Supplements and SafetyView Film
TRADE SHOW SALESMAN: This is a product that was formulated for people who are severely—
TRADE SHOW SALESMAN: It would be great for older individuals that are concerned about—
TRADE SHOW SALESMAN: —joint supplement—
GILLIAN FINDLAY, Correspondent: [voice-over] It’s estimated that half of all Americans take a health supplement every day.
TRADE SHOW SALESMAN: That one is going to be amazing for supporting—
TRADE SHOW SALESMAN: —encapsulates the nutrients in a non-GMO soy—
GILLIAN FINDLAY: It’s a $30-plus billion industry.
TRADE SHOW SALESMAN: I will guarantee you that this will change your reality within three to five days.
GILLIAN FINDLAY: Companies range from big pharma to mom and pop.
CANDICE TRIPP, Owner, Purity First: I started in my kitchen making them by hand back in the ‘80s. I would order the ingredients, I would order the capsules, and with a plate of 100 capsules, I would weigh it out and fill them up, and you have a bottle of 100 capsules of any particular vitamin you wanted.
GILLIAN FINDLAY: [on camera] Do you have background in pharmacology or medicine or any expertise in this area?
CANDICE TRIPP: I did some college, but most of my time was spent in the medical libraries at Stonybrook.
GILLIAN FINDLAY: So you sort of were self-taught, then, were you?
CANDICE TRIPP: Self-taught, correct. Yes.
GILLIAN FINDLAY: [voice-over] Candice Tripp called her company Purity First. She says she was helped by her then husband, Terence Dulin, a chiropractor.
[on camera] And what was his academic background or expertise in this area?
CANDICE TRIPP: He was a chemist. He was a chemist in college, and then he went on to chiropractic school.
GILLIAN FINDLAY: [voice-over] From modest beginnings, she grew the business into a half-a-million-dollar-a-year enterprise, selling on the Web, in stores and through local alternative health care providers.
VINCENT GROSSO, Purity First Customer: Purity First is a great name, and I said,“Gee, how can you go wrong?” It’s what you would imagine that you would want in every single vitamin, that it’s absolutely pure.
GILLIAN FINDLAY: Vinnie Grosso was an early Purity First customer. The vitamins became part of his daily quest for better health.
VINCENT GROSSO: I felt fine. And of course, you know, I’m running every day. I’m feeling great up until the October, November, December timeframe of 2012, where I had some very unusual symptoms.
GILLIAN FINDLAY: It started with unexplained back pain that soon became debilitating. He then started hearing from other Purity First customers with troubling symptoms of their own.
VINCENT GROSSO: I’m hearing stories— “My daughter is an honor student and she’s on the swim team, but she’s been thrown out of school for being overly aggressive.” I’m talking to a woman who had lost her position in a choir because her voice had changed. I’m talking to another woman, who said, “I’ve got these incredible bleeding scales on my head, and I can’t go to work.”
GILLIAN FINDLAY: They were all taking the same vitamins, recommended, they say, by Terence Dulin, the chiropractor, now a naturopath. Dulin declined to be interviewed and denies any responsibility.
CANDICE TRIPP: Terry had come to me in January and asked me if I thought anything was wrong because he said there was some blood tests coming back that were funky. At that point, we had just had Hurricane Sandy come through, and a lot of people were getting sick after they were in their basements cleaning up water. And that’s why he had recommended people go see this other doctor. And they started going to see Dr. Spaeth.
VINCENT GROSSO: We had an examination, and he said to me, “What is it that all of you who have come to me in the past month and a half have one commonality. You’ve all taken Purity First B-50 vitamins.”
GILLIAN FINDLAY: It’s estimated there are 85,000 dietary supplements for sale in the United States today.
TRADE SHOW SALESMAN: Right here, I have our liposomal D—
TRADE SHOW SALESMAN: So this is our bacopa. This is an herb that would be great for older individuals that are—
TRADE SHOW SALESMAN: The essential nutrients, like chromium—
GILLIAN FINDLAY: With so many pitches and promises, you might assume that some government agency has approved them before allowing them onto the market.
STEPHEN OSTROFF, M.D., Acting Commissioner, FDA: The FDA does not do any review of dietary supplements before they come onto the market, and I think that all consumers need to understand this.
GILLIAN FINDLAY: No testing, no obligation to provide any evidence a product is effective, or even safe. The one thing manufacturers do have to show is that they follow good manufacturing practices. The FDA conducts inspections for that, but it’and by information.
Dr. STEPHEN OSTROFF: We actually don’t know the total number of manufacturers that we need to be able to inspect because there is no formal registration system that is required of manufacturers that make dietary supplements, and so we do inspections of the ones that we know about.
GILLIAN FINDLAY: The FDA did know about a supplement manufacturer that used to operate here. In 2012 and again in the spring of 2013, MIRA Health Products was cited by FDA inspectors for violating manufacturing codes. Among the products MIRA produced, Candice Tripp’s Purity First vitamins.
CANDICE TRIPP: I had a lot of faith in MIRA because he was more of a smaller-scale manufacturer. He wasn’t one of these big pharmaceutical companies that just didn’t really make you warm and fuzzy.
GILLIAN FINDLAY: [on camera] Well, what did you do to try to verify that this was a reputable company that would make the product that you wanted?
CANDICE TRIPP: They’re supposed to test the product and give you an analysis at the end that what is in the capsule is what they’ve tested, and the certificate is supposed to be certified and this is what your product is.
GILLIAN FINDLAY: And did they give you those certificates?
CANDICE TRIPP: I believe— yes, they did. They gave us those, and there didn’t seem to be a problem.
