Imagine a government official approaching you outside your business one afternoon.  The official demands that you empty your pockets. You refuse and ask why. “Because you appear to have contraband in your pockets.”  When you ask what evidence he has he answers, “I’m not sure . . . yet.” What would you do in this case?

This example seems outrageous to Americans and their love relationship with rights to privacy and against unlawful search and seizure. But it is similar to FDA’s every day “regulatory” actions against … READ MORE

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We’d like to take a moment to introduce one of our partners here at FDAImports.com, the Global Food Safety Forum (GFSF), a 501(c)(3) focused on establishing dialogue, training, and private-public collaboration in all areas of food safety, imports and the food supply chain.  Founded and managed by GIC Group President/CEO and Chairman of GFSF, Rick Gilmore, GFSF creates key opportunities between the U.S. and China such as training events, workshops, delegation visits, consulting services, and research projects. We … 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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Imagine you’re a parent thinking about which private school to send your child to. You’re looking at School X and it seems like a great fit; it’s close, inexpensive, great teachers, etc… But as you peruse the school’s website you’re suddenly shocked to find a horrifying statistic. In 2008 the school had 20 students out sick, 40 students out in 2009 and then a whopping 80 students out sick last year! Looks like an epidemic! “There’s no way I’m sending my kid to that sick ward!” Looks like you just made your decision, right? But what’s the missing factor … READ MORE

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The FDA recently unveiled a new makeover for its website, www.fda.gov, and a brand new blog, “FDA Voice,” intended to provide more behind-the-scenes insight and commentary from FDA officials.  The rationale for the new look of the website is described by FDA Commissioner, Margaret Hamburg:
We have given the homepage a cleaner look and feel – by updating the design and reducing the number of links on the page. We have been working hard to improve your experience at FDA.gov, and hope that the changes we have made will help you find the information you need as quickly and easily as … READ MORE

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FDA re-posted its Import Refusal Report on its website, as we reported in March.  For each refused-entry, FDA gives the manufacturer’s name and address, the importer’s product description, and FDA’s rationale for the refusal, along with other information.  FDA, like everyone, occasionally makes mistakes and wrongly refuses some entries. Thankfully, when confronted by the right arguments, FDA will rescind a refusal upon demonstrating that it made a clear and unmistakable error.

However, even if FDA rescinds the refusal, the FDA … READ MORE

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The Food and Drug Administration is no small government agency.  In 2009 it boasted a 2.6 billion dollar budget and employed over 11,500 people spread from its suburban Maryland Headquarters to various national and international offices.  The charts and data below illustrate how the ever-expanding global network of importing and exporting has increased the roles (and burden) of FDA in regard to regulatory oversight.  As globalization continues to impact specific industries and the speed of communication and transport increases, we can only expect to see increased spending, staffing and legislation from FDA in the years ahead.  The FDAImports.com team brings decades of … READ MORE

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In an executive order signed last week, President Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any future regulations in the least-burdensome manner possible and with specific performance goals. Obama also instructed federal agencies to seek and assess all available alternatives to direct regulation before issuing a new rule.

In an opinion piece published in The Wall Street Journal, Obama singled out the FDA as an example of an agency whose regulations have caused confusion.

Cost benefit analysis must benefit the government too, you know.  Obama is not saying “Be nice … READ MORE

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