FDA News Digest

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest

FDA News Digest

April 14, 2008

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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

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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.]

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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.]

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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

 

 

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Our next issue will be sent April 21.

 

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