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FDA Expected to Release NDI Guidance for Dietary Supplement Industry

Monday, July 25, 2016

FDA is expected to issue a revised draft document governing new dietary ingredient (NDI) notifications to the agency.

Industry sources described release of the document as “imminent" and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).

While FDA had no comment on the timing of the new guidance, an agency spokesperson reiterated a previous statement that issuing a revised draft “remains a priority for the FDA."

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Source: Natural Products Insider