Food

Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

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How to Comment

Although you can submit comments on any guidance at any time (see 21 CFR 10.115(g)(2)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit electronic comments to
http://www.regulations.gov to docket number FDA-2017-D-5225

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2017-D-5225

Questions?

For questions regarding this draft document, contact the Office of Compliance, Center for Food Safety and Applied Nutrition (CFSAN), at 240-701-5986 (regarding human food), or the Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM), at 240-402-6246 (regarding animal food).

Contains Nonbinding Recommendations
Draft - Not for Implementation

January 2018

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.

FDA’s guidance documents, including this guidance, 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.  

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

Download Draft Guidance for Industry:
Foreign Supplier Verification Programs
for Importers of Food for Humans and Animals

Page Last Updated: 01/25/2018
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