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Healthy INSIDER Podcast: 25 Years After DSHEA & NDI Process Is Broken

Confusion within FDA and industry continues to stymie the new dietary ingredient (NDI) process.

Heather Granato

June 7, 2018

In 1994, Congress passed a landmark law—the Dietary Supplement Health & Education Act (DSHEA)—that included thoughts about how companies could bring new ingredients to market; in the 25 years since, the waters around new dietary ingredients (NDIs) have remained murky. At SupplySide East in New Jersey in April, Heather Granato, vice president of content, spoke with Marc Ullman, partner at Rivkin Radler, about the new dietary ingredient (NDI) process and what could or should happen with this process. Ullman recounts some of the challenges that industry has confronted, and the need for clearer direction from FDA.

Key points of this podcast include:

  • The disconnect between the regulation and FDA’s guidance documents, and how that has added to industry confusion.

  • Some of the common failures seen in the NDI notification process—including firms not identifying the ingredient.

  • The troublesome issues around internal communication breakdowns within the agency departments overseeing NDINs and GRAS (generally recognized as safe) affirmations.

Links and Resources:

About the Author(s)

Heather Granato

vice president, content, Informa Markets, Food EMEA division

Heather Granato is a 25-year veteran of the natural products industry, currently serving as the Vice President, Content, in Informa Exhibitions’ Global Health & Nutrition Network. She has been a presenter at events including SupplySide, Vitafoods, Natural Products Expo, the Natural Gourmet Show and the Folio: Show. Her publishing experience includes Natural Products INSIDER, Food Product Design, Country Living's Healthy Living, Natural Foods Merchandiser, Delicious Magazine and WomenOf.com. She was named a 2015 Top Woman in Media by Folio:; received the 2014 Visionary Award from the American Herbal Products Association (AHPA); and was awarded the CEO Merit Award for Content from Informa in 2014. Granato graduated magna cum laude from the University of Richmond, Virginia, in 1992 with a bachelor’s degree in journalism; she currently serves as a national vice president for Kappa Alpha Theta women's fraternity.

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