CHPA Chat: Scientific Credibility of the Dietary Supplements Category - Issues and Opportunities

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How has consumer empowerment, trust, and confidence in dietary supplements contributed to growth in the self-care aisle? With more than 70,000 products on the market, the dietary supplements segment has just experienced its largest annual growth rate since 1997. While the category is well regulated, gaps in quality assurance are out there with some inappropriate claims and adulterated products. Hear from Dr. Pieter Cohen as he shares his insights on how modernization of DSHEA will help improve category compliance and credibility.

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Anita Brikman: How has consumer empowerment, trust, and confidence in dietary supplements contributed to growth in the self-care aisle? With more than 70,000 products on the market, the dietary supplements segment has just experienced its largest annual growth rate since 1997. While the category is well-regulated, gaps in quality are out there with some inappropriate claims and adulterated products. Hear from Dr. Pieter Cohen as he shares his insights on how modernization of DSHEA will help improve category compliance and credibility, and ultimately benefit the consumer.

Welcome to CHPA Chat, conversations in the consumer healthcare industry, with Anita Brikman.

Anita Brikman: Hello, everyone. And thank you for checking out the CHPA Chat, the podcast of the Consumer Healthcare Products Association. We are thrilled to bring you a series within season one of CHPA Chat featuring our own dietary supplements expert, Dr. John Troup, as your host. As people become more and more interested in health and wellness, it's leading to greater demand for dietary supplements. John will explore current issues and topics of interest in the supplement space, bringing thought leaders on this show to offer a broad perspective about the category and the role it can play in consumer healthcare. Take it away, John.

John Troup: Thanks, Anita. I'm excited about today's interview and discussion with Dr. Pieter Cohen. Pieter, thanks for joining us.

Pieter Cohen: My pleasure, John.

John Troup: Pieter, you are currently associate professor at Harvard Medical School and a clinician at the Cambridge Health Alliance. Tell us a little bit before we start talking about some of the issues today facing dietary supplements. One is how did you get interested in medicine? And then secondly, as part of that, how'd you get interested in dietary supplements and studying the role of supplements?

Pieter Cohen: Sure. Well, in terms of medicine, it's actually a story that started in Brazil. I was studying ecology outside of the Amazon city of Belem. And when I was there, sand flies bit me and I knew that was happening, but what I didn't know was that one of them transmitted a tropical disease, leishmaniasis, into my leg. So it was really when I got back months later and this ulcer was growing on the back of my leg, that I needed really specialized care. Actually, to the point where the CDC was shipping up medication to Boston for the doctors to treat me, that got me fascinated with medicine. I then got interested in supplements because of my patients. I need to rely on supplements every single day in clinic. There's not a day that passes in clinic that I'm not recommending my patients are taking their supplements that sometimes I've prescribed, or other doctors have prescribed, so they're just essential part of medical care.

John Troup: Yeah. Yeah, go ahead.

Pieter Cohen: Oh yeah. But my interest in the safety of supplements really grew out of harms I was seeing. There were certain supplements, certain categories of supplements, that were posing some real risks to my patients. For example, weight loss supplements and certain weight loss supplements. And it was in investigating those that really drew me into this work.

John Troup: You've been a prolific author and investigator of the safe use of dietary supplements. And because of that, I think a great advocate for the category and its safe use in the category, but tell us a little bit more about how big of an issue do you see this? And when you talk to your patients, are they all successfully using supplements or a good majority of them having issues and trying to better understand how to use them? I mean, what are you seeing on the patient side that first brought about concern and made it that you wanted to write about this and be an advocate for safe use?

Pieter Cohen: Right. So I saw a lot of patterns that were worrisome. The supplements that we were encouraging our patients to use and really take every day, there was also patients had, from my perspective, an inappropriate trust in just about everything that was being sold as a dietary supplement. And that would sometimes lead to risk. So that would be to patients trying something that was being sold as if it would make them stronger, faster, the sports field, and then they end up with serious inflammation of their liver, for example. So it was these kind of scenarios, and really time after time, that made me concerned and want to see how can we create a better system? How could we fix this so that consumers are safe when they turn to supplements available for sale in the states?

John Troup: Yeah. So where does this overconfidence, if you will, on the part of consumers using supplements come from? Is it poor labeling, lack of sufficient clinical substantiation? What's at the root of this overconfidence, or is it just an overstatement of the benefits that are made by some products and inappropriate use of structure/function statements?

