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"New Dietary Ingredients"
FDA released on July 5th the highly anticipated Draft Guidance on New Dietary Ingredients (NDIs). The guidance document was intended to assist companies in determining when a 75-day premarket notification is required for dietary ingredients not “grandfathered” under the DSHEA. We previously announced the publication of this guidance
FDA’s interpretation of 21 U.S.C. § 350b limits “grandfathered” dietary ingredients to those marketed in the United States before October 1994. The FDA has focused 21 U.S.C. 350b(c) narrowly, concluding that the statutory language does not extend to include components or articles of food that were not specifically marketed. For example, in 2009, the FDA [...]
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ANH Comment: FDA NDI Guidance Imposes Substantial Economic Burdens
On Tuesday, August 2, 2011, Emord & Associates filed comments with the FDA and Office of Management and Budget (OMB) concerning the FDA’s proposed collection of information through 75-day New Dietary Ingredient notifications. We previously reported on the FDA’s proposed New Dietary Ingredient (NDI) guidance here and here.
Federal agencies frequently collect information [...]