Printer Friendly

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.
COPYRIGHT 2004 Rodman Publications, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:Industry News
Publication:Nutraceuticals World
Article Type:Brief Article
Geographic Code:9JAPA
Date:Apr 1, 2004
Previous Article:L-carnitine L-tartrate approved for foodstuffs for particular nutritional uses.
Next Article:Fuji forms U.S. subsidiary.

Related Articles
Fraud or find: a shopper's guide to food & supplement claims.
CHPA, CRN ask FDA for equal treatment of claims on foods & supplements with nutritive value; CRN urges FDA to reconsider qualified health claim...
Health claim grading system unveiled by FDA.
The new qualified health claims process; examining FDA's new qualified health claim rating system.
Vitamins & minerals; these two categories represent the foundation of the nutraceuticals industry and they are only getting stronger, however with...
Minerals in Japan: a perspective; Calcium and iron are the priority minerals in Japan.
Dairy-based nutraceuticals: a Japanese perspective; Japan is a country ripe with opportunity when it comes to dairy.
How solid is your substantiation? FDA has released a new guidance that reflects its current thinking on how it reviews evidence for health claims.
Does the evidence support the claim? As FDA ramps up enforcement in food and dietary supplements, companies need to know what claims can be made for...

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters