FDA Wants More NDI Notifications


SupplySide West 2014 Wrap-Up

A SupplySide West panel discussion offered insight about “Current Issues Regarding New Dietary Ingredient (NDI) Notifications.”

Kicking off the discussion was Cara Welch, Ph.D., acting team leader of the dietary supplements regulations implementation team in the division of dietary supplement programs at the U.S. Food and Drug Administration. Welch noted that a revised NDI guidance is on the way, though a specific timeline wasn’t discussed. “I hope it provides the clarification you are all looking for,” she said.

She also said that if and when the agency decides to put together a list of grandfathered-in ingredients that were marketed before 1994, “we will be looking for industry input—if we go forward on it.”

As for companies on the fence about submitting an NDI for review, Welch advised “Err on the side of caution. Submit it.” She said that in the 19 years that FDA has had an NDI review process in place, only 600 unique notifications have been submitted. “We want to see more,” Welch stated.

“You should not fear submitting an NDI,” said Corey Hilmas, M.D., Ph.D., senior vice president of scientific and regulatory affairs at the Natural Products Association. He noted that the NDI guidance only represents the agency’s current thinking on the topic, and is not legally binding. “Try and try again if you receive an incomplete or inadequate letter.”

He anticipates that FDA will release a revised NDI document by the end of 2014, and NPA will host a webinar explaining the technicalities of the document within 72 hours.

Published in WholeFoods Magazine, December 2014 (online 10/24/14)