Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.
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:
INSIDER’s Josh Long reports how in 2017, FDA objected to the majority of new dietary ingredient notifications for two primary reasons distinct from contesting the adequacy of companies' safety data: incomplete information or the ingredient doesn’t qualify.
Attorney Rick Collins shares thoughts on how companies can get their new dietary ingredients to market in compliance with regulations.
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.
You May Also Like
iHerb joins Amazon in stopping sales of NMN supplementsFeb 27, 2024
Family Dollar to pay $41.7 million fine over rodent infested warehouseFeb 27, 2024
The changing history of women’s nutritional ingredients over the yearsFeb 26, 2024
Third-party certification weeds out banned ingredientsFeb 26, 2024