The American Herbal Products Association (AHPA), Silver Spring, MD, has updated the AHPA NDI Database with 43 additional notifications submitted to the Food and Drug Administration (FDA) by marketers of new dietary ingredients (NDIs). AHPA regularly obtains NDI notifications from FDA's Division of Dockets Management's to populate the database, which now catalogues 670 notifications and FDA responses, including the most recently released records, dated through February 2013.
According to AHPA its latest NDI Database entries provide more evidence that companies would benefit from additional FDA guidance on what information should be provided to ensure FDA can properly identify NDIs. In response to roughly 40% of the latest notifications, FDA stated that it was “unable to establish the identity” of the NDI. AHPA and other supplement associations have asked FDA to issue revised NDI notification guidance, with a specific focus on what information is needed to identify the NDI. A review of the nearly 700 entries now in the AHPA NDI Database also reveals that many companies make costly but preventable errors when submitting NDI notifications to the FDA.
In response to roughly 15% of the latest notifications, FDA noted that the submitting firm did not comply with certain technical regulatory requirements. These companies frequently failed basic requirements like providing the Latin binomial and authority for botanicals, including references, or submitting English translations for documents published in another language.
“Companies often make the same, avoidable errors when submitting NDI notifications,” said AHPA information analyst Merle Zimmerman, Ph.D., the database manager. "The AHPA NDI database is the only comprehensive and up-to-date NDI resource that catalogues notifications and FDA responses to help companies avoid common pitfalls that can delay FDA review of a notification, or lead to a company's decision to refile an NDI notification."
Companies that use an NDI (a dietary ingredient not marketed in the U.S. prior to Oct. 15, 1994) must notify FDA about the safety of dietary supplements containing the NDI 75 days before marketing such products. AHPA regularly obtains NDI notifications and summarizes FDA responses to update the AHPA NDI Database.
“Given the significant resources companies invest on NDI notifications, companies should consider reviewing previous entries to learn from others' successes and mistakes,” Dr. Zimmerman said.
AHPA Updates its NDI Database
Published September 5, 2013