The Food Safety Modernization Act (FSMA) enacted January 4, 2011 set forth a variety of benchmark reporting requirements for FDA, one of which is a summary of the FDA’s foreign offices and their progress and direction for the future.  The FDA has recently submitted this report and it gives us a glimpse into the international intentions of FDA.  Being in the FDA Import Regulatory Consultant business, we think that’s kind of useful. FDA’s report discusses the agency’s vision for its field offices, a distinction between “posts” and “offices,” the tasks and activities of foreign posts, the past progress and … READ MORE

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This chart illustrates the percentages of U.S. food that is imported from other countries. Based on research by FDA and The U.S. Small Business Administration, this chart demonstrates that a significant portion of the United States food supply is imported and is imported by small businesses.

For more charts, graphs and FDA statistics please visit our Flickr channel.

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The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with an easy to use warning letter, untitled letter and cyber letter resource.  Although such information has always been available from FDA, it could only be obtained by a written request under the Freedom of Information Act … READ MORE

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FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law and the U.S. Food and Drug Administration (FDA) gained significant new authorities. Among other things, the FSMA made a number of changes to FDA Food Facility Registration authority. These provisions are effective on July 4, 2011 or sooner, if FDA issues a regulation implementing the provision.  Read to the end of this blog because there are two other provisions that will intersect with the registration provisions in dramatic ways, particularly for foreign food facilities and … READ MORE

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