Navigating Dietary Supplement Regulations

Echinacea, vitamins, and other dietary supplements have become a $5 billion industry, but the products don't need to be pre-approved by the FDA before they go on the market. How do we know what is really in our supplements? What regulations are currently in place? How can we keep ourselves safe and informed?

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JOHN DANKOSKY, HOST:

This is SCIENCE FRIDAY. I'm John Dankosky. Ira Flatow is away. If you walk into any nutritional supplement store today, it seems there are thousands of herbal remedies to treat anything that ails you: Echinacea for colds, dandelion root to help with water retention, grapeseed to promote healthy aging. So many people are including dietary supplements in their daily routine that it's now become a $5 billion industry.

But do you know exactly what's in the supplement pills you're taking? A group of Canadian researchers put out a recent study that used DNA bar-coding to test what was really in those bottles. They found that only two out of twelve companies put what they claimed was in their supplements in the bottles. The rest either had contaminants or substitutes, like rice or wheat.

So how do we know what is really in our supplements? What regulations are currently in place; how can we keep ourselves both safe and informed? You can call us with your questions about dietary and herbal supplements. Our number is 1-800-989-8255. That's 1-800-989-TALK. If you're on Twitter you can Tweet us @scifri. If you want more information about what we're talking about this hour, just go to our website. It's sciencefriday.com. You'll find links to our topic.

Let me bring in our guests. Victoria Maizes is executive director at the Arizona Center for Integrative Medicine and a professor of medicine and public health at the University of Arizona in Tucson, Arizona but she joins me in the New York studios today. Victoria, welcome.

VICTORIA MAIZES: Thank you. It's a pleasure to be here.

DANKOSKY: And David Schardt is senior nutritionist at the Center for Science in the Public Interest in Washington, D.C. David, welcome to our show.

DAVID SCHARDT: Thank you very much.

DANKOSKY: David, I'll start with you. Were you surprised by the results of this Canadian study?

SCHARDT: What was not surprising was the fact that the herbal supplement industry has this big problem with quality control. The results of this study really were consistent with what we've known goes on. For example, the last two years there's been two studies of black cohosh, which is a botanical that's touted for menopausal symptoms, and that study found that, in one of them, that one-third of the products didn't have any black cohosh and in the other, one-quarter of the products didn't have any black cohosh.

In this Canadian, new Canadian study, they found that about a third of the products did not have what the label said it had, so in that sense it's consistent with what we know, that there's a serious problem in the industry. What this - what was a little surprising was how widespread it is. This DNA bar-coding gives us, for the first time, a real peek into these products and they found so much, 59 percent of them contained plant material that wasn't listed on the label.

Nine percent of the products contained only rice or wheat. We're finding this kind of thing out for the first time.

DANKOSKY: And with things in there that aren't listed on the label, potentially there could be some things that might harm people, David?

SCHARDT: Potentially. They found small amounts of soy, which is, some people are allergic to soy. They've found a little bit of black walnut in one of the supplements. Some people are allergic to nuts, so it possibly could hurt someone. One of the St. John's Wort pills had none of that. It had senna, which is a botanical laxative and so that might be harmful to somebody.

I think more likely, though, that people are just going to be cheated, cheated out of their money. They're not going to get something that they thought was going to work for them. They're just wasting their money in many of these cases.

DANKOSKY: Victoria Maizes, you've seen this study. Do you think the contamination of dietary and herbal supplements is widespread?

MAIZES: Well, I agree with David. I think that the industry does have a problem, but I think this study does a disservice because it implies that most herbal products are bad and I'm not an expert on DNA bar-coding, but it's a new technology. It's not clear that it's accurate for botanical extracts, which can be denatured, the DNA could be denatured in the process.

And there are many validated methods that have been used and acknowledged by the United States Pharmacopeia, the European Pharmacopeia, and so I think this implication that these products were all of low quality is something we have to look at very cautiously. And the American Botanical Council actually did a very good review of the study - it's on their website - looking at the flaws in this study.

