The United States FDA Food Safety Modernization Act: the key new requirements.

摘要

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The law is the most significant amendment of United States food law since passage of the 1938 Food, Drug, and Cosmetic Act. FSMA shifts the focus of the United States Food and Drug Administration (FDA) from primarily reacting to food safety problems to prevention. The law provides FDA with new enforcement authorities designed to (1) achieve higher rates of compliance with prevention and risk-based food safety standards; (2) gives FDA authority to require that food manufacturers employ preventative food safety systems; (3) augments FDA's ability to police those food safety systems; and (4) enhances FDA's ability to detect, respond to, and contain problems when they do occur. The law also grants FDA new tools to hold imported foods to the domestic food standards. Moreover, the law directs FDA to build an integrated national food safety system in partnership with state and local authorities and expands the potential international collaboration. Some of the law's new authorities went into effect immediately, such as FDA's authority to order companies to recall food. Other authorities require FDA to prepare and issue regulations and guidance documents. The funding the Agency receives from Congress will affect how quickly FDA carries out these tasks. FDA has expressed commitment to implement the requirements through an open process with opportunity for input from all stakeholders. Although many requirements will not take place immediately, domestic and foreign food producers need to begin taking steps now to avoid the potentially harsh consequences of failure to comply.