FDA News Digest November 24, 2003 ________________________________________________ FDA OKs Cialis, Third Drug Approved for Treating Impotence The third oral drug for treating erectile dysfunction (impotence) has received FDA approval. Cialis (tadalafil) differs from other approved impotence treatments in that it stays in the body longer. Cialis works by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, producing an erection. Erectile dysfunction affects millions of men in the United States. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01265.html ______________________________________________________________ FDA Orders Green Onions from Eight Mexican Firms Held at Border Following recent outbreaks of hepatitis A infections in Tennessee, Georgia and Pennsylvania that were linked to raw green onions (scallions), FDA has ordered raw green onions from eight Mexican companies to be detained at the U.S.-Mexico border. The agency continues to investigate hepatitis A outbreaks in North Carolina. FDA is working with federal, state and Mexican authorities on the case. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00981.html ______________________________________________________________ FDA Offers Tips to Avoid Foodborne Illness This Holiday Season FDA is encouraging consumers to pay special attention to how they handle and prepare foods during the upcoming holiday season. Though foodborne illness is not common during the holidays, many people -- including children, the elderly, and those with weakened immune systems -- should be aware of the risks. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01263.html ______________________________________________________________ Agency Seeks Public Comments on Managing Qualified Health Claims FDA is requesting comments from the public on several topics involving qualified health claims and other potential initiatives to help consumers choose a healthy diet. Qualified health claims are ones not supported by significant scientific agreement. Among other issues, FDA is seeking comments on alternatives for regulating qualified health claims and on the appropriateness and nature of dietary guidance statements on food labels. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01266.html ______________________________________________________________ New Law Lets FDA Charge Fees to Help Speed Animal Drug Review The Animal Drug User Fee Act, signed Nov. 18, establishes a funding system for FDA's review of new animal drugs. Under the law, the agency can charge fees that will provide resources to help speed reviews and shorten the time for introducing new therapies for treating pets and food-producing animals. FDA is authorized to collect $5 million in user fees in fiscal year 2004. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00978.html ______________________________________________________________ Officials Praise Congressional Passage of Pediatric Research Act Health and Human Services Secretary Tommy G. Thompson and FDA Commissioner Mark B. McClellan, M.D., have issued a statement praising Congress for passing the Pediatric Research Equity Act. When signed into law, the act will enable FDA to require that drugs intended for pediatric use be tested in children. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00979.html ______________________________________________________________ RECALL The following product is being recalled for the reason shown. Go to the linked page for more information. Dean Milk Co. 2% Reduced Fat Milk (possible contamination with eggs) http://www.fda.gov/oc/po/firmrecalls/dean11_03.html ________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D.; to the Drug Information Association, Ottawa, Canada (Nov. 18) http://www.fda.gov/oc/speeches/2003/canada1118.html ______________________________________________________________ RECENT TESTIMONY FDA Acting Director of Vaccine Research and Review William Egan, Ph.D., before the House Subcommittee on Wellness and Human Rights (Nov. 13) http://www.fda.gov/ola/2003/simianvirus1113.html ______________________________________________________________ Latest FDA Consumer Magazine Available Online The latest issue of FDA Consumer, available online at http://www.fda.gov/fdac/603_toc.html, has articles on the following topics: * Heart health -- Prevention is the best weapon against heart disease, the nation's number one killer. * Menopausal hormone therapy -- FDA offers advice to women on using hormones to treat menopause symptoms. * Tanning risks -- The facts on "sunless" and "natural" tans. * Genetically engineered foods -- FDA is working to meet the challenges of regulating these future food products. * Climbing wheelchair -- A new device allows people with impaired mobility to climb stairs, curbs, and more. * Orphan products -- How FDA is helping people with rare diseases. * Cochlear implants -- Children with these hearing implants have an increased risk of developing bacterial meningitis. * FDA's bionic skeleton -- After three decades on the road as a teaching device, "Yorick" comes to rest in the Smithsonian Institution. * * The issue also has: * * a commentary on diagnosing heart disease * a report on a California company that agreed to pay $92.4 million to settle charges after pleading guilty to covering up medical device malfunctions * the "fda.gov" column, which reviews and previews health-related websites. _______________________________________________________________ Thanks for subscribing to FDA News Digest. 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