AHPA NDI Database Shows Increase of Recent Notifications Filed Successfully
Eight of the 21 new dietary ingredient (NDI) notifications released by the U.S. Food and Drug Administration (FDA) between January 1, 2018 and May 31, 2018 were filed by the agency without substantive comment. The vast majority of these (17) complied with all submission regulations (21 CFR 190.6).
The recently received data have been analyzed and entered into AHPA’s (American Herbal Products Association) NDI Database, which now contains information on more than 950 individual NDI notifications and includes written summaries of FDA’s responses (when available), as well as information on the dates of notification and type of response made by the agency in each case.
“This recent data show a significant increase in the percentage of compliant notifications compared to the numbers seen during the corresponding period in 2017,” said Merle Zimmermann, PhD, AHPA’s chief information analyst. “These NDI notifications suggest that the supplement industry and FDA are effectively working together to accomplish the shared goal of bringing new, safe and effective products to the market.”
NDI notifications must be submitted at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce and meet certain requirements for the submission to be reviewed by FDA.
FDA does not “approve” or “disapprove” NDI notifications. Instead, the agency generally provides one of several types of responses. According to FDA, examples of these responses include, but are not limited to:
- A letter of acknowledgement without objection
- A letter listing deficiencies that make the notification incomplete
- An objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety
- A letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI is not a dietary ingredient as defined by regulation or the product is excluded from the definition of “dietary supplement” under current regulations because it is not intended for ingestion).
The AHPA NDI Database provides a reliable, fast way to browse and search current notifications, with “Outcome Statements” also provided to help users quickly understand FDA responses, including issues that resulted in FDA objections, and related notifications are indexed as they are identified. The AHPA NDI database can be browsed by report number as well searched freely by company and ingredient, including common or Latin names for botanicals.
For more information, visit http://ahpa.org/Resources/NDIDatabase.aspx.
