Alliance for Natural Health-USA Files Public Comment Challenging the FDA’s Guidance
on New Dietary Ingredients (December 2, 2011)
The Alliance for Natural Health-USA (“ANH”) filed public comments with the FDA on
December 2, 2011 calling the FDA’s interpretation of the DSHEA and its New Dietary
Ingredient provisions “outrageous.” FDA accepted public comments in response to
its July 2011 Guidance document concerning the New Dietary Ingredient statute, 21
U.S.C. 350b. Under the FDA guidance, the ANH explained that between 22,240 and 41,700
nutritional supplements would likely be removed from the market, at an economic loss
of between $5.6 billion and $10.5 billion. Moreover, ANH explains that the FDA’s
interpretation of the NDI statute is legally infirm and without authority.