On the U.S. dietary supplement scene, few issues have caused more consternation, exasperation and frustration over the past few decades than the new dietary ingredient notification filing process. From the Food & Drug Administration’s ambiguity about what an NDI submission should convey to the agency’s lack of compliance enforcement to that dog of a draft guidance issued in 2011, there has been plenty for industry to grumble about and, many say, not enough to cheer.
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