FDA News Digest February 9, 2004 ______________________________________________________________ Rule Prohibits Supplements Containing Ephedrine Alkaloids (Ephedra) FDA has published a final rule banning the sale of dietary supplements containing ephedrine alkaloids (ephedra). Supplements with ephedra have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. But FDA determined that ephedra presents an unreasonable risk of illness or injury. It has been linked to serious adverse health effects, including heart attack and stroke. FDA continues to advise consumers not to use ephedra-containing products. Press release: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01021.html Questions and answers: http://www.fda.gov/oc/initiatives/ephedra/february2004/qa_020604.html Background information: http://www.fda.gov/oc/initiatives/ephedra/february2004/ Ephedra-Containing Supplements Seized Due to False Claims FDA has seized several ephedra-containing supplements from Massachusetts-based Musclemaster.com after alleging that the company made unfounded claims on its Web site. The company allegedly claimed the supplements enhance the athletic and muscle performance of consumers without adequate scientific basis to support the claims. The seizure included Betatrim Dietary Supplement, Thermbuterol "Fat Burner Energizer," and "Stacker Packer" Stacker 2. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01020.html ______________________________________________________________ FDA Fiscal '05 Budget Request Has Large Increase for Food Defense The Bush administration's $1.8 million FDA budget request for fiscal year 2005 contains a $65 million increase earmarked for strengthening FDA's role in a new interdepartmental program for defending the nation's food supply. The request also contains substantial increases for mad cow disease protection, medical device reviews, and consolidation of many of the agency's facilities in a single location in Maryland. Press release (overall budget): http://www.fda.gov/bbs/topics/NEWS/2004/NEW01014.html Press release (food defense): http://www.fda.gov/bbs/topics/NEWS/2004/NEW01015.html ______________________________________________________________ Guidance Aims to Improve Communication in Consumer-Directed Ads FDA has issued three draft guidance documents designed to improve communications to consumers and healthcare providers in direct-to-consumer advertising. The guidances provide, for example, alternatives to the lengthy, technically written summaries of prescription drug risks in print ads. The guidances are part of FDA's strategic plan, part of which aims to provide consumers the accurate information they need to make informed choices. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01016.html ______________________________________________________________ FDA Establishes System to Refer Misleading Company Statements to SEC FDA has announced new measures to help improve the manner by which FDA assists the Securities and Exchange Commission. Under the new procedure, any FDA employee who believes that a publicly held, FDA-regulated firm has made a false or misleading statement to the investment public can initiate a process for referring the matter to the SEC for enforcement. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01019.html _______________________________________________________________ FDA Approves First Drug for Treating Rare Membrane Cancer FDA has approved Alimta (pemetrexed disodium) for use in combination with the drug cisplatin to treat patients with malignant pleural mesothelioma, a rare cancer of the membranes that cover internal organs. Typically associated with a history of asbestos exposure, this cancer begins when asbestos fibers lodged in the lung attach to the outer lung lining and chest wall, causing tumors to grow. In a clinical trial, patients given Alimta and cisplatin lived three months longer than those treated with cisplatin alone. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01018.html ______________________________________________________________ Justice Dept. Will Appeal Ruling Prohibiting 'Shared Exclusivity' On FDA's behalf, the Department of Justice will appeal a recent decision by a district court that prohibited FDA from granting "shared exclusivity" to several generic drug companies for paroxetine hydrochloride tablets. With shared exclusivity, FDA awards marketing approval and the accompanying 180 days of exclusive generic marketing rights to more than one manufacturer of a generic drug. FDA considers shared exclusivity important because it provides consumers access to lower-cost generic versions of some of the most widely used drugs. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01279.html ______________________________________________________________ FDA, J&J Warn Consumers About Counterfeit Contraceptive Patches FDA and Johnson & Johnson are warning consumers about an overseas Internet site that is selling counterfeit versions of J&J's Ortho Evra contraceptive patch that contain no active ingredients. These fake patches provide no pregnancy protection. The patches are sent in plastic bags without identifying numbers or other labeling information. The seller of the patches, apparently based in India, sells other products that purport to be versions of FDA-approved drugs, and the agency is investigating those products as well. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html ______________________________________________________________ Screening Test Kits Seized for Manufacturing Violations At FDA's request, various screening test kits were seized from Ohio-based PerkinElmer Life Sciences Inc., after the agency determined the kits were not manufactured in accordance with its good manufacturing practice standards. The test kits are used to screen for several genetic diseases in newborns and hemoglobin and central nervous system diseases in adults, such as sickle cell anemia and multiple sclerosis. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01278.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Pasta & Co. Tuna Noodle Casserole (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/pastaco02_04.html Peregrina Cheese Co. Queso Fresco Fresh Cheese (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/peregrina02_04.html Don Pancho Mexican Pastry and Mexican Pastry Pan Fino (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/puentes02_04.html Stew Leonard's Seafood Salad or Lite Seafood Salad (undeclared soy and crab) http://www.fda.gov/oc/po/firmrecalls/stewleonard02_04.html ______________________________________________________________ RECENT TESTIMONY FDA Deputy Commissioner Lester M. Crawford, D.V.M., before the Senate Committee on Agriculture, Nutrition, and Forestry, concerning BSE (Jan. 27) http://www.fda.gov/ola/2004/bse0127.html For an archive of testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be February 17. 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
