Draft Guidance

FDA Releases Third and Final Installment of Intentional Adulteration Draft Guidance

Posted on February 19, 2020

On February 13, the FDA released a supplemental draft guidance to support compliance with the Intentional Adulteration (IA) rule under the Food Safety Modernization Act (FSMA). This draft is the

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FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule

Posted on October 7, 2019

As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive

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Public Comments Urge FDA to Allow “Potassium Salt” as Alternative Name for “Potassium Chloride” in Food Labeling

Posted on October 2, 2019

Food manufacturers, including Nestle USA and Kraft Heinz, have submitted public comments on FDA’s draft guidance regarding the use of “potassium chloride salt” as an alternative common or usual name

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FDA Issues Draft Guidance on Reconditioning Fish

Posted on September 17, 2019

The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry, titled, “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance explains two potential

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FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements

Posted on June 5, 2019

FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety

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FDA Issues Initiation of Voluntary Recall Draft Guidance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Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “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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