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AHPA Files Additional Comments on NDIs

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By: Sean Moloughney

Editor, Nutraceuticals World

To clear up confusion surrounding exactly who should submit pre-market notification materials for new dietary ingredients (NDIs), The American Herbal Products Association (AHPA), Silver Spring, MD, filed additional comments to FDA toward the end of February. According to AHPA, 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 Mr. McGuffin. “I sincerely hope that the agency’s continuing call for ‘dialogue’ provides an opportunity to correct this kind of inaccurate guidance.”

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