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Judge to FDA: Get Your FSMA Regulations Done Already.
July 5, 2013
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As we have long reported, the FDA has been quite derelict in getting the new Food Safety Modernization Act regulations in place. Deadlines have come and deadlines have gone and still no guidelines. This delay has resulted in the case of <em>Center for Food Safety, et al. v. Margaret Hamburg, et al.</em>, USDC, NDCA. There’s a <a href="http://www.huffingtonpost.com/2013/05/21/fda-food-safety_n_3314205.html">history of decisions</a> in the case that make clear the Court’s frustration with the FDA and that frustration has now boiled over. In a <a href="http://pdf.wcmlaw.com/pdf/FDAOrder.pdf">recent decision</a>, the Court has ordered the FDA to publish all proposed regulations by November 30, 2013, with the comment period to end by March 31, 2014, and the final regulations to be published by June 30, 2015. We’ll see if a court order compels action where bureaucratic momentum did not.
If you have any questions about this post, please contact Bob Cosgrove at rcosgrove@wcmlaw.com.