AG/FDA Blog

FDA Updates Some Recall Practices

FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018).  It essentially discloses FDA’s intent to accelerate the release of recall informa… Read More
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Analysis of FDA’s Nutrition Policy Priorities for 2018

The FDA recently released a “2018 Strategic Policy Roadmap” outlining (among other things) its nutrition-related policy priorities for the coming year.  In the Roadmap, FDA lists nutrition as one of its four top issues for this year. The Agency… Read More
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FDA Denies Use of Claim for Vitamin D Reducing MS Risk

Last week, the FDA concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of multiple sclerosis (MS). The petition, submitted on behalf of Bayer, requested use of the claim “Vitamin D may reduc… Read More
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Upcoming Webinar: Avoiding the Food Labeling Class Action Trap

The food and beverage industry is facing an unprecedented number of threats from class action cases alleging misleading labeling and advertising. Approximately two new lawsuits against manufacturers, distributors and retailers were filed each week in… Read More
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“Milk” Comes from Breasts/Udders

According to the Wall Street Journal: “Organic milk sales have cooled as the very shoppers who drove demand for the specialty product not long ago move on to newer alternatives, leaving dairy sellers and producers grappling with oversupply….Now,… Read More
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United Fresh and OFW Law Launch Legal Labeling Review Service

OFW Law has joined with the United Fresh Produce Association (UFPA) to provide members access to a legal review of product labels.  UFPA brings together companies across every segment of the fresh produce supply chain, including growers, shippers, f… Read More
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Focus on Food Recalls

In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures.  Recall policies and procedures likely will be a focus of FDA in the coming year. The Office of Inspector General (OIG) within… Read More
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FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry.  The Guidance is, in part,… Read More
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FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1]  The webpage includes deadlines for the following rules:… Read More
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FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA): #235 – Current Good Manufacturing Practic… Read More
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