FDA News Digest December 15, 2003 ______________________________________________________________ Draft Advisory Updates Recommendations on Methylmercury in Fish FDA has released a draft advisory containing revised recommendations regarding fish and shellfish consumption for people at risk from exposure to the high methylmercury levels found in certain fish varieties. Groups at risk include pregnant women, nursing mothers, women who may become pregnant, and young children. The recommendations were discussed at a meeting Dec. 10-11 of the FDA Food Advisory Committee. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01270.html Draft advisory: http://www.fda.gov/oc/opacom/mehgadvisory1208.html _______________________________________________________________ New Lab Culture Test for Identifying Anthrax Cleared for Marketing FDA has cleared for marketing the Redline Alert, a test kit for clinical laboratories to use with culture testing to help distinguish the organism that causes anthrax disease from similar organisms. Designed to be used with other laboratory tests, the Redline Alert can be performed in about 15 minutes and does not require specially trained personnel or special instrumentation. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00992.html _______________________________________________________________ Injectable Gel Approved for Treating Facial Wrinkles FDA has approved the injectable gel Restylane as a treatment for filling moderate-to-severe wrinkles around the nose and mouth. Restylane is the third injectable product approved for treating facial wrinkles. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01271.html _______________________________________________________________ Guide Explains FDA, Customs Policy on Food Import Compliance FDA and the U.S. Bureau of Customs and Border Protection have issued a guide that describes how the two agencies plan to maintain an uninterrupted flow of food imports while improving food safety as part of the provisions of the Bioterrorism Act of 2002. Under the Act, FDA must receive prior notice of all human and animal food, drinks, and dietary supplements imported or offered for import to the United States. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00995.html Compliance Policy Guide: http://www.cfsan.fda.gov/~pn/cpgpn.html _______________________________________________________________ Drug, Biologic Sponsors Now Required to Submit Labeling Electronically FDA has revised regulations to require that proposed labeling for certain drugs and biologics be submitted to the agency electronically as part of applications for approval of those products. This standardized format will allow FDA to ensure that information provided by product sponsors is accurate and to communicate information that doctors and patients need to use products. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00991.html _______________________________________________________________ FDA Reaffirms Hepatitis A Link to Raw Green Onions FDA, along with the Centers for Disease Control and Prevention and state and local health officials, have confirmed that several recent outbreaks of hepatitis A have been linked to eating contaminated raw or undercooked green onions (scallions) traced to Mexico. Though the exact source of the contamination has not been determined, FDA is continuing its investigation in cooperation with the Mexican government. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00993.html _______________________________________________________________ FDA Decides Not to Regulate Aquarium 'Glofish' FDA has issued a statement saying that because tropical aquarium fish are not used for food purposes, it will not regulate the genetically engineered zebra danio fish called "Glofish." The agency says there is no evidence that Glofish pose any more threat to the environment than the unmodified species sold widely in the United States. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00994.html _______________________________________________________________ FDA Honors W. Leigh Thompson for Work in Medicine, Public Health For accomplishments in a career spanning nearly four decades, W. Leigh Thompson, M.D., has been awarded the FDA Commissioner's Special Citation. The honor cites Thompson's work in critical care, pharmaceutical development innovations, information technology management, and collaborations with regulators. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00996.html _____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Lucerne Chocolate Almond Ice Cream (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/safeway12_03.html Stop & Shop Assorted Party Cookies (undeclared milk and nuts) http://www.fda.gov/oc/po/firmrecalls/stopshop12_03.html Atlantis Salmon Spread, Chicken Salad (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/atlantis12_03.html Wisconsin Cheesecake Co. Candy Bar Cheesecakes (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/wisconsinccake12_03.html Asian Boy Dried Ginger (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/BCN12_03.html ______________________________________________________________ PUBLIC MEETINGS 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 heart disease, genetically engineered foods, and menopausal hormone therapy? Find out by taking our quiz at http://www.fda.gov/fdac/quiz/onlinequiz14_js.html. ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be December 22. 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
