It’s been eight years since the Food Safety Modernization Act (FSMA) was signed into law. With that, the U.S. Food and Drug Administration (FDA) started issuing new regulations designed to strengthen the food safety system. At the same time, they took the “educate while regulate” approach to compliance and enforcement of new FSMA regulations. Most compliance dates for the seven major rules, including FSVP, have now gone into effect.
Foreign Supplier Verification Program (FSVP)
The FSVP rule had its first compliance date in May 2017. It requires that importers of food products develop a verification program demonstrating that their suppliers have adequately controlled for any chemical, physical, and microbiological hazards that occur during production and processing.
- As we reported last year, FDA stepped up the number of FSVP inspections in 2018. Those early
inspections focused on whether an importer has an FSVP plan in place for each food and not the detailed specifications of the plans. - FDA’s Inspection Observation Data for the last two years show a clear trend: FDA issued citations to 289 U.S. importers of food and beverages (including very small importers) for not developing an FSVP in FY2018, up from 111 in FY 2017, a 260% increase.
- FDA guidance allowing the use of “UNK” in place of a DUNS number for the unique facility identifier (UFI) required with each entry through U.S. Customs is likely to end soon. This temporary guidance started in May 2017. Importers without a DUNS number should not wait to contact Dun and Bradstreet (D&B) to obtain their free number.
- With most larger importers having been subject to the FSVP rule since at least March 2018, we would expect FDA to step up inspections in 2019, which will further encourage importers to create compliance FSVP plans.
Education for Importers
Although FDA has issued a number of guidance documents to help importers understand and comply with FSVP, there remains confusion about what food importers and manufacturers are required to do to be in compliance
with the law. Attorney, John F. Johnson, will be part of a panel in New Jersey on March 6, 2019. If you have questions about how well your plans meet FSVP requirements or what to look for in your supplier’s compliance
history, this half-day session will give you the chance to connect with people who can help.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
