The current new dietary ingredient (NDI) draft guidance will be finalized before the end of the year with no modifications, accord to Brian Frisby, general manager, KGK Compliance Advisors, who said he has sources inside FDA. In this podcast, Frisby discusses the NDI enforcement and notification best practices with Sandy Almendarez, editor in chief, INSIDER. They cover:
- Why ingredient suppliers and finished product brands should create master substantiation files for each of their products and how those help with NDIN notifications (NDINs).
- What is needed to prove history of use prior to October 1994, which would allow a brand not to submit an NDIN.
- How ingredient suppliers establish an expectation of safety in their NDINs so FDA won’t object to the notification.
This podcast was recorded in Santa Fe, New Mexico, as part of the annual United Natural Products Alliance (UNPA) member retreat.
- Hear Almendarez’s wrap up of the event in the Healthy INSIDER Podcast 74: Supplement Ruminations in Santa Fe. H
- Hear a podcast with UNPA member retreat speaker Peter Reinecke, principal, Reinecke Strategy Solutions in the Healthy INSIDER Podcast 80: Expectations in the New U.S. Political Climate.
- And hear a podcast with UNPA member retreat Speaker Jim Thomas, program manager, Etc. Group in the Healthy INSIDER Podcast 81: Synthetic DNA Labeled as ‘Natural’