Supplements and Safety

>> Tonight on Frontline... >> A multi-billion-dollar- a-year industry.

>> ...the debate over supplements.

>> How could it be that you can sell something without any evidence that it's safe or effective?

>> They say their products will make you healthier.

>> Consumers derive a benefit.

Over half the country every day takes a supplement safely and effectively.

>> But critics say that many have fraudulent claims, could be dangerous, and should be regulated.

>> It almost takes a sacrificial lamb to die before the Food and Drug Administration can take any action.

>> Correspondent Gillian Findlay investigates.

>> Oh, that doesn't smell good.

>> Very strong, fishy smell.

>> "Supplements and Safety," a Frontline/New York Times special report.

>> This is a product that was formulated for people who are under severe stress.

>> So this is an herb that would be great for older individuals that are concerned about their memory... >> FINDLAY: It's estimated that half of all Americans take a health supplement every day.

>> That one is going to be amazing for supporting the... >> Encapsulates the nutrients in a non-GMO... >> This is a very potent antioxidant.

>> FINDLAY: It's a $30-plus-billion industry.

>> I will guarantee you that this will change your reality within three to five days.

>> FINDLAY: Companies range from big pharma to mom and pop.

>> 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.

>> FINDLAY: Do you have a background in pharmacology, or medicine, or any expertise in this area?

>> I did some college, but most of my time was spent in the medical libraries at Stonybrook.

>> FINDLAY: So you sort of were self-taught, then, were you?

>> Self-taught, correct, yes.

>> FINDLAY: Candice Tripp called her company Purity First.

She says she was helped by her then husband Terence Dulin, a chiropractor.

And what was his academic background or expertise in this area?

>> He was a chemist.

He was a chemist in college and then he went on to chiropractic school.

>> FINDLAY: From modest beginnings, she said she grew the business into a half-a-million-dollar- a-year enterprise, selling on the Web, in stores, and through local alternative healthcare providers.

>> 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."

>> FINDLAY: Vinnie Grosso was an early Purity First customer.

The vitamins became part of his daily quest for better health.

>> I felt fine, and of course, you know, I'm running every day, I'm feeling great, up until the October, November, December time frame of 2012 where I had some very unusual symptoms.

>> 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.

>> 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."

>> 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.

>> 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.

>> We had an examination, and he said to me, "What is this, "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."

>> FINDLAY: It's estimated there are 85,000 dietary supplements for sale in the United States today.

>> Right here I have our Liposomal D. >> So this is our bacopa.

This is an herb that would be great for older individuals that are concerned about their memory.

>> Retains the essential nutrients like chromium... >> FINDLAY: With so many pitches and promises, you might assume some government agency has approved them before allowing them onto the market.

>> 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.

>> 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's limited by resources and by information.

>> 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 we know about.

>> 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.

>> 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.

>> FINDLAY: What did you do to try to verify that this was a reputable company that would make the product ]that you wanted?

>> 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.

>> FINDLAY: And did they give you those certificates?

>> I believe yes, they did, they gave us those and there didn't seem to be a problem.

>> FINDLAY: But by 2013, there was a problem.

Dr. Kenneth Spaeth, who specializes in environmental health, is the 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.

>> 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."

>> FINDLAY: By now Purity First customers had started hiring lawyers and sharing their stories.

>> Change in the voice, change in the sexual organs, hair growth on a young lady who was one of our clients, basically developing mustache, 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.

>> FINDLAY: It would take the FDA nearly six months to get the Purity First vitamins off the market, a response Dr. Spaeth calls "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.

>> 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.

>> FINDLAY: One of his biggest complaints is the amount of time it took just to get somebody to call him back.

He says 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?

>> 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.

We had 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.

>> Two women from the FDA came in and they 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."

Okay.

Do you want us to stop selling the product?

"No, you don't have to stop selling the product.

Nobody died," they said.

>> FINDLAY: "Nobody died."

Those were their words.

>> Their words were, "Nobody died, you don't have to pull the product."

>> 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?

>> Great question.

Their response to me was, "People call the FDA all the time to report minor things.

So don't worry about it."

>> FINDLAY: The FDA "strongly denies" those things were said.

>> Some vitamins manufactured here on Long Island are triggering some health concerns.

>> The FDA recently issued a recall... >> FINDLAY: In the end, Purity First withdrew the vitamins under pressure.

>> We're in Farmingdale in front of Mira Health Products.

>> FINDLAY: Mira was forced out of business by the FDA.

Nobody from the company would speak to us.

36 people are now suing the companies, and no one knows how many people in total may have been harmed.

>> Spaeth had brought up that he was looking for... >> FINDLAY: For Vinnie Grosso and his lawyer, it was a sobering look into a troubled world.

>> 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.

>> 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.

>> 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.

>> We got fed up.