GILLIAN FINDLAY: [voice-over] But by 2013, there was a problem. Dr. Kenneth Spaeth, who specializes in environmental health, is a man those Purity First customers turned to to investigate their symptoms. He arranged for the B-50 vitamins to be tested, and the results were a shock. The capsules were laced with two anabolic steroids.
Joe Kueler, Candice Tripp’s current husband, took it up with MIRA’s owner.
JOE KUELER, Purity First: I called Mike and said pretty much, “What could have happened?” And you know, he was making the male enhancement pills, and he said, “Joe,” he said “if they found any type of steroids in there, the only thing I could possibly think is maybe the mixer was not cleaned enough.”
GILLIAN FINDLAY: By now, Purity First customers had started hiring lawyers and sharing their stories.
CHRIS MEAGHER, Plaintiffs’ Attorney, Meagher & Meagher, White Plains, NY: A change in the voice, change in the sexual organs, hair growth on a young lady was one of our clients, basically developing moustache, beard, the female sexual organs taking on a male configuration. For the men who ingested these things, they developed what’s called gynecomastia. You end up with male breasts.
GILLIAN FINDLAY: It would take the FDA nearly six months to get the Purity First vitamins off the market, a response Dr. Spaeth called “glacial.” He declined to be interviewed on camera, but he shared email exchanges with us detailing his efforts to get the FDA to act.
Spaeth says he suspected contamination, but his first inquiry went unanswered. When he emailed again, asking if the lack of response was a lack of interest, he was referred to the FDA’s hotline for adverse reactions, called Medwatch. Spaeth had tried the line, been transferred and put on hold before being disconnected twice.
Five weeks later, he was still frustrated. “Will you tell me what your plans are?” he wrote. “I have 20 very worried patients and little to offer them.”
Among the officials Spaeth was writing to was Daniel Fabricant, then head of the FDA’s Division of Dietary Supplements.
DANIEL FABRICANT, Ph.D., Div. of Dietary Supplements, FDA, 2011-14: We took that information. While it was helpful, it didn’t make the whole case. We had to make the case at FDA, and we did, and removed the product successfully.
GILLIAN FINDLAY: [on camera] One of his biggest complaints is the amount of time it took just to get somebody to call him back. He says that one of the operators— “She acted as if I was telling her that aliens put messages in my Cheerios.”
Now, that doesn’t suggest that you’ve got a particularly robust system in place to allow people to report problems when they happen, right?
DANIEL FABRICANT: Well, I can assure you the government worked very quickly. The agency is acting to remove the product across the board, across the country. So it’s a bit more of a heavier scientific lift than just a doctor having an intuition or a feeling about something. They have to build evidence, court-ready evidence, to take away somebody’s product, somebody’s manufacturing operation.
And that’s exactly what we did. And doing that in six months, the team at the FDA worked diligently and worked quickly to do that, which was quite a successful accomplishment.
CANDICE TRIPP: Two women from the FDA came in and were speaking with us about how there seems to be a problem with one of our products. When we asked which product, they said, Oh, that didn’t matter yet. OK. “Do you want us to stop selling the product?” “No, you don’t have to stop selling the product. Nobody died,” they said.
GILLIAN FINDLAY: [on camera] “Nobody died”— those were their words.
CANDICE TRIPP: Their words were, “Nobody died. You don’t have to pull the product.”
GILLIAN FINDLAY: If there was any concern at all, why didn’t you just pull it from the market? I mean, why did you not do it yourself?
JOE KUELER: Great question. Their response to me was, “People call the FDA all the time to report minor things, so don’t worry about it.”
GILLIAN FINDLAY: [voice-over] The FDA strongly denies those things were said.
NEWSCASTER: So vitamins manufactured here on Long Island are triggering—
NEWSCASTER: The FDA recently issued a recall—
NEWSCASTER: The FDA wants—
GILLIAN FINDLAY: In the end, Purity First withdrew the vitamins under pressure. MIRA was forced out of business by the FDA. Nobody from the company would speak to us. Thirty-six people are now suing the companies, and no one knows how many people in total may have been harmed.
For Vinnie Grosso and his lawyer, it was a sobering look into a troubled world.
VINCENT GROSSO: I was very concerned, and then I realized that this whole industry needs change and how much danger we’re all in not just from Purity First, likely, but from others that can put anything into these little bottles and put a seal and a label on it.
GILLIAN FINDLAY: In 2013, the Children’s Hospital of Philadelphia had had enough. Worried about the number and quality of the supplements their patients were arriving with, hospital pharmacists decided to challenge manufacturers.
SARAH ERUSH, Pharm.D., Pharmacy Clinical Manager: Families are showing up literally with shopping bags full of dietary supplements. The regulatory issues in the United States are that you have to— if a patient brings a medication into a hospital, we have to, as pharmacists, verify that this is a quality product, it is what it says it is, it’s labeled appropriately, it’s being dosed appropriately, and so on.
PAUL OFFIT, M.D., The Children’s Hospital of Philadelphia: We got fed up. We took a step back and we said, “OK, we’re going to ask these companies to at least meet a labeling standard.” They have to send us something called a certificate of analysis, which means they’ve had their product analyzed by an independent party that says that what’s on the label is what’s in the bottle.
Ninety percent of the companies never responded. And of the 10 percent that responded— of that 10 percent, often they would send us certificates of analysis where was what on the label wasn’t even close to what was in the bottle. And these were the ones who responded to us, which made us fearful of an industry that we couldn’t trust.
SARAH ERUSH: For example, this is an aqueous Vitamin D drop. So we use Vitamin D in premature infants. It says it should have 400 International Units per one ml of solution. However, it tells us that the results are that it’s 213 percent of the legal value. So it’s more than double what it says that it is.
