AHPA Files Further Comments with FDA on NDI Process

(Silver Spring, MD, September 23, 2005) -- 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) submitted additional comments to the Food and Drug Administration (FDA) on how FDA ought to 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 describes 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 new dietary ingredients 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.

The NDI notification process, mandated by the Dietary Supplement Health and Education Act of 1994, requires that information that shows a new ingredient will reasonably be expected to be safe be submitted to FDA at least 75 days before the product is marketed. FDA solicited input on the NDI program and AHPA submitted comments in February (see the AHPA Press Releases of February 24, 2005, at http://www.ahpa.org/pr_050224.htm, and of February 1, 2005 at http://www.ahpa.org/pr_050201.htm).
The comments AHPA filed today are online at http://www.ahpa.org/05_0923_ahpa_ndi_addendum2.pdf


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA's mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org

Karen Robin, Director of Communications
Telephone: (301) 588-1171, x-107
Email: [email protected]
Website: www.ahpa.org

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