FDA News Digest
August 29,
2005
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IN THIS WEEK'S ISSUE
-- FDA Seeks Public Comment on 'Plan B'
-- New Web Page Provides Links to All of FDA's RSS Feeds
-- Tollefson Appointed FDA Assistant Science Commissioner
-- Recalls/Safety Alerts
-- Public Meetings
-- Question of the
Week
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FDA Seeks Public Comment on 'Plan B'
In a statement delivered Aug. 26, FDA Commissioner Lester M. Crawford, D.V.M., announced FDA's response to an application by Barr Labs to allow "Plan B" emergency contraception to be sold over the counter. Before deciding on the application, the agency will solicit public comment to help it resolve the unique regulatory and policy issues related to the application.
http://www.fda.gov/bbs/topics/news/2005/NEW01223.html
New Web Page Provides Links to All of FDA's RSS Feeds
FDA has created a Web
page with links to all of the
agency's RSS feeds. Included are feeds for press releases, recalls, food news
and medical device news. RSS -- or
Really Simple Syndication -- is a burgeoning format that allows easy
distribution of news and other Web content. Users can access the material
through a news reader or "aggregator," which downloads and displays the
feeds.
Tollefson Appointed FDA Assistant Science Commissioner
FDA has named Linda R. Tollefson, D.V.M., as its assistant commissioner for science. A rear admiral in the U.S. Public Health Service's Commissioned Corps, Tollefson has been with FDA 21 years. Most recently, she served as deputy director of FDA's Center for Veterinary Medicine. In her new position, she will coordinate FDA Commissioned Corps affairs and direct the agency's Offices of Women's Health and Orphan Products Development.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01221.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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RECALLS/SAFETY ALERTS
Majestic International Spice Corp.'s Extra Fancy Basil
Reason for recall: Salmonella contamination
http://www.fda.gov/bbs/topics/answers/2005/ans01365.html
HyTop Blueberry Muffin Mix; 7-oz. size
Reason for recall: undeclared whey and eggs
http://www.fda.gov/oc/po/firmrecalls/morrison08_05.html
Medline Industries' Personal Hygiene Admission kits containing Medline alcohol-free mouthwash
Reason for recall: Burkholderia cepacia contamination in the mouthwash
http://www.fda.gov/oc/po/firmrecalls/medline08_05.html
Certain lots of Allison's Gourmet Kitchens' BBQ Beans; 1-, 3-, and 5-lb. sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/allison08_05.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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Under discussion: pending application for rheumatoid arthritis treatment
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12532d090605.html
Sept. 8-9 -- Endocrinologic and Metabolic Drugs Advisory Committee
Under discussion: pending application for diabetes treatment
Location: Silver Spring, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12536dd09080905.html
Sept. 13 -- FDA "Vision 2006" meeting; this is the first in a series of three public meetings aimed at informing consumers about agency programs and getting feedback. Discussion topics will include drug safety, direct-to-consumer advertising, dietary supplements, FDA's "Critical Path" initiative, and the advisory committee process.
Location: Miami, Fla.
http://www.fda.gov/oc/initiatives/vision2006.html
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
Are dietary supplements approved by FDA?
Under the Dietary Supplement and Health Education Act (DSHEA) of 1994, manufacturers of dietary supplements are responsible for making sure their products are safe before they go to market. They are also responsible for determining that the claims on their labels are accurate and truthful. Dietary supplement products are not reviewed by the government before they are marketed, but FDA has the responsibility to take action against any unsafe dietary supplement product that reaches the market. If FDA can prove that claims on marketed dietary supplement products are false and misleading, the agency may take action also against products with such claims.
You may find some
useful information on FDA's dietary supplement Web site, "Tips for the
Savvy Supplement User: Making Informed Decisions and Evaluating Information" at
http://www.cfsan.fda.gov/~dms/ds-savvy.html. Tips related to
basic points consumers should consider, questions to ask health professionals,
suggestions for searching the Web or evaluating research, and ways
to check common assumptions are
available.
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