Unregulated, lucrative — and risky

Dietary supplements are a $30 billion industry, but health risks can go unwatched

By Tara Bannow / The Bulletin / @tarabannow

Countless bottles of supplements containing the stimulant ephedra lined store shelves. Their labels were crowded with exclamations in bold text, their colors bright and flashy, and huge musclebound models flexed at each potential customer. The promises were the same as the supplements of today: bigger muscles, less fat, more energy. Turn your life around with a clattering bottle of pills.

Over a two-year period beginning in 2000, Shawn Smith of Multnomah County bought Metabolife 365 and Yellow Jackets from a Walmart, a Fred Meyer, a 7-Eleven and a Vitamin World.

Around the same time, Timothy Deeter bought Ergolean in Linn County.

In early 2002, Damon Violette of Washington County bought Metabolife 365 on the advice of a trainer at his gym.

Less than two years after he started taking the supplements, Smith had a heart attack that caused permanent damage to his heart and brain. Deeter had a stroke followed by years of seizures. Violette had a stroke just one month after he started taking the supplements. He’s had three more since.

All of the supplements these men took contained ephedra, a shrub-like plant whose active ingredient acts as a powerful stimulant. It took more than a decade and hundreds of reports of heart attacks and strokes before the U.S. Food and Drug Administration banned the substance. But even though ephedra is gone, not much has changed in the way potentially dangerous supplements saturate the market with almost no oversight. More than 85,000 dietary supplements are being sold in the U.S. — things like vitamin C and fish oil, but also many geared toward people trying to build muscle or lose weight — and surveys show roughly half of Americans take them. As it was with ephedra, manufacturers don’t have to tell the FDA what products they’re selling, and it generally takes multiple reports of serious side effects before the FDA — whose limited manpower doesn’t stand a chance against the continuous churning of new products — investigates and gets them taken from shelves.

This is a far cry from the FDA’s careful regulation of prescription medications, whose manufacturers must painstakingly prove their efficacy with years of trials on animals and humans.

“I think one of the injustices in American society is the fact that herbal medicines and dietary supplements are essentially unregulated,” said Frederick Fraunfelder, an ophthalmologist at the University of Missouri who performed extensive research into the ocular side effects of supplements while at Oregon Health & Science University in Portland. “There are no standards on the production of these agents. There is no regulation. So you don’t know what you’re taking.”

Before Violette, now 46 and living in Beaverton, had his first stroke, he was healthy and active. He rode his bike regularly and had a good job. Until one night he woke up to go to the bathroom and something didn’t feel right. His then-wife called an ambulance.

Today, he’s lost his peripheral vision, he can’t drive and his short attention span prevents him from holding a job. His concerned father and step-mother, who live 10 minutes away, say the former workaholic is paranoid and struggles with filling his long days.

“It’s totally screwed him up,” said his father, Louie Violette, of Tigard. “He was just trying to get healthier, working out at the gym and everything, holding a good job, and trying to get buff.”

Damon declined an interview, writing in a Facebook message that he’s been afraid to talk to people since the stroke, and still prefers to be only in small groups.

A brief history of supplement regulation

It wasn’t always this way.

Many industry experts today describe the supplement industry as a modern-day Wild West. They pinpoint the slip into anarchy to the 1994 Dietary Supplement Health and Education Act, a law that essentially left it up to supplement manufacturers to ensure their products were safe. It also gave them direct access to the market without any kind of FDA interference — or even knowledge, for that matter.

Before the law, the FDA placed heavy scrutiny on supplements. Some were classified as foods, meaning manufacturers had to prove their ingredients were safe before selling them. Other supplements were classified as drugs if their packaging made claims about disease prevention or improved bodily functions. In those cases, supplements were subject to the same rigorous premarket approval process as medications. DSHEA marked a turning point in the supplement industry, removing many of the regulatory barriers for manufacturers and helping it grow to the estimated $30 billion industry it is today.

“After DSHEA, the FDA just kind of shrugged its shoulders,” said Stephen Gardner, director of litigation for the Center for Science in the Public Interest, a consumer advocacy group that regularly sues supplement companies over unsupported health claims. “There’s some really good people at FDA, but institutionally, it just hit the brakes.”

Stephen Gardner is director of litigation at the Center for Science in the Public Interest.

