FDA News Digest January 21, 2003 __________________________________________________________________ New Warnings Proposed for OTC Contraceptives with Nonoxynol-9 FDA has proposed that over-the-counter vaginal contraceptive drugs containing the spermicide nonoxynol-9 carry new warnings that the products do not protect against infection from HIV or other sexually transmitted diseases. FDA will gather public comments for 90 days on the proposed warning and how best to present it. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01191.html __________________________________________________________________ Certain Gene-Therapy Trials Temporarily Halted FDA has placed on hold all active gene therapy trials using retroviral vectors to insert genes into blood stem cells. The agency took this action after learning that a second child treated successfully for an immunodeficiency disease in such a trial has developed a leukemia-like condition. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01190.html __________________________________________________________________ FDA Survey Finds Physicians Have Mixed Views on Direct-to-Consumer Rx Ads Reporting on its recent survey of 500 physicians, FDA says that many in the medical community believe that direct-to-consumer advertising for prescription drugs can play "a positive role" in patient interactions and, when done correctly, can increase patient awareness of diseases that can be treated. But some doctors said they felt the ads can cause misperceptions about the risks and benefits of the advertised drugs. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01189.html __________________________________________________________________ FDA, SAMHSA Join to Alert Public to Dangers of Prescription Drug Abuse Data released by FDA and the Substance Abuse and Mental Health Services Administration show that in 2001, nearly three million youths aged 12 to 17 reported they had, in their lifetimes, used prescription medications such as pain relievers and stimulants for nonmedical purposes. The two agencies have joined forces to launch an education campaign that will focus public attention on the dangers of abusing prescription drugs. http://www.samhsa.gov/news/newsreleases/030116nr_rx.htm __________________________________________________________________ New Task Force Aims to Improve Consumer Nutrition Information FDA has formed an 11-member internal task force that will develop scientific guidance for establishing standards for qualified health claims in foods. The group is a key element of an agency initiative that aims to make available to consumers more and better information about the health benefits of food and dietary supplements. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00864.html __________________________________________________________________ Jan. 29 Public Meeting, Satellite Broadcast to Discuss Bioterrorism Act FDA will sponsor a public meeting Jan. 29 to discuss two sections of the Bioterrorism Act of 2002 regarding registration of food facilities and prior notice of imported food shipments. The meeting will be broadcast by satellite to locations across the country, including sites in New York, Illinois, Maryland, Washington state, and Texas. Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-660.htm Meeting registration: http://www.fda.gov/oc/bioterrorism/meeting01_29.html __________________________________________________________________ RECALLS The following products, or certain lots of them, have recently been recalled for the reasons shown. Go to the linked page for more information: Ancom Anti-Hypertensive Compound Tablets (unapproved new drug): http://www.fda.gov/oc/po/firmrecalls/herbsland01_03.html EnfaCare LIPIL Infant Formula Powder (bacterial contamination): http://www.fda.gov/oc/po/firmrecalls/meadjohnson01_03.html T. Marzetti "Two-Lightful" Caesar Dressing (undeclared anchovies): http://www.fda.gov/oc/po/firmrecalls/marzetti01_03.html Hearty Hero Meatball Sandwiches (undeclared egg white protein; product mispacked in Hearty Hero Cheeseburger Sandwich cartons): http://www.fda.gov/oc/po/firmrecalls/pinnacle01_03.html County Fare/BakerGirl White Cake Mix (undeclared nonfat dry milk and egg whites): http://www.fda.gov/oc/po/firmrecalls/amendt01_03.html Harry and David Milk Chocolate, Cherry, and Coffee Truffles (undeclared almonds and hazelnuts): http://www.fda.gov/oc/po/firmrecalls/bearcreek01_03.html __________________________________________________________________ How's your knowledge of health-related topics such as West Nile virus, depression, and contact lenses? Find out by taking our 9-question quiz at http://www.fda.gov/fdac/quiz/onlinequiz9_js.html __________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be January 27. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
