What will happen starting March 19, 2018?
Starting March 19, all imported human food shipments from foreign suppliers having less than 500 Full Time Equivalent employees (FTEs) will be subject to FSVP declaration during the Customs entry process. In most cases, Customs Automated Commercial Environment (ACE) system will require the FSVP Importer’s name, contact information, DUNS# and FDA registration number as indicated by the HTS code and/or FDA Product Code submitted through the system. This declaration will trigger in FDA’s data systems identification of a target for an FSVP inspection at the importer’s premises. The chances of an FDA FSVP inspection will increase substantially beginning early April 2018.
Note: This blog is focused on human food regulations. While animal food is also subject to FSVP, it has its own timeline. Read more about that here.
What about Very Small Businesses?
Food that is imported from a foreign supplier that is a “Very Small Business” is not subject to FSVP until March 19, 2019. In this instance, Very Small Business means a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale. The average Food Importer must have a system that ensures (and documents) both the imported shipments subject to FSVP now and the shipments not subject to FSVP at this time (i.e., supplied by Very Small Businesses).
The FSVP requirement doesn’t apply at all to firms that import food from foreign suppliers subject to seafood HACCP or juice HACCP.
How do I prepare for the enforcement date?
To prepare for the possibility of FDA inspection, you need to have your FSVP ready. We anticipate that FDA’s initial inspections will be focusing more on whether the importer has an FSVP or not for each food, rather than a deep audit into the FSVP plan itself. Read our blog on recent FSVP Enforcement actions.
FDA has set a goal of completing over 1,000 FSVP inspections in 2018, and FDA will need to work quickly to achieve this goal. To help manage your FSVP plans, FDAimports.com has recently launched FDAiVerify.com, which is the portal to a cloud-based subscription-service platform (powered by 3iVerify). FDAiVerify.com gives any food importer Complete Confidence in its FSVP Compliance status. Contact us today to learn more.
