Maryland-based consulting firm, FDAImports.com, has launched a new website designed to assist companies with understanding U.S. Department of Agriculture (USDA) permit approval requirements and obtaining a permit for their product.  The website, USDAPermits.com, explains the approval process in simple English and allows companies to quickly and easily begin the process of obtaining a USDA permit.

“Many companies find out about the unique USDA permit requirements for the first time when their shipment is held at … READ MORE

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Customs brokers and importers who act as U.S. Agents on behalf of their foreign food manufacturing suppliers now face a new financial risk under the Food Safety Modernization Act.  Before FSMA there was no such thing as an inspection fee for a foreign facility that might become subject to a reinspection.  Now, FDA reinspections will incur a $289/hour (foreign reinspection fee) charge from FDA. FDA expects to use these charges to generate $25 million per year in … READ MORE

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If you remember only one thing about FDA-related legal matters involving imported products it should be this:  Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.

For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company.  FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed … READ MORE

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Technology is central to the success (or even existence) of FDA’s food tracking and tracing pilot currently underway as part of FSMA’s new authority grant to the Agency.  If you have not read our first blog about the pilot conducted by FDA and IFT please read that here now.  What the statute accurately communicates but vastly underestimates is the difficulty and scale of the role of technology in the successful development of the program.   Sec. 204 2(B) of FSMA states that FDA … READ MORE

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The U.S. Food and Drug Administration recently unveiled a new pilot program studying tracking and tracing technologies for high-risk foods. The pilot is contemplated in Sec. 204 of the Food Safety Modernization Act (FSMA), a legislative initiative aiming at reducing foodborne outbreaks and increasing the FDA’s ability to quickly identify and report outbreaks to the American public. In a post on the FDA’s Transparency Blog, Sherri McGarry, Senior Adviser, Coordinated Outbreak Response and Evaluation Network Office of Foods at FDA, communicated her view of the importance of this pilot; “When a foodborne outbreak occurs, it is up to … READ MORE

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Recent statements from the CDC regarding food safety trends and statistics have been wildly reductionist and inconclusive. But they do provide us with hints about the future direction of federal government thinking with respect to managing food safety risks: Food tracking and supply chain tracing.

Enter the Digital Database Savior

“We need better – and more – information about what foods are causing outbreaks and where those foods are coming from,” said Hannah Gould, CDC epidemiologist, in a recent presentation. “Knowing more … READ MORE

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The Food Safety Modernization Act
View more presentations from FDAimports.com
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.  Make sure you visit our online home base … READ MORE

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Question:  What’s worse than driving a stolen car around town?

Answer: Not knowing that you’re driving a stolen car!

If you know something horrible is about to happen, you can prepare for it.  But it’s a whole different story when something bad is about to happen to you and you have no clue that it’s coming!  That’s exactly the conversation we’re having with dietary supplement importers about the coming FDA imported food fees beginning October 1st, 2011.  Much … READ MORE

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36 million pounds of ground turkey. 

That’s a ton of meat, 18,000 tons of meat to be precise. That’s the weight of 120 million brand-new iphones (without the box).  So if almost everyone in Japan bought an iphone-4 today and then put them all on a scale, that’s how much the recalled turkey meat would weigh.

Confused yet? Good.

An importer or manufacturer goes through this same kind of mental trauma every second of every day during a recall or … READ MORE

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Following the two day FDLI conference, U.S.-China Food and Drug Law, in June 2011, FDAImports.com and ExporttoUSA.com.cn will provide three additional training opportunities FREE in Beijing on June 15, 2011 and in Shanghai on June 17, 2011. These sessions will give attendees the opportunity to receive valuable … READ MORE

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