Joe Kline / The Bulletin

The FDA has an agreement with the Federal Trade Commission that divides oversight of supplement claims, with the FDA looking at product labels and the FTC at advertising.

DSHEA also made the FDA responsible for proving a supplement causes harm in order to get it taken off the market, a process that — in the rare case the FDA pushes forward — takes several years. Meanwhile, the market is constantly being flooded with countless new products that promise to melt away fat or to build powerful muscles, far surpassing any agency’s reasonable ability to track.

In most cases, the FDA’s best chance at protecting the public from a supplement once reports of injuries start coming in is to send a warning letter to the company, which, in most cases, is enough to scare it into a voluntary recall. If that doesn’t work, the FDA in rare cases also seizes products and suspends companies’ registrations.

In fact, although the Food Safety Modernization Act of 2011 gave the FDA the authority to mandate supplement recalls, so much work goes into proving a product is harmful that warning letters are still its most common tool to get supplements pulled from shelves.

The FDA learns about side effects through its Adverse Events Reporting System, an online portal through which health care professionals and members of the public can report injuries they sustained from medications and supplements. Manufacturers are required to submit any adverse event reports they receive to the FDA. If enough reports come in concerning a product — “enough” being the key word, as there is no threshold — the FDA investigates.

Between 2008 and 2011, the FDA received 6,307 reports of health problems concerning dietary supplements, 71 percent of which were mandatory reports from manufacturers, according to a 2013 Government Accountability Office report. That number excludes the many people who experienced adverse events but didn’t report them to the FDA. Poison control centers, for example, handled more than 7,300 calls related to adverse events from dietary supplements between 2008 and 2010.

In its report, the GAO criticized the FDA for not collecting information on how it uses the reports it receives for consumer protection and for not making public potential safety concerns brought to its attention by the reports.

Perhaps the most jarring example of the FDA’s inability to regulate harmful products came with ephedra, a powerful stimulant derived from a plant that was long used by Chinese physicians to quell colds. Supplement manufacturers in the 1990s began marketing products containing ephedra’s active ingredients, ephedrine alkaloids, as weight-loss drugs, often mixing them with caffeine.

For years, they were hugely popular in the U.S., sold in big-name products like Metabolife, Hydroxycut and Stacker, and the companies who made them — many of them tiny outfits operating out of garages or warehouses — raked in the profits.

But then the reports starting coming in. Young, healthy people were having strokes. They were dropping dead from heart attacks.

“The FDA started getting concerned because all these young people who shouldn’t be sick, who shouldn’t be having strokes and shouldn’t be dying of sudden cardiac arrest, were,” said Leslie O’Leary, a Portland attorney who has sued several ephedra manufacturers. “That’s what prompted them to investigate after seven or eight years, once they had enough data to investigate.”

Until the FDA implemented its ephedra ban in 2004 — more than a decade after the agency began receiving reports of serious side effects — O’Leary said it was up to attorneys like her to take on the companies selling the supplements. She represented dozens of clients who assumed they were taking a safe product. Unfortunately, once the cases reached her, the damage was done, she said.

“By the time I’m contacted by a family, somebody is really seriously sick or dead,” O’Leary said.

And often the companies that made the supplements simply declared bankruptcy once they were sued, which made it very difficult for attorneys to collect damages for their clients.

“Bankruptcy gives them a fresh start and lets them off the hook,” said David Sugerman, a Portland personal injury attorney.

And even when ephedra and other dangerous stimulants like it are banned, its manufacturers simply pull it off the shelves, reformulate it with a new concoction of ingredients, slap on a new label and send it back to stores, said Melinda Manore, an Oregon State University nutrition professor who has researched weight loss products.

That means even though ephedra is off the market in the U.S. — it can still be purchased online from overseas companies — Manore said there is still plenty to be concerned about when it comes to supplements that contain stimulants. No one tests the products to be certain of what’s in them, so they could contain twice as much of the stimulant listed on the label.

“That could be very dangerous,” she said.

Lots of supplement manufacturers claim they test their own products, but Manore said independent testing from an entity that won’t profit from the sale is necessary to prove something is safe.

Oftentimes, supplements will contain multiple varieties of stimulants. Their labels will list caffeine as an ingredient in addition to other stimulants such as synephrine, yohimbe or yerba mate, but they won’t add up the total amount of caffeine from all of those ingredients, Manore said.

