FDA News Digest October 14, 2003 ______________________________________________________________ To Avert Terrorism, Food Firms Must Register, Alert FDA to Imports As part of its efforts to protect the nation's food supply against terrorism and other food-related emergencies, FDA has published two rules that require registration of all domestic and foreign food facilities, and advance notice of any imported human or animal foods. The new rules, which become effective Dec. 12, 2003, are required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. http://www.fda.gov/oc/bioterrorism/furls/ ______________________________________________________________ Lotion-Like Product Approved for Treating Menopausal Hot Flashes FDA has approved Estrasorb, a topical estrogen therapy product for treating moderate-to-severe symptoms of hot flashes and night sweats associated with menopause. Estrasorb is a lotion-like product that women apply daily to their legs, thighs or calves. The product is absorbed into the bloodstream to achieve its effect. For more information about menopausal hormone therapy, go to http://www.4women.gov. FDA Estrasorb press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01255.html ______________________________________________________________ FDA Stops Sale of Bogus Obesity and Impotence Treatments At FDA's request, a U.S. district court has ordered Jared R. Wheat and five Georgia-based companies to stop selling and distributing dietary supplements that make false claims for treating obesity and impotence. Though FDA had repeatedly warned Wheat and the companies about their illegal actions, they continued to make the false claims. The court order stops sale and distribution of the products until FDA can review any revised labeling and promotional literature. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00953.html __________________________________________________________ FDA Warns About Use of Decorative Contact Lenses With Halloween approaching, FDA is warning consumers about serious risks of using decorative contact lenses without first seeing an eye care professional. These lenses -- which are sold at flea markets, convenience stores, and on the Internet -- can cause permanent eye injury and could lead to blindness. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00955.html __________________________________________________________ Glavin Named as FDA's Senior Counterterrorism Official FDA has announced the appointment of Margaret O'K. Glavin as the agency's new assistant commissioner for counterterrorism. A nationally recognized food safety expert, Glavin will provide executive-level policy and program direction for FDA's counterterrorism-related strategic, legislative and interagency activities. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00954.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. CoaguChek PT test strips (faulty package seals) http://www.fda.gov/cdrh/recalls/recall-091203.html Misys Heathcare Systems laboratory software versions 5.2, 5.23 and 5.3 (defect could affect results) http://www.fda.gov/bbs/topics/NEWS/2003/NEW00956.html Sharp's Non-Alcohol Brew (may contain alcohol) http://www.fda.gov/oc/po/firmrecalls/sharpsbrew10_03.html Golden Luck Inc. "Leek Sauce" (possible contamination with Clostridium botulinum) http://www.fda.gov/oc/po/firmrecalls/goldenluck10_03.html Triunfo Import Food Corp. Queijo tipo Mineiro cheese (potential contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/triunfo10_03.html Y.J.X. Bakery products: Black Bean Moon Cake (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/beanmoon10_03.html Lotus Seed Moon Cake (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/lotusseed10_03.html Napoleon Cake (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/napoleon10_03.html ______________________________________________________________ PUBLIC MEETINGS Oct. 23 -- Public Meeting on Obesity; Bethesda, Md. http://www.fda.gov/oc/opacom/hottopics/obesity.html Oct. 23-24 -- Workshop on Counterterrorism Products Regulated by the FDA Center for Biologics Evaluation and Research; Bethesda, Md. http://www.fda.gov/cber/meetings/cntrtrrsm102303.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ______________________________________________________________ HOW'S YOUR KNOWLEDGE of health-related topics such as generic drugs, the flu, and dietary fats? 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