FDA News Digest for November 17, 2003

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FDA News Digest
November 17, 2003
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Following Hepatitis A Outbreaks, FDA Urges
Cooking Green Onions, Avoiding Others

FDA is advising consumers that several recent outbreaks of the liver disease
hepatitis A have been linked to raw or undercooked green onions (scallions).
The agency says consumers can minimize the possibility of getting hepatitis
A from green onions by cooking the onions thoroughly and avoiding foods at
restaurants that contain raw or lightly cooked green onions. Hepatitis A
outbreaks linked to green onions have occurred in Tennessee, North Carolina
and Georgia. An outbreak in Pennsylvania is still under investigation.
Press release:  http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01262.html
Questions and answers about the outbreaks:
http://www.fda.gov/opacom/faqs/hepatitisa.html
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FDA Approves First Chewable Contraceptive Tablet for Women

FDA has approved Ovcon 35, a spearmint-flavored contraceptive tablet that
can be swallowed whole or chewed and swallowed. Like other birth control
pills on the market, Ovcon 35, available only in a 28-day regimen, is
effective for pregnancy control when used as directed. Risks of using the
product are similar to other oral contraceptives -- increased risks of blood
clots, heart attacks and stroke.
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01260.html
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FDA, NCI Collaborate to Help Improve Cancer Treatments

FDA and the National Cancer Institute are collaborating on two initiatives
to aid in the development and use of better cancer treatments. The joint
program will link cancer researchers electronically to FDA, reducing time
for promising cancer drugs to be reviewed for clinical trials. It also will
create a corps of doctors and scientists expert in clinical research,
regulatory approval, and translating breakthroughs to clinical practice.
http://www.nci.nih.gov/newscenter/pressreleases/FriendsFDANCI
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N.Y. Company Destroys Dietary Supplements After Making Bogus Claims

FDA has witnessed the destruction of about 90,000 units of Royal Tongan
Limu, a dietary supplement falsely promoted on the Internet to treat cancer,
arthritis, and other diseases. Following an FDA investigation earlier this
year, Dynamic Essentials, the company that distributed the product, ceased
operations and no longer promotes or sells the product online. The destroyed
product was worth about $2.7 million.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00976.html
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FDA Warns U.S. Consumers About Canadian Recall of 'Diskus' Asthma Drugs

FDA is warning U.S. consumers who may have obtained from Canada (online or
through a storefront) any of three types of "Diskus" asthma medicines --
Ventolin, Flovent or Serevent -- that these products are being recalled in
Canada and should not be used.  The agency emphasizes that the FDA-approved
Diskus products Advair and Serevent, sold in the United States through
legitimate sources, are not part of this recall.
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01261.html
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FDA Foods Official to Head Nutrition Project for World Health Organization

Christine Taylor, Ph.D., director of FDA's Office of Nutritional Products,
Labeling, and Dietary Supplements, has been chosen to head a special project
on nutrition issues for the World Health Organization. In the two-year
assignment, which begins in January, she will develop approaches to help WHO
assess food-related health risks by creating nutrition risk-analysis models.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00977.html
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RECALLS

The following products are being recalled for the reasons shown. Go to the
linked page for more information.

Old Fashioned Foods snack cheese spreads and spreadable cream cheese
(possible Listeria monocytogenes contamination)
http://www.fda.gov/oc/po/firmrecalls/mayville11_03.html

West Front Andrew Corp. Sliced/Smoked Nova Salmon (possible Listeria
monocytogenes contamination)
http://www.fda.gov/oc/po/firmrecalls/westfront11_03.html

Seoul Shik Poom Inc. Biscuits (Jong-Hap Cooki) (undeclared eggs)
http://www.fda.gov/oc/po/firmrecalls/seoulshik11_03.html

For an archive of FDA-related recalls and safety alerts from the last 60
days, go to http://www.fda.gov/opacom/7alerts.html
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RECENT SPEECHES

FDA Commissioner Mark B. McClellan, M.D., at the Urban Institute (Nov. 12);
topic: "Protecting and Advancing America's Health Through 21st Century
Patient Safety"
http://www.fda.gov/oc/speeches/2003/urbaninstitute1112.html

For an archive of speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm
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PUBLIC MEETINGS

Nov. 20 -- FDA Workshop: Exploring the Link Between Food Labeling and Weight
Management; Bethesda, Md.
https://secure.z-techcorp.com/cmt/meetings/meeting_detail.cfm?meeting_id=26

For a list of upcoming FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html.
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