Inside NPA's FDA Ties, Mandatory Registry Pushback, and the Fight Over Peptide Innovation

In this interview with Nutritional Outlook Senior Editor Nicholas Saraceno, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), discusses how the organization determines when to publicly challenge industry-critical research versus when underlying science warrants genuine concern. Fabricant points to NPA's long-running dispute with the Clean Label Project, including a 2020 cease-and-desist letter, arguing the group's heavy metals testing methodology lacks transparency around lab selection and product sourcing. He also addresses a recent Nature Metabolism study linking glucosamine to Alzheimer's disease risk through a glycosylation mechanism, arguing the study failed to account for far larger dietary contributors to glycosylation, such as ultra-processed foods, compared with a standard 500 mg glucosamine capsule.

Fabricant frames these responses as necessary given what he describes as a pattern of state lawmakers using dietary supplements to generate press attention, pointing to proposed restrictions on ingredients like creatine, which he calls one of the most studied food ingredients in existence. He argues that if NPA doesn't respond to critical narratives, other voices will fill that vacuum.

The conversation also covers the Alliance for Natural Health USA lawsuit challenging FDA's interpretation that the "authoritative statement" health claims pathway applies only to conventional foods rather than dietary supplements. While Fabricant says the case isn't NPA's own litigation, he expresses support for the effort.

A full transcript of their conversation can be found below.

Nicholas Saraceno: You have experience at the FDA, as you were formerly a director of their Division of Dietary Supplement programs prior to joining NPA, which gives you a different vantage point. Does your time at the FDA change how you interpret and read FDA's reasoning in denying the underlying petition? And do you think the agency's interpretation of like authoritative, I know you can't really get into it too much, but is it likely to hold up under scrutiny or how does, I guess if you can't respond too much to that, how is your time at the FDA kind of impacting your mindset nowadays?

Fabricant: It certainly does. It was great work. I love the agency. I think that, you know, we're lucky at NPA that we do have those ties to the agency. I think it's incredibly important. I think you look across the landscape of FDA regulated industries. There's always an interest in having that FDA perspective, and really speaking their language. In some of what they put forth, I don't think a lot of it's surprising.

FDA sometimes wants to hold the line. Their job is to regulate a big industry, and so sometimes they're going to put that first. The attorneys there, I think sometimes are risk-averse. They win. FDA wins a lot of their cases, ironically, not against us. We've done well on NMN and NAC, we were the only ones. I think it's important to understand their thinking, because that's really how the policy gets shaped. It doesn't mean they're always right, it doesn't mean they're infallible or anything like that.

And I think overall, ANH's tone has been very respectful of the agency. At the same time, recognizing that, hey, some things may be different. I'm grateful, that experience was great. It's great for our members. I think that's the biggest thing, is it helps our members navigate. We're highly regulated, and I think a lot of times the agency's job and our job as the trade association is the same that it's consumer safety. Making. sure that the laws are upheld.

For a commodity that 70%-plus of the country uses, there's still on some level confusion in terms of how the commodity is regulated, it's unfortunate, but I don't think it's as big a deal as people make it because I do think there are people who understand the laws throughout the industry. That's a big part of our role. And certainly my time at the agency helped, I think tremendously continues to help.

On that note, there is a webinar, I think Josh told you about tomorrow with FDA. we still try to work with the agency as much as possible on issues just because they're the regulator, they're the chief regulator, they're the regulator we want, We don't want 51 regulators. I don't want 50 states and FDA, I want FDA. They've got the people with the credentials there. And we don't always agree, but that's important. Those are the people we need to have the discussions with.

Daniel Fabricant: Definitely. And I'm curious in terms of NPA's, what's kind of thinking ahead here, what is on the association's agenda radar right now when it comes to additional regulatory or legislative priorities that you believe finished product manufacturers should be kind of paying closer attention to as we kind of look ahead here over the next several months? Is there anything you want bring to light for everybody?

Saraceno: Qw covered a lot of this at our Fly-In Day. You should have been there. Make sure you're there next year, Nico. Got to be there. But our 3 main points to Fly-In, there was some other talk. We talked about MPL (mandatory product listing) and what a terrible idea that is, which I think most people agree. I know some groups are going to make their run at it. No one's communicated effectively how it benefits the industry.

Furthermore, they're advocating it for it without the biggest issue, which is uniformity with the states. Like we just talked about, we want 1 regulator. We think FDA is a really good regulator. We think the laws are really good. We don't need states that are motivated by plaintiff's bar suits and getting attention regulating our industry, because frankly speaking, a lot of it they don't understand, and that's fair.

There's a lot of great people at state departments of public health, but it doesn't mean they don't deal with this all day, every day, whereas FDA does. I think that's first and foremost, is we need one. It's 30 years-plus past DSHEA, we need to say, hey, we've got 1 regulator on these issues. Whatever that entails, we want to focus on that, so that's first and foremost. Then I think we continue to push on health savings accounts.

I was at an event yesterday on the Hill to expand health savings accounts in general. It wasn't specific to our legislation, but actually they were looking at what if all Americans had a health savings account under the current health care system? Interesting concept. It’s odd that right now there's 44 million households in America with health savings accounts. Ninety percent of them are employer funded. You can buy a sea kayak on those, but you can't buy a vitamin D supplement? It just doesn't make sense, so we're continuing to fight on that. I don't know legislatively if there's a real appetite, but we're certainly going to work on the Internal Revenue Service and see what happens there.

The other big issue that we've dealt with—we talked about NAN, NM—is the drug preclusion issue. The table is still really heavily tilted in the favor of pharma, to the point where we have new emerging technologies. We had the meeting with FDA in March on innovation. NPA really led the way in moving that forward and getting that done. You have new technologies. People think peptides, they think of GLP-1s, they think of the injector site, they think of weight loss. No, no, no. Glutathione is a peptide. There are peptides we eat every day throughout the diet. People are coming up with new technologies in ways to make them more bioavailable. When you eat them orally in a pill, a capsule, what have you, so as those emerge, we don't want to see those opportunities go, oh, no, no, that's completely a product of pharmaceuticals.

There are people working on peptides from eggs, milk, responsible for lean body mass, responsible for cognition, that are every day health and wellness products that aren't pharmaceuticals. We want to make sure we've got a path to market for those, because otherwise, don't get me wrong, the industry is doing very well. But the lifeblood of any industry is innovation, so we have to be able to innovate.