So if we’re dosing premature infants who need very tiny doses if this drug, we’re now potentially giving them double what they should get, and could really put them at risk for toxicity.
GILLIAN FINDLAY: In the end, only 35 supplements met the hospital’s standards.
SARAH ERUSH: I come away very worried and dismayed, worried mostly about what the American public is being exposed to because it’s essentially a complete unknown. When you’re buying a dietary supplement, unless you have some proof of what’s in that product, it could be anything.
GILLIAN FINDLAY: At the New York Botanical Gardens, you can find many of the herbs we buy in bottles in their natural state. This is black cohosh, commonly recommended to women to treat symptoms of menopause. In 2010, gynecologist David Baker decided to check out what so many of his patients were taking. He bought dozens of brands of black cohosh supplements and starting testing the DNA.
Prof. DAVID BAKER, M.D., Stony Brook Univ. School of Medicine: Thirty percent had no black cohosh. And in the samples that we found, we could identify the other plants, as well, and they were from ornamental plants from China.
GILLIAN FINDLAY: Baker and his colleagues published the result in an academic journal, but they didn’t get much attention, so they kept on testing. Other supplements produced results that were no less disturbing.
Dr. DAVID BAKER: Upwards of 15 percent of supplements like saw palmetto are not saw palmetto. Supplements like devil’s claw— 100 percent are not devil’s claw or contaminated with some other problem.
What I see in this is that there are those who take the easy way out, the fraudulent way, and want to put something in the bottle that’s cheap and readily available. And buyer beware.
GILLIAN FINDLAY: With billions of dollars at stake, it’s no surprise that the supplement industry is a powerful force in Washington. There are four separate lobby groups, the largest the Natural Products Association, headed by Daniel Fabricant.
DANIEL FABRICANT: You know, a lot of the products now, you’ll see private label. A lot of the contract manufacturers that make the private label are our members, as well.
GILLIAN FINDLAY: It’s the same Daniel Fabricant who until 2014 was in charge of regulating dietary supplements at the FDA. He defends what critics have called a disturbing revolving door.
DANIEL FABRICANT: Folks who understand an industry make for very effective regulators. I think it certainly worked to the consumers’ benefit, which at the end of the day, I think FDA and the industry are in the same business, is to make sure consumers have access to safe, healthy products.
GILLIAN FINDLAY: [on camera] Do you accept that there is a problem with adulteration, though, in the natural health food industry?
DANIEL FABRICANT: There may be some supply chain issues we need to be mindful of. But again, I think that there are federal authorities that cover that, that ensure the products are made to— you know, made to certain quality parameters. It’s defined by law. And if firms don’t, there are clear consequences.
So I think that that’s the important thing, is Americans have a high degree of confidence in the products because of that.
GILLIAN FINDLAY: [voice-over] But just months after leaving the FDA, Fabricant didn’t sound so confident himself. In a presentation to a trade association conference, he shared some of the results of FDA inspections.
[on camera] You talked about some of the findings, the companies that were doing no testing, have no idea of what they’re buying or selling, companies that have no standards—
DANIEL FABRICANT: Sure.
GILLIAN FINDLAY: —inadequate records being kept, no specifications set. And this is a quotation. “The extreme of this observation is more common than expected,” which I read to be, “This is worse than we thought.”
DANIEL FABRICANT: The extreme, those are the companies we took action against. Those are the companies that we drove out of business. I’m speaking from my experience when I was a regulator, when we saw those problems and they were extreme, we threw the book at people. And so I think that that’s— you know, that’s good news for consumers.
GILLIAN FINDLAY: How many companies did you throw out of business?
DANIEL FABRICANT: Quite a number. I think we processed over 25 injunctions during my time at the agency, so—
GILLIAN FINDLAY: In an industry that has 4,000 or more manufacturers, is that significant?
DANIEL FABRICANT: I got my 25. You get yours.
GILLIAN FINDLAY: [laughter] I’m not a regulator. I don’t think that’s going to happen!
DANIEL FABRICANT: It is significant. It’s very significant.
GILLIAN FINDLAY: [voice-over] The FDA division in charge of the supplement industry is tiny, just 25 employees. They target companies they consider the most risky, but agree the problem remains much bigger than that.
Dr. STEPHEN OSTROFF: Because of the targeting and because of, traditionally, the way this industry has developed over time, we do see a higher proportion of inspections that we do with dietary supplements, a higher proportion of them that have substantial problems than in other categories that we regulate.
GILLIAN FINDLAY: [on camera] How much does that worry you?
Dr. STEPHEN OSTROFF: Of course it’s a concern because, ultimately, this isn’t about us and it isn’t about the companies, it’s about the consumers.
GILLIAN FINDLAY: [voice-over] To many, supplements may look like prescription drugs, but there is a big difference. Drug makers have to prove their products are safe and effective before putting them on the market. Those who make supplements don’t, not unless they’re introducing a new ingredient that’s never been marketed before.
PIETER COHEN, M.D., Asst. Professor, Harvard Medical School: It’s an absurd system. In the future many years, we’ll look back and we’ll say, “How could we have possibly done this?”
It took a hundred years of thoughtful regulatory advances to ensure that drugs — now we’re talking about prescription drugs — are both safe and effective. How could it be that the clock turned back to the world of the 1920s, 1930s, when you can sell something without any evidence that it’s safe or effective?
DAVID KESSLER, M.D., Commissioner, FDA, 1990-97: We are back at the turn of the century when snake oil salesmen could hawk their potions with promises that couldn’t be kept.
GILLIAN FINDLAY: In the early 1990s, the head of the FDA was David Kessler. He’d arrived in office promising tougher regulations for supplements, in particular demanding health claims be backed by scientific evidence.