Pieter Cohen: So I think there are a number of factors that lead to overconfidence in supplements. One is how that there... You walk into a store, bright lights, friendly store personnel that are talking to you about various products. And oftentimes, you'll have supplements sitting right next to other products such as over-the-counter drugs, like Tylenol and aspirin, that are extremely tightly regulated by the FDA. And it's really hard for consumers to distinguish the two. I mean, it's only those of us on the inside who really know the difference between a drug's fact label and a supplement facts label. That's not something that an average consumer is going to have any insight into. And certainly, what that means in terms of the regulatory framework for those two categories.
So I think there's a lot of reasons in addition to... In my opinion, we have problems with structure/function claims. I know this is going to be controversial in some circles, but I think that structure/function claims are being stretched in a way that misleads consumers to think that these products are going to have immediate health effects that they don't necessarily have. So I think there's multiple factors contributing to the overconfidence.

John Troup: In 1994 there's a Dietary Supplement Health and Education Act that actually helped to at least frame a regulatory environment for dietary supplements. And it's been around now for, what, 26 plus years, but is there a need and an opportunity for that act to be modernized in a way that helps enforcement to make sure that the unscrupulous players that are making inappropriate structure/function statements don't anymore? What can be done in the category given the regulatory framework that's available, but still lets inappropriate statements to be made that yields to this overconfidence of consumers?

Pieter Cohen: Yeah. John, I think we are at a really exciting time, where I can envision practical changes that many of us from various different perspectives can come together and ensure that the consumer confidence in supplements is supported by the quality of the products. And not just the most ethical firms, but every single product being sold as dietary supplement in the United States. So I think we have a really exciting, unique opportunity right now to see some positive change in this way.

John Troup: There's a big initiative across the retailers in America that are introducing quality assurance programs, where they add another layer of a request for information to substantiate that the product has met quality labeling and provide the quality assurance necessary the product testing. Do you think that's one good step that can facilitate what you're talking about or are there other, say, regulatory requirements or even legislation that should be done that would complement even the retailer initiatives that are taking place?

Pieter Cohen: Yeah. I think that we need to compliment this work so that every supplement, no matter where you buy it, if you buy it from the most meticulous retailers or you're buying it online, that consumers have a way of checking and ensuring that it's appropriate in terms of it's permitted under the law, the FDA is aware of its sale, and there's no reason for any concern about the product. So I think we could really use this to springboard onto a much broader program that includes all dietary supplements.

John Troup: Yeah. There's been somewhere in the neighborhood of 70,000 products estimated to be classified as a dietary supplement in America, so that's a lot. Even you and I have talked about it in the past as industry as a whole on the importance of a mandatory product listing, where then the FDA would have a clear and easier line of sight of what's out there and what's being said. Do you think that's enough? With 70,000 products on the market, mandatory product listing would certainly help, but that's probably not enough either, is it?

Pieter Cohen: Well, I definitely am supportive of a product registry, but one that would have to have enough teeth in it to make it useful. If we just have a product listing process where everyone's required to submit the paperwork to the FDA prior to sale and the FDA is required to post all that on their websites and maintain a database, I don't really see we're doing much more than creating a lot more bureaucracy, a little bit for firms, but a lot for the FDA. And that would likely just tie them up from doing the most important stuff, making sure that the firms are producing high-quality products, that the products out there are safe, the dangerous ones are removed.

But on the other hand, I think that if we were to design a listing, a registry, that has sufficient teeth to make it truly transparent to consumers. For example, if the FDA has concerns about ingredients, that that should be clearly flagged right there on the registry. If the registry is tied to a QR code, a specific code that consumers can use right at the point of sales and see if there's any concerns that the FDA has raised with this product or this firm, those are the steps that I would see would be necessary for a listing or a registry to be useful. If the FDA is not able to use it to enhance transparency, I'm not so sure that a listing will do much more than create a lot more paperwork for the agency.

John Troup: So it sounds that you would be a proponent of not only mandatory product listing, but also along with that, some kind of a consumer education or tool that could help facilitate the awareness of a consumer on the appropriate use or selection of a product.

Pieter Cohen: It would be very important to be transparent. Examples, John, that I'm thinking about are, let's say, a firm submits a label to the FDA that includes an ingredient that the FDA has already determined is not permitted in supplements. I see no reason why the FDA would be required to place that on the registry. On the other hand, what if the FDA is decided after the fact that an ingredient is of potential concern or there might be safety issues with an ingredient at a certain dose? I would like to see that the registry includes the ability, and the FDA has the authority, to place information about that directly onto the registry.

You're raising other very interesting questions though. What sort of information could be tied there and used there? And of course, this immediately draws segues into what we were talking about before, it could be used for misinformation too. If structure/function claims, especially ones that stretch reality, are permitted to be placed right there on the FDA website at the point of sale, we'd have to think carefully whether or not that sort of information is doing more harm than good.

