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GUIDANCE DOCUMENT
The aim of this doc is to supply steering for business on the necessities for a international provider verification program (FSVP) in 21 CFR half 1, subpart L, that importers of human or animal meals should set up and comply with to make sure that every meals they import into the US meets relevant U.S. necessities and isn’t adulterated or (for human meals) misbranded with respect to allergen labeling.
Usually, FDA’s steering paperwork don’t set up legally enforceable obligations. As an alternative, guidances describe the Company’s present pondering on a subject and ought to be seen solely as suggestions, except particular regulatory or statutory necessities are cited. The usage of the phrase ought to in Company guidances signifies that one thing is recommended or really helpful, however not required.
This steering gives questions and solutions to facilitate importers’ understanding of the FSVP necessities.[1] The pronouns “I,” “me,” and “you” are used on this steering to discuss with the importer. “Company” and the pronouns “we” and “our” are used to discuss with FDA. The time period “meals” consists of meals for people and animals and has the which means given in part 201(f) of the Federal Meals, Drug, and Beauty Act (FD&C Act) (21 U.S.C. 321(f)), besides that, for the needs of FSVP, “meals” doesn’t embrace pesticides as outlined in 7 U.S.C. 136(u) (21 CFR 1.500). “Meals” consists of:
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[1] As a result of FDA’s FSVP laws pertain to the importation of human and animal meals, they comprise a number of phrases which might be related or similar-sounding to these additionally utilized by U.S. Customs and Border Safety (CBP) referring to the importation of all merchandise. Nonetheless, because of the totally different authorities applied by FDA and CBP, these phrases might have totally different meanings. The place related, this steering clarifies these variations in sure Questions and Solutions. For steering from CBP on fundamental importing and exporting, see Basic Importing and Exporting | U.S. Customs and Border Protection (cbp.gov).
For questions concerning this doc, you might contact the FSMA Technical Help Community online, by mail at
Meals and Drug Administration
5001 Campus Drive
Wiley Constructing, HFS-009
Attn: FSMA Outreach
Faculty Park, MD, 20740
or by cellphone at 1-888-SAFEFOOD (1-888-723-3366).
You’ll be able to submit on-line or written feedback on any steering at any time (see 21 CFR 10.115(g)(5))
If unable to submit feedback on-line, please mail written feedback to:
Dockets Administration
Meals and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written feedback ought to be recognized with this doc’s docket quantity: FDA-2017-D-5225.
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