FDA News Digest January 5, 2004 ______________________________________________________________ FDA Supports USDA Safeguards Taken Against Mad Cow Disease FDA has declared its support of safety policies announced Dec. 30 by the U.S. Department of Agriculture to protect the nation's food supply from bovine spongiform encephalopathy (BSE, or mad cow disease). New procedures will build on existing programs and add another layer of protection for the American public. FDA press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW01002.html USDA press release: http://www.usda.gov/news/releases/2003/12/0449.htm More BSE information: http://www.fda.gov/oc/opacom/hottopics/bse.html _______________________________________________________________ FDA Plans to Prohibit Dietary Supplements Containing Ephedra Advising consumers to stop using dietary supplements with the ingredient ephedra, FDA also plans to issue a final rule banning sale of ephedra-containing supplements. Ephedra has been used in recent years to aid weight loss, enhance sports performance, and increase energy. But it acts like adrenaline and can cause dangerous effects on the heart. Press release: http://www.hhs.gov/news/press/2003pres/20031230.html More information: http://www.fda.gov/oc/initiatives/ephedra/december2003/ _______________________________________________________________ Anthrax Vaccine Found Safe, Effective Against All Routes of Exposure FDA has published a final rule concluding that the licensed anthrax vaccine is safe and effective for prevention of anthrax disease, regardless of the route of exposure. The rule is part of an ongoing review of biological products licensed before 1972, when responsibility for licensing these products moved to FDA from the National Institutes of Health. The anthrax vaccine was first licensed in 1970. http://www.fda.gov/bbs/topics/NEWS/2003/NEW01001.html ______________________________________________________________ FDA Investigates Reports of Unlicensed Flu Vaccine Sales, Administration After receiving reports of offers to sell unlicensed flu vaccine, and of individuals who are not licensed healthcare professionals administering questionable flu vaccine, FDA is investigating the matter with other federal and state officials. Only three vaccines are licensed for use in the United States, and these are available only from licensed sources such as doctors, pharmacies and healthcare clinics. FDA urges healthcare providers to buy the vaccine only from reputable distributors with proper evidence that the vaccine is licensed for sale in the United States. Consumers who have questions about the vaccine should ask a doctor or pharmacist. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01275.html More flu vaccine information: http://www.fda.gov/cber/flu/flu.htm ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Brie President Soft-Ripened Cheese Double Cream; 7 oz, gold foil wedges (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/lactalis12_03.html South Bend Chocolate Co. 5-pc. Assortment, 4-pc. Turtles, 1-lb., 2-lb., and Snowy Evening tins, Snowmen Towers, and certain fudge products (undeclared peanuts, tree nuts and egg products) http://www.fda.gov/oc/po/firmrecalls/southbend12_03.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be January 12. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
