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Amends section 801(a) (21 U.S.C. 381(a)) by modifying the seventh sentence to add authority to destroy any article refused admission under the section if the Secretary of Health and Human Services determines it presents a significant public health concern, and by replacing wording in the eighth, ninth, and tenth sentences with the phrase "drug, device, or other article."
Adds a new prohibited-act paragraph (jjj) to section 301 (21 U.S.C. 331) making the unauthorized movement, or introduction or delivery for introduction into interstate commerce, including export, of an article that the Secretary has decided to destroy under the seventh sentence of section 801(a) a prohibited act.
Allows the Secretary of Health and Human Services (acting through the FDA Commissioner) to order destruction of drugs, devices, or other articles that were refused admission when the Secretary determines they pose a significant public health concern. The law also makes it illegal to move, attempt to move, or introduce into interstate commerce (including export) any article the Secretary has ordered destroyed, and it requires the FDA to issue final implementing regulations within 90 days. The changes take effect 180 days after enactment.
Amend 21 U.S.C. 381(a) (section 801(a) of the FD&C Act) seventh sentence to allow destruction of any article refused admission under this section if the Secretary of Health and Human Services determines the article presents a significant public health concern.
Amend 21 U.S.C. 381(a) eighth, ninth, and tenth sentences by replacing wording so each place refers to "drug, device, or other article."
Add new subsection (jjj) to 21 U.S.C. 331 (section 301 of the FD&C Act) making it a prohibited act to unauthorizedly move, or introduce or deliver for introduction into interstate commerce (including export), an article that the Secretary has decided to destroy under the seventh sentence of section 801(a).
The amendments made by subsections (a) and (b) apply to articles beginning on the date that is 180 days after the date of enactment of this Act.
The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, must finalize necessary regulatory revisions to implement these amendments not later than 90 days after the date of enactment of this Act.
Who is affected and how:
Department of Health and Human Services / FDA: Must adopt and implement regulations quickly (within 90 days) to operationalize destruction authority, develop procedures, and coordinate with Customs and border/port authorities.
Manufacturers and applicants of drugs and medical devices: Face a heightened risk that refused shipments judged to pose a public health concern will be ordered destroyed and barred from re-entry, movement, or export. They may need to revise import compliance, quality-control, and recall procedures.
Importers, exporters, carriers, customs brokers, warehouses, and distributors: Must establish processes to identify refused items subject to destruction orders, to avoid moving or exporting such articles, and to comply with disposal rules. Operational disruptions, storage costs, and compliance burdens are likely.
Healthcare providers and patients: Indirectly affected if the destruction authority removes potentially contaminated or dangerous products from commerce quickly, improving public health protection; however, if supply-chain disruptions occur, certain products could face temporary shortages.
Trade and logistics sectors: Ports and logistics firms will need to coordinate with FDA and may incur costs managing segregated destroyed items and ensuring no prohibited interstate movement or exports occur.
State and local governments: Largely unaffected in terms of new regulatory duties; the provision imposes federal authority over items refused admission and does not create explicit state obligations or funding requirements.
Overall effect: The provision strengthens federal public-health authority over refused imports by enabling destruction and blocking their onward distribution, but it places near-term regulatory and operational burdens on FDA and private-sector import/handling actors to comply with new rules and to avoid unlawful movement or export of ordered-to-be-destroyed items.
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Referred to the House Committee on Energy and Commerce.
Introduced April 8, 2025 by Clay Higgins · Last progress April 8, 2025
Destruction of Hazardous Imports Act
Referred to the House Committee on Energy and Commerce.
Introduced in House
