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FDA Issues Initiation of Voluntary Recall Draft Guidance

Posted on April 24, 2019

Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “

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FDA Announces New Policies on e-Cigarettes and Cigars to Stem Surge in Youth Smoking

Posted on March 14, 2019

On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored

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FDA Releases Second Installment of Intentional Adulteration Draft Guidance

Posted on March 13, 2019

FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first

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FDA Issues Policy and Related Draft Guidance on Publicizing List of Retailers in Certain Food Recall Situations

Posted on September 27, 2018

FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption

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FDA Issues First Draft Guidance Document on Intentional Adulteration

Posted on June 21, 2018

As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food

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FDA Issues Draft Guidance on HARPC for Animal Food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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Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

Posted on January 19, 2018

As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current

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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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Menu Labeling Update: FDA Releases Supplemental Draft Guidance

Posted on November 8, 2017

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.

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FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

Posted on August 30, 2017

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and

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