In our August 11 blog post, we alerted our readers to new fees that FDA will begin extracting from food importers and foreign food manufacturers at $224 per hour ($335/hour for foreign travel). FDA will charge the new fees whenever FDA “re-examines” imported food it previously examined and found to be violative for some food-safety related reason. We explained how these fees will significantly increase the cost of importing food, which in turn will result in higher food costs for consumers. Under the FSMA, however, FDA was directed to consider the impact re-inspection fees will have on small businesses. … READ MORE

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In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.

On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a … READ MORE

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According to research done by www.FDAImports.com, The U.S. Food and Drug Administration (“FDA”) aggressively stepped-up the number of food-facility inspections in China last year according to the FDA Inspection Classification Database. Between fiscal year 2009 and 2010, FDA had a thirteen-fold increase in food-facility inspections in China. Last year’s dramatic increase foreshadows FDA’s greater international profile through inspecting foreign food-facility, which Congress mandated in the recently passed FDA Food Safety Modernization Act (“FSMA”).

China has played an increasingly important role in supplying food to the United States. Between 1999 and 2008, China went from the eleventh-largest supplier of … READ MORE

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Benjamin L. England, a former 17-year veteran of the FDA and former Regulatory Counsel, posted a video

today offering his insights into what Japanese exporters should expect in the coming months as they attempt to export products to the United States after the recent earthquakes and tsunami.  In light of the import alert issued by the FDA Mr. England states that, “Even for products that are not on the alert the FDA is conducting testing,” and that FDA scrutiny will be on … 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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