FDA News Digest January 12, 2004 ______________________________________________________________ FDA Provides 'Pathway' for Those Seeking to Market Breast Implants FDA has issued new guidance to help define the agency's recommendations for breast implant marketing applications. The guidance reflects information received over the last 10 years related to assessing the safety and effectiveness of these devices. This includes mechanical testing, modes and causes of ruptures, clinical study information, postapproval requirements, and labeling. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01003.html ______________________________________________________________ Flour, Corn Seized from Pest-Infested Mill in Virginia At FDA's request, U.S. marshals have seized goods from Reed Creek Milling in Wytheville, Va., after the agency found that the mill failed to provide adequate protection against pest contamination in flour and corn processed at the facility. FDA inspectors found many indications that insects and animals may have come in contact with the mill's products. FDA is seeking a court order to seize all other food stored at the mill. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01276.html ______________________________________________________________ California Man Indicted for Selling Counterfeit Viagra A grand jury has indicted a man in California on charges of trafficking in counterfeit Viagra tablets manufactured in China. The three-count indictment alleges that the man conspired with a Beijing supplier to import at least 40,000 fake Viagra tablets into the United States. The charges carry a maximum possible penalty of 18 years in prison and a fine of more than $2 million. http://www.fda.gov/bbs/topics/NEWS/2004/doj0109.html ______________________________________________________________ FDA, Consumer Group Launch Bilingual Edition of OTC Drug Brochure FDA and the Consumer Healthcare Products Association have published a new edition of "Over-the-Counter Medicines: What's Right for You," for the first time in Spanish as well as English. The popular brochure, long available in English, stresses the importance of treating OTC medicines with respect. It includes information on reading OTC medicine labels, avoiding drug interactions, using OTC drugs while pregnant or nursing, and other helpful tips. The sponsors plan to market the information to the nation's Hispanic population. http://www.chpa-info.org/pdfs/04-1_Whats_Right_English_Spanish.pdf ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Haram-Christensen Oebel Rum Stollen (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/stollen01_04.html Agro Sun Brand Sundried Tomatoes (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/agro12_03.html Coosemans DC Sun Dried Yellow Tomatoes; 12 oz. (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/coosemans12_03.html Yilin Dried Bamboo Shoots; 12.3 oz. (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/jvtrading12_03.html _____________________________________________________________ PUBLIC MEETINGS 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 January 19. 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
