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FDA Extends Comment Period on Draft Dietary Supplement Guidance

The Food and Drug Administration is extending the comment period on its draft guidance for industry on dietary supplement ingredient notifications and related issues which was issued on July 3, 2011. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications. It is a requirement of the Food Safety Modernization Act.

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Comments are now due by December 2, 2011 (from October 3).

(See ITT's Online Archives or 07/01/11 and 07/06/11 news, 11070137 and 11070612, for initial and detailed BP summaries of the draft guidance.)