FDA News Digest February 3, 2003 __________________________________________________________________ FDA Proposes Two Regulations Related to Food Bioterrorism FDA has proposed two regulations as part of the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (also called the Bioterrorism Act of 2002). The law gives the agency new authority in protecting the nation's food supply against terrorist acts and other threats. One proposal would require domestic and foreign food facilities to register with FDA by Dec. 12, 2003. The other proposal would require that prior notice be given to FDA before food is imported or offered for import into the United States. FDA is accepting public comments on the proposals for 60 days. Registration of Food Facilities Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00865.html Fact sheet: http://www.cfsan.fda.gov/~dms/fsbtact6.html Proposed regulation (PDF file): http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-npr0001.pdf Prior Notice of Imports Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00866.html Fact sheet: http://www.cfsan.fda.gov/~dms/fsbtact7.html Proposed regulation (PDF file): http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0278-npr0001.pdf __________________________________________________________________ New Initiative Aims to Boost Development of Innovative Medical Products FDA has announced a broad initiative that will help make innovative medical technologies available sooner while reducing the costs of developing safe and effective medical products and maintaining the agency's consumer protection standards. The initiative affects all four FDA product review areas (drugs, biologics, devices, and veterinary medicine) and will be developed in collaboration with other agencies and expert groups such as the National Institutes of Health. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html Initiative report: http://www.fda.gov/bbs/topics/news/2003/beyond2002/report.html __________________________________________________________________ FDA Urges Applications to Market Radiation Treatment Prussian Blue FDA has called on manufacturers to submit marketing applications for Prussian blue. This mineral has been shown to be safe and effective for treating people for internal contamination with radioactive elements such as cesium-137, a potential component of conventional explosive devices with radioactive materials ("dirty bombs"). Prussian blue can reduce the body's burden of exposure to radioactive particles by binding with them in the gut and causing them to be eliminated from the body. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00868.html __________________________________________________________________ First Biologic Therapy for Most Common Form of Psoriasis Is Approved FDA has approved Amevive (alefacept), an injected medication that treats adults with moderate-to-severe plaque psoriasis, the most common form of the disorder. Psoriasis, characterized by skin scaling and inflammation, affects an estimated 5.5 million people in the United States, most of them adults. Amevive is believed to work by simultaneously blocking and reducing the cellular component of the immune system thought to play a role in the disease process. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01194.html __________________________________________________________________ 'Operation Cure.All' Targets Swiss Company Making Bogus Health Claims The Federal Trade Commission has charged a Switzerland-based company and its U.S. counterpart with making phony health claims for a variety of dietary supplements and devices sold online. Among the targeted products are "the Zapper," purported to kill disease-causing parasites with electricity, and the "Syncrometer," purported to diagnose diseases. FTC worked with FDA and others on this case as part of "Operation Cure.All," a six-year-old program to crack down on unscrupulous Internet marketers. http://www.ftc.gov/opa/2003/01/drclark.htm __________________________________________________________________ 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: 'Always Save' Taco Seasoning (unlabeled wheat, soy and milk): http://www.fda.gov/oc/po/firmrecalls/ampacco01_03.html Witor's Golden Poker Milk Chocolate Pralines (undeclared peanuts): http://www.fda.gov/oc/po/firmrecalls/mayfair01_03.html Master Chao candy (undeclared peanuts): http://www.fda.gov/oc/po/firmrecalls/ho01_03.html __________________________________________________________________ PUBLIC MEETINGS 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 the FDA News Digest. Our next posting will be February 10. 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
