Apocalypse now? FDA unveils draft guidance on new dietary ingredients (NDIs)
JULY: “Horrifically broad, anti-innovative, incredibly burdensome,” and “likely to bury FDA under a mountain of paperwork”. Never one to hold back, lawyer Marc Ullman was not impressed when he first read the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) back in July.
And he was not alone. Within days, the message from the dietary supplements sector was loud and clear. The guidance was contrary to the letter and the spirit of the legislation it was designed to clarify, and must be stopped.
But FDA dietary supplements chief Dr Dan Fabricant (pictured) was unrepentant. Putting everything else aside, he said, “it is clear to everybody from the numbers of NDI notifications submitted – only 700 since DSHEA [Dietary Supplements Health & Education Act, 1994] was passed – that the industry has not adequately addressed the NDI provision in the law.
“Just look at the numbers. Something isn’t right. We know from the Institute of Medicine that around 1,000 new dietary supplements are launched on the market every year.
"Can you look me in the face and tell me that only 50 of these a year meet the criteria for an NDI notification? But that’s all we’re getting. The numbers speak for themselves.”
Five months later, however, the trade remains united in its opposition, with comments submitted ahead of the Dec 2 deadline revealing that the message to Dr Fabricant has not changed: Tear it up and start again.
Click here to watch Stephen Daniells’ round-up of the sector’s comment to the FDA.
Click here to read all of our coverage about the guidance.
