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AHPA Files Further Comments on NDIs

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By: Sean Moloughney

Editor, Nutraceuticals World

Making a distinction between new dietary ingredients (NDIs) that are unprocessed and those in the form of “semi-purified” extracts, the American Herbal Products Association (AHPA), Silver Spring, MD, submitted additional comments in late September to FDA on how it should further address NDIs. AHPA expressed its position that, in the case of an unprocessed herb or botanical, a single complete NDI notification is sufficient, “and that there should be no requirement for any other distributor of exactly the same botanical…to submit a separate notification.” By “unprocessed,” AHPA described botanical ingredients that have had only minimal post-harvest processing, limited to cleaning, dehydration and size reduction (i.e., mill­ing). However, semi-purified extracts of botanicals that are NDIs are produced by using unique proprietary processes and may result in significantly different end products even if made from the same herbal ingredient. “The information that serves as a basis for a conclusion that data and information establishing that one semi-purified extract of a new herb will reasonably be expected to be safe may not be relevant to another,” said AHPA’s president Michael McGuffin. “Each manufacturer of such extracts should submit an NDI notification with the requisite safety information.” Semi-purified extracts result in a narrow spectrum of highly concentrated constituents, often from the use of such modern technologies as selective solvents or preparative chromatography.

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