FDAImports.com recently assisted a Chinese company with removal from FDA Import Alert 53-17, “Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.”  This case is of particular interest, because it is a reminder that FDA makes mistakes too. In this case, FDA wrongly added the company to Import Alert even though the cosmetic presented no actual safety risk or violation.

FDA Import Alert 53-17 is a very common Import Alert for cosmetic products with China, Mexico, and Canada having the most companies listed.  Typically, an Import Alert listing comes … READ MORE

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Myth #1:  If FDA tests/rejects something then there must be a problem with it The FDA tests things all the time, even if there is not a problem with the shipment. The FDA uses Import Alerts, which are country or industry-wide notices that flag shipments due to prior problems, even if the problem does not actually appear in the current shipment. The FDA refuses countless shipments which might be just fine simply because they come from a region that is on Import Alert. This occurs because FDA … READ MORE

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Sources

• http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm286302.htm

• http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm287783.htm

• http://www.gpo.gov/fdsys/pkg/CFR-2011-title40-vol24/pdf/CFR-2011-title40-vol24-sec180-371.pdf

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The FDA has implemented a “test and hold” policy for all incoming orange juice into the United States, looking for evidence (or not) of Carbendazim, a pesticide residue.  Yet FDA clearly states that the EPA “has concluded that consumption of orange juice with carbendazim at the low levels that have been reported does not raise safety concerns.”  So just to clarify… there are no safety concerns with the presence of Carbendazim in imported orange juice at the detected levels, but FDA has a … READ MORE

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FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts.  An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why they should not be on Import Alert.  FDAImports.com is pleased to report on two recent success stories of obtaining removal from FDA Import Alert on relatively short time frames.
Case #1: Sunglasses (Import Alert #86-07)
FDA began automatically … 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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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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The www.FDAImports.com, LLC expert team of FDA consultants and FDA attorneys obtained removal of another client processor from another FDA Import Alert, this time, Import Alert #72-03, “Detention without Physical Examination and Intensified Coverage of Pig Ears and other Pet Treats Due to the Presence of Salmonella.”

A 2004 FDA examination and sampling found Salmonella in untreated rawhide scraps. FDA placed the Mexican processor on the Import Alert Red List. That shipment was a one-time event, as the Mexican supplier was in the business of processing and shipping finished rawhide pet chews and treats – not unfinished rawhide scraps.   However, in … READ MORE

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