Dr. DAVID KESSLER: The industry went bonkers. Everything exploded. I mean, I’ve taken on some of the hardest regulatory issues. You know, I did tobacco. Tobacco looked easy compared to dietary supplements.
What happened was the dietary supplement industry recognized that the standard that we set — significant scientific agreement — would require it, before it could make a claim, to have a scientific basis. And they just couldn’t make any claim. And they saw, literally, billions of dollars at stake, and they unleashed a lobbying campaign that was second to none.
GILLIAN FINDLAY: The campaign was as dramatic as it was effective..
TELEVISION COMMERCIAL ACTORS: Freeze! Hey guys, guys, it’s only vitamins…
GILLIAN FINDLAY: …complete with Hollywood stars.
TELEVISION COMMERCIAL ACTOR: Vitamin C, you know, like in oranges—
DAN HURLEY, Author, Natural Causes: Congress received more letters regarding this than they ever received regarding the Vietnam war.
GILLIAN FINDLAY: Dan Hurley has written what many consider the definitive account of the industry’s battle with the regulator.
Dr. DAVID KESSLER: …we hear people claiming that FDA…
GILLIAN FINDLAY: While David Kessler tried to convince Congress, behind the scenes another Kessler was at work.
DAN HURLEY: Jerry Kessler ran a large dietary supplement company. He was a very strong-willed character.
JERRY KESSLER: The FDA is going to limit potencies of vitamins, which is what they’ve said. The FDA is going to take herbs and make them drugs. The FDA—
DAN HURLEY: And he called together every leading manufacturer to come out to his ranch in California, which used to belong to Ray Kroc of McDonald’s, OK? So Jerry basically stands up before the group and says, “This is either the end of our industry or a new beginning. And we have to defend our interests.”
GILLIAN FINDLAY: Jerry Kessler would turn out to be a very effective lobbyist, joining forces with powerful political friends—
Sen. ORRIN HATCH (R), Utah: —because today, we honor the wishes of 100 million people, consumers of dietary supplements—
GILLIAN FINDLAY: —friends like Senator Orrin Hatch of Utah. The senator declined to be interviewed. His state is seen as the global center for dietary supplement manufacturing. His son has lobbied for the industry, and Hatch himself has owned shares in at least one supplement company. He’s never hidden the fact he’s a believer.
Sen. ORRIN HATCH: We know that the American people are not a bunch of kooks or a bunch of dummies! And what the people want is the right to use products which have helped them for centuries!
GILLIAN FINDLAY: The campaign worked.
DAN HURLEY: Jerry Kessler said, “Forget this law that’s going to actually regulate. We need a law that says you can’t regulate these products.” And he named it The Dietary Supplement Health and Education Act. He came up with the name of it, Jerry Kessler did, a manufacturer.
GILLIAN FINDLAY: The one concession the FDA did get was an agreement that manufacturers would not make unproven health claims. And so, for example, they can’t say their products “cure“ arthritis or “prevent” heart disease. But they can say they “support” things like bone density, “promote” cardiovascular health.
Dr. DAVID KESSLER: What Congress did is basically said, “Industry, you go make the claims, and if FDA has a problem with it, FDA has to prove it’s false or misleading.” So the horse is out of the barn. FDA then has to go seize the product, go into court, and it has the burden.
VOICE ON FLOOR OF CONGRESS: …784, a bill to amend the Food, Drug and Cosmetic Act to establish standards with respect to dietary supplements…
GILLIAN FINDLAY: Problems with the legislation would become apparent even before it passed. The FDA was getting complaints about popular new weight loss supplements containing an ingredient called ephedra. Manufacturers fought the FDA for more than a decade.
NEWSCASTER: Yesterday, 23-year-old Steve Bechler became the first baseball player ever to die—
GILLIAN FINDLAY: It wasn’t until a young major league pitcher died after taking ephedra that sales were halted.
NEWSCASTER: —a new stimulant called ephedra—
GILLIAN FINDLAY: By then, more than 160 deaths had been linked to the supplement.
HERBERT BONKOVSKY, M.D., Wake Forest Baptist Medical Center: It almost takes a sacrificial lamb to die of liver injury or some other injury before the Food and Drug Administration can take any action.
GILLIAN FINDLAY: Dr. Herbert Bonkovsky is an investigator with a liver injury network funded by the National Institutes of Health. He’s concerned about the harm supplements are causing.
Dr. HERBERT BONKOVSKY: This has been sort of the fastest growing kind of liver injury that we’re observing in the drug-induced liver injury network. The frequency with which we see this has roughly tripled in the last 10 years. About 7 percent of all the cases that we’ve enrolled into this network over the years were due to these. In the last couple of years, it’s been around 20 percent.
PIETER COHEN, M.D., Asst. Professor, Harvard Medical School: It’s incredibly hard to quantify the current problem, how much harm are supplements are doing. Just yesterday, I was talking to a patient who suffered a bleeding stroke into his brain after taking just one workout supplement. And the reason why we don’t know is that there’s no effective system to detect harm from supplements.
GILLIAN FINDLAY: Take what happened in Hawaii in the summer of 2013. There was an outbreak of liver problems health officials would link to a diet and workout supplement.
LINDA WONG, M.D., Transplant surgeon, Univ. of Hawaii: We didn’t know if it was something in the Hawaiian population or some sort of contaminant, or what exactly the problem was.
GILLIAN FINDLAY: The state’s only transplant center was overrun. An initial cluster of seven patients grew to more than two dozen, two of them sick enough to need new livers.
Dr. LINDA WONG: It was difficult. It was stressful because people were calling up and they were continually referring new patients, and I don’t have enough organs to give. I don’t know how I could put all these patients on a transplant list and possibly save all of them.
