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Abbott enters Consent Decree with FDA on Cronobacter infant formula outbreak and recall

Bill Marler

Here are the highlights of the Consent Decree : Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. In the complaint, filed by the U.S.

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FDA: Another infant death likely linked to Abbott formula

Bill Marler

The FDA apparently became aware of the death on June 10, 2020. So far, the FDA has received 129 complaints linked to Abbott formula products, including 119 since the product recall in February. According to the FDA, this would bring the total to five illnesses with three deaths. Attorney sued Abbott and several employees.

FDA 269
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Citizen Journalism at its best – eFoodAlert and insights into “Abbott Nutrition: The Gathering Storm”

Bill Marler

Between September 1, 2019 and September 20, 2021, Abbott Nutrition received seventeen consumer complaints regarding multiple Similac powdered formula products. APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR. The complaint was reviewed by an internal Abbott Nutrition Medical Team. FDA not blameless.

Nutrition 258
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FDA review panel picked to help fix FDA

Bill Marler

Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. This team brings the right combination of FDA and other government experience along with deep subject matter expertise and first-hand systems and operations knowledge,” said Jane E. Robert Califf, Commissioner of Food and Drugs, at FDA.

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Elevated Lead Levels in Cinnamon prompt FDA Warning and Recalls

Bill Marler

Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. What is the problem?

FDA 276
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FDA Relaxes Nutrition Facts and Menu Labeling Requirements for Restaurants and Food Manufacturers During COVID-19 Emergency

Modern Restaurant Management

Food and Drug Administration (FDA) has issued two temporary food labeling guidance documents that attempt to balance industry supply and demand during the novel coronavirus pandemic. The requirements apply to products, including ingredients, that are typically purchased by restaurants to further prepare for sale to consumers.

Nutrition 164
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House and Senate Oversight on Cronobacter and Infant Formula this week

Bill Marler

Now the House and Senate are set to ask questions of the Industry and FDA about how the outbreak happened and how it impacted the supply of infant formula. Here is a preview of the FDA’s position See full testimony – FDA Testimony ECOI Infant Formula 5.25.2022 final : TESTIMONY OF. CALIFF, M.D. COMMISSIONER OF FOOD AND DRUGS.

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