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

# §384a. Foreign supplier verification program

- (a) **In general—**
  - (1) **Verification requirement—** Except as provided under subsections [(e)](#e) and [(f)](#f), each importer shall perform risk-based foreign supplier [verification](/usc/21/360eee.md?p=28) activities for the purpose of verifying that the [food](/usc/21/321.md?p=f) imported by the importer or agent of an importer is—
    - (A) produced in compliance with the requirements of [section 350g of this title](/usc/21/350g.md) or [section 350h of this title](/usc/21/350h.md), as appropriate; and
    - (B) is not adulterated under [section 342 of this title](/usc/21/342.md) or misbranded under [section 343(w) of this title](/usc/21/343.md?p=w).
  - (2) **Importer defined—** For purposes of this section, the term “importer” means, with respect to an article of [food](/usc/21/321.md?p=f)—
    - (A) the United States owner or consignee of the article of [food](/usc/21/321.md?p=f) at the time of entry of such article into the United States; or
    - (B) in the case when there is no United States owner or consignee as described in [subparagraph (A)](#a-2-A), the United States agent or representative of a foreign owner or consignee of the article of [food](/usc/21/321.md?p=f) at the time of entry of such article into the United States.
- (b) **Guidance—** Not later than 1 year after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall issue guidance to assist importers in developing foreign supplier [verification](/usc/21/360eee.md?p=28) programs.
- (c) **Regulations—**
  - (1) **In general—** Not later than 1 year after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations to provide for the content of the foreign supplier [verification](/usc/21/360eee.md?p=28) program established under [subsection (a)](#a).
  - (2) **Requirements—** The regulations promulgated under [paragraph (1)](#c-1)—
    - (A) shall require that the foreign supplier [verification](/usc/21/360eee.md?p=28) program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported [food](/usc/21/321.md?p=f) in compliance with—
      - (i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under [section 350g of this title](/usc/21/350g.md) or [section 350h of this title](/usc/21/350h.md) (taking into consideration variances granted under [section 350h of this title](/usc/21/350h.md)), as appropriate; and
      - (ii) [section 342 of this title](/usc/21/342.md) and [section 343(w) of this title](/usc/21/343.md?p=w).[^1]
    - (B) shall include such other requirements as the [Secretary](/usc/21/321.md?p=d) deems necessary and appropriate to [verify](/usc/21/360eee.md?p=28) that [food](/usc/21/321.md?p=f) imported into the United States is as [safe](/usc/21/321.md?p=u) as [food](/usc/21/321.md?p=f) produced and sold within the United States.
  - (3) **Considerations—** In promulgating regulations under this subsection, the [Secretary](/usc/21/321.md?p=d) shall, as appropriate, take into account differences among importers and types of imported [foods](/usc/21/321.md?p=f), including based on the level of risk posed by the imported [food](/usc/21/321.md?p=f).
  - (4) **Activities—** [Verification](/usc/21/360eee.md?p=28) activities under a foreign supplier [verification](/usc/21/360eee.md?p=28) program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.
- (d) **Record maintenance and access—** Records of an importer related to a foreign supplier [verification](/usc/21/360eee.md?p=28) program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly [authorized](/usc/21/360eee.md?p=2) representative of the [Secretary](/usc/21/321.md?p=d) upon request.
- (e) **Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP—** This section shall not apply to a [facility](/usc/21/364.md?p=3-A) if the owner, operator, or agent in charge of such [facility](/usc/21/364.md?p=3-A) is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such [facility](/usc/21/364.md?p=3-A):
  - (1) The Seafood Hazard Analysis Critical Control Points Program of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
  - (2) The Juice Hazard Analysis Critical Control Points Program of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
  - (3) The Thermally Processed Low-Acid [Foods](/usc/21/321.md?p=f) Packaged in Hermetically Sealed Containers standards of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration (or any successor standards).

  The exemption under [paragraph (3)](#e-3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid [Foods](/usc/21/321.md?p=f) Packaged in Hermetically Sealed Containers under part 113 of chapter[^2] 21, Code of Federal Regulations (or any successor regulations).

- (f) **Additional exemptions—** The [Secretary](/usc/21/321.md?p=d), by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of [food](/usc/21/321.md?p=f) imported in small quantities for research and evaluation purposes or for personal consumption, provided that such [foods](/usc/21/321.md?p=f) are not intended for retail sale and are not sold or distributed to the public.
- (g) **Publication of list of participants—** The [Secretary](/usc/21/321.md?p=d) shall publish and maintain on the Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a current list that includes the name of, location of, and other information deemed necessary by the [Secretary](/usc/21/321.md?p=d) about, importers participating under this section.

## Footnotes

[^1]: So in original.
[^2]: So in original. Probably should be “title”.

## Source credit

(June 25, 1938, ch. 675, § 805, as added Pub. L. 111–353, title III, § 301(a), Jan. 4, 2011, 124 Stat. 3953.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title.

### Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, 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 2206, 2251, and 2252 of this title.