FDA News Digest August 23, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- Rx Depot Agrees to Stop Importing Unapproved Drugs from Canada -- U.S Plans to Defend 'Vigorously' Against Vermont Imported Drugs Suit -- FDA Updates Its Review of Antidepressant Drugs in Children -- Rodent Contamination Prompts Seizure of Foods from Tenn. Company -- Fraser to Direct Regulations and Policy Office in FDA Foods Center -- Recalls/Market Withdrawals -- Public Meetings ____________________________________________________________ Rx Depot Agrees to Stop Importing Unapproved Drugs from Canada Rx Depot Inc. and Rx of Canada LLC have signed a consent decree that prohibits them from importing unapproved drugs from Canada. The companies had taken prescriptions from U.S. customers, sent the orders to a Canadian pharmacy, and received a commission when the drugs were shipped. FDA says the companies' actions "posed a significant public health threat." http://www.fda.gov/bbs/topics/news/2004/NEW01105.html U.S Plans to Defend 'Vigorously' Against Vermont Imported Drugs Suit FDA has released a statement saying that the federal government will defend itself "vigorously" against the state of Vermont's Aug. 19 suit that alleges FDA violated existing statutes when it denied Vermont's recent petition to import prescription drugs from Canada. http://www.fda.gov/bbs/topics/news/2004/NEW01107.html FDA Updates Its Review of Antidepressant Drugs in Children In preparation for a meeting Sept. 13 and 14 of an FDA advisory committee that will discuss possible labeling changes and other regulatory actions related to the use of antidepressants in children, FDA has released updated information on this subject. The agency has been reviewing studies of antidepressants in children since June 2003, after an initial report appeared to suggest an increased risk of suicidal thoughts and actions in children given the antidepressant drug Paxil. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01306.html Summaries of pediatric studies: http://www.fda.gov/cder/pediatric/Summaryreview.htm Rodent Contamination Prompts Seizure of Foods from Tenn. Company U.S. marshals, at FDA's request, have seized various foods from Tennessee-based Hung Hua Trading Inc. due to extensive rodent infestation in the company's warehouse facility and cold storage area. Included in the seizure were shrimp, sweet rice, and lo mein noodles, typically used to prepare restaurant foods. http://www.fda.gov/oc/po/firmrecalls/hunghua08_04.html Fraser to Direct Regulations and Policy Office in FDA Foods Center Leslye M. Fraser, S.M., J.D., has been named director of the Office of Regulations and Policy in the FDA Center for Food Safety and Applied Nutrition. She will oversee the agency's food and cosmetic regulations, guidance documents, and policy development, and she will provide management oversight for international activities. She brings to the job a broad background in federal law and rulemaking. http://www.fda.gov/bbs/topics/news/2004/NEW01106.html _____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Neighbors brand coffee and tea; various flavors (undeclared almonds) http://www.fda.gov/oc/po/firmrecalls/neighbors208_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 ______________________________________________________________ PUBLIC MEETINGS Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html 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 August 30. 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
