FDA News Digest October 12, 2004 ____________________________________________________________ IN THIS WEEK'S ISSUE -- Loss of Half of Season's Flu Vaccine Prompts Revised Recommendations -- FDA, FTC Take Action Against Sellers of CortiSlim, CortiStress for False Claims -- Recalls/Market Withdrawals -- Recent Speeches -- Congressional Testimony -- Public Meetings ____________________________________________________________ Loss of Half of Season's Flu Vaccine Prompts Revised Recommendations After British regulators suspended the Chiron Corporation's license to manufacture Fluvirin vaccine -- which was to make up about half of this season's supply of flu vaccine for the United States -- the federal Centers for Disease Control and Prevention issued guidance on who should be given priority to receive the remaining vaccine supply. For example, all children aged 6 to 23 months and all adults over 65 should be given priority. CDC recommendations: http://www.hhs.gov/news/press/2004pres/20041005b.html HHS statement: http://www.dhhs.gov/news/press/2004pres/20041005.html FDA, FTC Take Action Against Sellers of CortiSlim, CortiStress for False Claims The Federal Trade Commission has taken regulatory action against the marketers of the dietary supplements CortiSlim and CortiStress after determining that the products were marketed with false or unsubstantiated claims of weight loss with reduced risk of serious health conditions. In addition, FDA sent a warning letter to the marketers of CortiSlim, citing unsubstantiated claims that the product "eliminates cravings," "controls appetites," and "diminishe[s] hunger and stress eating." Federal law requires such claims to be backed up with credible scientific evidence. http://www.ftc.gov/opa/2004/10/windowrock.htm ____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reason shown. Go to the linked page for more information. Assi brand dried sweet potato (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/dried_sweetpotato10_04.html Smak marinated mushrooms (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/mushrooms10_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 _____________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the R&D Leaders' Forum (Oct. 5) http://www.fda.gov/oc/speeches/2004/leaders1005.html To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm _____________________________________________________________ CONGRESSIONAL TESTIMONY FDA Acting Director of the Office of Vaccines Research and Review William Egan, Ph.D., before the House Subcommittee on Labor, Health and Human Services, Education and Related Agencies; subject: regulation and oversight of vaccines in the United States (Oct. 5) http://www.fda.gov/ola/2004/vaccines1005.html _____________________________________________________________ PUBLIC MEETINGS Oct. 19 -- Preparation for International Conference on Harmonization Meetings in Yokohama, Japan http://www.fda.gov/ohrms/dockets/98fr/oc04242.pdf Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm For a list of 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 October 18. 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
