FDA News Digest February 2, 2004 ______________________________________________________________ Expanded 'Mad Cow' Measures Designed to Boost U.S. Safeguards FDA has put in place several new public health measures designed to bolster existing "firewalls" against bovine spongiform encephalopathy (BSE or mad cow disease). Included is a ban on a wide range of bovine-derived material from human food, dietary supplements and cosmetics. FDA also is prohibiting certain previously allowed practices involving feed for cattle and other ruminant animals. http://www.hhs.gov/news/press/2004pres/20040126.html ______________________________________________________________ 2nd FDA/Customs 'Blitz' Underscores Risks of Illegal Medicine Imports A second "blitz," conducted in late 2003 by FDA and the U.S. Customs and Border Protection agency to examine imported medicine shipments, has uncovered 1,728 unapproved drugs. These included foreign versions of FDA-approved drugs, along with drugs that have been recalled, require special storage, require close physician monitoring, and contain addictive controlled substances. FDA points to these findings as additional evidence of the serious risks posed by illegal importation of prescription drugs. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html ______________________________________________________________ Administration Proposes Budget Increase for Medical Devices in FY '05 As part of its fiscal year 2005 budget, the Bush administration has requested a $25.6 million increase over the previous fiscal year's funding for FDA's medical device program. The increase will help FDA reach performance goals for the prompt review of medical devices so those products can be marketed quickly. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01012.html ______________________________________________________________ Guidance Aims to Improve Information on Use of Investigational Drugs FDA has issued a draft guidance designed to make further information about the use of investigational drugs more readily available to patients. The document is intended to help patients with serious or life-threatening diseases who cannot be treated with existing therapy and who don't meet the eligibility criteria or are otherwise unable to participate in a clinical trial. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01010.html ______________________________________________________________ New Web Site Explains Required Labeling of Trans Fats in Foods A 2003 FDA rule requires food manufacturers to list on labels the amount of trans fats found in their foods. To help consumers understand the new labeling, which must be in place no later than January 2006, the FDA Center for Food Safety and Applied Nutrition has created a Web site with helpful background on trans fats and how to minimize them in the diet. Though found in many food products, trans fats have been shown to raise levels of LDL ("bad") cholesterol and increase the risk of heart disease. The site includes sample "Nutrition Facts" labels showing where trans fat information will be located. http://www.cfsan.fda.gov/~dms/transfat.html ______________________________________________________________ Consumers Warned Not to Feed Infants 'Better than Formula Ultra Infant Immune Booster 117' FDA is warning consumers that Better Than Formula Ultra Infant Immune Booster 117, sold over the Internet as a dietary supplement, should not be fed to infants. Even though the manufacturer, NSP Research Nutrition of Mt. Clemens, Mich., labeled the product as "a dietary supplement," FDA is concerned that the product may be used as an infant formula as a result of its labeling. If the product is used as formula, there are no assurances that it would support growth of infants, that it contains nutrients essential for infants, or that is has been manufactured using good practices. Also, the label lists a number of ingredients that have not been evaluated for safe use in infant formula. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01009.html ______________________________________________________________ Acheson Named Director of Food Safety and Security David W.K. Acheson, M.D., has been appointed director of the Food Safety and Security Staff in FDA's Center for Food Safety and Applied Nutrition. With a strong background in both food safety and infectious diseases, Acheson will provide leadership across a wide range of food safety and security issues currently facing FDA. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01013.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Vantin, a prescription antibiotic; 200 mg. tablets; Lot #K08210301 (package may contain Lanoxin, a cardiac drug) http://www.fda.gov/oc/po/firmrecalls/graham02_04.html ______________________________________________________________ Is it a good idea to get an ultrasound image to add to your baby's scrapbook? Can you catch an illness from your pet? Find out how much you know about these and other health-related topics by taking our 10-question FDA Consumer quiz at http://www.fda.gov/fdac/quiz/onlinequiz15_js.html. _____________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be February 9. 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
