Dietary Supplement Innovation Act
Latest action (10 Sep 2026): Introduced
What this bill does
H.R. 10336, the Dietary Supplement Innovation Act, would amend the Federal Food, Drug, and Cosmetic Act's rules on "drug preclusion"—the provision that generally bars marketing a substance as a food or dietary supplement once it has been approved as a drug or has undergone public clinical drug trials. The bill rewrites the list of exceptions to this bar, adding new criteria such as whether the substance's use in food is meant to enhance food safety rather than produce therapeutic effects, and whether related clinical trials have been inactive for at least seven years or discontinued. It also creates a new process (Section 413A) directing the FDA to weigh factors like dosage, route of administration, and safety when deciding if a drug has been "added" to a food, and it makes FDA warning letters and similar agency statements on this issue immediately challengeable in court, with the government bearing the burden of proof. A related technical change is made to the definition of "dietary supplement."
The bill primarily affects dietary supplement manufacturers, ingredient developers, and the FDA, by changing how the agency determines whether a supplement ingredient is barred because of overlap with drug development, and by giving companies a clearer path to challenge FDA enforcement actions in court.
The bill was introduced on September 10, 2026, by Rep. Diana Harshbarger and referred to the House Committee on Energy and Commerce. It has not yet been voted on, and would need committee action, House and Senate passage, and the President's signature to become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
This bill is in the first stage of the legislative process. It was introduced into Congress on September 10, 2026. It will typically be considered by committee next before it is possibly sent on to the House or Senate as a whole.
Common questions
- What does H.R. 10336 do?
- H.R. 10336, the Dietary Supplement Innovation Act, would amend the Federal Food, Drug, and Cosmetic Act's rules on "drug preclusion"—the provision that generally bars marketing a substance as a food or dietary supplement once it has been approved as a drug or has undergone public clinical drug trials. The bill rewrites the list of exceptions to this bar, adding new criteria such as whether the substance's use in food is meant to enhance food safety rather than produce therapeutic effects, and whether related clinical trials have been inactive for at least seven years or discontinued. It also creates a new process (Section 413A) directing the FDA to weigh factors like dosage, route of administration, and safety when deciding if a drug has been "added" to a food, and it makes FDA warning letters and similar agency statements on this issue immediately challengeable in court, with the government bearing the burden of proof. A related technical change is made to the definition of "dietary supplement." The bill primarily affects dietary supplement manufacturers, ingredient developers, and the FDA, by changing how the agency determines whether a supplement ingredient is barred because of overlap with drug development, and by giving companies a clearer path to challenge FDA enforcement actions in court. The bill was introduced on September 10, 2026, by Rep. Diana Harshbarger and referred to the House Committee on Energy and Commerce. It has not yet been voted on, and would need committee action, House and Senate passage, and the President's signature to become law.
- Has H.R. 10336 become law?
- Not yet. As of 10 Sep 2026, H.R. 10336 is introduced.
- Who sponsored H.R. 10336?
- H.R. 10336 was sponsored by Rep. Diana Harshbarger [R-TN1] (Republican-TN), with 0 cosponsors.
- What's the latest action on H.R. 10336?
- Introduced (10 Sep 2026).
Related bills in Health
Tyler’s Law
Kay Hagan Tick Reauthorization Act
Priority for Pediatric Cures Act
Expressing support for the designation of the week of September 13 to 19, 2026, as “National Co-Responder and Crisis Clinician Week”.
Bill100 mirrors the public U.S. legislative record from Congress.gov and GovTrack and adds plain-English AI summaries. It is an information tool, not legal, compliance or lobbying advice, and it is not affiliated with the U.S. Congress or any government agency. AI summaries can simplify or omit detail — every bill links to the official source; verify there before you rely on it.