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The current new dietary ingredient (NDI) draft guidance will be finalized before the end of the year with no modifications, according to Brian Frisby, general manager, KGK Compliance Advisors, who said he has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.
The current new dietary ingredient (NDI) draft guidance will be finalized before the end of the year with no modifications, accord to Brian Frisby, general manager, KGK Compliance Advisors, who said he has sources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’
VP of Content, Informa
• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.
• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.
• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.
Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.
In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!
Arizona State University
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