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, VP, Partnerships & Sustainability

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

VP, Partnerships & Sustainability, Informa Markets, Food EMEA division

Heather Granato is a 30-year veteran of the natural products industry, currently serving as vice president, partnerships & sustainability, in the Food EMEA division of Informa Markets. She is based in London, and leads efforts related to industry partnerships and broader sustainability initiatives for the Vitafoods and Food ingredients brands. She has been a presenter at events including SupplySide, Vitafoods, Food ingredients, Natural Products Expo, the Natural Gourmet Show and the Folio: Show. Her publishing experience includes Natural Products Insider, Food Product Design, Vitafoods Insights, Country Living's Healthy Living, Natural Foods Merchandiser, Delicious Magazine and Granato serves as the founding president of Women In Nutraceuticals, a global non-profit founded in 2022 focused on empowering women in the nutraceutical industry; she is also on the board of directors for the Organic & Natural Health Association. From 2016 to 2022, she was a vice president on the national governing board of Kappa Alpha Theta women’s fraternity. Granato was named to the FOLIO: 100 list of top media professionals in 2018, and was selected as a 2015 Top Woman in Media by FOLIO:. She received the 2014 Visionary Award and the 2018 Journalistic Excellence Award from the American Herbal Products Association (AHPA); and was honored with the CEO Merit Award for Content from Virgo in 2014. Granato graduated magna cum laude from the University of Richmond, Virginia, in 1992 with a bachelor’s degree in journalism.

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