U.S. Food Importers: Be Prepared!

The Foreign Supplier Verification Programs regulation within the Food Safety Modernization Act requires a unique facility identifier be provided with each line entry that identifies the FSVP importer for that line item. FDA identified the DUNS number as the acceptable UFI.

FDA also recognized that many importers didn’t have DUNS numbers, so since 2017 it’s allowed importers without DUNS numbers to use the entity identification code “UNK”. FDA recently announced that option will no longer be allowed as of July 24. So, importers who need a DUNS number should apply ASAP! 

Foreign Suppliers: Beat the Rush!

Producers, FDA also extended your time to acquire a DUNS number. It was supposed to be in place by Dec. 31, 2020 but the agency extended it, again because many facilities did not yet have a DUNS number. The extension was granted through the end of the next FDA facility registration cycle, Dec. 31, 2022. Nobody expects that requirement to be further delayed, so foreign suppliers without DUNS numbers should acquire a DUNS number now so everything is in place well before the facility renewal period opens Oct. 1.

Some Notes for All:

• Importers and suppliers may obtain a DUNS number from Dun & Bradstreet free of charge.
• It may take as long as a month to get a number; that’s why I’m recommending foreign suppliers apply now – it will make your renewal process go much smoother.
• D&B also provides an expedited service for a fee. BUT, by acting soon, can avoid any need for the expedited service.
• To obtain a DUNS number, contact D&B directly by phone at 866-705-5711 or at https://www.dnb.com/duns-number/get-a-duns.html.
• FDA issued an updated guidance for industry on obtaining DUNS numbers.
• DUNS numbers are specific to a location, so if your firm has more than one production facility, you’ll need one for each location. For importers with more than one facility, you’ll only need a DUNS numbers for offices/locations where the records and the qualified individual are located. So, if your firm has more than one office but anyone who meets the definition of a qualified individual is in one of those offices and can access all the needed records, you likely would need only one DUNS number and you would provide the DUNS number for that location.
• The DUNS number is telling FDA where to go to conduct its inspection, so it’s critically important to provide the correct DUNS number.

It’s impossible to cover all of this in a short blog. It’ll serve you well to click on the link above to the guidance document and/or take the Food Safety Preventive Controls Alliance course: Human Food course for producers; FSVP course for importers. I participated in three Human Food rule course offerings and have taught roughly 100 FSVP sessions. There’s no doubt these courses are the best way to understand the rule(s) that pertain to your firm. 

In terms of FDA facility registration, I have to agree with the many who say AFI is the best option for a facility registration agent for foreign firms. The reason is simple: for less than what most firms charge for that service alone, the agent service is included in the cost of AFI membership. So, in addition to getting agent services from an entity well-suited to offer that service, your firm gets ongoing information about U.S. requirements and trends and is “associated” with major U.S. importers and others who regularly refer to the AFI membership directory when in need of suppliers. Learn more about how AFI can help you with FDA Facility Registration.