Mister on NDI guidance: ‘We are terribly disappointed.’
CRN chief executive Steve Mister was commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications.
NDI process now ‘sounds an awful lot like food additive petition process’
The Dietary Supplements Health and Education Act (DSHEA) of 1994 requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives are required to demonstrate ‘reasonable certainty’ that no harm will result from use of the additive, CRN chief executive Steve Mister told NutraIngredients-USA.com.
“But if you look at the section on safety requirements in the NDI guidance and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.
“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely.
“But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed.”
FDA is trying ‘freeze industry in 1994’
As to what constituted an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients assumed to have been ‘grandfathered in’ under DSHEA into NDIs was alarming enough, he said.
“They are trying to freeze industry in 1994 and lock us into extraction processes used 20 years ago.”
However, the fact that separate NDI notifications for supplements containing the same NDI are required ifthesupplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, meant the FDA would be “flooded” with NDI submissions, claimed Mister (although the FDA argues that this has always been made clear to the trade).
“It really concerns me that ingredient suppliers cannot seek an NDI notification and then allow customers to piggyback off it.”
‘Absolute nonsense with no basis in science’
The section in the guidance claiming that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all - even if it is chemically identical to its ‘natural’ counterpart - was particularly troubling, although not unexpected, he said.
“We were warned about this when the FDA recently argued that synthetic homotaurine was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”
Ullman, Shapiro & Ullman partner Marc Ullman said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”
Multiple NDI's required for the SAME Ingredient?
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