When the Dietary Supplement Health and Education Act of 1994 (DSHEA) passed, the supplement market was a fraction of what it is today. The market was valued at roughly $4 billion to $6 billion, with approximately 4,000 to 6,000 products sold largely through specialty retail and health food stores. Today, the market is estimated at $60 billion to $70 billion, with tens of thousands of products, many sold online. The industry did not just grow; it fundamentally changed.
What has not changed enough is the statutory framework. The result has been a mix of outdated rules, piecemeal reform efforts, increasing state activity and growing uncertainty around some of the most important legal issues facing the industry. The Organic and Natural Health Association has put forward a broader modernization proposal intended to create a single national, transparent framework rather than relying on isolated fixes.
Mandatory supplement product listing
The proposal creates a mandatory post-market product listing system in a new section 415A of the Federal Food, Drug and Cosmetic Act. That change is significant because it gives the Food and Drug Administration (FDA) real-time visibility into the marketplace without turning supplements into a premarket approval category.
The bill is explicit: no premarket approval, no label pre-clearance and no delay in marketing based solely on the listing’s content. At the same time, a product that should be listed but is not properly listed would be deemed adulterated, subject to a good-faith cure provision and protection for technical or clerical errors. The listing system also includes a public database, limits on the information FDA may require, and procedural protections before FDA publicly identifies a specific product or responsible person as non-compliant.
The proposal also recognizes marketplace realities by protecting retailers and platforms that rely in good faith on listing status, so long as they do not have additional knowledge that the product is adulterated or misbranded.
Oversight funding
Listing alone is not enough. The bill authorizes appropriations for dietary supplement oversight from fiscal years 2027 through 2031, with funds tied to post-market activities such as inspections, new dietary ingredient (NDI) notification review, serious adverse event investigations, recalls, enforcement, and operation of the listing system. Just as important, the legislation bars use of those funds to create a premarket approval regime or to expand listing demands beyond what Congress has expressly authorized.
Preemption
States are responding to legitimate safety concerns, but the current trajectory points toward a fragmented patchwork of dietary supplement rules. The proposal addresses that directly by establishing a national uniformity framework. It would preempt non-identical state requirements relating to labeling, warnings and disclosures, claims, ingredient safety determinations, current good manufacturing practices, adverse event reporting and recordkeeping, product listing and registration, product classification and lawful marketing under the revised drug-preclusion provision.
The bill does not eliminate state authority. States may still enforce requirements that are identical to federal law. But it prevents the creation of parallel state systems. Also, it limits private litigation by making clear that there is no private right of action to enforce dietary supplement requirements and that alleged violations of the act cannot be used as predicate claims under state law.
Drug preclusion
That pathway allows a manufacturer or distributor to ask FDA to determine that a supplement use is not prohibited because it is materially different from the approved or investigated drug or biologic and is safe under the intended conditions of use.
Drug preclusion remains one of the most consequential and misunderstood issues in the industry. The revised bill clarifies preclusion by rewriting section 301(ll), the prohibited-acts provision, instead of leaving the issue tied up in the dietary supplement definition. That matters because it makes the issue one of lawful marketing rather than product identity.
The new framework preserves first-marketed protection for substances that were on the market as or in food or dietary supplements before drug approval, biologic licensure, or the institution and public disclosure of qualifying clinical investigations. It also narrows the threshold for clinical investigation so that preclusion is not triggered by early exploratory work. To count, an investigation must go beyond an initial exploratory Phase 1 or Phase 2a study and must be designed to generate meaningful safety and efficacy information from sufficient human exposure.
Equally important, preclusion does not continue forever. It applies only so long as the sponsor demonstrates active pursuit of development under FDA jurisdiction. If active pursuit is not shown during any consecutive 12-month period, preclusion ends, subject to a limited temporary waiver. That prevents indefinite blocking of supplement ingredients based on dormant or abandoned development programs.
The bill also creates a material difference petition pathway in section 413(h). That pathway allows a manufacturer or distributor to ask FDA to determine that a supplement use is not prohibited because it is materially different from the approved or investigated drug or biologic and is safe under the intended conditions of use. In making that determination, FDA may look at route of administration, mechanism of action, dosage, composition, intended use and claims, and safety. No single factor controls.
New dietary ingredient modernization and pathways
The idea is not to outsource FDA authority, but to encourage better submissions and a more efficient review process while preserving FDA as the final decision-maker.
The bill goes further than product listing and preclusion. It also modernizes the NDI framework itself. First, it creates a grandfather reset directing FDA to establish and update a list of ingredients that were lawfully marketed in supplements before Oct. 15, 1994, or before Jan. 1, 2015. Ingredients on that list would be presumed not to be new dietary ingredients unless there is evidence of a significant or unreasonable risk under labeled conditions of use.
Second, it creates a clearer pathway for bioidentical ingredients. Synthetic or semi-synthetic ingredients that are chemically and molecularly identical to lawful dietary ingredients are recognized as dietary ingredients under the definition, but remain subject to the NDI process and, when appropriate, a safety-equivalency showing.
Third, the bill creates a voluntary third-party review program for eligible NDI notifications and safety-equivalency submissions. The idea is not to outsource FDA authority, but to encourage better submissions and a more efficient review process while preserving FDA as the final decision-maker.
Other modernization provisions
The proposal also modernizes claims communication by allowing FDA to establish a voluntary monograph-style pathway for certain disease and structure/function claims, and by removing the current disclaimer requirement for lawful structure/function claims. It clarifies that ingestion includes oral, sublingual, and orally dissolving delivery systems, and it draws clearer lines between supplements and cosmetics by addressing permissible cosmetic structure/function claims and transdermal systemic-delivery claims.
Finally, it amends the Internal Revenue Code to allow dietary supplements to qualify for reimbursement under FSAs, HSAs, Archer MSAs, and related arrangements.
The bottom line
This proposal is broader than the piecemeal changes that have circulated in recent years. It is designed to strengthen consumer trust, improve FDA oversight, preserve national uniformity, modernize the treatment of ingredients and claims and support responsible innovation under a single, clear and transparent framework. If the industry wants a durable modernization strategy, this is the kind of architecture Congress should be considering.