We took a step back and we said, "Okay, 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 what's on the label is what's in the bottle.

90% of the companies never responded.

And of the 10% that responded, of that 10%, often, they would send us certificates of analysis where what was 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.

>> 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% of the labeled 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 of this drug, we're now potentially giving them double what they should get, and could really put them at risk for toxicity.

>> FINDLAY: In the end, only 35 supplements met the hospital's standards.

>> 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 are buying a dietary supplement, unless you have some proof of what is in that product.

It could be anything.

>> 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 started testing the DNA.

>> 30% had no black cohosh, and the samples that we found, we could identify the other plants as well, and they were from ornamental plants from China.

>> FINDLAY: Baker and his colleagues published the results 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.

>> Upwards of 15% of supplements like saw palmetto were not saw palmetto.

Supplements like devil's claw 100% 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, a fraudulent way, and want to put something in the bottle that's cheap and readily available, and buyer beware.

>> 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.

>> A lot of products now, you'll see "private label."

A lot of the contract manufacturers that make the private label are members as well.

>> 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.

>> Folks who understand an industry make for very effective regulators.

I think it certainly works to the consumers' benefit, which at the end of the day, I think FDA, the industry are in the same business-- to make sure consumers have access to safe, healthy products.

>> FINDLAY: Do you accept that there is a problem with adulteration, though, in the natural health food industry?

>> There may be some supply chain issues we need to be mindful of, but again, I think there are federal authorities that cover that, that ensure that products are made to certain quality parameters as defined by law.

And if firms don't, there are clear consequences.

So I think that's the important thing, and Americans have a high degree of confidence in the products because of that.

>> FINDLAY: 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.

>> FINDLAY: 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, 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."

>> Those are the companies we took action against, those are the companies 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's good news for consumers.

>> FINDLAY: How many companies did you throw out of business?

>> Quite a number.

I think we processed over 25 injunctions during my time at the agency, so... >> In an industry that has 4,000 or more manufacturers, is that significant?

>> I got my 25, you get yours.

>> FINDLAY: I'm not a regulator.

I don't think that's going to happen.

>> It is significant.

It's very significant.

>> FINDLAY: 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.

>> 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.

>> FINDLAY: How much does that worry you?

>> 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.

>> FINDLAY: To many, supplements may look like prescription drugs, but there's 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.

>> 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 1920s, 1930s, when you can sell something without any evidence that it's safe or effective?

>> We are back at the turn of the century, when snake oil salesmen could hawk their potions with promises that couldn't be kept.

>> 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.

>> The industry went bonkers.

Everything exploded.

I've taken on some of the hardest regulatory issues.

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.

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.

>> FINDLAY: The campaign was as dramatic as it was effective.

>> Freeze!

>> Whoa, hey!

Guys, it's only vitamins!

>> FINDLAY: Complete with Hollywood stars.

>> Vitamin C. You know, like in oranges?

>> Congress received more letters regarding this than they ever received regarding the Vietnam War.

>> FINDLAY: Dan Hurley has written what many consider the definitive account of the industry's battle with the regulator.

>> We hear people claiming that FDA... >> FINDLAY: While David Kessler was trying to convince Congress, behind the scenes, another Kessler was at work.

>> Jerry Kessler ran a large dietary supplement company, was a very strong-willed character.

>> 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... >> 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, okay?

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."

>> FINDLAY: Jerry Kessler would turn out to be a very effective lobbyist, joining forces with powerful political friends.

>> Today, we honor the wishes of 100 million people: consumers of dietary supplements.

>> 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.

>> 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.

>> FINDLAY: The campaign worked.

>> 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.

>> 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.

>> 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.

>> 784, a bill to amend the federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements... >> 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.

>> Yesterday, 23-year-old Steve Bechler became the first baseball player ever to die in spring training... >> FINDLAY: It wasn't until a young major league pitcher died after taking Ephedra that sales were halted.

>> A new stimulant called Ephedra.

>> FINDLAY: By then, more than 160 deaths had been linked to the supplement.

>> 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.

>> Hi, I'm Dr. Bonkovsky.

Thanks for being here.

>> FINDLAY: Dr. Herbert Bonkovsky is an investigator with the Liver Injury Network funded by the National Institutes of Health.

>> Let me get a listen of your lungs... >> FINDLAY: He's concerned about the harm supplements are causing.

>> Just lie back there.

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 ten years.

About 7% 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%.

>> It's incredibly hard to quantify the current problem, how much harm are supplements 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.

>> 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.

>> We didn't know if it was something in the Hawaiian population or some sort of contaminant or what exactly the problem was.

>> 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.

>> 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.

>> Sad news tonight from the family of a Maui woman.

The mother of seven who fell ill after taking diet pills has died.

