Letter from congressman asks FDA to ramp up NDI enforcement

By Hank Schultz

- Last updated on GMT

"Companies which skirt FDA requirements for NDI notifications are putting consumers at risk" - Steve Stockman, 36th Congressional District of Texas. Photo credit: Gage Skidmore, Flickr
"Companies which skirt FDA requirements for NDI notifications are putting consumers at risk" - Steve Stockman, 36th Congressional District of Texas. Photo credit: Gage Skidmore, Flickr

Related tags Ndi notification Question Ndi

A letter from the office of Texas congressman Steve Stockman to the Food and Drug Administration urges the agency to better police the filing of New Dietary Ingredient notifications.  The letter says that there are some ingredients in the market whose manufacturers should have filed notifications and have not.

The letter mentions three specific ingredient categories: zinc carnosine, pyrroloquinoline quinone (PQQ) and astaxanthin.  In all three categories, Stockman said NDI notifications have been submitted by individual companies who have seen other companies bring follow-on ingredients to market without filing their own NDI notifications on their ingredients. “Those companies which skirt FDA requirements for NDI notifications are putting consumers at risk by offering illegal versions of supplements whose ingredients have not been properly vetted by the FDA,”​ Stockman wrote.

Three companies cooperated on move

Stockman said he was made aware of this situation by “three separate, reputable multinational corporations.”​  Those corporations are Fuji Chemicals, which markets astaxanthin derived from algae (and for which it has filed several NDI notifications), Mitsubishi Gas Chemical, which has filed a NDI notification on its PQQ ingredient, and ingredient development and marketing firm XSTO Solutions, which works with Japanese firm Hamari Chemicals on their zinc carnosine ingredient.  All three entities pooled their resources to commission Garden City, NY-based attorney Marc Ullman (who lists all three as clients) to make the initial approach to Stockman.

“There are both public health and economic reasons that would justify FDA moving forward on the issue,”​ Ullman, a principal in the firm Ullman, Shapiro & Ullman told NutraIngredients-USA.

Draft NDI guidance

The issue of who has the responsibility for filing notifications on New Dietary Ingrdients has been there from the time that then-President Bill Clinton signed the Dietary Supplement Heath and Education Act (DSHEA) into law in 1994.  But it has really picked up steam in the last several years after FDA filed its guidance on the subject in July 2011, a document that provoked a strong reaction from industry stakeholders, including Senators Orrin Hatch, R-UT and Tom Harkin, D-IA who cooperated in writing DSHEA.  After a couple of high-level meetings between the senators and FDA, the agency agreed to a subsequent series of meetings with stakeholders such as the major trade associations aimed at coming up with a revised version of the guidance. Those meetings have taken place and the issues raised and suggestions made are winding their way through the agency.

In the meantime, though, FDA has moved forward with enforcement based on some of the principles in the guidance. For example, the agency issued several warning letters to the makers of products that contained DMAA, saying that the products were adulterated because there was no NDI notification on the ingredient.

Who has to file?

So if a follow-on ingredient was identical in every way, including in its manufacturing process, to an ingredient that already has a NDI notification, does the subsequent ingredient need its own filing?

Ullman NIU
"There are both public health and economic reasons that would justify FDA moving forward on this issue" - Marc Ullman.

“I don’t think it’s a simple yes-no question,”​ said Michael McGuffin, president of the American Herbal Products Association.  But proving that identical nature is the rub, as manufacturing details and specifications can be redacted in the version of the notification that is made public. So how to know your ingredient is, in fact, the same thing and is made the same way?

“You can’t assume that just because somebody filed an NDI for an ingredient that is called by a certain name, that every manufacturer of an ingredient that has a label on the barrel that uses the same word, that that is the same ingredien​t,” McGuffin said.

“And does it use the same process? No other manufacturer can know if they use they use the exact same process.  So even though I started out by saying it’s not a simple yes-no question, I think the answer is yes, you need to file a new notification with some exceptions,”​ he said.

For Ullman, the question of whether additional manufacturers of NDIs need to file their own notifications does not admit exceptions.  “It’s black-letter law,”​ he said. “We have been seeking FDA enforcement on this issue for some time.”

Possible contaminants quantified

Dan Murray, vice president of business development for XSTO Solutions, said the thought process that XSTO and Hamari went through when they filed the notification on zinc carnosine in 2002 had to do with the intellectual property on the molecular combo.  Defending a composition of matter patent would be easier with a NDI notification in place, he said.  And as this molecule isn’t found in nature in the same way that Hamari put it together (even though the constituents come from nature), it made sense to have that safety information on file with FDA, he said. Extracting metals like zinc always involves some risk of additional things coming along like lead, Murray said.  The NDI notification precisely characterizes the levels of any additional constituents in the finished ingredient, he said, and demonstrates that they are at safe levels.  This is information unavailable to subsequent manufacturers of the ingredient, he said.

The marketer of one of the ingredients mentioned in the letter, Virun Nutra Biosciences, which markets a form of PQQ, says that its ingredient is a naturally occurring constituent of milk and many plants and therefore a NDI notification is not needed in this case.

“We believe it is covered under DSHEA,”​ said Philip Bromley, CEO of Virun.

Murray said Stockman’s letter is the culmination of long frustration on the issue on the part of industry.

“I don’t think FDA is doing anywhere near a thorough enough job to police NDIs and it is essentially left to industry to police fellow companies and we don’t have the enforcement tools,”​ Murray said.

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