“It stacks them in the supplement,” shes aid. “You wouldn’t know how much you’re getting, because they’re not required to do that. It really takes somebody analyzing the product to find out what’s actually in it.”

Many of today’s supplements are plant-based, which means they could be more potent depending on the soil conditions or where they’re grown, O’Leary said. When she had ephedra plants tested for cases, O’Leary said, she found that many of them contained a lot more amphetamine than others. In other cases, the manufacturers were simply adding ephedrine to the batches. “People should always be wary of herbal supplements,” she said. “The FDA has very little authority. And if the FDA isn’t watching over them, who is?”

Alluring weight-loss promises

Following the births of her first through fourth children, Bend resident Cynthia Poore never had trouble getting skinny again.

It wasn’t until she had her fifth child that Poore found she just kept gaining weight. She was active at the time — working a job that had her darting back and forth across a Walmart store, doing Zumba fitness classes regularly and chasing around kids at night.

Her doctor tested her thyroid levels; everything came back normal. Even her doctor was stumped.

Meanwhile, Poore kept seeing commercials for the weight-loss pills Slimquick.

“I’m like, ‘No, I’m not trying that,’” she said. “But then I’d see the commercials a million times, and I’m like, ‘You know what? I’ll try that one.’”

Cynthia Poore, pictured outside her home in Bend, has tried several diet pills and supplements in an attempt to lose weight but hasn't found much success.

Joe Kline / The Bulletin

So it began. Slimquick had absolutely no impact on Poore’s weight, but the rush of taking a pill with the promise of an easy solution gave her hope. It started her down the path that befalls many middle-aged women, who go from one weight-loss pill to the other, strung along by ruthless advertising and a relentless sense of hope. In two years, Poole has spent nearly $400 on at least six different supplement regimens.

None have caused any major problems — the It Works! pills did cause her to throw up constantly during the few weeks she took them — but they also have done nothing for her weight.

“It’s kind of like I’m on a never-ending search for that one cure to get my skinny real quick,” she said.

Some of the diet pills and supplements Cynthia Poore has tried in an attempt to lose weight. She said none of the supplements helped her lose weight.

Joe Kline / The Bulletin

Poore’s experience aligns with research by Manore, of OSU, which looked at four different types of weight-loss supplements and found no strong evidence supporting their use. Those varieties that had been tested showed only modest effects — with little or no longterm follow-up — others have had zero or limited trials into their effectiveness.

“It just amazes me that people will spend so much money on stuff when they don’t know what’s in the product,” she said, “and the outcome is relatively small.”

Manore’s weight-loss solution? Old-fashioned diet and exercise.

“Everybody wants to do it quickly without too much work,” she said, “and, unfortunately, it doesn’t work that way.”

Overall, Manore believes consuming lots of green tea and fiber and eating low-fat dairy products could complement a healthy lifestyle to prevent weight gain over time. But since green tea extracts are so commonly contaminated with other products, such as stimulants that can cause liver damage, she recommends people just drink the tea to get the benefits.

The Center for Science in the Public Interest has sued companies over bogus weight-loss claims, most of which include the marketing guise of being “natural,” a gimmick Gardner said he detests. For example, when various unscrupulous companies were promoting acai berry supplements as a natural fat burner, Gardner said his team knew right away it was nonsense.

“We wanted to sue somebody, but every company we found was offshore,” he said. “None of them were based here.”

Consumers tend to think things that are natural are good for them, but that’s simply not true, Gardner said. After all, he said, sugar, fat and salt are natural.

“People are entitled to be wrong,” he said. “Companies are not entitled to take advantage of that. When you prey on people’s lack of knowledge because we’re not all food scientists, that’s predatory, abusive behavior. It’s a deceptive practice.”

The dangerous stimulant ephedra, for example, was often marketed as an all-natural product, and is referred to by its Chinese name, ma huang, Gardner said.

“Somebody from China knew damn well what it was,” he said, “but somebody from Dallas, who might know that ephedra should be avoided — ‘Well this is natural; it’s ma huang. It’s been used in Chinese treatments for millennia.’”

Poore said she still occasionally takes a weight-loss supplement called garcinia cambogia . She’s been using it for about a month and a half and although she hasn’t noticed a benefit, she takes it because it says on the bottle that it’s natural.

