FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence

FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam Guggenheim.For both of those developments, she says, "I'm not holding my breath."

FDA's current draft guidance on new dietary ingredient notifications and advice for showing whether ingredients are grandfathered in for use might be as good as it gets for supplement manufacturers and marketers, according to attorney Miriam Guggenheim's sense of the agency's plans.

The agency has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for...