FDA News Digest June 21, 2004 ________________________________________________ THIS WEEK'S NEWS -- Updated FDA Handbook Gives Latest Information on Breast Implants -- FDA Offers Patient Information on Implanted Stent for Leg Arteries -- Tarantino Named to Head FDA Office of Food Additive Safety -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ Updated FDA Handbook Gives Latest Information on Breast Implants Women considering breast implants can get the latest information to help them make an informed choice from a revised online handbook called "FDA Breast Implant Consumer Handbook -- 2004." The handbook covers types of implants, potential complications, issues to consider such as mammography and breastfeeding, and other information resources. http://www.fda.gov/cdrh/breastimplants/indexbip.html FDA Offers Patient Information on Implanted Stent for Leg Arteries FDA's Center for Devices and Radiological Health has created a Web page with information for patients about the IntraStent DoubleStrut Stent, which was approved on June 8. The device is a flexible metal mesh that can be implanted in the large arteries that supply blood to the pelvis and legs to help maintain adequate blood flow. http://www.fda.gov/cdrh/mda/docs/p030045.html Tarantino Named to Head FDA Office of Food Additive Safety FDA has appointed Laura Tarantino, Ph.D., to head the Office of Food Additive Safety in the agency's Center for Food Safety and Applied Nutrition. She will oversee the agency's review of food and color additives, generally recognized as safe (GRAS) substances, and foods derived from recombinant DNA technology. http://www.fda.gov/bbs/topics/news/2004/NEW01078.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS ONGOING RAW ALMOND RECALL As part of an earlier recall of raw almonds by Paramount Farms due to possible Salmonella contamination, several almond distributors and retailers continue to conduct their own recalls. For a complete list of all almond recalls to date, go to http://www.fda.gov/oc/po/firmrecalls/almonds.html. To view information about just the most recent recalls from each outlet, go to the links that follow: Sahadi Fine Foods Shelled Almonds (25-lb. package) http://www.fda.gov/oc/po/firmrecalls/sahadi06_04.html Royal Food International Almond Raw (5-, 10-, and 25-lb. boxes) http://www.fda.gov/oc/po/firmrecalls/royal06_04.html Bucks County Distributors California Dyno Trail Mix (4-oz. plastic containers, 1-gal. bags and 12-lb. dispensers) http://www.fda.gov/bbs/topics/news/2004/NEW01077.html GKI Foods Milk Chocolate English Almond Butter Toffee, Jumbo English Almond Butter Toffee, and Gourmet Sugar-Free Almond Butter Toffee; sold under various brand names http://www.fda.gov/oc/po/firmrecalls/gki06_04.html The following other products are being recalled for the reasons shown. Go to the linked pages for more information. Penzeys Hungarian Half-Sharp Paprika (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/penzeys05_04.html Sunshine Brand Alfalfa Sprouts (5-oz. package, 6-lb. bulk trays) and Sunshine Brand Spicy Sprout Mix (5 oz. packages) http://www.fda.gov/oc/po/firmrecalls/sunshine06_04.html Catsmo Artisan Smokehouse Smoked Salmon (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/catsmo06_04.html Buckler Non-Alcoholic Brew (possible excess yeast in product) http://www.fda.gov/oc/po/firmrecalls/buckler06_04.html For a listing 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 ______________________________________________________________ PUBLIC MEETINGS July 20-23 - National Health Information Infrastructure 2004: Cornerstones for Electronic Healthcare; Washington, D.C. http://www.hsrnet.net/nhii/welcome.htm 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 June 28. 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