FDA News Digest November 1, 2004 __________________________________________________________ IN THIS WEEK'S ISSUE -- Artificial Disc Approved as Alternative to Treat Lower Back Pain -- 'Qualified' Claim Links Olive Oil to Reduced Heart Disease Risk -- Consumers Reminded About Risks of Drinking Unpasteurized Juice -- Otto to Head FDA Cellular, Tissue and Gene Therapies Office -- Recalls/Market Withdrawals -- Recent Speeches -- Public Meetings __________________________________________________________ Artificial Disc Approved as Alternative to Treat Lower Back Pain FDA has approved the Charité artificial disc for patients who have lower back pain associated with degenerative disc disease. The device -- a plastic core sandwiched between two metal plates -- is intended to replace a diseased or damaged spinal disc in patients who have had no relief from low back pain after at least six months of non-surgical treatment. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01320.html <http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01320.html> 'Qualified' Claim Links Olive Oil to Reduced Heart Disease Risk FDA is allowing a "qualified health claim" that links consumption of olive oil to a reduced risk of coronary heart disease. The claim reflects limited but not conclusive evidence showing the benefit of using olive oil in place of foods high in saturated fat. http://www.fda.gov/bbs/topics/news/2004/NEW01129.html <http://www.fda.gov/bbs/topics/news/2004/NEW01129.html> Consumers Reminded About Risks of Drinking Unpasteurized Juice FDA has issued a reminder to consumers that there are health risks associated with drinking juice or cider that hasn't been pasteurized to kill harmful bacteria. Such juices may be sold in bottles or by the glass in supermarkets, at farmer's markets, at roadside stands, or in juice bars. FDA advises consumers who don't want to risk illness to avoid them or to boil them to kill any harmful bacteria. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01321.html <http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01321.html> Otto to Head FDA Cellular, Tissue and Gene Therapies Office FDA has named Edward Otto, Ph.D., to head its Office of Cellular, Tissue and Gene Therapies. The office consolidates FDA's resources and expertise to regulate product development within those three emerging technologies. Otto brings to the job a strong background in gene therapy, with experience as an executive of two biologics companies. http://www.fda.gov/bbs/topics/news/2004/NEW01126.html <http://www.fda.gov/bbs/topics/news/2004/NEW01126.html> _________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Oral-B CrossAction Power and PowerMAX toothbrushes and refills (brush head can come loose during brushing) http://www.fda.gov/cdrh/recalls/recall-102704.html <http://www.fda.gov/cdrh/recalls/recall-102704.html> "Jelly Candy Pops Sour Zip Kids" candy (undeclared egg) http://www.fda.gov/bbs/topics/news/2004/NEW01128.html <http://www.fda.gov/bbs/topics/news/2004/NEW01128.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 <http://www.fda.gov/opacom/7alerts.html> To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml <http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml> _________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Drug Information Association (Oct. 26) http://www.fda.gov/oc/speeches/2004/dia1026.html <http://www.fda.gov/oc/speeches/2004/dia1026.html> To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm <http://www.fda.gov/speeches/speechli.htm> _________________________________________________________ PUBLIC MEETINGS Nov. 5 -- FDA Science Board Meeting; Rockville, Md.; agenda includes FDA Critical Path Initiative, FDA's final report on pharmaceutical current good manufacturing practices, and an internal peer review of the FDA Office of Regulatory Affairs' pesticide program. http://www.fda.gov/oc/advisory/accalendar/2004/fda12603d110504.html <http://www.fda.gov/oc/advisory/accalendar/2004/fda12603d110504.html> Nov. 8 -- Stimulating Innovation in Medical Technology; Washington, D.C. http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23064.htm <http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23064.htm> Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002; Gaithersburg, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm <http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm> For a list of FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html <http://www.fda.gov/opacom/hpmeetings.html> _________________________________________________________ Thanks for subscribing to FDA News Digest. 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