Press releases from FDA http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml en-us Fri, 06 Nov 2009 10:36:00 -0500 tina.gilliam@fda.hhs.gov The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites. Fri, 06 Nov 2009 10:36:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif. Thu, 05 Nov 2009 20:56:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189400.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189400.htm A joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers was announced today by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). Thu, 05 Nov 2009 15:26:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189311.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189311.htm The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Thu, 05 Nov 2009 13:54:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189295.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189295.htm The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. Wed, 04 Nov 2009 11:42:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189081.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189081.htm A Virginia doctor was sentenced in federal court on charges that he wrote prescriptions over the Internet for people whom he had never met or examined, as well as tax evasion. Wed, 04 Nov 2009 00:00:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189394.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189394.htm The U.S. Food and Drug Administration and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) have sent a team of seafood specialists to Bangladesh this week to help train local officials on aquaculture safety and quality control techniques. Mon, 02 Nov 2009 17:07:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188750.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188750.htm The U.S. Food and Drug Administration (FDA) today released a listing of eight recent consumer health information updates concerning the safety of FDA-regulated products. Mon, 02 Nov 2009 17:01:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188748.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188748.htm The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sibelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests. Mon, 02 Nov 2009 15:28:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188717.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188717.htm The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009. Mon, 02 Nov 2009 15:19:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188715.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188715.htm The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. Mon, 02 Nov 2009 14:26:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188708.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188708.htm The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. Fri, 30 Oct 2009 14:16:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188543.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188543.htm Jeffrey H. Sloman, Acting United States Attorney for the Southern District of Florida, David Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Daniel W. Auer, Special Agent in Charge, Internal Revenue Service, Criminal Investigation Division, and Henry Gutierrez, Postal Inspector in Charge, U.S. Postal Inspection Service, announce that late yesterday afternoon, a federal jury convicted defendant Frank Sarcona, a/k/a Frank Sarcone, a/k/a Dave Johnson, 57, of Boca Raton, FL, of conspiracy to commit mail, wire fraud, and criminal contempt of court; conspiracy to commit money laundering; and multiple counts of substantive mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court. Sentencing has been scheduled for January 15, 2010 at 9:00 a.m. before U.S. District Court Judge Kenneth A. Marra. Fri, 30 Oct 2009 00:00:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188776.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188776.htm XIN HE, aka FAITH HE, 46, of Issaquah, Washington, was found guilty today in U.S. District Court in Seattle of a felony count of Misbranding of a Drug While Held for Sale and two misdemeanor counts of Receipt & Proffered Delivery of Adulterated Device. HE was ordered into immediate custody by U.S. District Judge Marsha J. Pechman after she rendered her verdict. Fri, 30 Oct 2009 00:00:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188768.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188768.htm The U.S. Food and Drug Administration and WebMD Health Corp. today announced an expansion of their partnership to provide increased access to FDA’s consumer health information. This second phase of the partnership includes expanded content and multimedia tools at www.webmd.com/fda. WebMD is personalizing FDA health information for consumers with five new online FDA sections that will initially focus on allergies and asthma, children’s health, diabetes, heart health and vitamins and supplements. Thu, 29 Oct 2009 12:15:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188374.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188374.htm Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries. Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Wed, 28 Oct 2009 19:04:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188305.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188305.htm A few spaces remain for the U.S. Food and Drug Administration’s Second Annual Science Writers Symposium on Nov. 4-5, 2009. Wed, 28 Oct 2009 15:19:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188266.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm188266.htm The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow. Mon, 26 Oct 2009 18:27:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187966.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187966.htm The U.S. Food and Drug Administration announced today that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Fri, 23 Oct 2009 18:31:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187813.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187813.htm The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005. Mon, 19 Oct 2009 18:44:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187174.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187174.htm