Responding to Recent Supplement Research and Regulatory Developments

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: Ladies and gentlemen, welcome to another edition of the Nutritional Outlook video series. Of course, I am Nico Saraceno, senior editor of Nutritional Outlook magazine. Today, we have a very special guest. He is Dr. Daniel Fabricant, president and CEO of the Natural Products Association, often known as NPA for short. Dr. Fabricant, thank you for taking the time to hop on and join me today. I really appreciate it.

Daniel Fabricant: Good to be with you, Nico.

Saraceno: Awesome. We do have a few things to get to Dr. Fabricant, so let's just dive right in. As you know, the NPA has been quite outspoken when it comes to challenging methodology behind reports like the Consumer Reports and the Clean Label Project's heavy metals testing, and you recently issued a statement on the glucosamine-Alzheimer's study that's published in Nature Metabolism. A lot of the members can check that out on your website.

As these headline-grabbing studies and reports are continuing to surface almost by the day, practically, how would you say the NPA decides when a methodological critique is warranted, versus when the underlying science is generally raising a concern that the industry needs to address? How do you handle that? How is your process there?

Fabricant: It's a great question. First and foremost, we're an advocate for the industry. We've advocated for the industry successfully for 90 years. Whether it's responding through the media, dealing through the courts, all 3 branches of government, but specifically with those 2 issues.

Clean Label we've taken issue with going back to 2020. We actually sent them a cease-and-desist in 2020 for some of their methodological issues. There's a history there. Our understanding is they use 1 lab. We don't know how they select products. There seems to be a pay-for-play mode. A lot of these questions have never been answered, and there have been lawsuits and a lot of that's filed under seal, so ven if the answers are there, people don't know. As it pertains to Clean Label and the Attorney General of Texas investigation, I think we've been very clear about that. That's something that just is spreading the message that. And as you said, they bring up Prop 65 limits.

There are nationally recognized limits on things like heavy metals. Unfortunately, our soil isn't 1000% devoid of lead or other heavy metals. Neither is the air, so holding supplements to a standard that doesn't really exist in nature is of benefit to the plaintiffs' bar, not public health. The fact that any of those products really, to my understanding, and we haven't seen all the data. Nobody has. That's part of the problem too, but you're going to raise that, oh, there's these heavy metal concerns, and of course that's going to scare people, and for what?

When it's those types of things, it is a scare tactic. We go back pretty hard because the challenge is this. We see this time and time again, especially in the states. We've been fighting the states for over 10 years now for age restriction and those sorts of things. People go, well, you guys used a slippery slope argument, because there is a slippery slope, right? Once there's the smallest cut, people go, oh my God, it's all terrible.

You look at the state proposals, they're on things like creatine. Creatine outside of probably salt and caffeine is the most studied food ingredient on the planet. The safety record is astounding. These are the sorts of things where when you see them, we have to respond back, because if we don't, someone else fills the narrative. Nature abhors a vacuum, and we want to make sure that the industry is given a fair chance.

When these things emerge, they're not done to give the industry the fair chance. They’re done with a lot of, dare I say, they're motivated by, I don't think are the purest reasons. State politicians now know if they mention dietary supplements, they get more press than they ever gotten in their career. So it's important that we're mindful of that.

Now you take the study on Alzheimer's and glycosylation. That theory on glycosylation is good science. However, the notion that a pill, a 500 mg capsule of glucosamine, when people's diets are loaded with ultra- processed foods, foods that are cooked in seed oils, things of that nature that are more responsible and have a larger mass for glycosylation.

People on average, I think, eat something in the neighborhood of 2-3 lb of food a day, versus a 500 mg capsule. What do we think is actually, you know, and so that study didn't control for that. In theory, it's a great scientific theory, yes. And glycosylation—that's what we need on the knees. That's how glucosamine works. And glycosyl, you know, re-glycosylates the tissue, the soft tissue of the knee, which cuts down on wear and tear, or arthritic issues, those sorts of things. The notion that that's the cause of Alzheimer's when they didn't look at all of these people's diets—you just go, come on, that's cherry picking.

It depends on the story. I know sometimes it sounds like we're just the same. We just hit back no matter what, but I think, and we hope and we know people don't have a lot of time. It's amazing. People spend more time than ever on their cell phones, but read less, it appears, at least the specifics. We want to make sure and make those points clear. We’re grateful for the opportunity to talk to you and hopefully lay some of that bare.

Saraceno: I think there's always 2 sides to every story. I mean, people are going to certainly believe what they want to believe, so it's always nice to hear everything. We talked about this, of course, before we started recording, but as you know, there's this new Alliance for Natural Health, also known as ANH, lawsuit, which is challenging FDA's position that the "authoritative statement" pathway for health claims only applies to conventional foods, not dietary supplements.

From what you can share, where does NPA come down on this interpretation? And if the plaintiffs were to succeed, how significant of a shift would that be for the types of claims your member companies can make without going through, say that traditional rulemaking process? What can you share on that, at this point in time?

Fabricant: There’s a lot of different thoughts on that. I think by and large, it's not our lawsuit. We’re certainly supportive of ANH. Love what Rob Verkerk does with that group. And I think their aim is the same as ours, which is to help to allow more health freedom, more communication about products. In that vein, yeah, I think it's a good thing.

I don't know all the nuances, and the ins and outs of the case, so I'm somewhat reticent to speak about it, but it is ironic that there's been a lot of talk about claims revision by both the Administration. As recent as last weekend, there was a conference in Spain on carotenoids. Dr. Cara Welch from FDA who used to be an NPA-er, respect her tremendously. She gave a talk and talked about how the agency is…no decisions have been made, but certainly some of the things they're thinking about, as it pertains to claim substantiation.

I think there are a lot of similarities between food claims and dietary supplement claims, but there are some differences as well. I think understanding those differences and where they may be more amenable. And frankly speaking, there's a lot more research on dietary supplements. We go to clinicaltrials.gov, a lot more research on supplements than there are on foods per se. I think that's an important consideration as well is, how that the weight of those studies, doesn't mean all the studies are necessarily quality studies. But what weight is there in those studies that can move the process along faster? Ultimately, I think the frustration by many, and I'm not going to speak for NIH, but I would imagine the frustration is since NLEA in 1990, we've got 14 full health claims and 8 qualified health claims, or 9 qualified health claims.

We're the country of the First Amendment. So I think it's like, hey, wait a second. If the studies are there, is there a way we can get that information out? Truthful, not misleading, not making disease claims, of course, within the scope of the law. I think those sorts of efforts are consistent with where our organization's been. But it's also it sounds like it's consistent where maybe the current administration is thinking that there needs to be more information out there. W