=========================================================================
Date:         Thu, 14 Sep 2006 14:47:14 EDT
Reply-To:     FDA-DSFL@VM.CFSAN.FDA.GOV
Sender:       FDA-DSFL Electronic Newsletter <FDA-DSFL@VM.CFSAN.FDA.GOV>
From:         Dietary Supplement/Food Labeling Electronic Newsletter
              <DSFL@VM.CFSAN.FDA.GOV>
Organization: Food and Drug Administration
Subject:      FDA-DSFL Newsletter September 2006 (#11)
 
   * *   Dietary Supplement/Food Labeling Electronic Newsletter  * * *
   * * * *             FDA-DSFL@vm.cfsan.fda.gov               * * * *
 
WHAT IS "FDA-DSFL"?
 
FDA-DSFL is an electronic newsletter from the Food and Drug Administration's
Office of Nutritional Products, Labeling, and Dietary Supplements
(ONPLDS), in the Center for Food Safety and Applied Nutrition (CFSAN).
Its purpose is to give interested parties access to key information and
updates on dietary supplements, food labeling and nutrition issues.
 
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September 2006 (#11)
 
IN THIS ISSUE:
 
The Tenth Circuit Court of Appeals Upholds FDA's Decision Banning Dietary
Supplements Containing Ephedrine Alkaloids
 
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DIETARY SUPPLEMENTS
 
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The Tenth Circuit Court of Appeals Upholds FDA's Decision Banning Dietary
Supplements Containing Ephedrine Alkaloids
 
On August 17, 2006, the United States Court of Appeals for the Tenth Circuit in
Denver, Colorado upheld the Food and Drug Administration's (FDA) final rule
declaring all dietary supplements containing ephedrine alkaloids adulterated,
and therefore illegal for marketing in the United States, reversing a decision
by the District Court of Utah.
 
The Tenth Circuit Court of Appeals' ruling demonstrates the soundness of FDA's
decision to ban dietary supplements containing ephedrine alkaloids, consistent
with the Dietary Supplement Health and Education Act (DSHEA) of 1994.  The Tenth
Circuit Court of Appeals also found that Congress clearly required FDA to
conduct a risk-benefit analysis under DSHEA.
 
The FDA conducted an exhaustive and highly resource-intensive evaluation of the
relevant scientific data on ephedrine alkaloids before issuing its final rule,
which became effective in 2004.  The court found that the 133,000-page
administrative record compiled by the FDA supports the agency's findings that
dietary supplements containing ephedrine alkaloids pose an unreasonable risk of
illness or injury to users, especially those suffering from heart disease and
high blood pressure.
 
No dosage of dietary supplements containing ephedrine alkaloids is safe and the
sale of these products in the United States is illegal and subject to FDA
enforcement action.
 
 
 
NOTE:
 
*  TO GET PAST ISSUES OF FDA-DSFL, go to Electronic Information Networks:
http://www.cfsan.fda.gov/~dms/infonet.html.
 
 
********************************
 
FDA Web Page Addresses:
 
*  Dietary Supplements  http://www.cfsan.fda.gov/~dms/supplmnt.html
*  Food Labeling and Nutrition  http://www.cfsan.fda.gov/label.html
*  Infant Formula http://www.cfsan.fda.gov/~dms/inf-toc.html
*  Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html
*  Center for Food Safety and Applied Nutrition
   http://www.cfsan.fda.gov/list.html
 
Other Federal Government Links:
 
*  Federal Trade Commission http://www.ftc.gov/
*  Office of Dietary Supplements, NIH
   http://dietary-supplements.info.nih.gov/
*  US Department of Agriculture
 - Food Safety and Inspection Service http://www.fsis.usda.gov/index.htm
 - Food and Nutrition Service http://www.fns.usda.gov/fns/
 
Non-Federal Government Links:
 
*  National Academy of Sciences
   http://www.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports
 
 
Please forward this issue to colleagues and friends and tell them how to
subscribe. Thank you for sharing this update.
 
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Your Listowners:
   Amy Odegaard  <Amy.Odegaard@fda.hhs.gov>
   Kathy Smith   <Kathleen.Smith1@fda.hhs.gov> for content information
 
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