1 in 4 NDI notifications get no objection

1 in 4 NDI notifications get no objection

AHPA NDI Database shows 10 of 40 recent NDI notifications acknowledged by FDA without objection, demonstrating that companies are effectively navigating the NDI system.

The American Herbal Products Association (AHPA) recently received partial information on 40 new dietary ingredient (NDI) notifications submitted to the Food and Drug Administration (FDA) between November 2012 and February 2014. Ten of these notifications were acknowledged by FDA without objection.

The recently received data have been analyzed and entered into AHPA's NDI Database, which now contains 710 NDI notifications and summaries of FDA's responses when available. The database enables users to search notifications by company and ingredient, including common or Latin names for botanicals. An "Outcome Statement" is also provided to help users quickly understand FDA responses, including any issues that resulted in FDA objections.

Companies that want to use a dietary ingredient not marketed in the U.S. before Oct. 15, 1994, are required to submit an NDI notification explaining why the ingredient is reasonably expected to be safe. This notification must be submitted at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce.

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: (1) letter of acknowledgement without objection; (2) letter listing deficiencies that make the notification incomplete; (3) objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; and (4) 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 fact that one in four NDI notifications were acknowledged by FDA without objection demonstrates that companies are effectively navigating the NDI system in order to meet consumer demand for innovative and safe dietary supplement ingredients," said AHPA Chief Information Analyst Merle Zimmermann, Ph.D., who manages the NDI Database. "AHPA's NDI Database helps companies effectively navigate the NDI notification process and avoid common pitfalls that can result in FDA objections."

Additional information about the NDI Database and other NDI-related resources is available online.



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