The trade can rail against the Food and Drug Administration's new dietary ingredient (NDI) guidance as much as it likes, but it cannot honestly pretend to be shocked or even surprised by it, according to the man in charge of the FDA’s dietary supplements division.
Daniel Fabricant was speaking to NutraIngredients-USA.com following the publication of a draft guidance document on NDI notifications some industry sources claim will thwart innovation and raise question marks over the legal status of scores of dietary supplements already on the market.
But Fabricant insisted the controversial document did not in fact contain any surprises, adding: "You can work through each point that people claim is shocking and debunk it. There are no surprises in this document. The industry asked for clarity and we’ve delivered. This is not a doomsday scenario, it will just mean that [the industry] has to put in more effort than has previously been applied.”
‘Just look at the numbers. Something isn’t right’
Putting everything else aside, said Fabricant, “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.”
‘There are no surprises in this document’
Meanwhile, what the FDA was looking for as evidence that products were safe was hardly unreasonable, he claimed.
“This [safety data required in an NDI submission] isn’t new. If you are introducing a product to the market that has already been in the diet for years, you need to show that it has a safe history of use. This is not being anti-innovative.
“If it is a new ingredient that has not been in the diet before you need data to show why you have the reasonable expectation that it is safe. I don’t think that is asking too much. We have to strike a balance between public health and consumer access to supplements, and clearly the public health aspect has not had its proper due.”
He added: “If your product is on the market, you should have the data [to demonstrate it is safe]. If there is an absence of data, how do you get to a reasonable expectation of safety?”
Synthetics and botanical extracts
On the issue of synthetic botanical constituents, which the FDA guidance says are not dietary ingredients at all, even if they are chemically identical to their ‘natural’ counterparts, Fabricant said FDA’s position on this had been made very clear in its responses to two recent citizen’s petitions.
There was a “very good chance” that there were several products currently on the market containing synthesized versions of botanical extracts that were not dietary ingredients, said Fabricant. However, he would not name names or cite what enforcement activity was planned to address this anomaly.
‘I honestly don’t know what people think has changed’
Meanwhile, reports claiming that the guidance imposed significant new burdens on makers of finished products by requiring NDI submissions on the supplement/formula being presented to market, and not on the raw ingredient were puzzling, he said.
“Quite honestly, I don’t know what people think has changed. It has always been the case that the supplement containing the NDI is subject to the NDI notification.”
And to those arguing it will be an administrative nightmare for companies making changes to formulas/target groups/conditions of use to have to prepare new NDI notifications for each different supplement containing an NDI, he said: “Why is this a great burden? You should have the data.”
Meanwhile, the news that industry lists of ‘grandfathered’ ingredients are not considered by the FDA to be authoritative should come as no surprise, he said.
And while collating evidence to demonstrate that ingredients assumed to be grandfathered were on the market prior to 1994 might sound challenging given the length of time that has passed, companies have known since 1994 that they needed to keep records proving their products had been on the market, he said.
“I just don’t see how people can be shocked by this.”
What happens next?
All stakeholders have the opportunity to share their concerns with the FDA, he said, but until the FDA had processed the comments he could not say when final/revised guidance would be issued.
“Obviously we will listen carefully to comments and not just people being upset. We certainly want to put out final guidance on this, but I can’t say when until we have all the comments in.”
Click here to read the guidance document.