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July/August 2014 Issue
Last Updated Wednesday, July 23 2014
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Congress Urges FDA to Act on Draft NDI Guidance



Published July 9, 2013
Related Searches: Regulation Dietary Supplement Quality & Safety Regulations
Representatives Frank Pallone (D-NJ) and Brett Guthrie (R-KY) sent a letter to the Food and Drug Administration as a reminder that congress is still focused on the draft NDI notification guidance. Key members of congress on the Energy and Commerce Committee and the Dietary Supplement Caucus signed the bipartisan letter, addressed to Margaret Hamburg, M.D., commissioner for FDA.
 
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 over 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 letters 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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