FDA News Digest March 24, 2003 ________________________________________________________________ FDA, Arkansas Warn Company That Obtained Unapproved Canadian Drugs FDA has sent a warning letter to Rx Depot Inc., notifying the company that its "storefront" operation, which causes prescription drugs to be shipped from Canada into the United States, is illegal and a risk to public health. The agency is especially concerned because Rx Depot has made misleading assurances to consumers about the safety of the drugs. FDA is acting in cooperation with the Arkansas State Board of Pharmacy. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00882.html ________________________________________________________________ FDA's 'Liberty Shield' Guidance Aimed at Protecting Food Supply FDA has issued four guidance documents designed to help manufacturers minimize the risk of tampering or other criminal or terrorist actions related to the nation's food supply. The agency also has announced increased surveillance of domestic and imported foods, as well as enhanced collaboration with other government agencies. The efforts are part of "Operation Liberty Shield," a national plan to increase protections for U.S. citizens and the country's infrastructure, while maintaining the free flow of goods and people across the nation's borders. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00881.html ________________________________________________________________ HHS Inspector General Asked to Investigate FDA-Sponsored Clinical Trial FDA has asked the inspector general of the Department of Health and Human Services to investigate significant concerns about a clinical trial FDA sponsored. The trial, which was examining bone mass in U.S. Naval Academy midshipmen, had apparent lapses which could result in divulging personal medical information to persons not associated with the study. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00883.html ________________________________________________________________ Final Phase of Consolidating Certain Biologic and Drug Reviews Concluded FDA has completed the last phase of its consolidation of certain biological product reviews into the agency's Center for Drug Evaluation and Research, a move begun last year to produce a more efficient, effective and consistent review system for human drugs and biologics. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00880.html ______________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: Ancom Anti-Hypertensive Compound Tablets (unapproved drug) -- http://www.fda.gov/oc/po/firmrecalls/taichien03_03.html Topps Vitality Fat Free Chocolate Milk (excess vitamins A and D) -- http://www.fda.gov/bbs/topics/NEWS/2003/NEW00884.html Harmony Farms Fresh Alfalfa Sprouts, Gourmet Salad Sprouts, and Fresh Alfalfa & Oregon Onion Sprouts (possible Salmonella contamination) -- http://www.fda.gov/oc/po/firmrecalls/harmony03_03.html J&D Fine Foods Fancy Candy Platter (undeclared peanuts) -- http://www.fda.gov/oc/po/firmrecalls/j&dfinefood03_03.html Food Club Brand Tartar Sauce (undeclared eggs) -- http://www.fda.gov/oc/po/firmrecalls/carriagehouse03_03.html Market Basket Brand Brownie Fudge Ice Cream (undeclared eggs) -- http://www.fda.gov/oc/po/firmrecalls/hood03_03.html Peregrina Brand Queso Fresco Fresh Cheese (possible Listeria monocytogenes contamination) -- http://www.fda.gov/oc/po/firmrecalls/peregrina03_03.html Master Chao Brand Sweetened Winter Melon Candy (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/ho03_03.html ________________________________________________________________ PUBLIC MEETINGS FDA Science Forum to Discuss Risk Assessment, Cancer, Public Health The 9th Annual FDA Science Forum will be held in Washington, D.C., April 24-25. Open to the public, the forum brings FDA scientists together with industry, academia, consumers, and others to share information about the science-based mission of the agency. Discussion topics for this year's forum include risk assessment, cancer treatments, and public health initiatives in the wake of 9/11/01. Forum information: http://www.dcscienceforum.org FDA Consumer article about Forum: http://www.fda.gov/fdac/features/2003/203_science.html Summaries of 2002 Forum sessions: http://www.fda.gov/oc/meetings/2002sciforum.html April Workshop to Discuss Risk Management for Drugs, Biologics FDA will sponsor a public workshop April 9-11 in Washington, D.C., to present the agency's current thoughts on risk management for drug and biologic products (excluding blood products other than plasma derivatives) and to solicit public opinions on the subject. http://www.fda.gov/cder/meeting/riskManagement.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ________________________________________________________________ How's your knowledge of health-related topics such as menopause, smallpox, and asthma? Find out by taking our 9-question quiz at http://www.fda.gov/fdac/quiz/onlinequiz10_js.html. ________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be March 31. 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
