Description
This guidance represents the Food and Drug Administration's (FDA) and U.S. Customs and Border Protection's (CBP) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA, CBP, or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
3Food imported or offered for import into the United States; Articles of food imported or offered for import into the U.S.; Food products brought into the U.S.; food offered for import into the U.S.
The primary product category regulated by this guidance.
Food items described with FDA Product Codes 37Y--01 or 72E--99
Stakeholders
3Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Entity responsible for submitting NDINs
The IOR's name, address, and FEI are required for the WEF request.
Identified Hazards
Hazards
1Condition that may delay physical movement of food shipments
Related CFR Sections (9)
- 21CFR1.276§ 1.276 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR1.285§ 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part ?
(a) Consequences. If an article of food from a foreign facility that is not registered as required under section 415 of the act ( 21 U.S.C. 350d ) and subpart H of this part is imported or offered for import into the United States, the food is subject to being held under section 801(l) of the act ( Read full regulation →
- 21CFR1.225§ 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United StatRead full regulation →
- 21CFR1.243§ 1.243 Is food registration information available to the public?
(a) The list of registered facilities and registration documents submitted under this subpart are not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information Act). In addition, any information derived from such list or registration documents that would disclose the identity or location Read full regulation →
- 21CFR1.283§ 1.283 What happens to food that is imported or offered for import without adequate prior notice?
(a) For each article of food that is imported or offered for import into the United States, except for food arriving by international mail or food carried by or otherwise accompanying an individual, the consequences are:Read full regulation →
- 21CFR1.281§ 1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered for import into the United States, except by international mail, you must submit the information for the article that is required in paragraphs (a)(1) through (18) of this section:Read full regulation →
- 21CFR1.235§ 1.235 How and when do you cancel your facility's registration information?
(a) Notification of registration cancellation. You must cancel a registration within 60 calendar days of the reason for cancellation (e.g., your facility ceases operations, ceases providing food for consumption in the United States, or is sold to a new owner).Read full regulation →
- 21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read full regulation →
Related Warning Letters (1)
- 2021-05-04
New Drug/Misbranded
Immune & Genetics Protocols, LLC
See Also (8)
- Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments (Status: Final)
- Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4) (Status: Final)
- CPG Sec 100.250 Food Facility Registration (Human and Animal Food) (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Small Entity Compliance Guide: Registration of Food Facilities (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)
- Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (Status: Final)
- CVM GFI #239 Human Food By-Products For Use As Animal Food (Status: Draft)