---
kind: "section"
citation: "21 U.S.C. § 384b"
title: "21"
title_heading: "Food and Drugs"
number: "384b"
heading: "Voluntary qualified importer program"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/384b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VIII — Imports and Exports"
---

# §384b. Voluntary qualified importer program

- (a) **In general—** Beginning not later than 18 months after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall—
  - (1) establish a program, in consultation with the [Secretary](/usc/21/321.md?p=d) of Homeland Security—
    - (A) to provide for the expedited review and importation of [food](/usc/21/321.md?p=f) offered for importation by importers who have voluntarily agreed to participate in such program; and
    - (B) consistent with [section 384d of this title](/usc/21/384d.md), establish a process for the issuance of a [facility](/usc/21/364.md?p=3-A) certification to accompany [food](/usc/21/321.md?p=f) 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) **Voluntary participation—** An importer may request the [Secretary](/usc/21/321.md?p=d) to provide for the expedited review and importation of designated [foods](/usc/21/321.md?p=f) in accordance with the program established by the [Secretary](/usc/21/321.md?p=d) under [subsection (a)](#a).
- (c) **Notice of intent to participate—** 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](/usc/21/321.md?p=d) of such intent at the time and in a manner established by the [Secretary](/usc/21/321.md?p=d).
- (d) **Eligibility—** Eligibility shall be limited to an importer offering [food](/usc/21/321.md?p=f) for importation from a [facility](/usc/21/364.md?p=3-A) that has a certification described in [subsection (a)](#a). In reviewing the applications and making determinations on such applications, the [Secretary](/usc/21/321.md?p=d) shall consider the risk of the [food](/usc/21/321.md?p=f) to be imported based on factors, such as the following:
  - (1) The known safety risks of the [food](/usc/21/321.md?p=f) 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](/usc/21/321.md?p=f) safety standards for a designated [food](/usc/21/321.md?p=f).
  - (4) The compliance of the importer with the requirements of [section 384a of this title](/usc/21/384a.md).
  - (5) The recordkeeping, testing, inspections and audits of [facilities](/usc/21/364.md?p=3-A), traceability of articles of [food](/usc/21/321.md?p=f), temperature controls, and sourcing practices of the importer.
  - (6) The potential risk for intentional adulteration of the [food](/usc/21/321.md?p=f).
  - (7) Any other factor that the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (e) **Review and revocation—** Any importer qualified by the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.
- (f) **False statements—** Any statement or representation made by an importer to the [Secretary](/usc/21/321.md?p=d) shall be subject to [section 1001 of title 18](/usc/18/1001.md).
- (g) **Definition—** For purposes of this section, the term “importer” means the [person](/usc/21/321.md?p=e) that brings [food](/usc/21/321.md?p=f), or causes [food](/usc/21/321.md?p=f) to be brought, from a foreign country into the customs [territory](/usc/21/321.md?p=a-2) of the United States.

## Source credit

(June 25, 1938, ch. 675, § 806, as added Pub. L. 111–353, title III, § 302, Jan. 4, 2011, 124 Stat. 3955.)

## Notes

### 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 sections 2251 and 2252 of this title.