“It’s all herbs and healthy-for-you stuff,” she said. “They advertise it as all natural. There’s no side effects. It all comes from plants, supposedly.”

The popular TV show host Dr. Oz has touted garcinia cambogia, produced from a small, purple fruit called the malabar tamarind, on his program as a “natural” way for busy people to lose weight. In one segment, Oz, whose full name is Mehmet Oz, stands in front of a large screen with the exclamations, “No exercise. No diet. No effort.”

Garcinia cambogia contains the botanical extract hydroxycitric acid (HCA), which some say speeds up metabolism and suppresses fatty-acid synthesis. Randomized controlled trials generally do not show an impact on weight loss, however.

Victor Navarro, chairman of the division of hepatology and liver transplantation with the Einstein Healthcare Network in Philadelphia, has observed garcinia cambogia as the common denominator among more and more patients sustaining liver injuries after taking supplements. He said he’s very concerned about the dangers of the supplement and plans to contact Oz to encourage him to talk about its potential side effects, although he’s not sure even that will help.

“Even if he expresses a note of caution to the public — coming from a really sort of biblical figure like that — they may not hear the caution,” Navarro said. “They may just hear him speak positively about a product and then, all of a sudden, they’re using it.”

U.S. Sen. Claire McCaskill, D-Missouri, scolded Oz in a June Senate hearing for making false claims about products. Oz responded that he personally believes in the products he features on his show.

McCaskill told Oz she wanted to make an example of him because of the tremendous power he holds over his viewers.

“We didn’t call this hearing to beat up on you,” she said, “but we did call this hearing to talk about a real crisis in consumer protection.”

Serious side effects

Navarro and his colleagues, concerned about the devastating effects they had seen from dietary and herbal supplements on patients’ livers, are about to publish a national study that found dietary supplements are responsible for nearly 20 percent of drug-related liver injuries in hospitals in 2012, up from 7 percent a decade earlier. Those figures are likely underrepresenting the extent of the problem, though, because they only include people referred to liver specialists at hospitals across the country, Navarro said.

The researchers followed 845 patients between 2004 and 2013. They found that of those who sustained liver injuries, about 11 percent of those whose injuries were caused by dietary supplements were severe enough to require transplants. Among those whose injuries were from pharmaceutical drugs, only 3 percent needed transplants.

“There is a lot of work to do to convince the public that these have to be used with caution,” he said.

The liver takes such a beating from medications and supplements because its job is to reduce the products to their components after they’re ingested and eliminate them from the body.

Although the majority of liver injuries are caused by various prescription medications, as a definable group, dietary supplements are the second-leading class of drugs to cause liver injuries, behind antibiotics, Navarro said. The type of supplements the patients took varied, but the largest identifiable groups were bodybuilding supplements, followed by weight-loss supplements, he said.

That was a surprising finding for Navarro, as he said people who take supplements tend to be younger and healthier than people who take prescription medications. It may be that doctors are more likely to perform transplants on younger, healthier patients because their long-term outcomes are generally better, he said.

What’s more likely the case, Navarro said, is people are using supplements in risky ways. They’re taking too many. Fasting while taking them. Mixing them. And they’re usually not telling their doctors.

“I suspect that it has something to do with the behavior of how these products are used that may contribute to them leading to certain toxicities,” he said.

Additionally, very few of the supplement-related liver injuries Navarro sees are the result of taking a single herb. Rather, they more commonly follow the consumption of a mixture of herbs from various supplements.

“I suspect that it’s the mixtures that might come together and form a particularly toxic combination and be responsible for the injury also,” he said.

The side effects of supplements extend well beyond the liver. When a 35-year-old woman turned up last year at the Oregon Health & Science University emergency room sweating with slurred speech and difficulty walking, emergency medicine physician Robert Hendrickson and his colleagues recognized the problem right away: serotonin toxicity.

It took longer to figure out how the patient’s serotonin levels had reached a life-threatening level. After a few doses of an antidote in eight-hour intervals, her symptoms subsided and Hendrickson, associate medical director of the Oregon Poison Center, asked her what medications she was taking. It turns out, in addition to the antidepressant she had been taking for two years, she had recently begun taking garcinia cambogia to lose weight. After some research, Hendrickson realized garcinia cambogia causes serotonin levels in the brain to increase — the same effect prompted by selective serotonin reuptake inhibitors (SSRIs), medications used to treat depression. Together, the mixture spelled disaster for the patient, who had been to the ER before for the same problem but never told doctors she was taking the supplement.

