FDA News Digest June 14, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Women Warned Not to Use Domperidone to Increase Breast Milk -- FDA Seeks Comments on Inhalers With Ozone-Depleting Propellants -- Recalls/Market Withdrawals -- Congressional Testimony -- Recent Speeches -- Public Meetings ______________________________________________________________ Women Warned Not to Use Domperidone to Increase Breast Milk FDA is warning breastfeeding women not to use the unapproved drug domperidone to increase milk production. The agency is concerned about reported health risks associated with any use of the drug, including cardiac arrhythmias, cardiac arrest, and sudden death. FDA has sent letters to several pharmacies that were compounding products containing domperidone, warning them that the drug is illegal in the United States. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html FDA Seeks Comments on Inhalers With Ozone-Depleting Propellants FDA is asking for the public's input regarding a proposal to withdraw "essential use" status for albuterol metered-dose inhalers that contain chlorofluorocarbon (CFC) propellants. CFC is known to deplete the ozone layer. The agency has tentatively determined that two non-CFC inhalers now on the market should be satisfactory alternatives for patients being treated for diseases such as asthma, emphysema, and chronic bronchitis. Comments will be accepted for 60 days. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01293.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: Certain types and sizes of King Nut and Peterson Nut brand trail mixes and raw whole almonds http://www.fda.gov/oc/po/firmrecalls/kanan06_04.html Certain types and sizes of Jeppi Nut brand raw whole almonds, raw diced almonds, nut mix, and Koala Bear Mix http://www.fda.gov/oc/po/firmrecalls/jeppinut06_07.html Apple Valley Vegetarian Foods Emporium raw whole almonds (1 lb. package) http://www.fda.gov/oc/po/firmrecalls/applevalley06_04.html Argires brand tropical mix http://www.fda.gov/oc/po/firmrecalls/antonargires06_04.html Fort Fudge Shop Vanilla Nut Fudge (6 oz. packs) http://www.fda.gov/oc/po/firmrecalls/fortfudge06_04.html The following other products are being recalled for the reasons shown. Go to the linked pages for more information. Various types of Sun-Sen alfalfa sprouts; 4-oz. and 1-lb. sizes (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/sunsen06_04.html Various types and sizes of Fuji Natural Foods alfalfa sprouts (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/fuji06_04.html Umpqua brand Lite Praline Pecan and Pralines n' Cream ice cream and Pacific Crest Windigo Pass Pecan ice cream (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/umpqua06_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 ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D., before the Senate Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia; subject: Dietary Supplement Health and Education Act -- 10 Years Later (June 8) http://www.fda.gov/ola/2004/dssa0608.html FDA Acting Commissioner Lester M. Crawford, D.V.M., before the House Committee on Government Reform; subject: the nation's obesity epidemic (June 3) http://www.fda.gov/ola/2004/obesity0603.html For an archive of FDA testimony since 1996, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Association of Academic Health Centers' 11th Congress of Health Professions Educators (June 7) http://www.fda.gov/oc/speeches/2004/ahce0607.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ PUBLIC MEETINGS July 20-23 -- NHII 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 21. 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