>> 32 cases of liver damage... >> The product is OxyElite Pro... >> The dietary supplement OxyElite Pro... >> 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.

>> 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.

>> 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.

>> 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.

>> FINDLAY: But only halfway through the first bottle, Cynthia's eyes started turning yellow.

Her doctor had bad news.

>> That's when he told me that, "Your liver is shot, pretty much.

You'll possibly need a liver transplant."

>> 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 website.

They phoned several times.

But it wasn't until they approached the state health authorities that the FDA finally called them back.

>> They told one of our liver doctors that, you know, they thought she was a prankster because she had sent in her private email address and, you know, kept bugging them, and, you know, they didn't think we were real.

>> FINDLAY: They weren't taking you seriously.

>> No.

It would be nice if there was a system that, you know, we could use and get some consistent results.

>> FINDLAY: But the FDA says they do have a system.

That's what Medwatch is.

>> 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.

>> 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?

>> 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 into the FDA that alerted us to the problem in Hawaii, we were able to remove the product within a month.

>> FINDLAY: By that point, there were 56 cases of liver damage that had been reported, and this was for a company that only six months earlier had had another formulation removed.

>> There weren't 56 cases reported until sometime after we had the product removed.

We had the product removed with effectively about 20 cases.

>> FINDLAY: 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.

>> I have to be able to travel, and I can't do that now.

I can't go on a ship because they don't carry the meds that I need continuously.

>> 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 Pro deny all claims against them.

>> The allegations against USP Labs and its operators... >> FINDLAY: But in November 2015, the Justice Department launched a criminal case against the company and arrested four of its executives on fraud charges.

>> ...vigilant when it comes to the health and safety of the American public.

>> ♪ It's a great, big beautiful day... ♪ >> Omega-3 is essential for good health.

>> FINDLAY: The promises are endless.

>> The minerals your kids need!

>> 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.

>> Now, supplements, I get this question all the time.

I only take four pills... >> FINDLAY: Our screens blare advice on how to get health from a pill.

>> Today, I'd like to talk to you a little bit about supplementation.

>> FINDLAY: Reputations have been built on dispensing that advice.

>> Everyone should be taking a multi-vitamin, multi-mineral product.

>> FINDLAY: But amid all the hype, what's often lost is the science.

♪ It's a great, big beautiful day to be alive... ♪ >> When people walk into the dietary supplement or vitamin store, they think that everything is just perfectly safe.

>> 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.

>> So I've got vitamins for children and vitamins for adults.

The problem is that 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.

>> FINDLAY: Offit believes we simply take too many.

>> I think multivitamins don't hurt, which is to say, vitamins at or around the recommended daily allowance for each of those vitamins.

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 that if you take a megavitamin, 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.

>> And how do you know what's too much?

>> 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.

>> FINDLAY: 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.

>> You know, you're not meant to eat eight cantaloupes.

It's a dangerous thing to do, to go against what nature intends.

>> 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.

>> 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.

>> 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.

>> 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-- okay, 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 crossed the line.

And now study after study shows that in fact, it's true.

You can take too much in the way of antioxidants.

>> 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.

>> This may be 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 antioxidant vitamins I think are very strong.

>> FINDLAY: Vitamin D is not an antioxidant, but it is one of the top-selling vitamins in America, pushed with information that's often confusing.

>> If I had to pick one vitamin to push to everybody to think about and get in their lives, it's vitamin D. >> 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.

>> I've recommended 5,000 IUs daily... >> Around 5,000 IUs tends to be perfect... >> FINDLAY: On one website, I answered just three questions-- my age, my height, and my weight-- and I was told I needed 10,000 international units a day, 16 times the IOM's recommendation.

>> 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."

>> FINDLAY: Evidence is what Dr. JoAnn Manson is accumulating here.

She's collected blood samples from over 25,000 people.

>> The VITAL trial is, to our knowledge, the largest randomized clinical trial of vitamin D supplementation in the world.

>> 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.

>> 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.

>> 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.

>> DHA Omega-3 in particular is extremely important.

>> FINDLAY: It also helps prevent disease, according to the man who heads one of the largest fish oil trade associations.

>> There's certainly ample evidence that it helps things like reducing blood pressure, reducing your risk of coronary death.

>> FINDLAY: But the science behind fish oil is a little more complicated than that.

>> So these are two capsules.

This is a FDA-approved product... >> 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.

>> And give it a smell.

>> FINDLAY: It smells a little bit fishy, but not bad.

>> Right.

You're gonna have always some smell.

>> FINDLAY: 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.

>> This is a common supplement for fish oil.

See what that smells like.

>> FINDLAY: Oh... >> What?

>> FINDLAY: That doesn't smell good.

That smells like it's going bad.

>> Yeah, right.

It's a very strong fishy smell.

>> FINDLAY: 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.

>> 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.

