U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 6 Mar 2008 05:47:49 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: March 6, 2008

The following new items were added to the CDRH web pages on March 5, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	510(k) Final Decisions - February 2008
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 6 Mar 2008 11:05:32 -0600 (CST)
Subject: FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs

FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
Thu, 6 Mar 2008 09:49:00 -0600

The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 6 Mar 2008 14:26:06 -0600 (CST)
Subject: FDA MedWatch - Unapproved Over The Counter Drugs Marketed For The Prevention and Treatment of STDs

FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The products pose a serious health threat to unsuspecting consumers who don't know that these products are not FDA approved and have not been proven safe or effective. Consumers who are currently using these products should stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products.

Read the complete 2008 MedWatch Safety Summary, including a link to FDA's News Release regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#STDs

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