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FDA FSVP NEW PRODUCT FORM

Overview: When a food product under FDA oversight is offered for entry into the United States, the U.S. Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will prompt the filer to transmit a code: When prompted, enter “FSV” as the Entity Role Code. This code will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation and will trigger a request for the FSVP Importer’s name, email address, and DUNS number as the UFI recognized as acceptable by FDA.

CODE   |

 

FSV

DATA ELEMENT  |

 

Entity Role

Code

CONDITION

 

If Government Agency program code is FOO and processing code is NSF, PRO, ADD, DSU, FEE, then the following FSVP-related details will be mandatory for all FDA FOO lines unless Industry Codes 16 or 32 are present in PG02: 

 PG19  DUNS #, FSVP Importer Name, Address are required.

 PG20  All elements, except Apt#, are required AND 

  Country and State are required. (50 US States, DC and PR)

 PG21  Qualifier Code = FSV and eMail address are required.

  Individual’s name and telephone number are required.

Important: If line item is a food, beverage, or supplement and the following codes are not transmitted, the entry will be rejected.

"UNK" is no longer acceptable, if used the entry will be rejected by CBP.

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Company the Supplier?

Company the Supplier
Yes
No
Filing Resource Links

FDA/CBP Guidance Documents and Other Resources

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CBP GUIDANCE

FDA ACE/ITDS Guide 

Download

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CBP GUIDANCE

ACE CATAIR Appendix PGA

Download

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FDA GUIDANCE

Acceptable FSVP UFI

Download

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CBP GUIDANCE

FSVP Compliance Dates

Access

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Contact United Safety Agents with all questions or requests 

Our firm works closely with Customs Brokers and freight forwarding providers to ensure that their clients comply with the Foreign Supplier Verification Program and clear the FSVP-portion of entry.

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Contact information will only be used to send results and will never be shared with third-parties.

All information is treated as confidential.

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