Prohibiting Tianeptine and Other Dangerous Products Act of 2026
Summary
What This Bill Does
The Prohibiting Tianeptine and Other Dangerous Products Act amends the Federal Food, Drug, and Cosmetic Act to make it a prohibited act to introduce or deliver into interstate commerce any product marketed as a dietary supplement that does not meet the statutory dietary-supplement definition. It also prohibits introducing a dietary supplement prepared, packed, or held with the assistance of, or at the direction of, a person debarred under FDCA section 306. The bill adds these violations to import-refusal provisions and seizure/condemnation provisions, so FDA can stop covered products at the border and pursue seizure after distribution.
Who Benefits and How
Consumers benefit from stronger FDA tools against tianeptine-style products and other dangerous products masquerading as dietary supplements. FDA benefits from explicit prohibited-act, import-refusal, and seizure hooks. Compliant supplement manufacturers benefit when noncompliant competitors face clearer enforcement.
Who Bears the Burden and How
Supplement marketers, importers, distributors, and manufacturers must ensure products meet the dietary-supplement definition and are not prepared with debarred-person assistance. FDA must enforce the new prohibited acts at import and seizure stages. Retailers may lose inventory or suppliers if products are refused or condemned.
Key Provisions
- Creates a prohibited act for introducing products marketed as dietary supplements that do not meet the FDCA dietary-supplement definition.
- Creates a prohibited act for dietary supplements prepared, packed, or held with assistance from a debarred person.
- Adds the new violations to FDA import-refusal and seizure or condemnation authorities.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Adds new FDCA prohibited acts targeting products falsely marketed as dietary supplements and supplements prepared with debarred-person involvement, with import refusal and seizure consequences.
Key Policy Areas
Healthcare, Food & Beverage, Pharmaceuticals
Primary Purpose
Adds new FDCA prohibited acts targeting products falsely marketed as dietary supplements and supplements prepared with debarred-person involvement, with import refusal and seizure consequences.
Policy Domains
Substantive provisions
Identified Gains
- Consumers
- FDA
- Compliant supplement manufacturers
Identified Costs
- Supplement marketers
- Dietary supplement importers
- Retailers
- FDA
Legislative Progress
In CommitteeReferred to the House Committee on Energy and Commerce.
Introduced in House
Mr. Pallone introduced the following bill; which was referred to …
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "fda"
- → Food and Drug Administration
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology