Dietary Supplement Innovation Act
Sponsored By: Representative Harshbarger, Diana [R-TN-1]
Introduced
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.
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- 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.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Ban on certain drugs in foods
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. There are seven exemptions, including products marketed before October 15, 1994, products marketed before any FDA approval or public trial disclosure, substances whose trials have been inactive or discontinued for at least seven continuous years, certain safe new animal drugs, uses limited to food-safety pathways that meet GRAS or food-contact rules, smoking‑cessation products marketed before the 2007 FDA law, or an FDA administrative order approving the use. When deciding if a drug was “added” to a food or supplement, the Secretary would have to consider route of administration, recommended dose or serving, concentration or composition, and the degree of safety when added to food or to a dietary supplement (with supplement safety assessed under section 402(ff)). If enacted, these rules would take effect upon enactment.
Faster court review of FDA notices
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 Secretary-controlled website statements asserting a 301(ll) violation. In those immediate-review cases, the United States would bear the burden of proof to show the challenged introduction would violate section 301(ll). If enacted, this change would take effect upon enactment.
Sponsors & CoSponsors
Sponsor
Harshbarger, Diana [R-TN-1]
TN • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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