or adopt ingredient bans, shifting decision-making authority to the FDA. Indeed, it could create a situation where the FDA may reconsider whether certain ingredients should be marketed by granting state-level relief without the FDA taking any action nationwide.
California Proposition 65
Proposition 65 requires warnings when exposure to listed chemicals exceeds state-defined thresholds, even when the FDA has not established exposure limits or determined that such levels pose a safety risk. In the dietary supplement context, the FDA has historically declined to set quantitative thresholds for trace contaminants such as lead.
Courts have generally declined to find Proposition 65 preempted in food and dietary supplement cases, often relying on the FDA's silence and the absence of a direct federal conflict. The bill could give greater weight to that silence by strengthening arguments that state warning obligations impose affirmative requirements where federal law imposes none. Even if courts ultimately reject those arguments, the bill could invite renewed litigation and uncertainty.
In summary:
- The bill's preemption language could have effects extending beyond labeling and formulation, including state retail restrictions, age-of-sale laws, and ingredient prohibitions
- State consumer-protection and public-health laws, including ingredient bans and warning requirements, may face increased preemption scrutiny
- Although Proposition 65 has historically survived FDCA preemption in the food and dietary supplement context, the bill could materially alter the litigation landscape by reframing the significance of FDA silence
- FDA's historical decision not to set exposure thresholds or prohibit certain ingredients may become a central feature of preemption analyses, with state-by-state outcomes potentially driven by the bill's exemption mechanism rather than uniform national standards
Stakeholders should closely monitor the bill's progress and consider its potential implications for compliance, enforcement, and litigation strategy.