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

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

June 26, 2018, The Rose Sheet

Miriam Guggenheim spoke at the American Conference Institute and Council for Responsible Nutrition's Legal, Regulatory, and Compliance Forum and is quoted by The Rose Sheet in an article regarding FDA's current draft guidance on new dietary ingredient (NDI) notifications. According to Guggenheim, the agency has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994.

Commenting on efforts by supplement industry trade groups to compile and administer lists of ingredients available pre-DSHEA, Guggenheim said, "There just hasn't for many reason been a will to get together and establish a definitive list. FDA has said repeatedly it will not rely on an industry-generated list. They want to see evidence of contemporaneous marketing prior to 1994." She added, "The problem is we're 24 years out. We need to come up with media and marketing materials, which is very, very difficult to do."

"Despite the attention and the meeting in the fall, this is too big a bridge to cross at this stage so far from the enactment of DSHEA. Absent significant safety concerns, this doesn't seem to be an agency priority at this point or a good use of the agency's limited resources," Guggenheim said. Safety also guides FDA's priority for NDI regulation enforcement, she added. "I'm not holding my breath for finalization of the guidance. I think FDA has said what it wants to say on this topic. I think FDA will use its authorities and resources to achieve what it wants to achieve rather than finalize the guidance."