FDA News Digest April 26, 2004 ________________________________________________________________ -- New Drug Approved to Treat Immobility in Parkinson's Disease Patients -- FDA Outlines Science-Based Approach to Dietary Supplement Enforcement -- China to Resume Imports of U.S. Cosmetics -- Couple Charged in $1.5 Million Scheme to Defraud Diabetes Test Maker -- Recalls/Market Withdrawals -- Public Meetings ________________________________________________________________ New Drug Approved to Treat Immobility in Parkinson's Disease Patients FDA has approved Apokyn (apomorphine) to treat patients with Parkinson's disease during so-called "off periods," in which the patient becomes immobile or unable to perform regular activities. Given by injection, Apokyn is the first therapy approved to treat off periods while they are occurring. About 1.5 million Americans have Parkinson's, which results in tremors, rigidity, instable posture, slowness, and difficulty moving. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01284.html FDA Outlines Science-Based Approach to Dietary Supplement Enforcement FDA has unveiled a science-based plan to help ensure that consumers are protected from unsafe dietary supplements. The plan includes stepped up efforts to inspect supplement manufacturers, remove mislabeled or adulterated products from the market, and refuse entry into the United States of unsafe foreign supplements. The agency also is scrutinizing supplement labeling and challenging false claims of effectiveness in treating various diseases. http://www.fda.gov/bbs/topics/news/2004/NEW01055.html China to Resume Imports of U.S. Cosmetics Following meetings this month with FDA officials, China has agreed to resume imports of U.S. cosmetics. China had suspended these imports in January on public health grounds after a cow in Washington state was found infected with bovine spongiform encephalopathy, or mad cow disease. As part of the agreement, two U.S. cosmetics trade associations will certify that cosmetics imports from the United States do not contain any animal ingredients prohibited in China. http://www.fda.gov/bbs/topics/news/2004/NEW01056.html Couple Charged in $1.5 Million Scheme to Defraud Diabetes Test Maker A California couple has been charged with nine counts of mail fraud, money laundering, and conspiracy in an alleged scheme to defraud Roche Diagnostics Corp. by illicitly obtaining and selling the company's diabetes test strips. The couple allegedly made more than $1.5 million from the scheme. FDA's Office of Criminal Investigations assisted the Federal Bureau of Investigation in the case. http://www.fda.gov/bbs/topics/news/2004/doj042104.pdf ________________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Medtronic Inc.'s Micro Jewel II Model 7223Cx and GEM DR Model 7271 implantable cardioverter-defibrillators (possible problem with charging time) http://www.fda.gov/oc/po/firmrecalls/medtronic04_04.html Country Farms Old-Fashioned Wheat Bread (undeclared buttermilk) http://www.fda.gov/oc/po/firmrecalls/earthgrains04_04.html Certain Zander's Butter Blend Margarine products (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/zanderscream04_04.html Certain Crystal Farms Butter Blend Maragine Quarters and Butter Blend Margarine Solids (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/crystalfarms04_04.html For a listing of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ________________________________________________________________ PUBLIC MEETINGS April 27-28 - FDA Foods Advisory Committee/Nutrition Subcommittee will discuss health claims for coronary heart disease and evidence supporting a possible daily value for trans fatty acids. (Washington, D.C.) http://www.fda.gov/ohrms/dockets/ac/cfsan04.html May 18-19 -- FDA Science Forum will showcase FDA's scientific achievements, present topics of interest to FDA and its constituents, and promote internal and external scientific collaborations. (Washington, D.C.) http://www.cfsan.fda.gov/%7Efrf/sxsfin04.html 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 FDA News Digest. Our next posting will be May 3. 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
