Tag: recall
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Warning Letter Provides Insight on FDA’s Priorities
By Of Counsel John Johnson III The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to…
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FDA Releases Guidance on Initiating Voluntary Recalls
The U.S. Food and Drug Administration (FDA) has issued draft guidance on initiating voluntary recalls of food and other agency-regulated products. The guidance discusses (i) “what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures”; (ii) “preparations firm in the distribution channel should consider making to…
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FDA Releases Final Guidance on Voluntary Recalls
The U.S. Food and Drug Administration (FDA) has announced the availability of “Public Warning and Notification of Recalls,” final guidance that aims to “increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled.” “We’re taking…
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FDA Releases Reports and Guidance on Nutritional Panels, Recalls, Serving Sizes, More
The U.S. Food and Drug Administration (FDA) has released several reports and guidance documents on food-related issues, including draft guidance on reasonable serving sizes and a report on foodborne illnesses in restaurants. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column…
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Salmonella Outbreak Prompts Lawsuit Against JBS Tolleson
A consumer has filed a lawsuit alleging that he contracted Salmonella from beef supplied to a restaurant by JBS Tolleson Inc. Rozich v. JBS Tolleson Inc., No. 18-1929 (D. Nev., filed October 8, 2018). The plaintiff alleges his infection stemmed from an outbreak of Salmonella that resulted in JBS recalling nearly seven million pounds of…
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Draft Guidance on Food Recalls Issued
The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency may find that identifying retailers is necessary during Class I recalls—”recalls where there is a reasonable probability that the use of, or exposure to, the food will cause…
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Rose Acre Farms Sold Contaminated Eggs, Lawsuit Alleges
A woman has filed a lawsuit alleging she was hospitalized after eating Salmonella-contaminated eggs from Rose Acre Farms Inc. Roberts v. Rose Acre Farms, Inc., No. 18-61082 (S.D. Fla., filed May 14, 2018). The plaintiff alleges that she purchased eggs packaged by Coburn Farms, a Sav-A-Lot Food Stores brand, and became ill enough to require two…
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New Egg Recall Involves Man Involved in Prior Recall
An Ohio poultry facility linked to the latest egg recall over Salmonella-contamination concerns was reportedly the recipient of a $125 million investment by Austin “Jack” DeCoster, the man who owned the two Iowa farms linked to the August 2010 recall of 550 million potentially contaminated eggs. The Ohio Agriculture Department apparently indicated earlier this year…