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Minimizing the risk of litigation by complying with the Food Safety Modernization Act

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As discussed in prior blog posts, the Food Safety Modernization Act (FSMA) aims to prevent contamination of the United States food supply by requiring that food facilities be in compliance with a series of regulations in order to distribute products in the U.S.  The FSMA was signed into law by President Obama on January 4, 2011.    

 The FSMA requires that all food facilities, domestic and foreign, be registered with the US Food and Drug Administration (“FDA”) in order to manufacture, process, pack, or store food for animal or human consumption in the US.[1]  If a facility fails to comply with the registration requirements, products manufactured by foreign facilities will be refused entry into the U.S. and domestic facilities will be unable to legally sell products in interstate commerce.[2]  Every two years, every food facility must renew its registration.[3]  Facilities that registered prior to October 1, 2012 must renew their registration. [4]

The FSMA has granted the FDA greater authority to hold imported foods to the same standard as domestic foods—making it even more difficult for companies who wish to import into the US food from other companies.[5]  Importers are now required to verify that any foreign suppliers have controls in place to guarantee that the food they produce is safe.[6]  Qualified third parties are now able to certify that foreign food facilities are in compliance with U.S. food safety standards.[7]  Foreign facilities that produce foods that are at a high risk of contamination may be required to receive third-party certification or another form of compliance in order to be admitted into the US.[8]  The FDA is able to refuse entry to food from any facility that has denied the FDA inspection access or is located in a country that has denied the FDA access.[9]

Although the FSMA presents challenges to food companies, if companies educate themselves on the registration requirements and pay close attention to their suppliers, they will be in compliance.  Additionally, importers that are offering food from program-certified facilities are able to participate in a program that expedites the process.[10]