NEWSCASTER: Sad news tonight from the family of a Maui woman. The mother of seven, who fell ill after taking diet pills, has died.
NEWSCASTER: The Department of Health reports 32 cases of liver damage—
NEWSCASTER: The product is OxyElite Pro, and health officials want to know—
NEWSCASTER: —dietary supplement OxyElite Pro—
GILLIAN FINDLAY: Just two months before the outbreak, the makers of OxyElite Pro had been pressured to pull an earlier formulation from the market following years of complaints. The new version included a compound called aegeline.
Dr. HERBERT BONKOVSKY: Now, aegeline is a normal component of the bael tree, and it’s been used as a natural product by naturopathic healers for centuries, usually fairly safely.
But they didn’t use bael tree extract. They bought aegeline from a Chinese drug company that made aegeline — at least, the company claimed it was aegeline — and within a few months, they began to observe patients with liver failure, mostly in Hawaii but not entirely.
GILLIAN FINDLAY: Cynthia Novida is a chief petty officer with the U.S. Navy based in San Diego. She turned to OxyElite Pro to help pass fitness tests.
CYNTHIA NOVIDA: It helped keep my weight down. It helped, you know, just give me that extra push during a workout, and I was liking it and I would take it.
GILLIAN FINDLAY: But only half-way through the first bottle, Cynthia’s eyes started turning yellow. Her doctor had bad news.
CYNTHIA NOVIDA: That’s when he told me that “Your liver is shot pretty much. You’ll possibly need a liver transplant.”
GILLIAN FINDLAY: She would get a transplant.
The FDA has linked OxyElite to more than 70 cases of liver damage. The company declined to be interviewed and denies any responsibility.
Doctors in Hawaii still remember how slow the FDA was to act. They say they followed all the directions on the agency’s Medwatch Web site. They phoned several times. But it wasn’t until they approached the state health authorities that the FDA finally called them back.
Dr. LINDA WONG: They told one of our liver doctors that, you know, they thought she was a prankster because she had sent in her, you know, private email address, and you know, kept bugging them, and you know, they didn’t think we were real.
GILLIAN FINDLAY: [on camera] They weren’t taking you seriously.
Dr. LINDA WONG: No. It would be nice if there was a system that, you know, we could use and get some consistent results.
GILLIAN FINDLAY: But the FDA says they do have a system. That’s what Medwatch is.
Dr. LINDA WONG: Right. But I don’t know if they’re overwhelmed, but the way it stands is there’s— you know, we’re not getting a response as quick as we probably should be.
GILLIAN FINDLAY: In Hawaii, there were reports of a cluster of people who developed severe liver problems. The doctor in the case we have spoken with raises troubling questions. Repeatedly, she says, she and her colleagues tried to contact Medwatch, tried to report and tried to get advice from the FDA as to what to do. And repeatedly, she says, they heard nothing back.
Had you heard this before?
DANIEL FABRICANT, Ph.D., Div. of Dietary Supplements, FDA 2011-14: No. I can’t deal with hearsay and speculation, and I’m not going to speculate. What I can tell you is when the documents did come in the FDA, that alerted us to the problem in Hawaii, we were able to remove the product within a month.
GILLIAN FINDLAY: By that point, there were 56 cases of liver damage that had been reported, and this was for a company that only had six months earlier had had another formulation removed.
DANIEL FABRICANT: There weren’t 56 cases reported until sometime after we had the product removed. We had the product removed with effectively about 20 cases.
GILLIAN FINDLAY: [voice-over] Cynthia Novida is one of more than 100 people who are now suing the makers of OxyElite Pro. A 23-year veteran with the Navy, she had hoped to get her 25-year service pin. That’s not likely to happen now.
CYNTHIA NOVIDA: You know, I have to be able to travel and can’t do that now, can’t go on a ship because they don’t carry the meds that I need continuously.
GILLIAN FINDLAY: Her doctors tell her the price of that one pill is that she’ll have to take 19 pills every day for the rest of her life. The makers of OxyElite deny all claims against them.
JUSTICE DEPT. OFFICIAL: The allegations against USP Labs and its operators—
GILLIAN FINDLAY: But in November 2015, the Justice Department launched a criminal case against the company and arrested four of its executives on fraud charges.
JUSTICE DEPT. OFFICIAL: —vigilant when it comes to the health and safety of the American public.
TELEVISION COMMERCIAL: Omega 3 is essential for good health.
GILLIAN FINDLAY: The promises are endless.
TELEVISION COMMERCIAL: The minerals your kids need and—
GILLIAN FINDLAY: But even if what you buy in those bottles is real, critics contend there’s a bigger problem. Many supplements simply don’t work. What’s worse, they could be doing you harm.
- OZ SHOW GUEST: Now, supplements. I get this question all the time. I only take four pills—
GILLIAN FINDLAY: Our screens blare advice on how to get health from a pill.
TV HOST: Today, I’d like to talk to you a little bit about supplementation.
GILLIAN FINDLAY: Reputations have been built on dispensing that advice.
ANDREW WEIL, M.D.: —that everyone should be taking a multi-vitamin, multi-mineral product as insurance against—
GILLIAN FINDLAY: But amid all the hype, what’s often lost is the science.
PAUL OFFIT, M.D., The Children’s Hospital of Philadelphia: When people walk into the dietary supplement or vitamin store, they think that everything is just perfectly safe.
GILLIAN FINDLAY: In addition to being a pediatrician, Paul Offit is a best-selling author whose book “Do You Believe in Magic?” questions our supplement habit.
Dr. PAUL OFFIT: So I’ve got vitamins for children and vitamins for adults. The problem is, is when you look on the back, you find that a number of these vitamins are contained in amounts that are much greater than the recommended daily allowance.