DANKOSKY: But beyond this study, David seems to be suggesting that there have been other studies that do suggest that sometimes what is supposed to be in the supplements isn't in the supplements. I guess I wonder how the herbal supplement world deals with this issue. Clearly there is a problem out there.

MAIZES: Well, I agree. I think that we deserve better regulation, that the American public deserves to have herbs that are safe, that are effective, that are of high quality, that are labeled accurately so that what it says on the label is indeed what's in the bottle and that there are no contaminants or adulterants. I do think we've come a long way since good manufacturing processes were put in place and required of all companies. That happened in 2007.

I think that another level of control is that many stores - I have no relationship to any of these stores, but places like Sam's Club, or Costco or Whole Foods have strict quality control on top of that. And so this idea that nobody can get good quality herbal product I think is a bad idea, especially since herbs, generally speaking, are much safer than pharmaceuticals.

We have over 100,000 deaths a year from pharmaceuticals. We have very rare deaths - not zero, but rare from herbs. And so when we take the herbs away, often we end up with a more dangerous situation to our public.

DANKOSKY: Well David, let's just understand exactly what the regulatory requirements are right now for these supplements. Explain what oversight, if any, the FDA has, for instance.

SCHARDT: Well, there's what we consider rather loose oversight. The supplements are considered food, not drugs, and so they don't have as strict regulation as prescription drugs or over-the-counter drugs. There are good manufacturing practices regulations, which manufacturers are supposed to follow. It involves sanitary production. What goes in the bottle and what's labeled as in the bottle should match.

They can't put in things that are not labeled or not supposed to be there. One of the problems is that there's no testing. FDA does not test these products. In fact, no one really does aside from one small operation called consumerlab.com. And so the herbal supplement manufacturers have basically gotten away, for a long time, without having much oversight or much testing or verification of their products by independent bodies.

And the result is that you see this continuing problem. The study didn't suggest that all products are bad. It found, in fact, they could authenticate half of them. The problem is that a third of them didn't - had something else substituted for what was on the label and that's close enough to almost a 50/50 chance of when you go into a store, your chances are one in two or maybe two in three that you'll get a quality product.

Those odds are not high enough. The consumers deserve better.

DANKOSKY: Why isn't there more testing, Victoria?

MAIZES: Well, what David mentioned is that herbs are regulated differently from drugs, so the FDA regulates them, essentially, as food and there are different standards. I think we would do well having tighter regulation in the United States. Canada has actually done a very good job. Health Canada regulates them as natural health products, so not exactly as drugs but not like food either.

And so in Canada you have to apply and register your products. You have to have data for safety and efficacy. You have statements on the bottles that say what it's good for. We only have structure/function claims. And they have mandatory caution labels if there's a risk to someone to using that herb together with a medicine or if people with certain conditions shouldn't use it.

So I do think that we could do a better job regulating our drugs. David mentioned consumerlab.com. That is one group that independently verifies. You have to pay a fee to use their site, but I think that it is one way for American consumers to choose products that have been third-party tested, pulled off the shelf, be sure that what it says on the label is indeed in the label.

But also the United States Pharmacopeia, the USP, and the NSF also put their labels on products that have gone through their verification processes.

DANKOSKY: We're talking about herbal supplements on the program today and we'll take your calls at 1-800-989-8255 in just a moment, but I want to bring into the conversation Dick Durbin, who's a U.S. senator from Illinois and you introduced the Dietary Supplement Labeling Act in August of this year. Senator Durbin, welcome to the show. Maybe you can tell us what this act is trying to address.

SENATOR DICK DURBIN: I think most Americans would be surprised to know that the dietary supplements which they've purchased, such as vitamin supplements for example, are not registered with the U.S. Food and Drug Administration with any basic information. The bill that I've suggested is that every manufacturer provide the FDA with a copy of their label as well as a list of ingredients, provide some basic information about quantities and whether there's any chemical included in the product that might interact with other drugs or cause some difficulty. It's just basic information. And a batch number, so if something goes wrong, we can find out what happened.

