FDA News Digest August 4, 2003 ______________________________________________________________ FDA Proposes to Revise Blood Storage and Container Labeling Rules FDA has proposed a rule that combines, simplifies and updates regulations related to blood container labeling and to the storage and shipping temperatures of frozen blood components. The rule will help the blood industry comply with existing regulations at reduced costs. FDA will accept comments on the proposal until Oct. 28. Federal Register notice: http://www.fda.gov/cber/rules/labelstorbld.htm ______________________________________________________________ New Hemophilia Treatment is First Without Blood-Derived Additives FDA has licensed a new type of clotting factor to treat people with hemophilia A. Called antihemophilic human factor VIII, the product is made by recombinant DNA technology and is the first kind produced without using additives derived from human or animal blood. People with hemophilia A are unable to form blood clots and are at risk of serious and life-threatening bleeding. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01241.html ______________________________________________________________ Growth Hormone Approved for Treating 'Short Stature' in Children FDA has approved Humatrope, a brand of growth hormone, for long-term treatment of children with short stature of unknown origin. The approval restricts therapy to the shortest 1.2 percent of children, which corresponds to heights of less than 4'1" in 10-year-old boys and girls. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01242.html ______________________________________________________________ Notice Updated About Meningitis Risk in Children With Cochlear Implants FDA has alerted healthcare providers about a recent study showing that children with cochlear implants--electronic devices that help restore hearing--are at greater risk of developing bacterial meningitis than children in the general population. Meningitis is an infection in the fluid around the brain and spinal cord. The notice, which updates a 2002 alert, recommends several ways to decrease meningitis risk and discusses factors that may predispose implant recipients to develop meningitis. http://www.fda.gov/cdrh/safety/cochlear.html ______________________________________________________________ Labeling Requirement Dropped for Snack Food Fat Substitute Olestra FDA will no longer require manufacturers of foods containing the fat substitute olestra to display a statement about the ingredient's gastrointestinal effects, that it inhibits absorption of certain vitamins, and that these vitamins have been added to compensate for the loss. The agency based its decision on a review of several studies showing that the additive causes milder effects than initially believed. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01245.html ______________________________________________________________ FDA Sets FY 2004 User Fees for Medical Device Industry FDA has announced its schedule of user fees aimed at improving the agency's performance in reviewing new devices. FDA charges the fees to fund resources that will help reduce the average time needed for reviewing applications, which will allow safe and effective devices to get to patients sooner. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01244.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Land O'Lakes Salted Stick Butter, 1-lb. package (bits of metal) http://www.fda.gov/oc/po/firmrecalls/landolakes07_03.html Manor Delicatessen Potato Salad (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/manodeli07_03.html Eastwell Trading Dried Fruit Candy, Sweet Potato (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/eastwell07_03.html Schmaltz Herring, 7-oz. containers (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/schwartz07_03.html Viola Filled Chocolates (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/eagle07_03.html Energy Club Nutty Fruit Mix (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/energyclub07_03.html Ricoa Curly Tops Milk Chocolate (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/everlasting07_03.html Flowers Foods breads -- 19 varieties under the names Broad Street Bakery, Cobblestone Mill, Country Farms, Flowers, and Winn-Dixie (may contain small pieces of metal screen) http://www.fda.gov/oc/po/firmrecalls/flowers07_03.html Capricious Washed Curd Cheese (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/capricious07_03.html ______________________________________________________________ RECENT TESTIMONY FDA Chief Counsel Daniel E. Troy, before the Senate Committee on the Judiciary (Aug. 1) http://www.fda.gov/ola/2003/genericdrugs0801.html ______________________________________________________________ PUBLIC MEETINGS For a list of upcoming FDA meetings, seminars and public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be August 11. 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
