Charting the Path Forward on NDI Guidance in a Time of Industry Criticism

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FDA’s revised new dietary ingredient (NDI) draft guidance debuted to decidedly mixed reviews from the dietary supplement industry in August. Just among heads of associations, responses ranged from “guardedly optimistic” to calling the guidance flat-out “depressing.”

While the revised guidance puts a few wins back in industry’s court, there is still enough language remaining from the heavily criticized July 2011 draft guidance to distress many. At this point, there’s no telling exactly how strong industry pushback on the guidance will be until we actually see public comments. But early indications are that the response will be more measured this time around.

As industry representatives lead the response to the guidance, there is a general sense of treading more carefully because criticisms of the industry are extremely high right now. Since July 2011 when FDA released the first draft guidance, the industry has undergone investigations from attorneys general, probes by lawmakers, and negative coverage from mainstream media, all shedding doubt among consumers about the safety, efficacy, and trustworthiness of dietary supplements.

“Certainly we’re very concerned about the public-relations media perceptions and consumer perceptions around these issues,” said Loren Israelsen, president of the United Natural Products Alliance, during an August NDI webcast. “We also know that if this issue [of responding to the NDI guidance] is not managed carefully and thoughtfully, that it will likely fan the flames of [criticism that the dietary supplement industry is unregulated].”

If industry members push back too hard, “will we appear to be an industry that is not interested in doing the sort of safety work that is expected of us?” Israelsen asked. “Or is our argument that FDA has simply imposed so many burdensome requirements that it’s simply not possible to do what they asked?”

None of this is to undercut the fact that there are legitimate concerns from industry that portions of the revised guidance are unclear or that some of the guidance may go beyond the scope of what is prescribed by the laws governing supplements. “There’s a lot of work that still needs to be done to pull this guidance back into a stricter compliance with the statutory framework and with our actual obligations under the law,” said Michael McGuffin, president of the American Herbal Products Association (AHPA), during an AHPA NDI webcast.

But industry must also face the possibility that FDA may decline to amend the guidance much further. Some, like A. Wes Siegner, Jr., an attorney at Hyman, Phelps & McNamara, don’t believe the agency is likely to make drastic revisions. “My feeling...is that we didn’t make a lot of progress last time, and filing critical comments again this time is likely to have much the same effect,” he said during the AHPA webcast. “I do think that some progress can be made, and I’m not saying that the trade associations should not continue efforts to push back. That clearly needs to be done. But I don’t expect that the final guidance, if it is ever issued, will be all that much different.”

Ultimately, the final guidance may not be something industry loves but instead something industry will need to learn to live with, Steve Mister, president and CEO of the Council for Responsible Nutrition, pointed out. What’s more, that doesn’t have to mean the end of the world.

For one thing, guidance is not binding regulation. And while “law-abiding companies will want to follow” FDA’s NDI guidelines, “my point is if there are particular issues where we just fundamentally disagree with the agency, we can continue to fundamentally disagree” and take up the challenge elsewhere, such as in the courts, Mister said.

Dan Fabricant, CEO of the Natural Products Association, also said that there may still be alternative paths to market for some NDI ingredients, “and as long as you can get to the market, that’s the key thing.” He said, “I think that’s how people need to look at this. Is their market access being restricted? If it is, okay, fine, there’s a real issue there. But if it’s not, and it’s just an issue of semantics, well, that’s not the hill I think the industry wants to die on.”

Those are the matters industry members will want to balance as they craft their public comments to FDA. Getting on the same page in this era of industry scrutiny is also important. As Israelsen said, while there are “different views about all of this at the moment in the industry,” it will be “really critical to see if we can get to harmonized points of understanding so that we speak with one voice.”

Jennifer Grebow
Editor-in-Chief

Also read:

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