Proposed H.R. 10336 Would Balance Innovation, Access to Dietary Supplements—Yet Change the Definition

Wednesday, October 7, 2026

On September 10, 2026, Congresswoman Diana Harshbarger (R-TN) introduced H.R. 10336—the Dietary Supplement Innovation Act—which would modernize the U.S. Food and Drug Administration’s (FDA) drug preclusion provision to encourage pharmaceutical innovation while increasing and protecting consumer access to dietary supplements.

Harshbarger asserts in a Fact Sheet that the drug preclusion provisions of the federal Food, Drug, and Cosmetic Act (the “FD&C 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 in a news release.

While focusing on the drug preclusion provisions of the FD&C Act, H.R. 10336 would also affect the definition sections of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 21 U.S.C. § 321(ff)(3)(A) and (B)—changing how a legitimate dietary supplement is defined. We explore the provisions of the bill below.

DSHEA—which amended the FD&C Act to establish standards for dietary supplements—provides in § 321(ff)(3) that a dietary supplement includes articles approved as a new drug or licensed as a biologic that

[were], prior to such approval, certification, or license, marketed as a dietary supplement…unless the Secretary has issued a regulation…finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful[.]

However, a dietary supplement does not include articles approved as a new drug, licensed as a biologic, or certified as an antibiotic—or those authorized for investigation as a new drug, biological, or antibiotic, with publicly disclosed, substantial clinical investigations—which

[were] not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation…finding that the article would be lawful[.] (Emphasis added.)

Under the current framework, a substance that meets § 321(ff)(1) and (2)[1] could still be excluded from being a dietary supplement under § 321(ff)(3) based on drug status. H.R. 10336 would remove 21 U.S.C. § 321(ff)(3) from the definition of “dietary supplement” altogether, so that a substance described in 21 U.S.C. § 321(ff)(1) and (2) would be subject to the framework below.

Section 301(ll) of the FD&C Act, 21 U.S.C. § 331(ll), prohibits the addition of 1) FDA-approved drugs, 2) licensed biological products, or 3) drugs or biological products involved in substantial clinical investigations which have been instituted and made public, to any food, including dietary supplements. HR 10336 adds “Phase 2 or Phase 3” before “clinical investigations” (removing “substantial”); and expands the exceptions to the general rule as follows:

1. Grandfather Clause: Allows substances marketed as food or dietary supplements before October 15, 1994 (adding a firm date);
2. Pre-Approval Marketing: Allows substances marketed before any approval of the drug, any licensure of the biological product, or before Phase 2 or Phase 3 clinical investigations have been instituted and made public;
3. Abandoned/Inactive Development: Allows substances to be used in supplements if Phase 2 or Phase 3 clinical investigations have been on inactive status, withdrawn, or both for a continuous period of at least seven years preceding the addition of the drug or biological product in food or in a dietary supplement, or when the sponsor has publicly announced the discontinuation of drug development activities (adding a new, significant exception that ends perpetual preclusion);
4. Animal Drugs: Allows new animal drugs deemed safe (changing wording);
5. Safety Enhancement: Allows substances used to enhance food safety, in conformity with current regulations; conditions of use—including a regulation listing or affirming conditions under which the use of the drug or biological product in food is generally recognized as safe; or an effective food contact substance notification (streamlining current law);
6. Smoking Cessation: Allows products marketed for smoking cessation before the date (September 27, 2007) of enactment of the FDA Amendments Act of 2007 (moving the provision from “Safety Enhancement”); and
7. FDA Discretion: Allows the Secretary of the U.S. Department of Health and Human Services (HHS) to approve the use of a drug or biological product in food or dietary supplements through administrative order (modifying the previous “regulation after notice and comment”).

H.R. 10336 would add a new Section 413A to the FD&C Act so that when determining whether a drug, including a biological product, has been added to a dietary supplement, the HHS Secretary shall consider differences between the drug and the substance when added to the dietary supplement—for example, route of administration; recommended dosage; concentration or composition; or the degree of safety of the substance when added to a dietary supplement. Finally, H.R. 10336 makes FDA warning letters, related agency responses, or statements asserting a Section 301(ll) violation immediately reviewable in court.

The proposed legislation has received support from the Council for Responsible Nutrition (CRN), which issued a joint statement with the Consumer Healthcare Products Association (CHPA) and American Herbal Products Association (AHPA). Overall industry response was positive, yet Daniel Fabricant, president and CEO of the Natural Products Association (NPA), published an opinion piece on October 2, 2026, asserting that H.R. 10336 would “permanently enshrine the very pharmaceutical gatekeeping mechanism” that industry has opposed for years. 

“[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. “That is an extraordinary concession for the supplement industry to make.”

 While too early to tell if the legislation will pass, dietary supplement manufacturers should continue to do the following:

• Compliance: Keep complying with Section 301(ll); document each at-risk ingredient’s marketing history.
• Diligence & Product Design: Confirm each ingredient’s lawful status, including new dietary ingredient status.
• Labeling & Claims: Avoid disease claims; substantiate other claims; and use the DSHEA disclaimer.
• R&D/Clinical Strategy (dual-track risk): Coordinate internally so milestones do not trigger preclusion.
• Quality, Safety, and Documentation Readiness: Keep a regulator-ready file with specifications, records, and substantiation.
• FDA Engagement: Assume enforcement remains in play and reassess litigation strategy if review expands.

Dietary supplement industry groups, consumer advocacy groups, pharmaceutical companies, and medical and public health organizations with an interest in the legislation should monitor the bill's progress and consider submitting formal comments, testimony, or position statements to Congress regarding how H.R. 10336 may affect their respective interests and the public. If you have questions, please reach out to the authors.

Ann W. Parks contributed to this article

[1] Under 21 U.S.C. § 321(ff)(1), a “dietary supplement” contains one or more of the following dietary ingredients—vitamins, minerals, herbs or other botanicals, amino acids, dietary substances intended to supplement the diet, or concentrates, metabolites, constituents, extracts, or combinations of these ingredients. Under (2), the product must be intended for ingestion in a particular form (such as a tablet, capsule, powder, or liquid), must not be represented as a conventional food or as a sole item of a meal or the diet, and must be labeled as a dietary supplement.