The FDA will be “laughed out of court” if it tries to defend enforcement action against supplement manufacturers based on the argument that new dietary ingredient (NDI) notifications should apply to finished products, not ingredients, one industry leader has predicted.
The argument – contained in the FDA’s controversial new draft guidance on NDI notifications – has provoked a storm of controversy in the supplements trade, with critics claiming it was never the intent of Congress and would force firms to submit thousands of unnecessary regulatory filings .
But if the FDA sticks to its guns and the issue is tested in court, it could be on shaky ground, claimed American Herbal Products Association (AHPA) president Michael McGuffin.
The FDA has got this wrong
McGuffin, who was speaking to NutraIngredients-USA after attending a town hall meeting hosted by Senator Orrin Hatch to discuss the much-maligned guidance , said the FDA’s stance on this issue was untenable, as well as impractical.
“The FDA has got this wrong. Let's say it says to a company 'we’ve found this supplement and it contains an NDI – which you have notified us about – but you have now combined the NDI with chamomile without submitting a new NDI notification for the supplement'. Well the company will go to court, and the FDA will be laughed out of court.”
He added: “What they have told us for 16.9 years is that the NDI notification is for the ingredient, and then on July 5, 2011 [when the draft guidance was published], they say, what we really mean is that it’s for supplements. Well that’s not what the law says.
“You can twist the meaning of the word ‘it’ in the middle of one paragraph [of the Dietary Supplements Health and Education Act (DSHEA) of 1994], but the industry won’t tolerate a misreading of the law.”
How many NDI notifications should have been filed?
However, it was very clear that more NDI notifications should have been filed since DSHEA was passed, accepted McGuffin.
“Do I think that NDI notifications have been submitted for every new dietary ingredient introduced to the market since DSHEA? No, I do not. There is no doubt that the NDI notification process has not been well-managed by the FDA or by industry.”
Bosses of the five industry associations represented at Sen. Hatch’s town hall event in Utah this week had discussed how to coordinate their response to the guidance in a private meeting before the public meeting started, he said.
“We will almost certainly file comments individually, because we all have different styles and members. However, we might include a group statement at the top of all of our comments, or submit a unified statement or comment as a group as well.”
While various options were also being explored in the event that the FDA proved unwilling to make substantial revisions to the guidance, Congressional oversight was a “last resort”, he stressed. “This is something you talk about after everything else has been exhausted.”
According to the draft guidance, NDI notifications should be supplement-specific, not ingredient-specific, and are applicable only to the specific manufacturer that submits them.
Firms making changes to formulas, target groups or conditions of use for supplements containing NDIs must also prepare separate notifications for each new supplement.
Click here to read more about the town hall event in Utah.