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The Impact of Importing Food and Dietary Supplements under the Proposed Foreign Supplier Verification Rule By Marc Sanchez T he Food Safety Modernization Act (FSMA) continues to take shape and fundamentally shift the food safety landscape. Signed into law in 2011, FSMA sat quietly for two years. Deadlines for new rules came and went unnoticed with only minor provisions taking effect. The trickle of change is no more with the flow of information now gushing with each proposed rule. The latest proposed rules, the Foreign Supplier Verification Program (FSVP) and AccredMarc Sanchez is senior counsel and founder of Contract In-House Counsel and Consultants, LLC. He was recently named Adjunct Professor at Northeastern University where he will lecture on US FDA and International regulations and law. 16 Update November/December 2013 itation of Third-Party Auditors, appear small, but present a dramatic change in the law. The two proposed rules dovetail neatly with the overarching aim of FSMA. Jointly and individually the proposed rules represent a monumental shift in food safety - the first real change since Upton Sinclair's The Jungle sparked a movement that lead to the passage of the Pure Food and Drug Act in 1906. The central intent throughout FSMA is to push responsibility for monitoring and maintaining safety solely from the shoulders of the The Food and Drug Administration (FDA) to industry itself. Reviewing the FSVP and Accreditation rules provides plenty of examples of this shift. No longer is the FDA solely responsible for verifying the safety of foreign food. Industry now stands at the center of proactively identifying and managing risks. This requires a new approach to food safety. Reading FSMA rules requires attention to both the www.fdli.org http://www.fdli.org

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