(Silver Spring, MD) February 24, 2005 -- To address confusion about who, exactly, must submit pre-market notifications for new dietary ingredients (NDIs), the American Herbal Products Association (AHPA) submitted additional comments today to the Food and Drug Administration (FDA).
The issue of greatest concern is whether each company that sells a dietary supplement that contains an NDI must file a separate 75-day notice if the manufacturer of that same new ingredient has already successfully completed a notification.
“The existing regulations are clear that the notification for an NDI must be related to the use of the ingredient in a dietary supplement at a specified dosage level and for a clearly stated intended use,” said AHPA President Michael McGuffin, “If the NDI manufacturer provides information that shows that the ingredient is reasonably expected to be safe over a range of doses and uses, the marketer of a dietary supplement that conforms to those dose and use parameters should not be required to file a redundant submission.”
AHPA’s comments included a review of a portion of the FDA website that discusses the NDI requirements. AHPA’s comments identified as “erroneous” the Agency’s implication that notifications must be submitted by the manufacturer and the distributor of the NDI, as well as each manufacturer and distributor of dietary supplements that contain the NDI.
“Where DSHEA used the word ‘or’, FDA substituted the word ‘and’,” added McGuffin. “I sincerely hope that the Agency’s continuing call for ‘dialogue’ provides an opportunity to correct this kind of inaccurate guidance.”
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 recently solicited input on the NDI program and AHPA submitted its main comments earlier this month (see the AHPA Press Release of February 1, 2005, at http://www.ahpa.org/pr_050201.htm).
The additional comments AHPA filed today are posted online at http://www.ahpa.org/05_0224_ahpa_ndi_addendum.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