Summary

Prohibits interstate commerce and import of products marketed as dietary supplements if they do not meet the legal definition of a “dietary supplement,” and bars dietary supplements that were prepared, packed, or held with assistance or direction from persons who are debarred under federal law. Expands FDA authority to refuse admission at the border and to seize and condemn such products as violations of the Federal Food, Drug, and Cosmetic Act.

• Makes it illegal to introduce into interstate commerce products labeled as dietary supplements if they don't meet the statutory definition of 'dietary supplement.'
• Prohibits dietary supplements that were prepared, packed, or held with assistance or direction from federally debarred persons.
• Gives customs/FDA explicit authority to refuse entry to products violating the new rules at U.S. ports of entry.
• Adds the new violations to existing seizure and condemnation authorities, enabling FDA enforcement actions domestically and at the border.
• Does not create new spending or tax changes and contains no stated effective date in the text provided.
• Targets products that may be drugs or otherwise misbranded as supplements (e.g., substances like tianeptine) and closes a pathway for debarred individuals to influence supplement production.
• Increases compliance requirements for manufacturers, packers, distributors, and importers of dietary supplements.
• May prompt legal or regulatory questions about how the statutory "dietary supplement" definition is applied in particular cases.