AHPA Comments on FDA’s Premarket Notification Program for NDIs

The American Herbal Products Association (AHPA) filed comments today with the Food and Drug Administration (FDA) to help shape the content and format requirements for new dietary ingredient (NDI) notifications as required by the Dietary Supplement Health and Education Act (DSHEA). The NDI process requires dietary supplement manufacturers and marketers to submit information to FDA to show that a new ingredient will reasonably be expected to be safe.

Since the passage of DSHEA in 1994, FDA has posted online 260 NDI notification reports; some of those NDI notifications were incomplete or for old ingredients that did not need review. In October, 2004, FDA called a public meeting and requested comments on several specific NDI issues outlined in the Federal Register (the document can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.pdf). In that notice FDA stated, “The problems with NDI notifications … suggest that it may be helpful for FDA to consider ways to assist submitters of NDI notifications to ensure that they contain the information the agency needs to evaluate the notification.”

“We welcome the opportunity to dialogue with the agency,” said Michael McGuffin, AHPA’s president, “and we have much to offer FDA to facilitate its gatekeeper role of reviewing safety substantiation prior to NDIs coming to market.”

AHPA’s input includes pragmatic suggestions to winnow out dietary ingredients that are not new, including recognizing AHPA’s Herbs of Commerce, 2nd edition as a source document; suggests that a botanical's Latin binomial, author, and part be identified; and opposes FDA’s contention that the “chemical composition” or “active components” needs to be disclosed. AHPA urged FDA to reject filings for new dietary supplements, foods, and old, or already known, ingredients; and to allow a company to withdraw a notice. AHPA also outlined key factors to define the standard for “reasonably expected to be safe.”

“Bringing new products to market is important in every industry, including this one,” McGuffin said. “We are pleased that FDA is taking steps to implement DSHEA fully, including the NDI safety review process.” McGuffin and AHPA General Counsel Tony Young analyzed NDI reports for an article published last summer in the Food and Drug Law Journal, which FDA cited in its October notice. McGuffin summarized the article and made other comments at the meeting FDA held on this matter in November.

AHPA’s comments are posted on our website http://www.ahpa.org/05_0201_ahpa_ndi_comments.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
American Herbal Products Association
Telephone: (301) 588-1171, x-107
Email: [email protected]
Website: www.ahpa.org

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