John Troup: What about the opportunity of inspections? Right now, as I understand it, somewhere in the neighborhood of between 500 and 600 manufacturing facilities are inspected or audited by the FDA. It's not enough, right? And of those 500 to 600 sites that are audited, about a third of them are repeat visits from the year before, so the total number of manufacturers far exceeds what inspections are going on. Do you think there's a solution to that? And actually, if there is a solution, do you think that'll make the difference, particularly for, say, smaller companies that maybe haven't invested as much as they ought to in quality assurance and quality control?

Pieter Cohen: Well, these are great questions. I think first off, we need to figure out how to make the inspections useful, effective, before we just expand out what we're doing. I mean, from what I understand, what the FDA is seeing in terms of noncompliance with CGMPs, it's very similar year to year despite all the inspections that they're doing, which I agree with you are not nearly enough to get a handle on the entire industry. And we're also seeing that the FDA goes back to the same firm again and they find the same problem. And that ties up the agency too, of course. They have to do all these inspections at one firm and tying up their resources. So we're going to need to figure out some way for these inspections to have more consequences, honestly.

As far as I can see, even when they're very serious violations, it almost always is just a slap on the wrist, and the firm who's not compliant with CGMPs can continue to sell their products. This is another way that I'm thinking that the registry could be useful for transparency. Imagine a situation where a firm was in violation of CGMPs to such a level that requires a rapid return of the agency in a short period of time. That could be defined as some big concerns about the inspection. Why not flag all products made by that firm on the registry to be clear that the FDA is currently needing to reinspect them soon, because of problems they found the last time? Well, I think all of a sudden if that were point of sale and every consumer could see that when they purchase their product, all of a sudden I would expect compliance is going to pop way up in terms of CGMPs and we'd be in a much better position. So that's another idea of transparency and...

John Troup: Yeah. Similarly, your examples and discussions on consumers who were reporting adverse events, there's a method and a practice in the United States that requires reporting of adverse events of patients. Whenever they take something, it should be reported in a program called MedWatch. And depending on how serious that adverse event might be, a serious adverse event, it would actually require reporting to the FDA and, at the very least, voluntary product withdrawal from the market. But a lot of those adverse events aren't really followed up on, and there's no enforcement way to give that, to your example here, meat to take that information and then automatically or quickly take the product off the market. Do you see a link that's possible from clinical care to medical reporting to enforcement as a possibility, or is that just going to be too wieldy that it won't be effective?

Pieter Cohen: Well, I think first off, it's another caution, I guess, with a registry that I would want to make. Similar to the structure/function claims, I would not like to see those on the registry. I would also not want to see every time someone's reported something to MedWatch that those reports are linked to the registry. Because as we know, there's lots of different reasons reports get into the MedWatch system, and it's not necessarily that the supplement caused that harm. So we don't want spurious data to get in there. I'm sometimes struck by the fact that there can be really serious adverse events happening that never make it into the current system. So I think we need to not have those two connected, I think that would do a disservice to consumers.

But what I do think is that once the FDA evaluates MedWatch or independent data to suggest harm of an ingredient or a product, that delisting on the registry, or be able to remove it directly immediately from market would be, in my opinion, to make sure that everything on the registry is as safe as possible, would be essential. If the FDA didn't have the authority to delist a product based on safety, then, again, and instead they're tied up in court for years about every brand, we're not going to see improvement on that front.

John Troup: There's always, and for 50 plus years, ongoing debate within the healthcare community by and large on the value on the use of dietary supplements. And many in the healthcare community would even not recommend dietary supplements, is it because of the safety issue? And if that's the case, what will it take for this industry to have a better level of credibility with the healthcare system and healthcare providers? Is it these regulatory issues and frameworks that we're talking about, or is it something more than that that industry should be sensitive to and working on?

Pieter Cohen: I think the two most important things are, one, is the quality of the products. I think when we see study after study showing that the labels don't actually accurately capture what's actually in the supplement, that is really hard for us as physicians, because how can we recommend something when we don't even know what our patients are taking? The other part of it is when it comes to efficacy, and where there's a bit of a disconnect between... In medicine, we're trying to use things that have been proven valuable in multiple large clinical trials. Now, we are also using things that are very potent and might have many serious side effects, but we want to have had those clinical trials performed, so that we can understand the benefits, understand the risks, and then make a thoughtful decision for an individual patient.

I think the problem that we've run into often with physicians is in the claims. As soon as we start seeing claims that these supplements will do things without evidence from clinical trials in humans, that's really not going to build trust, I guess, among us. And there's just unfortunately a very large segment of supplements are making these kind of claims without large clinical trials.