>> 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% of fish oils tested failed to meet the industry's own standard.

>> 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.

>> FINDLAY: Well, what was the percentage that you discovered that were not in compliance with your standards?

>> It was around 20%.

>> FINDLAY: Would you agree that 20% is still problematic, from the consumer's point of view?

>> Well, if it's truly 20%, then yeah, we would like to see those 20% improved.

>> FINDLAY: 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.

>> I think for cardiovascular disease, one has to say there is no compelling evidence that taking fish oils protects against a 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.

>> 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.

>> FINDLAY: 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, that doesn't seem to be suggesting there's an overwhelming amount of evidence.

>> Yeah, well, I think what you're looking at are the abstracts.

>> But the conclusions are the conclusions.

>> But again, those papers are looking at very large areas of cardiovascular disease, and I think it's hard to argue that Omega-3s aren't important for how your heart functions.

>> FINDLAY: Many researchers agree-- if you get them from eating actual fish.

The problem is, science still hasn't proven it's true for supplements.

>> 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.

>> 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.

>> So many questions, so many concerns.

>> FINDLAY: Dr. Mehmet Oz... Dr. Joseph Mercola... ...and Dr. Andrew Weill all declined to be interviewed.

>> FINDLAY: 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.

>> 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 whatever the remedy is and it's dealt with.

>> 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.

>> And we looked at the results, and I was fairly astounded.

I was like, "Wow."

>> FINDLAY: 60% of the products contained ingredients not listed on their labels.

Even more astonishingly, one in three proved to be outright fakes.

>> 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?

>> 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.

>> Last December, my office purchased a variety of store brand herbal supplements from stores in different parts of New York state.

>> FINDLAY: Eric Schneiderman ordered up his own tests of herbal supplements, which produced even worse results.

>> Only 21% of the 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: Wal-Mart, 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.

>> FINDLAY: The attorney general demanded the company 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.

>> We're working with the attorney general's office so they understand more about the industry and we understand more of their concerns.

I think that it's important that we work together.

>> FINDLAY: Do you accept the findings that they've published?

>> Well, I haven't been able to review the findings.

>> FINDLAY: No, because they say because it's an active investigation, but what they have told you, do you accept them?

>> Without seeing the science, I'm a scientist first and foremost, I can't really comment on data I haven't seen.

>> FINDLAY: So is that a yes or a no?

>> That's a no.

>> FINDLAY: You say 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 2013.

>> I have seen that.

>> FINDLAY: And what do you make of that?

They're fairly similar findings.

>> I think they're the same challenges, though, the accreditation of the lab.

There's no mention of reference materials.

Reference materials are critical when you're doing DNA analysis.

Not knowing how you establish the baseline, what are you comparing?

>> FINDLAY: Newmaster's comparison was to that library of DNA he and international scientists have been collecting.

>> We've done this now thousands, actually tens of thousands of times for products, and the process works, and it works really well.

>> FINDLAY: Today, 14 states' attorneys general have come together to demand change, not only from the industry, but from the FDA and lawmakers.

>> 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.

>> FINDLAY: Since that interview, federal prosecutors and regulators announced they've taken action against over 100 companies.

>> We see a number of serious issues with dietary supplements and products falsely marketed as dietary supplements.

>> FINDLAY: There are now signs that at least some in the industry are adopting new technology to ensure accurate labeling.

>> We have implemented the use of DNA barcode technology here in our products.

I think it is a gamechanger.

It's new, and with newness comes, you know, first some early adopters.

>> FINDLAY: Nature's Way is among those leading the way.

The manufacturer is one of several who have now partnered with the Canadian scientists in a renewed effort to put quality first.

>> 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 in a commercial manner.

>> Take some of the sample and simply put it into... >> FINDLAY: Newmaster believes the partnership is just the beginning.

>> And load it into the machine, press "Go."

>> FINDLAY: He has refined his barcoding technology further, making it cheaper and easier to use.

>> 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 is 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.

>> FINDLAY: But that still leaves the question of what, if any, of this stuff actually works.

>> Using the herb combined with a standardized extract... >> It's a joint supplement that contains Perna... >> 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.

>> 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.

>> There is 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.

>> 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.

>> Next time on Frontline, the law... >> In most countries, sports betting online is legal except in the United States.

>> The loophole... >> The United States Congress carved out a piece of legislation that says fantasy sports is not gambling.

I didn't make that decision.

They did.

>> Online sports betting and the meteoric rise of daily fantasy sports.

>> You don't view what you do here as gambling?

>> No.

>> Go to pbs.org/frontline for more about many widely used supplements.

>> I think few people know the risks they're taking.

>> Over half the country every day takes a supplement safely.

>> Learn more of what states and regulators are doing to keep up with the industry.

>> There was just a massive fraud going on.

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