It’s the first of such cases Hendrickson has seen, and until he learns more, he warns people against mixing garcinia cambogia and antidepressants. Hendrickson hopes to learn more about whether there have been cases similar to the one he saw.

“If there is, I think this will be a little bit of a public health crisis,” he said, “and I think we probably will go to our public health agencies and also to the FDA to see if they can at least get out some information.”

Fraunfelder, the University of Missouri ophthalmologist, researched for years while at OHSU the lesser-discussed ocular side effects of supplements, which can range from something as benign as dry eyes to severe conditions like retinal hemorrhaging and transient vision loss.

He’s seen cases where patients taking ginkgo biloba, a supplement commonly used to treat tinnitus, ended up with retinal hemorrhaging. Niacin, a supplement shown to improve cholesterol levels, has been tied to decreased vision, cystoid macular edema — a condition that can cause retinal swelling — and discoloration of the eyelids, among other symptoms, Fraunfelder said. Lots of people take vitamin A, but too much can cause a condition called pseudotumor cerebri, in which intracranial pressure increases, a potentially blinding condition.

Fortunately, most of those side effects are reversible if people stop taking the supplements, Fraunfelder said. In any case, he said, doctors should familiarize themselves with such ocular conditions and should ask patients often what supplements they’re taking. Fraunfelder’s research has shown that half of the people who take prescription medications also take supplements.

“Through that, I found that half of them don’t tell their doctors that they take them,” he said. “That’s significant, because a number of these agents have significant bodily side effects.”

Loyal supplement fans

Tess Nordstog, the owner of the Bend supplement store Fit Pit, feels like she’s fighting a constant battle against what she calls the “government nutrition recommendations.” Her customers, many of them students at Central Oregon Community College, often share with her what they’re learning in their nutrition courses.

“I always joke with people, ‘I think government recommendations are what they have to feed prisoners or something,’” she said, “because it’s just not even necessarily healthy nutrition.”

Most of Nordstog’s customers visit her small shop along a busy stretch of U.S. Highway 97 because they want muscle tone. They want less body fat. Basically, they just want to look fit, she said, and the traditional nutrition guidelines won’t get them there.

Tess Nordstog, owner of Fit Pit, a company that sells supplements in Bend, stands in her store.

Joe Kline / The Bulletin

Nordstog’s recommendations — compiled from her own research and through trying supplements herself — are a 180-degree reversal from that of the establishment. Nordstog advocates for lots of protein, lots of carbs, lots of fats.

Fit Pit, the only nonchain supplement shop in Bend, is a modest-looking shop with little by way of decor aside from Nordstog’s scented candles near the register. The rows of shelves are packed with large tubs of protein powder, smaller bottles of preworkout supplements, mass gainers, fat burners and megavitamins.

Nordstog, 28, has a degree in advertising from the University of Oklahoma but said many of her general education courses covered nutrition and exercise science. And she’s got years of experience taking supplements herself.

“Tess is extremely knowledgeable,” said Chasity Barker, who first met Nordstog about a year ago while bulking up before her first bikini competition. “She’s good about directing you to the right path. I’ve been in there when people are like, ‘I want this,’ and she’s like, ‘You know, maybe you don’t. Maybe try going this route.’”

Barker, a 41-year-old corrective exercise specialist at Max Fitness in Bend, first set her sights on bodybuilding when she was 21 and has been taking supplements ever since. A half-hour before every workout, Barker takes the preworkout supplements Karbolyn, a powder she said is packed with carbohydrates, and noncaffeinated Kre-Alkalyn, a form of creatine.

“Basically, what it does, it just fuels you,” she said of her preworkout supplements. “It gives you that energy to get into your workout.”

Personal trainer Chasity Barker demonstrates exercises in her workout routine at Max Fitness in Bend. She says dietery supplements help fuel her workouts.

Joe Kline / The Bulletin

During her workouts, Barker pauses to take Xtend, a powdered supplement containing branched-chain amino acids (BCAA) that’s designed to promote muscle recovery and boost energy during workouts. Afterward, she takes more Kre-Alkalyn, which is swallowed in a capsule, and Cell K.E.M., another BCAA supplement taken in powder form.

