FDA News Digest April 19, 2004 ______________________________________________________________ -- Final Rule Prohibiting Supplements With Ephedrine Alkaloids Goes into Effect -- State Pharmacists Associations Join FDA to Educate Consumers About Risks of Foreign Drugs -- Repackager of Foreign Drugs Agrees to Comply With FDA Requirements -- FDA to Distribute Free Seniors' Guide on Safe Medicine Use -- Schneeman to Head FDA Nutrition, Labeling and Supplements Programs -- Ronan Appointed Head of FDA's Office of Legislation -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ Final Rule Prohibiting Supplements With Ephedrine Alkaloids Goes into Effect A final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra), published by FDA last Feb. 11, went into effect April 12., Ephedra supplements have been promoted to aid weight loss, enhance sports performance, and increase energy. FDA took the action because ephedra has been linked to significant adverse health effects, including heart attack and stroke. The agency determined that supplements containing ephedra present "an unreasonable risk of illness or injury." Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01050.html More information: http://www.fda.gov/oc/initiatives/ephedra/february2004/ State Pharmacists Associations Join FDA to Educate Consumers About Risks of Foreign Drugs FDA is partnering with state pharmacists associations to distribute educational materials explaining the risks of buying medicines from foreign sources. The latest association to join the effort is the Virginia Pharmacists Association. FDA is conducting this campaign and other similar consumer outreach programs to convey that medicines bought from outside the United States may be counterfeit or adulterated and that FDA cannot guarantee their safety. http://www.fda.gov/bbs/topics/news/2004/NEW01053.html Repackager of Foreign Drugs Agrees to Comply With FDA Requirements Illinois-based Phil and Kathy's Inc., a repackager of foreign drugs, has settled a court case by agreeing to comply fully with FDA regulations. FDA took action because inspections last year revealed that the company was importing and repackaging drug products that did not meet FDA's standards for approval. The company also repeatedly failed to comply with manufacturing practice requirements, which ensure that marketed drugs are safe, effective and properly made. Phil and Kathy's cannot make or distribute drugs until FDA has determined that conditions of the agreement have been met. http://www.fda.gov/bbs/topics/news/2004/NEW01052.html FDA to Distribute Free Seniors' Guide on Safe Medicine Use FDA is joining with the Council on Family Health (CFH) and the Administration on Aging to distribute "Medicines and You: A Guide for Older Adults," a free educational guide for seniors about safe and responsible medicine use. Created by the CFH, the guide urges seniors to read medicine labels and drug package inserts, follow directions carefully, and consult a healthcare professional with any questions about medicines. http://www.fda.gov/bbs/topics/news/2004/cfh0414.html Schneeman to Head FDA Nutrition, Labeling and Supplements Programs Barbara O. Schneeman, Ph.D., has been named to head FDA's Office of Nutritional Products, Labeling, and Dietary Supplements. With an extensive background in nutrition science, Schneeman will oversee development of policy and regulations for dietary supplements, nutrition labeling, food standards, infant formula, and medical foods. http://www.fda.gov/bbs/topics/news/2004/NEW01051.html Ronan Appointed Head of FDA's Office of Legislation Patrick Ronan has been appointed FDA assistant commissioner for legislation. Formerly a senior congressional staffer, Ronan will oversee the FDA office that answers queries from Congress, drafts testimony, and helps develop public health legislation. http://www.fda.gov/bbs/topics/news/2004/NEW01054.html _____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Autumn Trails Delite trail mix (undeclared peanuts, milk, and food colors) http://www.fda.gov/oc/po/firmrecalls/graysquirrel04_04.html Zander's Creamery butter and butterine products (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/zanders04_04.html _____________________________________________________________ PUBLIC MEETINGS April 22 -- FDA Science Board will meet to discuss the recent report of the FDA Obesity Working Group and the recently released "Critical Path" white paper about medical product development. (Rockville, Md.) http://www.fda.gov/oc/advisory/accalendar/2004/fda12603d042204.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 April 26. 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
