FDA News Digest November 17, 2003 ________________________________________________ Following Hepatitis A Outbreaks, FDA Urges Cooking Green Onions, Avoiding Others FDA is advising consumers that several recent outbreaks of the liver disease hepatitis A have been linked to raw or undercooked green onions (scallions). The agency says consumers can minimize the possibility of getting hepatitis A from green onions by cooking the onions thoroughly and avoiding foods at restaurants that contain raw or lightly cooked green onions. Hepatitis A outbreaks linked to green onions have occurred in Tennessee, North Carolina and Georgia. An outbreak in Pennsylvania is still under investigation. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01262.html Questions and answers about the outbreaks: http://www.fda.gov/opacom/faqs/hepatitisa.html ______________________________________________________________ FDA Approves First Chewable Contraceptive Tablet for Women FDA has approved Ovcon 35, a spearmint-flavored contraceptive tablet that can be swallowed whole or chewed and swallowed. Like other birth control pills on the market, Ovcon 35, available only in a 28-day regimen, is effective for pregnancy control when used as directed. Risks of using the product are similar to other oral contraceptives -- increased risks of blood clots, heart attacks and stroke. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01260.html ______________________________________________________________ FDA, NCI Collaborate to Help Improve Cancer Treatments FDA and the National Cancer Institute are collaborating on two initiatives to aid in the development and use of better cancer treatments. The joint program will link cancer researchers electronically to FDA, reducing time for promising cancer drugs to be reviewed for clinical trials. It also will create a corps of doctors and scientists expert in clinical research, regulatory approval, and translating breakthroughs to clinical practice. http://www.nci.nih.gov/newscenter/pressreleases/FriendsFDANCI ______________________________________________________________ N.Y. Company Destroys Dietary Supplements After Making Bogus Claims FDA has witnessed the destruction of about 90,000 units of Royal Tongan Limu, a dietary supplement falsely promoted on the Internet to treat cancer, arthritis, and other diseases. Following an FDA investigation earlier this year, Dynamic Essentials, the company that distributed the product, ceased operations and no longer promotes or sells the product online. The destroyed product was worth about $2.7 million. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00976.html ______________________________________________________________ FDA Warns U.S. Consumers About Canadian Recall of 'Diskus' Asthma Drugs FDA is warning U.S. consumers who may have obtained from Canada (online or through a storefront) any of three types of "Diskus" asthma medicines -- Ventolin, Flovent or Serevent -- that these products are being recalled in Canada and should not be used. The agency emphasizes that the FDA-approved Diskus products Advair and Serevent, sold in the United States through legitimate sources, are not part of this recall. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01261.html ______________________________________________________________ FDA Foods Official to Head Nutrition Project for World Health Organization Christine Taylor, Ph.D., director of FDA's Office of Nutritional Products, Labeling, and Dietary Supplements, has been chosen to head a special project on nutrition issues for the World Health Organization. In the two-year assignment, which begins in January, she will develop approaches to help WHO assess food-related health risks by creating nutrition risk-analysis models. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00977.html ________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. Old Fashioned Foods snack cheese spreads and spreadable cream cheese (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/mayville11_03.html West Front Andrew Corp. Sliced/Smoked Nova Salmon (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/westfront11_03.html Seoul Shik Poom Inc. Biscuits (Jong-Hap Cooki) (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/seoulshik11_03.html For an archive of FDA-related recalls and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D., at the Urban Institute (Nov. 12); topic: "Protecting and Advancing America's Health Through 21st Century Patient Safety" http://www.fda.gov/oc/speeches/2003/urbaninstitute1112.html For an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ PUBLIC MEETINGS Nov. 20 -- FDA Workshop: Exploring the Link Between Food Labeling and Weight Management; Bethesda, Md. https://secure.z-techcorp.com/cmt/meetings/meeting_detail.cfm?meeting_id=26 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 November 24. 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