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.