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This guidance document is intended to provide guidance and instructions to FDA regulated industry for obtaining information to help fulfill the Agency’s plans regarding product recalls. It represents the agency’s current thinking on product recalls. This guidance does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicab …

The food safety law passed by Congress on December 21, 2010 aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. FDA Commissioner Margaret A. Hamburg, M.D. issued a written statement shortly after passage. Key facts about this legislation are presented below. The FDA Food Safety Modernization Act (FSMA): Key Facts The burden of foodborne illness is considerable. Every year, 1 out of 6 people in the United Stat …

The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.In general, FDA regulates:Foods, including: dietary supplements bottled water …