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House Urges FDA to Act on Draft NDI Guidance

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By: Sean Moloughney

Editor, Nutraceuticals World

Representatives Frank Pallone (D-NJ) and Brett Guthrie (R-KY) sent a letter to FDA as a reminder that Congress is still focused on the draft New Dietary Ingredient (NDI) Notification Guidance. Key members of Congress on the Energy and Commerce Committee and the Dietary Supplement Caucus signed the bipartisan letter, addressed to FDA Commissioner Margaret Hamburg, MD.

Representatives Pallone and Guthrie along with their peers stated, “Congress, FDA and the dietary supplement industry all agree that guidance for industry on the New Dietary Ingredient (NDI) notification process is needed.” However, while FDA and the industry have been working on the topic for more than a year since the release of the Draft NDI Guidance in July 2011 and the close of the comment period in December of that year, they remain “concerned about the speed of progress on these discussions” and ask for information as to “when we can expect the agency to release a revised guidance.”

The letter’s authors urge FDA to “continue its efforts to bring clarity to this area of regulation, as it is critical to ensure consumers have access to safe and affordable dietary supplement products.”

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