FDA News Digest July 12, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- FDA, USDA Strengthen Safeguards Against 'Mad Cow Disease' -- FDA Clears Robotic Device for Assisting in Heart Surgery -- Software System Approved to Help Detect Lung Nodules -- Consumers Warned Not to Feed Infants Chinese Infant Formula -- Crabmeat Containing Antibiotic Drug Seized in Louisiana -- Recalls/Market Withdrawals -- Recent Speeches -- Public Meetings ______________________________________________________________ FDA, USDA Strengthen Safeguards Against 'Mad Cow Disease' FDA and the U.S. Department of Agriculture are taking measures to further strengthen protections for consumers against bovine spongiform encephalopathy (BSE, or "mad cow disease"). Among actions: a call for public comment on additional BSE-preventive actions; a rule prohibiting certain cattle-derived materials in human food and cosmetics; and a proposed rule on recordkeeping requirements. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01084.html Fact sheet: http://www.cfsan.fda.gov/~comm/bsefact2.html Questions and answers: http://www.cfsan.fda.gov/~comm/bsefaq.html BSE information: http://www.fda.gov/oc/opacom/hottopics/bse.html FDA Clears Robotic Device for Assisting in Heart Surgery FDA has cleared the da Vinci Endoscopic Instrument Control System for use in coronary artery bypass surgery. The robotic system allows a surgeon to perform heart surgery while seated at a console with a computer and video monitor. FDA had previously cleared the da Vinci system for other types of surgery, such as gall bladder. http://www.fda.gov/bbs/topics/answers/2004/ANS01298.html Software System Approved to Help Detect Lung Nodules FDA has approved a new kind of image analysis system that can help radiologists review computed tomography (CT) images to detect solid nodules in the lungs, which can be cancerous. Because the device works independently of the radiologist, it can detect suspicious areas that the radiologist may have missed. http://www.fda.gov/bbs/topics/answers/2004/ANS01300.html Consumers Warned Not to Feed Infants Chinese Infant Formula Because the safety and nutritional adequacy of infant formula from China are unknown, FDA is warning consumers not to feed the formula, Guan Wei Yuan, to infants. Federal law requires infant formula makers to certify that certain manufacturing standards were met when the formula was made. This information has not been submitted for Chinese formula. http://www.fda.gov/bbs/topics/answers/2004/ANS01299.html Crabmeat Containing Antibiotic Drug Seized in Louisiana U.S. marshals have seized nearly $87,000 worth of Bernard's brand frozen crabmeat in Louisiana after FDA found it to contain chloramphenicol, an antibiotic drug normally used to treat life-threatening infections. Under U.S. law, food products with chloramphenicol are banned from sale or import into the country. The drug could cause serious, even life-threatening reactions in a small number of susceptible people. http://www.fda.gov/bbs/topics/answers/2004/ANS01297.html _________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. Boston Scientific Taxus drug-eluting coronary stent system; two lots (faulty balloon mechanism) http://www.fda.gov/cdrh/recalls/recall-070104.html Arjo Alenti Lift Hygiene Chair (device has tipped, causing serious injury) http://www.fda.gov/cdrh/recalls/recall-060804.html Price Chopper Supermarkets Packed Smoked Mussels; 4 oz. (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/mussels07_04.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Banc of America Securities Healthcare Institutional Investor Conference (July 7) http://www.fda.gov/oc/speeches/2004/bascrty0707.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ PUBLIC MEETINGS July 20-23 - National Health Information Infrastructure 2004: Cornerstones for Electronic Healthcare; Washington, D.C. http://www.hsrnet.net/nhii/welcome.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be July 19. 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