GILLIAN FINDLAY: Offit believes we simply take too many.
Dr. PAUL OFFIT: I think multi-vitamins don’t hurt, which is to say vitamins at or around the daily recommended daily allowance for each of those vitamins.
But you need vitamins to live. The question is, do you get enough in food? And I think the answer to that question is yes. But now there are studies done showing if you use— take a mega-vitamin, you actually can hurt yourself. You actually can increase your risk of cancer, increase your risk of heart disease. I think few people know the risks they’re taking.
GILLIAN FINDLAY: [on camera] And how do you know what’s too much?
Dr. PAUL OFFIT: Here’s how you know what’s too much. You shouldn’t bypass the satiety level. Your stomach is only so big for a reason.
GILLIAN FINDLAY: [voice-over] He illustrates the point with 1,000 milligrams of Vitamin C. That’s one of these pills. To get the same amount of the vitamin from a food source, you’d have to eat between seven and eight entire cantaloupes.
Dr. PAUL OFFIT: You know, you’re not meant to eat eight cantaloupes. It’s a dangerous thing to do, to go against what nature intends.
GILLIAN FINDLAY: It’s even worse with Vitamin E, he says. This capsule has 1,000 International Units. You can also find Vitamin E in almonds, but to get the same 1,000 units, you’d have to eat a lot of almonds— 1,670, to be precise. Scientific studies have shown that that much Vitamin E can be dangerous.
Dr. PAUL OFFIT: If you take large quantities of Vitamin E as a supplement, you clearly and definitively increase your risk of prostate cancer. And in a better world, in a regulated world, were Vitamin E a regulated product, it should have a black-box warning on it that says just that.
GILLIAN FINDLAY: Vitamins E and C are antioxidants, and for years we’ve been told to take them because antioxidants are the mortal enemy of “free radicals,” cells linked to cancer and other diseases.
Dr. PAUL OFFIT: I mean, if you look at people, for example, who eat diets rich in fruits, rich in vegetables that contain antioxidants, they do seem to live longer and have lesser rates of cancer and heart disease.
So the thinking was, “Great. OK, now we’ve figured out a way to make ourselves healthier. Now let’s double down and take even larger quantities of antioxidants.” And that’s where we cross the line. And now study after study shows that in fact it’s true. You can take too much in the way of anti-oxidants.
GILLIAN FINDLAY: In response to the studies, in 2013, one of the world’s most important scientific journals published an editorial. “Enough Is Enough” argued, “The case is closed. Supplementing the diet of well-nourished adults with most supplements has no clear benefit and might even be harmful.”
Dr. Eliseo Guallar was the lead author.
ELISEO GUALLAR, M.D., Johns Hopkins: These might be the some of the best well-studied compounds in the history of mankind in terms of clinical trials. There are well over a couple hundred thousand people that have participated in clinical trials. So the conclusions that we have for anti-oxidant vitamins I think are very strong.
GILLIAN FINDLAY: Vitamin D is not an anti-oxidant, but it is one of the top-selling vitamins in America, pushed with information that’s often confusing.
TV HOST DR. OZ: Vitamin D - if I had to pick one vitamin to push to everybody to think about again in their lives, it’s Vitamin D.
GILLIAN FINDLAY: It’s true we do all need some Vitamin D. The Institute of Medicine recommends adults get 600 International Units a day. But look at the doses some others are suggesting.
TV HOST: —recommended 5,000 IUs daily, and if—
GILLIAN FINDLAY: On one Web site, I answered just three questions — my age, my height and my weight — and was told I needed 10,000 International Units a day, 16 times the IOM’s recommendation.
JoANN MANSON, M.D., Brigham and Women’s Hospital: When I hear that various groups are recommending 10,000 IUs a day, or even 5,000 IUs a day routinely, I really want to say,“Show me the data. Show me the evidence.”
GILLIAN FINDLAY: Evidence is what Dr. JoAnn Manson is accumulating here. She’s collected blood samples from over 25,000 people.
Dr. JoANN MANSON: The vital trial is, to our knowledge, the largest randomized clinical trial of Vitamin D supplementation in the world.
GILLIAN FINDLAY: Manson is comparing disease rates between those who take Vitamin D supplements and those who don’t. Final results won’t be known until 2017, but already she has concerns.
Dr. JoANN MANSON: Many people are taking too much vitamin D. The Institute of Medicine also recommended avoiding getting above 4,000 IUs daily because that could be associated with adverse events— calcium in the urine, which can be associated with kidney stones, high blood calcium, calcium in the arteries, vascular calcification, as well as soft tissue calcification.
And there are now studies that show a U-shaped curve that those who have high as well as low blood levels of Vitamin D have higher risk of cardiovascular disease, as well as all-cause mortality. So we can’t assume that more is necessarily better.
GILLIAN FINDLAY: The third most widely used supplement in America is fish oil. The Omega 3s contained in the oil are believed by many to be essential for good health.
ADAM ISMAIL, GOED fish oil trade association: DHA, Omega 3 in particular, is— is extremely important—
GILLIAN FINDLAY: It also helps prevent disease, according to the man who heads one of the largest fish oil trade associations.
ADAM ISMAIL: There’s certainly ample evidence that it helps things like reducing blood pressure, reducing your risk of coronary death.
GILLIAN FINDLAY: But the science behind fish oil is a little more complicated than that.
PRESTON MASON, Ph.D., Harvard Medical School: So these are two capsules. This is an FDA-approved product—
GILLIAN FINDLAY: Dr. Preston Mason is a Harvard University researcher. Here he’s comparing prescription-quality fish oil to the oil found in over-the-counter supplements.
