The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
Category Archives: Food Safety News
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
The U.S. Food and Drug Administration today permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.
FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars
The U.S. Food and Drug Administration announced today it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions.
Drew’s, LLC Issues Allergy Alert on Undeclared Milk and Egg in One Lot of Field Day Organic Ranch Dressing
Drew’s, LLC of Chester, VT is voluntarily recalling one lot code of Field Day Organic Ranch Dressing due to product mislabeling that has resulted in an undeclared milk and egg allergen. Consumers who have severe allergies to milk and/or egg run the risk of serious or life- threatening allergic reaction if they consume this product.
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New Seasons Market Issues Allergy Alert on Undeclared Peanuts in Creamy Almond Butter
New Seasons Market of Portland, Oregon, has initiated a voluntary recall of its New Seasons Market 16oz. Creamy Almond Butter because it may contain undeclared peanuts.
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FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness
The U.S. Food and Drug Administration today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.
FDA provides $21.8 million to states for FSMA produce safety rule implementation
The U.S. Food and Drug Administration today announced the awarding of a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.
Westby Cooperative Creamery Issues a Voluntary Product Retrieval Notice on a Specific, Single Production Lot of Cottage Cheese Product
Westby Cooperative Creamery has issued a voluntary product retrieval notice on a specific, single lot of 4% cottage cheese; manufactured and packaged on August 17, distributed to retail stores, and possibly sold to consumers on or before August 26, 2016.
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DATCP Issues Consumer Advisory for Cottage Cheese Produced By Westby Cooperative Creamery
The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP)�Division of Food and Recreational Safety is issuing a consumer alert for 4% cottage cheese made by Westby Cooperative Creamery located in Westby, Wisconsin. The presence of active alkaline phosphatase was discovered in samples during routine testing and may indicate that the product was not adequately pasteurized.
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Asher’s Chocolates/Lewistown, Inc. Issues Voluntary Recall of Candy Products Because of Possible Health Risk
Asher’s Chocolates/Lewistown, Inc., an affiliated partner of Chester A. Asher Inc. (“Asher’s”) is initiating a voluntary recall of multiple chocolates, chocolate bars, cellophane wrapped chocolates, and individually wrapped chocolates, etc. under the Asher’s brand due to possible Salmonella contamination of items produced in their Lewistown, PA facility distributed nationwide.
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