Every so often, Nordstog gets word from one of the companies she buys supplements from telling her to stop selling a certain product. The FDA warns companies if it receives enough complaints, which usually prompts them to stop selling the products.

But, the way Nordstog sees it, any time someone gets harmed from a supplement, it’s user error, not because the product is dangerous.

“It’s like, great, Joe Schmo takes five when it says on the bottle to take one, has a heart attack on the treadmill or whatever, and then it ruins it for everybody else,” she said.

Manufacturers using an ingredient called 1,3-dimethylamylamine, or DMAA, have in recent years voluntarily recalled their products after the FDA warned it would otherwise do so forcibly. Typically marketed as natural stimulant because it’s made from geranium extract, DMAA was often stacked in supplements with other stimulants like caffeine, often raising peoples’ blood pressures and causing heart attacks and strokes. The recall followed more than 100 reports of side effects from DMAA to the FDA, including six deaths.

That one hit home for Nordstog, who bought up her own personal hoard of the stuff when she found out it was getting banned.

“I love DMAA,” she said.

That’s typically how it goes when supplements are banned. People race out to buy them before they’re taken off shelves, either to take them themselves or sell them online. Nordstog usually lets her customers know ahead of time and waits for the mad rush.

Last year, two companies announced they would stop making their popular preworkout supplements Craze, a drink mix, and Driven, a pill, after independent tests found they contained a methamphetamine-like compound. The news shocked Nordstog.

“When I used to sell Detonate before we all knew there was something naughty in it; I was like, ‘This is my little customer service in a pill,’” she said, laughing. “And then I was like, ‘No wonder — I was on meth all day’ — just kidding, it wasn’t that bad.”

Tess Nordstog is the owner of Fit Pit, a company that sells supplements in Bend.

Joe Kline / The Bulletin

On the popular website Bodybuilding.com, users frequent the forums to express themselves and share tips on working out, dieting and supplements. The FDA is resoundingly unpopular among the forum’s users, who’ve posted dozens of rants slamming the agency for trying to ban the supplements users have found the most effective for muscle-building.

One user, posting under the name The Conqueror, reasoned that people who take supplements are not putting others in danger.

“Are you going to kill someone driving down the road? Are you going to kill somebody by operating heavy equipment. It doesn’t put you ‘under the influence’ or anything negative! WHAT? If you take too much or abuse it WHO PAYS the price....we would! IT’S OUR DAMN BUSINESS NOT THEIRS!!!”

Gardner, of CSPI, said attitudes like that demonstrate that many of the people who take supplements to build muscle are, simply put, committing drug abuse. They know the products are not good for their bodies but continue to take them because they work.

When Gardner is looking for unscrupulous supplement companies to sue, he said he generally focuses on companies that prey on desperate people — advertising useless products for weight loss, for example. CSPI sued Coca-Cola for saying their soft drink Enviga contained so much caffeine that consumers would burn more calories than they took in drinking it.

“For me, if I’m going to protect someone, I want to protect the unwitting, not the deliberate,” Gardner said. “They know they’re at risk and they’re mad in the rare moments the FDA bans something.”

Navarro, the hepatologist with the Einstein Institute, holds the opposite perspective. He said he believes the manufacturers who stack muscle-building supplements with various mixtures of banned stimulants and anabolic steroids represent the most egregious regulatory violations in the supplement industry. It would almost take a forensic lab to determine precisely what chemical combination is in each supplement, he said.

“What’s happening is that chemical companies or companies are learning to circumnavigate what the FDA looks for with these designer steroids by essentially chemically altering the steroid structure so that it becomes undetectable,” he said.

Another problem is that companies are not transparent on the labels about what’s actually in the products, said Brad Slate, a 44-year-old powerlifter who lives outside of Sunriver. He understands frustrations about the FDA’s recalls but said he thinks the bigger issue is companies’ ability to hide ingredients.

“Because, really, you should be able to sell any product you want as long as you’re forthcoming about what it is and what it does, but they’re subverting the truth,” said Slate, who works as an audio/visual services coordinator at St. Charles Health System.

Slate said these days, he tries to get most of his nutrition without supplements, but when he first started powerlifting three years ago, he tried sample packs of preworkout supplements.

