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Alliance for Natural Health On December 6, 2011
http://www.anh-usa.org/fda-violates-federal-law/
Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!
The period for comments to the FDA on the draft guidance on NDI notifications closed on December 2. Along with the hundreds of thousands of messages you sent and the 20,000 phone calls you made to FDA and Congress, ANH-USA also submitted formal comments [1].
The problem with the FDA’s draft guidance on New Dietary Ingredients is that it allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years [2]. If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by prison. With your favorite supplements off the market, it also would allow the drug industry to adapt and patent them [3], and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now.
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