The U.S. Food and Drug Administration today announced that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online.
FDA takes action against illegal marketing of tobacco products
The U.S. Food and Drug Administration today announced it issued 11 warning letters last week to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease.
BCS International Corp. Issues Allergy Alert On Undeclared Peanuts In Dr. Snack Choco Raisin With Sell By Date 03/05/2012
BCS Int’l Corp. of Long Island City, NY is voluntarily recalling DR. SNACK brand CHOCO RAISIN, 12 OZ. containers with “Sell By 03/05/2012” date code only because they may contain undeclared peanuts. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Globe All Wellness, LLC Issues a Voluntary Recall of Dietary Supplement Found to Contain an Undeclared Drug Ingredient
Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.
Undeclared Eggs in “Halal Plain” & “Halal Fruit Cake”
New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers to undeclared eggs in “Halal Plain Cake” and “Halal Fruit Cake”, packaged and distributed by Narala Bakery Inc. of 744 Coney Island Avenue, Brooklyn, New York. People who have severe sensitivity to eggs may run the risk of serious or life-threatening reactions if they consume this product.
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FDA approves Incivek for hepatitis C
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.
FDA: Do not feed SimplyThick to premature infants
The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.
FDA approves Sutent for rare type of pancreatic cancer
The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
United States requests seizure of adulterated cheese products at Wisconsin company
The United States Attorney’s Office, at the request of the U.S. Food and Drug Administration, filed a verified complaint on May 13, 2011, requesting that the U.S. Marshals seize cheese products distributed by Brunkow Cheese of Wisconsin Inc., after FDA inspections found evidence of rodent infestation. The U.S. District Court unsealed the case today, and documents show that the U.S. Marshals seized certain cheese products at the facility on May 17, and May 18, 2011.
FDA clears first test to diagnose Q fever in military serving overseas
The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The test was developed by Idaho Technology Inc.