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FDA begins dietary supplement initiative

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WASHINGTON, Nov 04, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration Thursday said it was implementing several new initiatives to regulate dietary supplements.

The initiatives are intended to help the supplement industry know what to expect from the agency, as well as to increase consumer assurance about the safety of dietary supplements and the validity of their labeling, FDA Acting Commissioner Dr. Lester Crawford said.

As part of the initiatives, the FDA is beginning a process for detecting safety concerns regarding dietary supplements. This will include collecting data from federal and state authorities, consumer groups, adverse event reports and foreign regulatory actions.

The agency also plans to hold a public meeting Nov. 15, during which it will seek public comment on the type, quantity and quality of evidence manufacturers should provide to obtain a pre-market safety notification for marketing supplement ingredients that were not on the U.S. market before Oct. 15, 1994.

The FDA also has issued a draft guidance document that seeks to define the amount, type and quality of evidence a manufacturer should have to substantiate claims made on labeling about the effects or benefits of supplements.

Copyright 2004 by United Press International.

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