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FDA's FSVP for Food Imports: Compliance Answers for Customs Brokers.

Baltimore, MD, May 12, 2017 --( Importers and foreign suppliers often turn to their international logistics team of customs brokers and freight forwarders to answer questions about U.S. Customs and U.S. Food & Drug Administration (FDA) regulations. In the case of FDA's Foreign Supplier Verification Plan (FSVP), there are a lot of questions as we get closer to the first compliance date of May 30, 2017.

Which Importers Must Comply in May?

FSVP is not a "one size fits all" regulation or implementation schedule. FDA requires all food (human and animal) importers to develop and implement a FSVP - with a few limited exceptions. A food importer is defined as "the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry " 21 C.F.R. 1.500. Notably, under this regulation "U.S. owner or consignee" is a term of art, which means "the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food."

"It's important to recognize that the 'importer' from an FSVP perspective is possibly different than the 'importer of record' from a Customs perspective. Frequently, they will be the same; however, when a shipment has a Customs foreign importer of record, the U.S. consignee may likely be the 'importer' for the purposes of the FSVP regulations or it maybe a party not even mentioned on the commercial import documents," notes attorney John F. Johnson III.

FSVP Importers must review their various foreign suppliers to determine their own compliance dates, as FSVP compliance for importers is based the food types and size of their foreign suppliers. One importer may have compliance dates ranging from May 2017 through July 2020 - or they may have no suppliers that fit the requirements and, therefore, are not subject to FSVP.

Unique Facility Identifier

FDA has mandated that certain ACE data elements will need to be submitted for each entry by the Customs Importer of Record that identify the FSVP Importer starting May 30, 2017 including a Unique Facility Identifier (UFI). At the end of March, FDA issued guidance that a DUNS number would be an acceptable UFI for FSVP compliance and urged all FSVP importers to request a DUNS number if they didn't already have one. Unfortunately, it can take several weeks to get a DUNS number, so last week the agency announced they "will temporarily allow the submission of 'UNK" (unknown) as the syntax for the DUNS number for the FSV Importer in PG19. "UNK' should only be used if the nine-digit, site-specific DUNS number is not available at the time the entry is transmitted." [1]

Our Recommendation for Brokers

As a regular part of good customer service, brokers often find themselves fielding questions about FDA compliance and enforcement actions - and with compliance dates looming and incomplete guidance from FDA itself, there could be a lot of FSVP-related questions this month. Benjamin L. England, Founder and CEO of urges brokers to "avoid advising importers on what they have to do to comply." FSVP is complex and confusing and brokers could face potential liability with importers if they answer inaccurately. It is better to reach out to a Subject Matter Expert, such as

About, LLC helps clients in every aspect of FDA, USDA, and Customs compliance and international business consulting, including FSVP compliance. With nearly 100 years of direct former FDA experience and dozens more practicing before Customs, FDA and other agencies, their understanding and experience in the industry is unparalleled. Their regulatory specialists and affiliated attorneys integrate regulatory and business strategies into a single source for solving regulatory and legal problems for foreign and domestic producers, importers, distributors and retailers.

[1] CSMS #17-000255 "Update to FDA Foreign Supplier Verification Program (FSVP) Data Requirements"

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Date:May 12, 2017
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