- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory AffairsCenter for Food Safety and Applied Nutrition
The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements. The pronouns “I,” “me,” and “you” are used in this guidance to refer to the importer. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” includes food for humans and animals and has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of FSVP, “food” does not include pesticides as defined in 7 U.S.C. 136(u) (21 CFR 1.500). “Food” includes:
- Articles used for food or drink for man or other animals,
- Chewing gum, and
- Articles used for components of any such article.
 Because FDA’s FSVP regulations pertain to the importation of human and animal food, they contain several terms that are similar or similar-sounding to those also used by U.S. Customs and Border Protection (CBP) relating to the importation of all merchandise. However, due to the different authorities implemented by FDA and CBP, these terms may have different meanings. Where relevant, this guidance clarifies these differences in certain Questions and Answers. For guidance from CBP on basic importing and exporting, see Basic Importing and Exporting | U.S. Customs and Border Protection (cbp.gov).
For questions regarding this document, you may contact the FSMA Technical Assistance Network online, by mail at
Food and Drug Administration
5001 Campus Drive
Wiley Building, HFS-009
Attn: FSMA Outreach
College Park, MD, 20740
or by phone at 1-888-SAFEFOOD (1-888-723-3366).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-5225.