PRESTON MASON: And give it a smell.
GILLIAN FINDLAY: [on camera] Smells a little bit fishy but not— not bad.
PRESTON MASON: Right. Smells— you’re going to have always some smell.
GILLIAN FINDLAY: [voice-over] One of the issues with fish oil is it’s delicate. It’s extracted as a byproduct from oily fish like anchovies. As the fish get crushed, the oil is exposed to oxygen. And it doesn’t take much oxygen to turn the oil rancid.
PRESTON MASON: This is a common supplement for fish oil. See what that smells like.
GILLIAN FINDLAY: [on camera] Oh!
PRESTON MASON: What?
GILLIAN FINDLAY: That doesn’t smell good. That’s— that smells like it’s going bad.
PRESTON MASON: Yeah. Right. Yeah. It’s a very strong, fishy smell.
GILLIAN FINDLAY: [voice-over] If it was simply an odor issue, that would be one thing. But oxidized oil contains oxidized lipids, one of the building blocks of cells. We’ve long known that lipids, when oxidized, can be harmful.
PRESTON MASON: So oxidized lipid triggers inflammatory responses within our body, particularly in our cells. And if we ingest oxidized lipid, we can trigger these inflammatory changes that can lead to things like cardiovascular disease.
GILLIAN FINDLAY: Recently, Mason published his own study of fish oil supplements. The results were consistent with other studies showing high levels of oxidation. One in New Zealand found 83 percent of fish oils tested failed to meet the industry’s own standard.
ADAM ISMAIL, GOED fish oil trade association: It was shocking to see such a high proportion of products that had high oxidation levels. And so we went and actually bought 47 products from the New Zealand market and had them tested at multiple labs, and we did not see that same effect.
GILLIAN FINDLAY: [on camera] Well, what was the percentage you that you discovered that were not in compliance with your standards?
ADAM ISMAIL: It was around 20 percent.
GILLIAN FINDLAY: Would you agree that 20 percent is still problematic—
ADAM ISMAIL: Well—
GILLIAN FINDLAY: —from the consumer’s point of view? I mean—
ADAM ISMAIL: If it’s truly 20 percent, then yeah, we would like to see those 20 percent improved.
GILLIAN FINDLAY: [voice-over] But improving the quality won’t address the other issue with fish oil, the growing questions about whether it prevents disease. Two years ago, epidemiologist Dr. Andrew Grey compiled all the best studies on fish oil as reported in the world’s most prestigious scientific journals.
ANDREW GREY, M.D., University of Auckland: I think for cardiovascular disease, one has to say there is no compelling evidence that taking fish oils protects against the first heart attack, or a second heart attack. And so people who are advised to do that, or are doing it, are wasting their time and their money.
GILLIAN FINDLAY: But the fish oil industry continues to insist there is a benefit, particularly for preventing heart attacks. We asked their spokesman to send us his best evidence, which included some of the same studies Grey had cited, and didn’t seem to support his case.
[on camera] This one says it doesn’t appear to reduce sudden cardiac death. The next one, insufficient evidence. “JAMA” 2012, overall, Omega-3 supplementation was not associated with a lower risk of all cause mortality.
Another journal— “The evidence is not clear-cut, and any benefits are almost certainly not as great as previously believed.”
So it doesn’t seem to be suggesting that there’s an overwhelming amount of evidence.
ADAM ISMAIL: Yeah, well, I think what you’re looking at are the abstracts.
GILLIAN FINDLAY: But the conclusions are the conclusions.
ADAM ISMAIL: Well, but again, those papers are looking at very large areas of cardiovascular disease, and you know, I think it’s hard to argue that Omega-3s aren’t important for how your heart functions.
GILLIAN FINDLAY: [voice-over] Many researchers agree, if you get them from eating actual fish. The problem is science still hasn’t proven it’s true for supplements.
PRESTON MASON, Ph.D., Harvard Medical School: Well, we would think that something that’s natural, that’s essential to normal cell function and body function would have clinical benefits. It just has to be proven.
But in the meantime, there’s certainly been a lot of promotion suggesting a benefit in everything from Alzheimer’s disease to cardiovascular disease. But we still need the strong clinical trials to validate those hypotheses.
GILLIAN FINDLAY: The same can be said about virtually every product the supplement industry sells. We wanted to discuss the issues with some of the industry’s most prominent advocates. Dr. Mehmet Oz, Dr. Joseph Mercola and Dr. Andrew Weil all declined to be interviewed.
While the debate continues over whether supplements actually work, in rural Guelph, Ontario, there is a botanist who may have found an answer to that other troublesome question, what’s actually in the pills and potions that we take.
Dr. Steven Newmaster is part of a worldwide effort to collect and catalogue nature’s wide array of DNA. He believes in the power of nature to heal.
STEVEN NEWMASTER, Ph.D., University of Guelph, Canada: I buy and use natural health products. I believe in them. I’ve used them all my life. I’ve used them with my family. We have that anecdotal evidence that you have some ailment, and you take a— whatever the remedy is, and it’s dealt with.
GILLIAN FINDLAY: So it’s an irony that Guelph University was responsible for one of the latest studies documenting problems with supplement quality. In 2012, Newmaster and his team randomly selected 44 herbal products off the shelves in Canada and the U.S. and started comparing them to the plant DNA in their databank.
STEVEN NEWMASTER: And we looked at the results. I was fairly astounded. It’s, like, “Wow.”
GILLIAN FINDLAY: Sixty percent of the products contained ingredients not listed on their labels. Even more astonishingly, one in three proved to be outright fakes.
STEVEN NEWMASTER: If I put my consumer hat on, that pissed me off because I go in to buy a product that I believe in, that I care about and I pay a lot of money for, and it’s not even in the bottle? Are you kidding me?