John Troup: Yeah. I have to ask you since everybody's thinking about it living in the world right now is the whole pandemic, COVID-19. There's been such an increase in the use of dietary supplements by consumers, in part a preventive care approach to COVID-19, has that been a good thing? Is that a bad thing? Have you seen an increased number of patient complaints or adverse events along with the growth in the category and the increased use of supplements, or what's happening on the other side in clinical care?

Pieter Cohen: Yeah. I've got to say, John, that in terms of COVID care, and I do a lot of it, I work in a COVID clinic and have been doing that since the pandemic started last March, patients are really sick in clinic and we have so many immediate concerns that we're dealing with, whether or not someone can walk safely into the room, or someone needs to go to the emergency room, that honestly I haven't had the time to flesh out. Oftentimes, even though it's an area that I, of course, am very interested in what's going on with our supplement use, because we have so many competing concerns. Are they going to be able to have food available when they're sick with supplements? Do they need to get on oxygen in the hospital? How can they keep their loved ones at home from getting infected? So I guess it's like the acuity of the issue from the medical side creates a lot of attention to this immediate needs and crisis. So I really don't have a good answer to you in terms of what people are doing in terms of supplement use and what's going on with that.

John Troup: Yeah. Thanks so much for you and your colleagues and all the work that you're doing on the front line. Do you have any idea of what number you were when you got your vaccine? I'm guessing you already had the vaccine, but were you one of the first receivers?

Pieter Cohen: Yeah. In Massachusetts... So people on the front lines were one of the first, probably on the second day it was being offered in Massachusetts [inaudible] health center I was able to get it. It was a big snow storm that day though, so I had to snowshoe four and a half miles into the hospital and four and a half miles back to get my vaccine. It was a day I will never forget. That is a medical success story that's just remarkable. That in March, we didn't even know what this disease would do when we showed up in clinic. And then I was able to have a vaccine going into my arm, which had FDA emergency use authorization, less than 12 months later. Incredible.

John Troup: Did you get the second shot already?

Pieter Cohen: Yeah, we got the second. It's already been two weeks on the second, so I'm kind of in the post-pandemic, living the post-pandemic life.

John Troup: Well, good. I'm glad to see you healthy, and again, thanks for all the work of you and your colleagues and taking care of so many patients. But anyway, in the last couple minutes that we have left, I'm a little curious, did you grow up in the Northeast? Are you Bostonian or...

Pieter Cohen: Yeah. I'm from [inaudible]. I've been a Red Sox fan since I could remember. I grew up right outside of Boston. Although I went away for undergrad and grad school, I came back and been here for my clinical practice. I've been practicing at Somerville for over 20 years now.

John Troup: Yeah. Well, I got to ask you if you're a big Boston area sports fan, how do you feel about Tom Brady, 43-year-old quarterback, winning a Super Bowl without being on the Patriots team? How do you feel about that? Excited?

Pieter Cohen: Well, it was extremely impressive. When I was 43, I mean, one of those hits would have me hospitalized for three months, and now I wouldn't even be able to walk. So it's a remarkable feat.

John Troup: Right. I got to ask you as a fan, not as a physician, how do you feel about Tom Brady's nutrition regimen and lifestyle regimen? Is that good? Or you're excited to see a guy be able to stay that fit for as long as he has?

Pieter Cohen: Yeah. I think it's always good if we're encouraging healthy lifestyle habits. I think we have to be careful of extrapolating. I think Tom Brady is incredibly unique, we think probably the best quarterback ever, so we should not extrapolate. It could be that his unbelievable skill and his dedication to his practice is 99.9% responsible for what he's up to and not any particular regimen. So I think we have to be careful in terms of extracting it. That's why I like to see the data, show me the data.

John Troup: I'm so glad to hear you say that, that means that I can keep eating tomatoes and avocados, thank God for that, and drinking a glass of wine. So Dr. Pieter Cohen, thanks very much for being the advocate that you are in the safe use of dietary supplements, and the difference that you and your publications make, and taking the time to talk to us about these important issues to help make the industry even better. Pieter, thanks very much for your time. Great, as always, talking to you.

For those of you who would like to learn more about his position in advocating for the safe use of dietary supplements, we'd encourage you to go to the New England Journal of Medicine and read the article that he co-authored with Scott Bass on the issues facing the dietary supplement industry and possible solutions.

Guest

Pieter Cohen with stethoscope and red tie
Pieter Cohen, MD
Associate Professor of Medicine, Harvard Medical School, Boston MA; Physician, Internal Medicine, Cambridge Health Alliance
Guest
 

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