FDA News Digest July 14, 2003 _______________________________________________ Food Labels Will Provide Information on Trans Fat A new FDA regulation will require manufacturers to list trans fat on the Nutrition Facts panel found on the labels of foods and some dietary supplements. Consumers will now have more information to help make healthier food choices as part of a heart-healthy diet. Research has confirmed the relationship between trans fat and an increased risk of heart disease. Press release: http://www.hhs.gov/news/press/2003pres/20030709.html Related materials: http://www.fda.gov/oc/initiatives/transfat/ _____________________________________________________________ FDA to Encourage Labeling, Competition to Aid in Healthy Diet Choices FDA has unveiled a new process to provide more science-based, FDA-regulated information on product labels about the health consequences of foods and dietary supplements. This process will improve information on dietary health benefits for consumers and will encourage product manufacturers to compete based on scientifically demonstrated health benefits of their products. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00923.html Related materials: http://www.fda.gov/oc/mcclellan/chbn.html ______________________________________________________________ First Test to Help Diagnose West Nile Virus Infection is Cleared FDA has cleared the PanBio West Nile IgM assay, the first test to aid in the clinical diagnosis of West Nile infection. The test detects a particular antibody, IgM, in blood serum within the first few days of the onset of illness. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00920.html ______________________________________________________________ FDA Clears Diabetes Device Combining Glucose Meter, Insulin Delivery FDA has cleared the first device that integrates a glucose meter and an insulin pump with a dose calculator. The glucose meter calculates and transmits information to the insulin pump automatically, preventing errors that can occur when patients input data manually. http://www.fda.gov/bbs/topics/news/2003/NEW00918.html ______________________________________________________________ Stent Maker Warns Health Professionals About Rare Blood Clot Problems Cordis Corporation, maker of a drug-treated stent used in angioplasty procedures to open clogged coronary arteries, has alerted health care professionals about a rare blood clot risk associated with the device. FDA is reviewing adverse events reports and is working with Cordis to determine the cause of the problem. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00919.html ______________________________________________________________ Injunction Filed Against Animal Feed Firm for Violating BSE Rules The Justice Department has filed an injunction against X-Cel Feeds Inc. after the company failed to comply with FDA regulations designed to prevent the establishment and spread of bovine spongiform encephalopathy (BSE, or "mad cow disease"). The injunction requires that the company implement corrections under FDA's supervision. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00924.html ______________________________________________________________ Ex-Pharmacy Worker Convicted in Illegal Drug Distribution Scheme A Florida man has been convicted of illegally distributing the prescription drugs Vicodin, Xanax, and Viagra. He had worked as a pharmacy deliveryman. His sentencing is scheduled for Sept. 18. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00922.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. Nortrel 7/7/7 Oral Contraceptive (packaging errors) http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01238.html Pinnacle Foods' Hearty Hero Meatball Sandwiches, mispacked in Hearty Hero Cheeseburger Sandwich cartons (undeclared egg white) http://www.fda.gov/oc/po/firmrecalls/pinnacle07_03.html ______________________________________________________________ RECENT TESTIMONY FDA Assistant Commissioner for Planning Theresa Mullin, Ph.D., before the House Subcommittee on Health (July 10) http://www.fda.gov/ola/2003/nih0710.html FDA Commissioner Mark B. McClellan, M.D., before the Joint Economic Committee, U.S. Congress; Topic: "Technology and Innovation: Their Effects on Cost Growth of Healthcare" (July 9) http://www.fda.gov/ola/2003/healthcare0709.html ______________________________________________________________ Latest FDA Consumer Magazine Available Online The July-August issue of FDA Consumer, available online at http://www.fda.gov/fdac/403_toc.html, has articles on the following topics: * Alzheimer's disease -- Researchers hold out hope for preventing and treating this devastating disease. * New cancer treatments -- FDA has OK'd new drugs for lung cancer and bone-marrow cancer under its accelerated approval program. * Streamlining cancer drug development -- FDA and the National Cancer Institute have joined together to benefit the more than one million Americans diagnosed with cancer each year. * Blood safety -- The American Red Cross has agreed to improve its blood storage practices and record keeping. * Reducing preventable device injuries -- One of FDA's top priorities is to reduce the more than 100,000 reported adverse health events involving medical devices that occur yearly. * Hispanic health -- FDA has renewed its commitment to help Hispanic consumers achieve good health. * SARS -- Federal agencies are working to prevent the spread of this emerging infectious disease threat. * Reporting problem products -- FDA is encouraging consumers to report problems with food and cosmetic products as part of an agency-wide initiative. The issue also has: * a commentary on the "hidden" victims of Alzheimer's disease * a report on a Colorado couple that was caught defrauding drug companies * the "fda.gov" column, which reviews and previews health-related websites. ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be July 21. 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
