Big interview: Daniel Fabricant, Food and Drug Administration (FDA)

FDA on NDI guidance: This is ‘not a doomsday scenario’ for supplements trade

By Elaine Watson

- Last updated on GMT

Related tags Ndi notifications Dietary supplements Dietary supplement Ndi

Fabricant: "This is not a doomsday scenario."
Fabricant: "This is not a doomsday scenario."
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Daniel Fabricant was speaking to following the publication of a draft guidance document on NDI notifications some industry sources claim will thwart innovation and raise question marks over the legal status of scores of dietary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.”

Grandfathered ingredients

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.

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Big Pharma's little pal the FDA

Posted by Mason X. Hamilton,

It has been quite obvious for years that one of the FDA's primary functions in the assumption of it's ever increasing authority in regulating the nutritional supplement industry has been to fatten the wallets of the bureaucracy and gate keepers and as well to eliminate the competition between pharmaceutical and nutritionally sourced health products. This NDI is just another effort to increase the cost of doing business for nutritional supplement companies. Our gov. has long believed that the safest industry is on that doesn't exist.

If fatality records were meaningful to the FDA, numerous pharmaceutical companies would have been closed, rather than either no response from the FDA or ridiculously low fines. In fact the FDA's record of approving deadly drugs should have closed the FDA as incompetent years ago.

The US now has many very safe and very dead industries - ones that didn't sufficiently own the gov. that was regulating them - unlike health-care - big pharma, insurance and corporate medicine.

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Lipstick on a pig

Posted by Gordon,

Toxicologists and bureaucrats control CODEX and the EU regulations that have killed the European supplement industry. Beware.

NDI: expensive paper-work drill - gleefully promoted by bureaucrats and toxicologists
…not unreasonable, but impractical

• Consultants and bureaucrats like NDI because it means more business and power for them. So let's test everything.
• What supplement on store shelves today is the same as it was in 1994? Probably none.
• Entire supplement industry has to subject virtually every product for toxicological testing. At what cost?
• Many products simply do not generate sufficient revenues to justify testing.
• And just how would FDA propose to handle these thousands of NDI applications?
• What is the end point we are trying to prevent?
• Where are the dead bodies and birth defective babies?
• This appears to be an expensive paper-work drill that gleefully is promoted by bureaucrats. So now that we have all of our paperwork in order, have we killed the industry?

[bulleted points edited from Bill Sardi comments on Toxocologist article]

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NDI requirements

Posted by A concerned consumer,

As currently written, the requirement for multiple manufacturers to submit an NDI for the same ingredient is redundant, a waste of time for FDA officials, each manufacturer involved, and a waste of taxpayer dollars. If I truly believed the intent and spirit of NDI requirements was consumer and patient safety, I would not be against this. I do agree that companies who adulterate products or ingredients should be called to task, this is a good thing. But the safety record of dietary supplements speaks for itself - no deaths since adverse event reporting was made law in Dec. 2006. It appears the FDA is focusing on the more financially successful companies, and the ones who will suffer in the end, will be the consumer, due to significantly higher costs for products that have already been proven safe over time. 17 years is a ridiculously long period - I suspect the agency was hoping for some deaths during that time. There were deaths - from FDA approved pharmaceutical drugs! Our taxpayer dollars should be directed toward the true safety issues in that area.

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