GILLIAN FINDLAY: Unlike similar studies in the past, this one got noticed, front page of the Health section in The New York Times, an article that was read by, among others, New York’s attorney general.
ERIC SCHNEIDERMAN, Attorney General, New York: Last December, my office purchased a variety of store brand herbal supplements from stores in different parts of New York state—
GILLIAN FINDLAY: Eric Schneiderman ordered up his own tests of herbal supplements, which produced even worse results.
ERIC SCHNEIDERMAN: —and found only 21 percent of products we tested, in fact, had DNA evidence that they contained the product listed on the label.
We found the results to be shocking. We purchased products from four major chains— Walmart, Walgreens, Target and GNC. We found asparagus DNA, houseplant DNA, rice and other things, but not the product that was on the labels. And it seemed that there was just a massive fraud going on.
GILLIAN FINDLAY: The attorney general demanded the companies stop selling the products. At first, the industry questioned the methodology. But then GNC, the largest of the supplement retailers, agreed to use DNA barcoding to authenticate its products. The industry spokesman, however, still isn’t convinced— Daniel Fabricant.
DANIEL FABRICANT: We’re working the attorney general’s office so they understand more about the industry and we understand more of their concerns. I think that that’s important that we work together.
GILLIAN FINDLAY: [on camera] Do you accept the findings that they’ve published?
DANIEL FABRICANT: Well, I haven’t been able to review the findings because—
GILLIAN FINDLAY: No, because— they say, because it’s an active investigation. But what they have told you— do you accept them?
DANIEL FABRICANT: Without seeing the science — I’m a scientist first and foremost — I can’t really comment on data I haven’t seen.
GILLIAN FINDLAY: So is that a yes or a no?
DANIEL FABRICANT: That’s a no.
GILLIAN FINDLAY: You haven’t seen the actual study from the attorney general so you can’t actually comment, but you have seen the study from Guelph University that was published in.
DANIEL FABRICANT: I’ve seen that, and you know—
GILLIAN FINDLAY: And what— what do you make of that? I mean—
DANIEL FABRICANT: Well, there’s some—
GILLIAN FINDLAY: —they’re fairly similar findings.
DANIEL FABRICANT: Well, I think some— their same challenges, though, is the accreditation of the lab. There’s no mention of reference materials. Reference materials are critical when you’re doing DNA analysis. You know, not knowing how you establish the baseline, what are you comparing?
GILLIAN FINDLAY: [voice-over] Newmaster’s comparison was to that library of DNA he and international scientists have been collecting.
STEVEN NEWMASTER: We’ve done this now thousands, actually tens of thousands of times for products, and the process works and it works really well.
GILLIAN FINDLAY: Today, 14 states’ attorneys general have come together to demand change not only from the industry but from the FDA and lawmakers.
ERIC SCHNEIDERMAN, Attorney General, New York: We think that there’s responsibility in Congress and there’s responsibility at the agency level. And we’re just going to keep pressing until we can get them to take action.
GILLIAN FINDLAY: Since that interview, federal prosecutors and regulators announced they’ve taken action against over 100 companies.
HOWARD SKLAMBERG, Deputy Commissioner, FDA: We see a number of serious issues with dietary supplements and products falsely marketed as dietary supplements.
GILLIAN FINDLAY: There are now signs that at least some in the industry are adopting new technology to ensure accurate labeling.
TRAVIS BORCHARDT, V.P., Nature’s Way: We have implemented the use of the DNA barcode technology here in our products. I think it is a game changer, right? It’s new, and with newness comes, you know, first some early adopters—
GILLIAN FINDLAY: Nature’s Way is among those leading the way. The manufacturer is one of several which have now partnered with the Canadian scientists in a renewed effort to put quality first.
TRAVIS BORCHARDT: We made contact with him and started a relationship, which included testing many of our herbal dietary ingredients for identity. Right now, testing is done off site at the University of Guelph, and Dr. Newmaster is working on some technology that could possibly be implemented, you know, in a commercial manner.
STEVEN NEWMASTER: Take some of the sample and simply put it into the—
GILLIAN FINDLAY: Newmaster believes the partnership is just the beginning.
STEVEN NEWMASTER: And load it into the machine, press go.
GILLIAN FINDLAY: He’s refined his barcoding technology further, making it cheaper and easier to use.
STEVEN NEWMASTER: You can start testing further back in the supply chain. What about that batch that came in and it’s a huge vat and it’s powder? The DNA is excellent in that. It’s easy. It’s cheap. It could be tested at where it’s being transported, and the supplier’s doing trading and buying. It could be tested at the producer, the farmer. It could be tested all the way along. And I think that’s an appropriate way to solve the problem.
GILLIAN FINDLAY: But that still leaves the question of what, if any, of this stuff actually works.
TRADE SHOW SALESMAN: We’re using the herb combined with a standardized extract—
GILLIAN FINDLAY: The industry is quick to criticize studies that challenge their products, but it hasn’t produced large, peer-reviewed studies of its own with clinical trials where supplements are tested against placebos.
DAN HURLEY, Author, Natural Causes: The crazy thing about the dietary supplement world is there are none of those studies, and the studies that are done say the stuff doesn’t work!
DANIEL FABRICANT: There’s new science out there all the time. Consumers are going to continue to take supplements because they derive a benefit. Over half the country every day takes a supplement safely and effectively.
PAUL OFFIT, M.D., The Children’s Hospital of Philadelphia: We love the notion of a magic pill. It’s something that makes it all better. It’s just too seductive. But it is a pill just like any other pill. The only difference is it’s an unregulated pill, and you don’t know what’s in it.