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FDA Issues Further Guidance Related to FSVP

FDA Issues Further Guidance Related to FSVP

On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program ("FSVP") regulation. The three-page fact sheet responds to questions such as (i) who's covered by the rule (see also chart prepared by FDA), (ii) what to do if covered by the rule, (iii) when would modified requirements apply under the rule, (iv) what foods and beverages are exempt from the rule, and (v) what are the FSVP compliance dates.

The guidance states that beginning on May 30, 2017, the date when the FSVP final rule is set to take effect, the filer of food offered for entry into the United States will have to transmit through the U.S. Customs and Border Protection Automated Commercial Environment system a code to identify whether the product is subject to FSVP regulation or not. The entity role code to indicate the article of food and importer are subject to FSVP regulation is "FSV." In this case, the filer will also have to indicate the importer's name, email address, and DUNS number as the UFI recognized as acceptable by FDA. For now, FDA is allowing filers to state "UNK" (to represent "unknown") if the importer has not yet provided a Dun & Bradstreet Data Universal Numbering System ("DUNS") number. If the food article is not subject to the regulation yet, the code must be "FSX," and if exempt from compliance because the food will be used for research or evaluation, the code must be "RNE." FDA stated that if codes are not transmitted the entry will be rejected and the filer will have to retransmit the entry line under the correct code.

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