FDA News Digest for January 29, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

January 29, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Corrects 'Misperceptions' Regarding Newer Contraceptives

    -- Web Pages Give Background on Newly Approved Cosmetic Products

»  Latest FDA Consumer Magazine Available Online

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Corrects 'Misperceptions' Regarding Newer Contraceptives

To correct recent news reports implying that newer generation hormonal contraceptives are less effective than those approved decades ago, FDA has issued a statement saying the newer products are "highly effective in preventing pregnancy." FDA said the news reports prompted "misperceptions" about the effectiveness of current contraceptive products.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01550.html

 

Web Pages Give Background on Newly Approved Cosmetic Products

FDA's Center for Devices and Radiological Health has posted online consumer information for three recently approved cosmetic products:

    *  Radiesse

    Intended use: temporarily adds volume to facial tissue to help smooth moderate-to-severe wrinkles and to treat facial fat loss in HIV patients

    More information: http://www.fda.gov/cdrh/mda/docs/p050052.html and http://www.fda.gov/cdrh/mda/docs/p050037.html

    *  ArteFill

    Intended use: smoothes wrinkles and folds around the mouth

    More information: http://www.fda.gov/cdrh/mda/docs/p020012.html

   * Cosmetic Tissue Augmentation Product

    Intended use: smoothes wrinkles around the nose and mouth

    More information: http://www.fda.gov/cdrh/mda/docs/p050033.html

 

To view an archive of past 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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Latest FDA Consumer Magazine Available Online

 

The latest issue of FDA Consumer includes articles on these topics:

 

»  Cancer drugs -- How FDA decides which ones to allow on the market.

»  Vaccines -- What's recommended for young children, adolescents and adults.

»  Flu shots -- Many people at high-risk of flu infections fail to get their yearly shot.

»  Nutrition label -- FDA introduces new tools to help consumers make healthy food choices.

»  Unapproved drugs -- New agency enforcement policies crack down on these products.

»  Breast implants -- FDA has approved marketing of silicone gel-filled implants.

 

The issue is online at http://www.fda.gov/fdac/107_toc.html.  

 

Subscribe to the print version of FDA Consumer:  http://www.fda.gov/fdac/orderform/fdap.html

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RECALLS/SAFETY ALERTS

Food Recalls:

 

Wegman's Fat Free Garden French Dressing, 16 oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/wegmans01_07.html

 

Various rice, pasta, and sauce products made by Leslie Elizabeth Inc. and sold under brand names such as Doms, Sociale, and Trade Winds

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/lesley01_07.html

 

Elegant Sweets Chocolate Cream Truffles, 3 oz., 4.5 oz., and 8.8 oz. sizes

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/elegant01_07.html

 

Ying Feng Foodstuffs brand melon candy, 12 oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/yingfeng01_07.html

 

El Norteno Brown Corn Cookies (Rosquete De Maiz), 6 oz. size

    Reason for recall: undeclared eggs

http://www.fda.gov/oc/po/firmrecalls/elnorteno01_07.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

Feb. 7-8 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: various aspects of establishing and conducting clinical trials including ethics, informed consent, and FDA's role

    Location: San Diego

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21138.htm

 

Feb. 9 -- Medical Devices 101: An Educational Forum

    Under discussion: FDA's medical device requirements for entrepreneurs, startup companies, and small businesses.

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-92.htm

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

Who performs liposuction and where is it performed?

 

Many liposuction surgeries -- procedures intended to remove fat deposits and shape the body -- are performed by plastic surgeons or dermatologists. Any licensed physician may perform liposuction. While professional societies may recommend training before performing liposuction surgery, no standardized training is required. As a result, there will be differences in experience and training in physicians performing liposuction.

 

You can ask your physician to tell you whether he or she has had specialized training to do liposuction or has successfully done liposuction before. But remember, even the best screened patients under the care of the best trained and experienced physicians may experience complications as a result of liposuction.

 

Liposuction may be performed in a doctor's office, surgical center, or hospital. Because liposuction is a surgical procedure, it is important that it be performed in a clean environment. Emergencies may arise during any surgery and access to emergency medical equipment or a nearby hospital emergency room is important.  

 

For more information on liposuction, see http://www.fda.gov/cdrh/liposuction/.

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