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FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

Posted on March 29, 2018

In the March 28, 2018 FDA Voice blog Dr. Gottlieb provided background and insight on the Intentional Adulteration rule.
The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing

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FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

Posted on March 20, 2018

As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA

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GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

Posted on March 7, 2018

The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination. A new report by the U.S. Government

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FDA Recognizes First Accreditation Body Under Accredited Third-Party Certification Program

Posted on February 2, 2018

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that

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FSMA Update: More Clarification on FSVP from FDA

Posted on January 30, 2018

As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document

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FDA Issues Draft Guidance on HARPC for Animal Food

Posted on January 24, 2018

As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA

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FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions

Posted on January 5, 2018

Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA).

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FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

Posted on December 11, 2017

Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to

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FSMA For Cotton Ginners?

Posted on November 28, 2017

Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)? If you are a cotton ginner that is not a farm the answer is currently yes.

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FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

Posted on November 3, 2017

As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal

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