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FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018).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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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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Starbucks Slack-Fill Class Action Holds No Water … or Milk Foam

Tall, Grande, and Venti are terms well-known to many American consumers looking for a latte or mocha at one of more than 13,000 Starbucks locations in the United States.  Most, if not all, of those consumers are aware that Starbucks baristas typical… Read More
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Top Priority for the 2018 Farm Bill: Protect Federal Crop Insurance

Of all the issues surrounding a new Farm Bill in 2018, perhaps none unifies American agricultural producers more than Federal Crop Insurance, provided by USDA’s Federal Crop Insurance Corporation (FCIC).  Be it North or South, big or small, row cr… 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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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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Patient – Consumer – Industry Coalition Suggests Reducing Government Barriers to Medication Non-Adherence

In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback… 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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Kristen O’Brien Joins OFW Law as Counsel in the Health Industry Policy and Regulatory Practice

Kristen O’Brien serves as Counsel in OFW Law’s Health Industry Policy and Regulatory Practice, which represents clients in the health care delivery system and innovative life sciences areas. She is principally responsible for the group’s work w… Read More
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