Title 21Food and DrugsRelease 119-73not60

§384b Voluntary Qualified Importer Program

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS › § 384b

Last updated Apr 5, 2026|Official source

Summary

Creates a voluntary program to speed up the review and import of food for importers who choose to join. The Secretary must start the program no later than 18 months after January 4, 2011, and must work with the Secretary of Homeland Security. The Secretary must also set up a way to issue facility certifications under section 384d that go with the imported food and must publish guidance about joining, losing, getting back into, and following the program. An importer can ask to use the program and must send a notice and application when and how the Secretary says. Only importers bringing food from a certified facility can qualify. The Secretary will decide who qualifies by looking at risk factors such as known safety risks; foreign supplier history; the exporting country’s regulatory system; the importer’s compliance with section 384a; the importer’s recordkeeping, testing, inspections, traceability, temperature control, and sourcing; risk of intentional adulteration; and other relevant factors. Qualified importers will be reviewed at least once every 3 years and can be quickly removed if they do not meet the rules. Any statement to the Secretary is covered by section 1001 of title 18. "Importer" means the person who brings food from a foreign country into the United States customs territory.

Full Legal Text

Title 21, §384b

Food and Drugs — Source: USLM XML via OLRC

(a)Beginning not later than 18 months after January 4, 2011, the Secretary shall—
(1)establish a program, in consultation with the Secretary of Homeland Security—
(A)to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and
(B)consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and
(2)issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with, such program.
(b)An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program established by the Secretary under subsection (a).
(c)An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner established by the Secretary.
(d)Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:
(1)The known safety risks of the food to be imported.
(2)The compliance history of foreign suppliers used by the importer, as appropriate.
(3)The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.
(4)The compliance of the importer with the requirements of section 384a of this title.
(5)The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.
(6)The potential risk for intentional adulteration of the food.
(7)Any other factor that the Secretary determines appropriate.
(e)Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.
(f)Any statement or representation made by an importer to the Secretary shall be subject to section 1001 of title 18.
(g)For purposes of this section, the term “importer” means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see section 2251 and 2252 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 384b

Title 21Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60