Congresswoman Diana Harshbarger (R-TN) introduced H.R. 10336, the Dietary Supplement Innovation Act, on September 10, 2026, targeting long-standing regulatory friction between pharmaceutical and supplement industries.
The bill aims to modernise the FDA’s drug preclusion provision, encouraging pharmaceutical innovation while broadening and protecting consumer access to dietary supplements across the United States.
Harshbarger argues in a Fact Sheet that drug preclusion provisions of the federal Food, Drug, and Cosmetic Act “have created regulatory uncertainty for dietary supplement and drug manufacturers alike.”
H.R. 10336 “delivers the regulatory certainty manufacturers need to innovate and invest with confidence, while establishing transparency and predictability within the drug preclusion framework and preserving consumer access to dietary supplements,” Harshbarger said.
Beyond drug preclusion, the bill would also alter definition sections within the Dietary Supplement Health and Education Act of 1994, specifically changing how a legitimate dietary supplement is legally defined under federal law.
Under the current framework, a substance meeting existing criteria could still be excluded from dietary supplement classification based on its drug status, a provision H.R. 10336 proposes to remove entirely.
The bill expands exceptions to general drug preclusion rules, including a grandfather clause for substances marketed before October 15, 1994, and a new exception for drugs whose Phase 2 or Phase 3 clinical investigations have been inactive or withdrawn for at least seven continuous years.
That abandoned-development exception is considered particularly significant, as it would end what critics have described as perpetual preclusion, giving supplement manufacturers a clearer path forward when pharmaceutical development stalls or is abandoned.
The legislation also grants the Secretary of the Department of Health and Human Services new discretion to approve a drug or biological product for use in food or dietary supplements through administrative order, replacing the previous notice-and-comment regulation requirement.
H.R. 10336 further adds a new provision requiring the HHS Secretary to consider differences between a drug and a substance when added to a dietary supplement, including route of administration, dosage, and safety profile.
The bill also makes FDA warning letters and related agency statements asserting drug preclusion violations immediately reviewable in court, a move that significantly expands the scope of judicial oversight over agency enforcement actions.
The Council for Responsible Nutrition, the Consumer Healthcare Products Association, and the American Herbal Products Association jointly issued a statement expressing support for the proposed legislation.
However, Daniel Fabricant, president and CEO of the Natural Products Association, published a critical opinion piece on October 2, 2026, warning that the bill would “permanently enshrine the very pharmaceutical gatekeeping mechanism” that the industry has long opposed.
“[D]isputes over who reached the market first, what constitutes the same article, and when a clinical investigation began could become predicates for prohibited conduct,” Fabricant writes, adding: “That is an extraordinary concession for the supplement industry to make.”
Supplement manufacturers are advised to maintain compliance with existing preclusion rules, document ingredient marketing histories, substantiate product claims, and prepare regulator-ready files while the bill’s progress through Congress remains uncertain.