DANKOSKY: What has been the hold-up for this sort of regulation in the past, Senator Durbin?

DURBIN: Well, I can tell you, since I've been trying for a long, long time to move in this direction, there are players in the industry that resist any type of disclosure and they certainly don't want to have to come forward and explain what is in their products. Many of them are overseas manufacturers selling in the United States their combinations and products which American consumers really don't appreciate and can't appreciate because of their complexity.

DANKOSKY: David Schardt, this idea of overseas producers, of course this is a big point. It's one thing to regulate producers here in the United States, but to regulate an entire world marketplace would be very difficult, don't you think, David?

SCHARDT: Yes. But this would move us closer to the Canadian system which, I agree with Victoria, would be much better for us. The Canadians deal with it. I think we in the United States can. It's going to require more vigilance on the part of manufacturers. They're used to not testing their products thoroughly, not having to provide information.

They're just going to have to learn how to do it.

DANKOSKY: Senator Durbin, I know that there are people who are part of the herbal supplement industry or people who take herbal supplements who say that a bill like yours is an attack on alternative medicine, that you're taking on something that actually helps them. What do you say?

DURBIN: What I say to them is, I got up this morning and I took my multivitamin, OK. I'm not at war with this industry. I want to be at least sure, as a consumer, of what I'm consuming and what my family would be consuming. Asking the manufacturers of these products for basic information, you know, so that we have on file batch numbers and labels and the chemical ingredients and quantities involved is not an attempt to close down the industry. It's an attempt to make it more responsible. Good dietary supplement manufacturers will be able to meet this burden without any problem. Those overseas who don't want to tell us about their combinations and what they might mean, I expect they'll resist it.

DANKOSKY: We're talking with Dick Durbin, a senator from Illinois and also David Schardt, a senior nutritionist with the Center for Science in the Public Interest. Victoria Maizes is here. She's executive director of the Arizona Center for Integrative Medicine. We're going to take your calls in a moment at 1-800-989-8255. That's 1-800-989-TALK as we talk about the herbal supplement industry and regulations. We'll be right back after this short break.

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DANKOSKY: This is SCIENCE FRIDAY. I'm John Dankosky and we're talking about dietary and health supplements. How do we really know what is in them? If you want to join us, it's 1-800-989-8255. That's 1-800-989-TALK. Let's to go Molly, who's calling from Boulder, Colorado. Hi there Molly. Go ahead. You're on SCIENCE FRIDAY.

MOLLY: Hi. Thanks for taking my call. I found your topic really interesting today and I want to state that I'm not opposed at all to taking vitamins and supplements, but I think that they can be highly overhyped and I think it's really important to look at the science behind them. And I want to mention that for listeners out there who know what the Cochrane Collaboration is.

It's a really important facet of science and medicine and what it does is it takes a look at systematic reviews of research in human healthcare and health policy. And so they use evidence-based healthcare to recognize what are the best treatments and so when they review things like, you know, how many supplements are best to take a day or, you know, like how many should we be taking? It's good to take a look at the evidence that we have.

DANKOSKY: And that's one place that we can look, and thank you for your phone call. I guess I'm wondering if people are looking for the science behind this and how herbal supplements work, Victoria Maizes, what are some other places they might turn?

MAIZES: Well, it's a great question. We at the University of Arizona Center for Integrative Medicine train physicians, nurse practitioners, physician assistants, how to study herbal medicine, how to make recommendations to patients, how to find good products. There's a wonderful database called Natural Medicines Comprehensive Database that's very useful for health professionals who are trying to answer their patients' questions about supplements.

And there's also the Office of Dietary Supplements, the National Center for Complementary and Alternative Medicine. They all have websites that list many of these dietary supplements and some of the research supporting or against their use.

DANKOSKY: Senator Durbin, before I let you go, our caller seems to be asking for more scientific information. I'm sure this is what you're hearing from your constituents. A lot of people use these supplements but they just want to know a little bit more where they can turn, where they can get good science. Is that what you're hearing?

