The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
Category Archives: Food Safety News
FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
Linden Cookies Issues Allergy Alert on Undeclared Milk in Mini Chocolate Chip Cookies and 3 Pack Chocolate Chip Cookies
Linden Cookies, Inc. in Congers New York is recalling fully baked Linden’s Chocolate Chip Cookies because they contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
Blue Ridge Beef of Eatonton, GA Recalls Product Because of Possible Health Risk
Blue Ridge Beef is voluntarily recalling two (2) of its frozen products due to their potential to be contaminated with salmonella and/or listeria monocytogenes. Salmonella and Listeria can affect animals eating the product. There is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surface exposed to these products.
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FDA takes action against four tobacco manufacturers for illegal sales of flavored cigarettes labeled as little cigars or cigars
The U.S. Food and Drug Administration today issued warning letters to four tobacco manufacturers — Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. — for selling flavored cigarettes that are labeled as little cigars or cigars, which is a violation of the Family Smoking Prevention and Tobacco Control Act. The companies received warning letters for products under the “Swisher Sweets,” Cheyenne,” “Prime Time” and “Criss-Cross” brands in a variety of youth-appealing flavors, including grape, cherry, wild cherry and strawberry.
Voluntary Class II Recall of Chocolate Hazelnut Butter CLIF® Nut Butter Filled
Clif Bar & Company is initiating a voluntary Class II recall of one production run of Chocolate Hazelnut Butter CLIF® Nut Butter Filled energy bars due to the presence of small plastic pieces found in a limited number of bars sold in the U.S. Clif Bar has not received any reports of injuries as a result of the plastic; however, the company is initiating the voluntary recall out of an abundance of caution.
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FDA takes steps to improve hearing aid accessibility
The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.
FDA takes steps to improve hearing aid accessibility
The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.