FDA News Digest - April 14, 2008

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FDA News Digest April 14, 2008 ___ IN THIS WEEK'S ISSUE » News -- More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized » Safety Alerts/Recalls » Upcoming Public Meetings » Consumer Health Information ________ NEWS More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized At FDA's request, U.S. marshals have seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, or to provide sexual enhancement, which caused them to be drugs under federal law. The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that consumers already may be taking. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01817.html To view an archive of recent FDA news releases, go to http://www.fda.gov/opacom/hpnews.html. To access the RSS feed of FDA news releases, go to http://www.fda.gov/bbs/topics/news/rssPress.xml. [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.] ___________ SAFETY ALERTS/RECALLS Safety Alert: › FDA has announced that at least 23 people in 14 states have been diagnosed with salmonellosis caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal. The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private-label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809"). Consumers should throw out any product in their homes from these recalled lots. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01819.html Food Recall: › Cracker Barrel Chocolate-Covered Almonds and Chocolate Double-Dipped Peanuts; 5-oz. bags Reason for recall: packaging is mislabeled http://www.fda.gov/oc/po/firmrecalls/crackerbarrel04_08.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html. To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.] __________________ UPCOMING PUBLIC MEETINGS April 16 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Under discussion: opportunities for enhancing global pediatric oncology drug development Location: Rockville, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-3676.htm April 24-25 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee Under discussion: pending application to market an implantable miniature telescope Location: Gaithersburg, Md. http://edocket.access.gpo.gov/2008/E8-5810.htm April 29-30 -- Public Workshop on Safety of Hemoglobin-Based Oxygen Carriers Location: Bethesda, Md. http://www.fda.gov/cber/meetings/hboc042908.htm For a complete list of meetings, seminars, and other public events sponsored or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html. CONSUMER HEALTH INFORMATION Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week: › Use Caution with Over-the-Counter Creams, Ointments http://www.fda.gov/consumer/updates/otc_creams040108.html › Warning About “Total Body” Liquid Supplements http://www.fda.gov/consumer/updates/totalbody040108.html To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420