DURBIN: That's what I'm hearing and let me tell you, I'm not ruling out dietary supplements, herbal supplements, as health aids and I think many of them are. I believe they are. But I think the standard we've tried to establish is are they safe; are they safe for the general public? Are there warnings that should be on the label relative to children, or for women who are pregnant or those who have compromised immune systems, that sort of thing?

And secondly, are they effective? When they claim to do certain things, do they in fact achieve those things? It's all consumers really need, I think, to get started: Basic information about the product and those two criteria. And I think there are opportunities out there and I applaud the research that tries to move us in new areas to find cures.

DANKOSKY: The Dietary Supplement Labeling Act is the work of Dick Durbin. He's a senator from Illinois joining us on the phone today. Thank you, Senator, so much for joining us on SCIENCE FRIDAY.

DURBIN: It's good to be with you. Thank you.

DANKOSKY: I want to turn back to you, David Schardt. One of the things that the senator just mentioned was the idea of the claims that are made. What can different herbal supplement makers claim that their products can do and where do they have to stop short? What things can't they claim?

SCHARDT: Well, the line in the sand that the FDA draws is that they cannot claim to prevent, mitigate or treat a disease, such as cancer, Alzheimer's Disease, heart disease. But they can make any claim short of that, and supplement manufacturers have become quite clever at suggesting but not quite explicitly claiming that they can affect some of these diseases.

So you'll see claims like supports a healthy heart or improves memory and clarity and attention. They can make those claims. Now, they're supposed to have - those are called structure/function claims and they do not have to be preapproved by FDA. Now, they're supposed to have substantiation for that. As a matter of the law, the original law in 1994 made no mechanism for actually those companies demonstrating that substantiation or even providing it to FDA.

One of Senator Durbin's, part of that new legislation he's proposing is that it would require companies upon FDA request to provide that substantiation and we think that would be great, because a lot of these claims really are not substantiated or are greatly exaggerated. If the public saw the basis for some of those, they would be appalled.

DANKOSKY: I want to go to Lisa, who's calling from Washington, D.C. Hello, Lisa. You're on SCIENCE FRIDAY. Hi Lisa, you're on the air. Let's go to Don, who's calling from Colorado. Hello, Don.

DON: From Boulder, Colorado?

DANKOSKY: You're on the air, Don.

DON: Thank you. Yes, I'd like to make a comment. I'm involved with Pharmaca Integrative Pharmacy, a chain of integrative medicine pharmacies in the western U.S. and I have been on over 85 facility tours throughout North America and Europe and Asia visiting manufacturing facilities of dietary supplements and one thing that I'd like to state is that I'm constantly reading information that the FDA does not have oversight or regulatory - does not have regulatory oversight on the dietary supplement manufacturers.

But I know for a fact that many of these facilities have FDA inspections to ensure that they're following the dietary supplement health and education good manufacturing practice guidelines outlined by the FDA and there are many great herbal and dietary supplement manufacturers in Europe and in North America that are putting out high quality, safe and effective dietary supplements.

And the final comment is that I think that the Dietary Supplement Health and Education Act needs to be updated to allow for American manufacturers to be able to put health claims on dietary supplements like they do in Canada, like they do throughout most of Europe, so that customers can be more informed on how to use the products because the current legislation, which allows for structure/function claims, does not go far enough for consumers to make informed choices on how to use a certain amount of the supplements that are on the market in America.

DANKOSKY: What's structure?

DON: Well, structure/function claims that are currently allowed under the Dietary Supplement Health and Education Act do not go far enough for customers to know how to use some of these supplements that are on the market.

DANKOSKY: I'll turn to Victoria Maizes. Maybe you can pick up on what our caller's talking about.

