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FDA to consider more extensive calcium claims.

Marine Bio, Okinawa, Japan, has been informed that the petitions it filed in October 2003 to allow more extensive health claims to be made for calcium, have been accepted for evaluation by the FDA. Once the 60-day discussion period has been completed and evaluations have been made, Marine Bio would expect a decision from the FDA around October this year.

Marine Bio filed five petitions on October 13, 2002, with FDA's Office of Nutritional Products, Labeling and Dietary Supplements to allow the following health claims to be made for calcium:

* May reduce risk of fractures of certain areas of the body

* May reduce risk of certain cancers

* May reduce risk of kidney and urinary stones

* May reduce risk of certain types of hypertension, including pre-eclampsia

* May reduce risk of certain gynecological disorders in women.

The petitions represent logical and valid evaluations of the scientific studies and clinical trials concerning the relationship between calcium and reduction in the risk of the above conditions. In each case, Marine Bio has petitioned the FDA to consider the scientific studies that establish the science supporting these claims and thereby justify permitting health claims that link consumption of calcium with reduction in those risks.
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Title Annotation:Industry News
Publication:Nutraceuticals World
Article Type:Brief Article
Geographic Code:9JAPA
Date:Apr 1, 2004
Words:199
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