FDA News Digest September 27, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- FDA Signs Federal-State Food Emergency Response Plan -- Changes Proposed for Improving Egg Safety at Farm Level -- FDA Approves Palladone for Management of Pain -- FDA Reaffirms Commitment to Good Health for Hispanics -- Recalls/Market Withdrawals -- Congressional Testimony ____________________________________________________________ FDA Signs Federal-State Food Emergency Response Plan FDA has joined with the U.S. Department of Agriculture and the Department of Homeland Security in signing a cooperative agreement with the National Association of State Departments of Agriculture to integrate federal and state plans for responding to emergencies that threaten the security of the nation's food supply. The agreement is a three-phase plan slated to be completely in place by June 2005. http://www.fda.gov/bbs/topics/news/2004/usda_092304.html Changes Proposed for Improving Egg Safety at Farm Level FDA has proposed a regulation to help reduce the number of illnesses caused by eggs contaminated with Salmonella bacteria. The proposal would require certain egg producers to implement Salmonella prevention measures on poultry farms. FDA estimates the measures would reduce Salmonella-related illnesses by 33,500 from the current 118,000 a year. http://www.fda.gov/bbs/topics/news/2004/NEW01117.html FDA Approves Palladone for Management of Pain FDA has approved Palladone (hydromorphone hydrochloride) capsules for the management of persistent moderate-to-severe pain in patients requiring continuous opioid pain relief for an extended period. Based on risks associated with the drug, including the potential for abuse, FDA has worked with the sponsor to develop a risk management program. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01315.html FDA Reaffirms Commitment to Good Health for Hispanics FDA and the National Alliance for Hispanic Health have reaffirmed their ongoing partnership devoted to helping the Hispanic community achieve and sustain good health. Among goals of the two groups are improvements in diagnosis of diabetes, high blood pressure, and eye diseases. http://www.fda.gov/bbs/topics/news/2004/NEW01118.html _____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reason shown. Go to the linked page for more information. Clarion and HiResolution cochlear implants (malfunction due to moisture) http://www.fda.gov/bbs/topics/news/2004/NEW01119.html Frito-Lay Tostitos Monterey Jack Queso Dip (possible contamination due to underprocessing) http://www.fda.gov/oc/po/firmrecalls/fritolay09_04.html Mini Oreo Chocolate Sandwich Cookies (package may contain Ritz Bits, potentially hazardous to milk-sensitive individuals) http://www.fda.gov/oc/po/firmrecalls/nabisco09_04.html Belweder Pickled Mushrooms (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/brooklyn09_04.html Smak Mushrooms Salad (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/desly09_04.html World Classics brand pesto sauce (undeclared walnuts and wheat) http://www.fda.gov/oc/po/firmrecalls/jcm09_04.html For a list 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 To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Office of Medical Policy Director Robert Temple, M.D., before the House Subcommittee on Oversight and Investigations; subject: antidepressant use in pediatric populations (Sept. 23) http://www.fda.gov/ola/2004/antidepressant0923.html To view an archive of past FDA Congressional testimony, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be October 4. 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
