AG/FDA Blog

Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents ac… Read More
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FDA Extends Certain FSMA Compliance Dates

FDA has published seven foundational rules to implement FSMA, and compliance dates are quickly approaching: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Earliest compliance date: Septemb… Read More
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FDA Updates 4 Proposed Rules Implementing FSMA

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address: Current Good Manufacturing Practice and Haz… Read More
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Deadlines for FSMA Final Rules Pushed Back

The court-ordered deadlines by which FDA is required to issue final rules under the Food Safety Modernization Act (FSMA) have been pushed back pursuant to a consent decree between FDA and two consumer groups. The two consumer groups, the Center for F… Read More
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Hidden Gems in the Farm Bill

By Nathan Fretz After three years of work, Congress passed the Agricultural Act of 2014 (the “farm bill”), which the President signed into law on Friday, February 7.  Despite a tumultuous and partisan 2012 and summer of 2013, the farm bill confe… Read More
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OFW Law’s MMXIII in Retrospect

As MMXIV starts, it’s time for a retrospective look at MMXIII.  What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interes… Read More
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FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import

FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the safety of imported foods. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Accredita… Read More
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Will FSMA Court-ordered Deadlines Set a Precedent?

The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka “Obamacare”) until 2015.  When questioned about the delay, White House Press Secretary Jay Carney said “peo… Read More
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FDA Extends Comment Period for FSMA Proposed Rules on Preventive Controls and Produce Safety

FDA has announced that it will extend for an additional 120 days the comment periods for two major proposed rules implementing the Food Safety Modernization Act (FSMA): preventive controls for human food (Current Good Manufacturing Practice and Hazar… Read More
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Court Orders FDA to Set a Timeline for Issuing Regulations Implementing FSMA

Yesterday, the U.S. District Court for the Northern District of California issued an order requiring FDA to propose new deadlines for issuance of regulations implementing the Food Safety Modernization Act (FSMA).  Center for Food Safety v. Hamburg,… Read More
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