The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.
Category Archives: Food Safety News
FDA expands uses of Vyvanse to treat binge-eating disorder
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
United States enters consent decree prohibiting illegal distribution of Luvena Prebiotic products
At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.
Freeland Foods Voluntarily Recalls Sunflower Seed Due to Potential Health Risk
Freeland Foods, Inc. of San Jose, CA is voluntarily recalling the Go Raw Organic Sunflower Seed, UPC number 8 59888 00009 7 with lot number “Enjoy before August 22, 2015 R5,” because it has the potential to be contaminated with Salmonella, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
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REO Spice & Seasoning, Inc VoluntarilyRrecalls REO Country Style Chili Seasoning Due to Undeclared Peanut Allergens
REO Spice & Seasoning, INC Huntsville, TX is recalling certain REO Country Style Chili Seasoning packages after learning that one ingredient purchased from a supplier may contain peanut protein allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life threatening allergic reaction if they consume this product.
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FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.
FDA takes steps to improve reliability of automated external defibrillators
The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.
Dairy Recall
Elevated Ice Cream Co. advises our customers that our dairy, Snoqualmie Gourmet Ice Cream Dairy in Maltby, has issued a voluntary recall of all dairy products processed in their plant. Elevated Ice Cream uses dairy products processed by Snoqualmie Gourmet, therefore we are asking all of our customers not to eat any ice cream which may be in your home freezers.
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Lime Green Grocer, Inc. Issues Allergy Alert on Undeclared Soy in the Thai Delight Burrito
Lime Green Grocer, Inc. of Seattle, Washington is recalling 783 individually wrapped Thai Delight Burritos, because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA approves first generic esomeprazole
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.