“That’s where it really gets into some of the crazy herbal stuff,” he said. “It really jacks you up, like speed or something.”

Change ahead?

Although the supplement industry is “pretty dismal” right now, Danica Harbaugh Reynaud sees change on the horizon.

She’s a geneticist, and her company, AuthenTechnologies in Richmond, California, tests samples of supplements — down to the DNA level — to get to the bottom of what they truly are. There are other methods of testing extracts, but Reynaud, who holds a doctorate in integrative biology from the University of California, Berkeley, said DNA is the most reliable.

The bulk of Reynaud’s clients are supplement manufacturers who want to make sure the ingredients they purchased from suppliers are the real deal. The FDA requires that companies do this, but most either don’t or they use a less stringent method than DNA identification. She also tests for attorneys who need the results for a lawsuit. Simply put, Reynaud’s customers are the small but earnest supplement manufactures, those who go the extra mile to make sure they’re selling what they say they’re selling.

But even among this group, which Reynaud said includes some of the most reputable companies in the world, about 25 percent of the extract samples are a different species from what the companies think they are. Usually, that means the herb supplier sold the manufacturer an adulterant rather than the extract it asked for.

That means in the real world, Reynaud said, the rate of adulteration is “actually much, much higher if we start looking at other companies that aren’t doing this testing or aren’t caring as much about the quality of their materials.”

In general, the more processed a supplement is, the longer it traveled to get from the supplier to the manufacturer, the more chances for either intentional or accidental adulteration. Products can accidentally be contaminated during shipping or storage, Reynaud said. There have also been cases where suppliers accidentally grew the wrong herb, she said.

The rates of adulteration are staggering among certain varieties of supplements, Reynaud said.

She’s been trying to get a hold of the raw material of garcinia cambogia from which the extract is derived, but none of the suppliers can produce it. She’s gone to trade shows and herb shops around Berkeley and called various suppliers she knows — no one has it.

“One of them, it was pretty hilarious, I said, ‘Really? You can’t give me any? I’ll buy it, $200 for 50 milligrams,’” she said. “He said, ‘No.’ I said, ‘Well, why?’ He said, ‘Because it’s mine.’”

In Reynaud’s mind, any company that has nothing to hide would share the raw material openly. Since none do, her suspicion is that most garcinia cambogia being sold in the U.S. is not an extract of garcinia cambogia at all. Extracts from herbs are typically sprayed onto a filler material such as maltodextrin, starch or rice. In the case of garcinia cambogia, she suspects most of what’s being sold is just chemicals sprayed onto filler material.

As a rule of thumb, anything that’s in TV commercials or on the radio — hoodia, the supplement advertised for weight loss a few years ago, for example – is more likely to be adulterated because it gets so popular that supply can’t keep up with demand, Reynaud said.

“Anything expensive, rare — or there is a fad — is kind of prime target for adulteration,” she said.

Reynaud said she thinks the media and the public’s attention to the problem has increased in recent years, and the FDA in turn has stepped up its enforcement, inspecting companies and issuing recalls when necessary. The FDA’s Tainted Weight Loss Products website warns the public of a new product several times a month, often because the product contains dangerous, banned controlled substances like sibutramine, which can cause life-threatening blood pressure increases.

“I’ve seen a huge shift toward companies, large and small, either caring more about identify testing or being scared into doing more identify testing,” she said. •

Common dietary and herbal supplements

Surveys show about half of people in the U.S. take dietary and herbal supplements, but because the FDA doesn’t regulate them, it’s impossible to tell what’s in them and whether they’re safe. Many ­— especially those used for muscle-building and weight loss — are either ineffective or harmful.

Green tea extract

What is it? Green tea contains caffeine and catechins, phytochemical compounds that act as antioxidants.

How does it work? Research has linked catechins to health benefits such as increased antioxidant activity in plasma, expanded blood vessels, increased fat oxidation, decreased fat absorption and reduced lipogenesis, the process by which foods are turned into body fat.

Evidence? The health benefits of green tea and green tea extract have been studied extensively. Green tea and caffeine mixtures common in weight-loss supplements have been linked to roughly 3 pounds more weight loss compared with control groups, although habitual caffeine use can dampen that effect. (The addition of caffeine to the green tea appears necessary in achieving the weight-loss effect.) According to the National Institutes of Health, there is insufficient evidence on the effectiveness of green tea extract in weight loss. However, some evidence has shown it can help moderately obese people lose weight.

