UNPA filed its comments on the New Dietary Ingredients draft guidance on Dec. 12, the last day the comment period was open. FDA released the updated draft of the guidance in August, and granted an extension of the comment period. Loren Israelsen, president of UNPA, said one of the universal themes of the comments that have been posted by FDA thus far is that the agency’s insistence that it has to see new safety information on every new product that contains an NDI both goes beyond the intent of the statute and creates a wholly unworkable situation.
“I would say there have been some universal themes in the comments and that is one of them,” Israelsen told NutraIngredients-USA. “This is ought to be a DI (dietary ingredient), not a DS (dietary supplement) system. It appears that there is a clear consensus that FDA is way overreaching here.”
Ingredients? Or finished products?
The core issue is whether FDA will budge on its assertion that in order to ensure the safety of new dietary supplement finished products in the marketplace, not only must the safety of new ingredients be evaluated, the safety of those ingredients must then be proven in each new combination of ingredients in a new finished product. Most if not all of those components will be ingredients that already have a history of safe use. Industry critics, including UNPA, have weighed in that this will create an unnecessary and costly flood of NDI Notifications that will fulfill a bureaucratic desire yet do almost nothing to increase consumer safety. What it really does, Israelsen said, is give FDA something it has pined for since the dietary supplement category was created: pre-market control.
“They have said that the NDI process is the only point of premarket control over dietary supplements and they have and they intend to use it,” Israelsen said.
The potential problem is huge, Israelsen added. UNPA’s comments included some data about the character of products in the marketplace. While there are single-ingredient supplements on the market, such as omega-3s, astaxanthin soft gels and others, they are in the minority. That would mean if the updated draft guidance goes into final form as is, each NDI could generate many dozens of additional filings.
“A recent review of 51,286 dietary supplement SKUs analyzed by Healthnotes, Inc., found that on average, dietary supplements sold in the U.S. contain 9.5 dietary ingredients. . . . the consequences of extending NDI notification to finished dietary supplements would bring a level of cost and a new regulatory burden that will directly affect the level of NDIN compliance that FDA seeks,” UNPA’s comments stated.
Flood of filings would swamp system
There is a train of thought in the federal regulatory sphere that the regulator’s job is to figure out what the underlying statute calls for and lay out an aim to accomplish that and damn the torpedoes. Israelsen opined that in a real world political process as this one, flexibility is called for and a regulator’s goal of perfection might get in the way of the ‘good.’ In this case that means ensuring the maximum number of companies possible comply with the rules for safely bringing new ingredients onto the market.
“We don’t think it’s lawful nor is it useful. FDA has not explained how they could manage this system nor how they could have enough staff to accomplish this,” Israelsen said
“You hear this argument from regulators that our job is to interpret the regulation and it’s whatever the law says and the cost is a side issue. But then we say, wait a minute, you are required to do an economic impact assessment. If I’m in Salt Lake City and I can only afford to put eight gallons of gas in my car and I say I have to drive to Denver anyway, what does that accomplish? I’ll end up hitchhiking the last part of the way,” he said.
When the GMP rules were put into place, there was lot of hand wringing and garment rending in the industry about the cost and whether it might put some of the smaller companies out of business. But there was an underlying acknowledgement that while some of the rules might have seemed burdensome, being able to prove that you know what you are making and you can prove that you make it that way every time were goals people really couldn’t quibble with. That’s far from the case here, Israelsen said.
“We know this is really going to put some of the smaller companies out of business. We’ve estimated that as much as 20% of the industry simply will not be able to comply,” he said.
ODI list, chemical alteration
In addition to the question of ingredients vs finished products, UNPA’s comments address other questions such as how an ODI list might assembled and what kind of authority such a list ought to have. UNPA also weighed in on FDA’s overly broad view of what kind of manufacturing changes might constitute ‘chemical alteration,’ thus creating a new ingredient. UNPA advocated a more restrictive view, one that might hinge on whether you can still identify the ingredient with the analytical tests you had been using before you applied your manufacturing change, such as switching to supercritical CO2 extraction. If the identity of the ingredient hasn’t changed in that sense, the existing safety information ought still to apply.
“We have been very concerned about how FDA had taken such an expansive view that it was setting up a situation in which ingredients were in a perpetual state of ‘newness.’ There is no ‘old’ anymore,” Israelsen said.
Also addressed was the question of synthetic copies of botanicals, which UNPA in concert with other industry stakeholders said ought not be excluded offhand as FDA has done. And there was one unique concern addressed: nanotechnology. UNPA agreed with FDA that ingredients using this technology deserve special attention and ought to have NDI filings in place.
“With nanotechnology ingredients do behave differently. They end up in different places in the body. We believe nanotechnology is a massive thing that is coming and we really need to understand it. We believe ingredients using nanotechnology should be clearly labeled as such,” he said.