Proposed Foreign Supplier Verification Rule under FSMA Released by FDA

The US Food and Drug Administration issued the long delayed and much anticipated Foreign Supplier Verification Rule under the Food Safety Modernization Act (FSMA) today. The highlights of the rule are provided below, including who is covered and when the rule will take effect. There are a number of exemptions and partial exemptions the posts to follow will explore. For now, if you you import food or finished dietary supplements it is imparative you read and understand how the rule will impact your operations.

The proposed rule is in-line with the Preventative Controls Rule and Produce Safety Rule released early this year. All three rules are adapting a widely followed hazard analysis approach to preventing outbreaks and contamination. The same approach used by larger facilities known as HACCP (Hazard Analysis and Critical Control Points). The Rule applies the approach across the playing field, adds record keeping components, and mandates the importer verify hazards are controlled before importing. The risk must be reasonably foreseeable as reasonably likely to occur and there are two options on how risks should be controlled.


The rule explains the difference in approaches:

Under Option 1 of this c, onsite auditing of the foreign supplier would be required for hazards to be controlled by the foreign supplier when there is a reasonable probability that

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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