AG/FDA Blog

Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act. See generally Food fo… Read More
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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FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include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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Doom and Gloom Challenges for Success Under FSMA

Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and animal food that have been sent to the Federal Register? Have you taken preliminary steps in your operation in advance of these r… Read More
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Five Unresolved Questions the Food Industry Should Be Looking for Answers to in FDA's Final FSMA Regulations

It’s August, which in Washington means Congress recesses, the President and much of the bureaucracy go on vacation and the wheels of government move more slowly than usual. However, that slower pace is going to be short-lived for the food industry.… Read More
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FDA Tweaks Its Four Foundational FSMA Proposed Rules

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA). Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Animal… 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 Hazard… 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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FDA Released its Proposed Animal Food Rule: What’s in it?

FDA published its proposed animal food rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, in the Federal Register yesterday. The proposed rule, which FDA promulgated pursuant to sect… 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 “peopl… Read More
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Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses. We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food. This wa… Read More
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