Reported side effects? Green tea extract has been associated with liver damage, especially if consumed on an empty stomach. Since green tea contains caffeine, the extract can cause dangerous interactions if combined with other stimulants, such as ephedrine or bitter orange. Side effects can also stem from high concentrations of the extract in a serving or contaminants within the supplements.

Garcinia cambogia

What is it? Garcinia cambogia is a small purple fruit also called the malabar tamarind that produces the botanical extract hydroxycitric acid (HCA).

How does it work? HCA may be helpful in weight loss because it speeds up the metabolism. Research has shown it suppresses fatty-acid synthesis.

Evidence? Randomized controlled trials generally do not show effects on weight loss, fat oxidation or appetite. According

to the California firm that analyzes the DNA of supplements, it’s unclear whether products sold in the U.S. as garcinia cambogia actually contain the raw extract. Instead, many likely contain chemicals and fillers.

Reported side effects? Garcinia cambogia has been linked to several reports of liver damage. It also can increase serotonin levels, so could be harmful if combined with some antidepressants. Combinations with other substances in weight-loss products can increase the risk for harm. In 2009, the FDA warned people to stop using Hydroxycut, a weight-loss product that contained garcinia cambogia, because of reports of severe side effects, including liver damage requiring transplants.

Miscellaneous fat burners

What are they? Products contain several different active ingredients, including conjugated linoleic acids (CLA), fatty acids commonly found in dairy products and beef, and L-carnitine, a derivative of the amino acid lysine that’s produced naturally in the body.

How do they work? CLA and L-carnitine are believed to help weight loss through their impacts on metabolism.

Evidence? CLA has been extensively studied, and some research has found it to decrease fat by 2.2 to 4.4 pounds in 12 weeks to 24 months. Research into L-carnitine has shown little evidence of effectiveness, although some 2011 research showed when combined with carbohydrates it indirectly increased fat oxidation during exercise.

Reported side effects? Neither CLA nor L-carnitine have been shown to cause serious side effects, although some CLA users report gastrointestinal distress.

Preworkout supplements for building muscle

What are they? They are designed to increase energy and strength to boost performance during a workout. Many brands do not disclose their contents in their entirety, instead listing “proprietary blends.” Some include stimulants such as caffeine, while others contain amino acids such as arginine or beta-alanine. It’s important to be aware of whether several different caffeine products are stacked together in a single product, as manufacturers generally do not add up the total amount of stimulants in a single product (For example: listed ingredients could include caffeine, yerba mate and guarana).

How do they work? Some preworkout supplements contain caffeine, a stimulant that increases mental alertness and possibly improves athletic performance. Others contain anabolic amino acids and branched-chain amino acids (BCAAs), which are components of proteins believed to promote the body’s ability to turn food into energy. Some supplements contain creatine, a substance the body produces naturally and stores in the muscles, as it’s believed to improve athletic performance and build lean body mass. Most combine several active ingredients.

Evidence? Users report high rates of effectiveness on reviews and forums; however, academic research has not shown the same and has emphasized the health risks of these supplements. One study showed the use of a caffeine-containing supplement improved reaction time, energy and mental focus, but research last year by the University of North Carolina at Chapel Hill found overall evidence to be inconclusive.

Reported side effects? Not all preworkout supplements contain stimulants, but those that do are associated with the highest rates of side effects, such as liver damage, heart attacks, strokes and high blood pressure. More common side effects include jitteriness, anxiety, increased heart rate, heart palpitations and effects on lipids and blood glucose. Some users report gastrointestinal side effects. The FDA has banned products containing 1,3-dimethylamylamine, or DMAA, a stimulant linked to illnesses and deaths.

Sources: National Institutes of Health; Melinda Manore, Oregon State University; Robert Hendrickson, Oregon Health & Science University; Victor Navarro, Einstein Healthcare Network

Images courtesy Wikimedia Commons

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Pulse Magazine Fall/Winter 2014

10:17 am | 11/10/14


The rise of e-cigarettes; Pediactric psychiatry shortage; Winter gear advice; meet a school nurse; Diet tips.