FDA News Digest for April 7, 2008

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

Title: FDA News Digest for April 7, 2008

FDA News Digest

April 7, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

    -- Federal Agents Seize More Than $1.3 Million of Illegal Dietary Supplements

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

FDA has approved Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid given in a two-dose series to infants from 6 to 24 weeks of age. Rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year. About 55,000 to 70,000 of those require hospitalization, and between 20 and 60 deaths are attributed to it.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01814.html 

 

Federal Agents Seize More Than $1.3 Million of Illegal Dietary Supplements

At FDA's request, U.S. marshals have seized more than $1.3 million of dietary supplements from Michigan-based LG Sciences, LLC. These products -- marketed and distributed online and in retail stores under the names "Methyl 1-D," "Methyl 1-D XL," and "Formadrol Extreme XL" --contain unapproved food additives or ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01815.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

Food Recalls:

 

›  Harry and David Chocolate Covered Select Blend Espresso Beans, 8-oz. size

Reason for recall: milk component not declared on package

http://www.fda.gov/oc/po/firmrecalls/harrydavid04_08.html

 

›  HC Fresh Frozen Salted Croaker (distributed in New York, New Jersey, Pennsylvania, Illinois and Texas)

Reason for recall: possible Clostridium botulinum contamination

http://www.fda.gov/oc/po/firmrecalls/grandsupercenter04_08.html

 

›  Unsweetened Puffed Rice and unsweetened Puffed Wheat, marketed under the Malt-O-Meal brand and other private labels, with "Best If Used By" dates between April 8, 2008 (coded as "APR0808"), and March 18, 2009 (coded as "MAR1809")

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/maltomeal04_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 10-11 -- Cellular, Tissue and Gene Therapies Advisory Committee

    Under discussion: safety testing for cellular therapy products derived from human embryonic stem cells

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24629.htm

 

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

   

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:

 

› Problems Digesting Dairy Products?

http://www.fda.gov/consumer/updates/lactose032508.html  

› Food Label Helps Consumers Make Healthier Choices

http://www.fda.gov/consumer/updates/foodlabels032708.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 14.

 

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