# 119-hr-10336: Dietary Supplement Innovation Act

119-hr-10336, Dietary Supplement Innovation Act, is a 119th Congress bill sponsored by Rep. Harshbarger, Diana [R-TN-1] (R-TN); status introduced; PRIA reads it as touching household money (as of 2026-09-17).

- Canonical: https://policyrisk.com/legislation/119-hr-10336
- As of: 2026-09-17
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-10336
- Congress: 119
- Title: Dietary Supplement Innovation Act
- Status: introduced
- Introduced: 2026-09-10
- Sponsor: Rep. Harshbarger, Diana [R-TN-1] (R-TN)
- Cosponsors: 0
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-17

## Summary

**Clarifies and limits when a drug or biological product prevents an ingredient from being sold as a food or dietary supplement.** The bill rewrites the drug preclusion test, lists specific exemptions for legacy and safety-focused uses, and creates a formal FDA evaluation process with faster court review of preclusion claims. - Manufacturers: Producers can continue using some legacy or approved substances if they meet one of seven exemptions, for example marketing before 1994 or prior FDA approval. - Regulators and courts: FDA must weigh differences like route of administration, dose, concentration, and safety when judging preclusion, and warning letters or similar claims can be reviewed immediately by a court with the United States bearing the burden of proof. - Consumers and products: The bill preserves uses tied to food safety, generally recognized as safe findings, and older smoking cessation products, while preventing new drug-type uses from being added to foods unless an exemption applies or the Secretary approves them.

## Provisions PRIA read

- Ban on certain drugs in foods: benefit, high. This bill would bar selling in interstate commerce any food or dietary supplement that contains a drug approved under section 505, a biological product licensed under section 351, or a substance that is the subject of publicly disclosed Phase 2 or Phase 3 clinical trials unless an exemption applies…
- Faster court review of FDA notices: benefit, medium. This bill would let companies get immediate judicial review of certain FDA communications that assert a food or supplement violates the law. Covered communications would include warning letters, some notice responses under 21 C.F.R. 101.93(a), certain responses under the new section 413(a)(2), and…

## Related bills

- 119-hr-4317: PBM Reform Act of 2025
- 119-hr-6225: PAUSE Act of 2025
- 119-hr-4706: Protecting Our Farms and Homes from China Act
- 119-hr-8443: End H–1B Visa Abuse Act of 2026
- 119-hr-3589: RESTORE Act
- 119-hr-2395: SHORT Act

## Sources
- [119-hr-10336 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/10336)

## Related
- [119-hr-4317: PBM Reform Act of 2025](https://policyrisk.com/legislation/119-hr-4317)
- [119-hr-6225: PAUSE Act of 2025](https://policyrisk.com/legislation/119-hr-6225)
- [119-hr-4706: Protecting Our Farms and Homes from China Act](https://policyrisk.com/legislation/119-hr-4706)
- [119-hr-8443: End H–1B Visa Abuse Act of 2026](https://policyrisk.com/legislation/119-hr-8443)
- [119-hr-3589: RESTORE Act](https://policyrisk.com/legislation/119-hr-3589)
- [119-hr-2395: SHORT Act](https://policyrisk.com/legislation/119-hr-2395)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-10336 (as of 2026-09-17).