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AHPA on NDIs

This article was originally published in The Tan Sheet

Executive Summary

The American Herbal Products Association submitted additional comments Sept. 23 to clarify between new dietary ingredients that are unprocessed botanicals and those in the form of "semi-purified" extracts. The comments supplement AHPA's original filings in February. "The NDI notification...for any NDI that is an unprocessed herb or other botanical...is satisfied by the first complete notification submitted for that NDI," AHPA states in its submission to FDA. "Once this requirement is satisfied there is no rational reason to require that it be satisfied by all subsequent marketers of the exact same unprocessed herb or other botanical." AHPA goes on to make the point that because "semi-purified extracts are unique to a particular manufacturer," manufacturers should be required to submit separate NDI notifications...
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