MAIZES: Well, I agree with Don. I think that it's very confusing for consumers. Structure/function claims, like "supports a healthy bladder." What does that mean? Does that mean it helps prevent bladder infections, does that mean if you get a bladder infection this is going to help treat it? They're incredibly confusing and I think that if we could update the regulations so that it was clear, this is what this herbal product does and this is the appropriate dose and these are the potential side effects and this is the person who should avoid taking it because there's potential danger or interaction. That would be great.

DANKOSKY: But how do we know it does what it does? I think that's the point of the conversation.

MAIZES: Well, there's a tremendous body of research, actually, about herbal medicine. There's long history of use in many, many cultures. Remember, herbs were our first medicines and many of the pharmaceuticals we use today are actually derived from herbs. So in some cases we have hundreds or even a thousand years of use of an herb and we also have randomized control trials.

There's the Cochrane Review that your previous caller mentioned that looks at meta-analyses. There's a lot of research that's been done about herbal products, but when someone goes to the health food store and is advised by a clerk saying this is the best product for your particular problem, in some ways that's practicing medicine without a license.

DANKOSKY: David Schardt, has there been enough research done into many of these herbs?

SCHARDT: There's certainly been research and, as a matter of fact, most of the recent research done in the United States has basically found that a lot of herbal supplements really don't work when they've been tested in large, randomized control trials with enough subjects, run by good quality investigators who know what they're doing. More often than not, we find that they don't work.

Now, the Canadian system, I should point out, those claims have to be preapproved. You have to submit evidence for a claim that you want to make and it's reviewed by scientists at Health Canada and then they establish which claims have been substantiated and companies can make those claims, but some claims have not been substantiated, and some of the claims that manufacturers want to make are not verified by the research and are not allowed in Canada. So, it works both ways. Companies may be able to make some claims but not others that they want to make.

MAIZES: You know, I certainly believe, David, that we need more research. We'll always say we need more research, that's part of the way science and medicine works. Having said that, as an integrative medicine physician, I use herbal products all the time. Let me give an example.

We have thousands, if not hundreds of thousands of people, who have reflux, GERD, heartburn. And they're taking these really potent medicines called proton pump inhibitors that are now available over-the-counter, that are extremely hard to get off of once you've gone on, because you have this rebound increase in acid production that makes it so difficult to get off.

So how do we get people off of these drugs that are, by the way, only studied and approved to be used short-term. And yet people stay on them for years and years and years, and they're associated with community-acquired pneumonia and hip fractures and all sorts of problems. Well, the way I get people off of them is with herbal medicines. So I, for example, would use DGL which is a deglycyrrhizinated licorice.

I would use a German product called Iberogast, which is a mixed chamomile product that helps. I might use melatonin. These herbs help me do something that patients often really badly want; they want help getting off of that drug that they now feel like they just can't possibly get off of.

DANKOSKY: Very quickly, how much of this is a placebo effect? People believe that things will work and they then work for them, because the placebo effect has been found in many cases to be very, very strong.

MAIZES: It's a great question and in our randomized controlled trials, we usually do test things against a placebo. Remember, that you could define the placebo as the body's innate healing mechanism at work. It's pretty amazing that you could give an inert subject and someone could get better. So I don't think we should discount the value of the placebo.

Having said that, some of these herbs have qualities that we have no conventional medicine corollary for, like milk thistle is an example. Milk thistle has been tested and been shown to be helpful when people have toxic liver damage from alcohol or from the death cap mushroom. We have nothing like it in Western medicine. It's not a placebo effect. It saves people who would die from mushroom poisoning.

DANKOSKY: We've been talking to Victoria Maizes, executive director of the Arizona Center for Integrative Medicine; a professor of medicine and public health at the University of Arizona in Tucson, Arizona. But she joined me today in the New York studios of SCIENCE FRIDAY.

Thank you so much for being here.

MAIZES: A pleasure.

DANKOSKY: David Schardt, a senior nutritionist at the Center for Science in the Public Interest in Washington, D.C., and, David, thank you very much for being here as well.

SCHARDT: My pleasure.

DANKOSKY: I'm John Dankosky and this is SCIENCE FRIDAY from NPR.

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