Monday, May 18, 2009

Sports Illustrated - What You Don't Know Might Kill You

Sports Illustrated takes a look at the sports supplement business, a $20 billion industry that is largely unregulated.

I'm a huge fan of a free-market for this kind of stuff (ephedra and prohormones should still be legal if you ask me), but I would welcome regulations that force supplement makers to list ALL ingredients and meet label claims for their products.

As usual, this article makes some specious claims, the usual media hysteria that is never founded in facts, only lies. Other than that hysteria, this is an interesting article.

What You Don't Know Might Kill You

SUPPLEMENTS Would-be experts and untested products feed a $20 billion obsession with better performance across all levels of sports

Last November, a month after his 32nd birthday, Rene Gonzalez moved with his wife and two young daughters from Miami to Cape Coral, a wetlands community whose canals have earned it the nickname the Little Venice of Florida. In Miami the competition in his chosen career—nutritional supplement sales—was fierce, and Cape Coral offered a less congested marketplace. He opened a small store, Just Add Muscle, in a strip mall near two gyms. "Opening the store is the first step," Gonzalez says in his native Massachusetts accent. "What I really hope to do is open my own manufacturing company. That's my dream: to franchise this store and manufacture my own supplements and then sell them in the stores."

Gonzalez has no background in chemistry or nutritional science. His previous job was restoring cars; before that he was in the Marines. What he knows about sports supplements—those pills, powders and drinks marketed to athletes and would-be athletes—he learned from using them (initially as a chubby adolescent hoping to add muscle) and from reading articles in magazines and online. Except for his own experiences, there is nothing to suggest that he is qualified to offer advice on supplementation, let alone to design and manufacture his own line of products.

Gonzalez's dream, however, is not as fanciful as it would appear.

The sports-supplement world has many power brokers whose origins are as improbable as Gonzalez's. They have risen along with an industry that in three decades has grown from a niche business serving iron-heaving behemoths to a broad-based juggernaut with nearly $20 billion in U.S. sales in 2007, according to the Nutrition Business Journal. As more and more players are revealed to have taken performance-enhancing drugs—Dodgers slugger Manny Ramirez being only the latest example—potent products line the shelves of Wal-Mart, Rite-Aid and 7-Eleven, more than 5,400 GNC stores and Vitamin Shoppes, and independent stores like Just Add Muscle.

Despite the move into the mainstream the industry remains fertile ground for kitchen chemists with little or no formal education in science or nutrition—and in some notorious cases former steroid users and dealers (page 57). They help decide what compounds go into the fat-burners, muscle builders and preworkout drinks consumed annually by an estimated 33.5 million Americans. Many of those consumers flock to supplements that revolutionized sports training, like powdered creatines, which provide the muscles used for explosive movements with concentrated fuel found in meats and fish.

But questions about the industry arose anew in December, when six NFL players were suspended for four games each by the league after testing positive for a banned diuretic in the weight-loss pills StarCaps. Then in January, Philadelphia Phillies reliever J.C. Romero, who won two World Series games last fall, received a 50-game suspension from baseball for testing positive for androstenedione—or andro, used most controversially by Mark McGwire—which Romero blamed on 6-OXO Extreme, an over-the-counter supplement marketed as a testosterone booster. Earlier this month the Ontario-based manufacturer MuscleTech issued a voluntary recall of Hydroxycut, a weight-loss aid and workout booster that comes in a variety of forms and whose sales topped nine million units last year. The recall came after the Food and Drug Administration (FDA) linked Hydroxycut, which is still available in many stores, to 23 cases of liver damage including the death of a 19-year-old boy.

In a 2007 study of supplements sold in the U.S, the screening company Informed-Choice found that 25% of the 58 supplement samples it tested contained steroids or stimulants banned by the World Anti-Doping Agency (WADA). Six years earlier, a study funded by the International Olympic Committee found that 15% of the 634 supplements it examined would likely cause an athlete to test positive. Michigan-based NSF International now screens supplements for MLB, the PGA and the NFL, and marks those not containing banned substances with an NSF seal. But only a dozen companies have volunteered their products for certification, and NSF can only vouch for the specific batch it tests.

There is a simple reason that the industry has become, in the words of Darryn Willoughby, director of the Exercise and Biochemical Nutrition Laboratory at Baylor, a Pandora's Box of false claims, untested products and bogus science. To sell any type of food or drug, a company must submit to scrutiny from the FDA. That scrutiny once applied to supplements such as concentrated milk, egg and soy powders, which fed the demand for nonperishable food additives during World War II. But in 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA), which allowed supplements—broadly defined as vitamins, minerals, herbs, amino acids and other products that don't contain approved pharmaceutical drugs and don't claim to treat diseases—to be sold with no proof of effectiveness or safety, and without approval from the FDA (page 59). That legislation, heavy with lobbyists' fingerprints, razed virtually every barrier to entry into the marketplace.

All it takes to become a sports supplement dealer is a little money and a phone call, like the one Gonzalez placed last year to a supplement manufacturer in Texas. Gonzalez ordered bottles of a muscle-building product that he named Monsterdrol, which were then made, packaged and marked with Gonzalez's label, Supplements911. When showing a visitor around his store in February, Gonzalez pointed to a bottle of Monsterdrol and described it as "your typical prohormone product." A steroid prohormone is a substance that the body converts to an anabolic steroid; andro is an example. But Dr. Don Catlin—CEO of Anti-Doping Research, a Los Angeles--based nonprofit that hunts down new performance enhancers, and the former director of the UCLA Olympic Analytical Laboratory—says that Monsterdrol is in fact methasteron, an anabolic steroid that, while not on the controlled substance list of the Drug Enforcement Administration (DEA), is "Number 1 on my danger list."

Yet Monsterdrol can be purchased off the shelf at Just Add Muscle, available to anyone under the Florida sun, and on Gonzalez's website, available to anyone anywhere.

Supplement companies follow the Wright Brothers rule: You're flying until you crash. In the 1990s ephedra was the golden herb of the supplement industry. It was sold in more than 200 products that purported to do everything from boost athletic performance to burn fat to intensify sex drive. In 1999 some 12 million Americans consumed products containing ephedra.

But the dangers of the herb became apparent in 2001. On July 31, Minnesota Vikings tackle Korey Stringer, who had been using an ephedra supplement, died of heatstroke in training camp. Three days later Northwestern University safety Rashidi Wheeler died of an asthma attack after a conditioning drill. He too had been taking an ephedra supplement. The American Association of Poison Control Centers later reported that 64% of the calls it received in 2001 about herbal products—or 1,1178 in all—concerned adverse reactions to supplements containing ephedra.

The herb's banishment from the U.S. market was sealed two years later when Baltimore Orioles pitcher Steve Bechler, who was using an ephedra product to lose weight, collapsed and died during spring training. "[Bechler] was a fat guy exercising in the heat," argues Jack Owoc, CEO and founder of the supplement manufacturer and retailer Vital Pharmaceuticals (VPX) in Davie, Fla., echoing a common sentiment in the industry that ephedra was safe if used properly. (Stringer, too, was overweight.) VPX exploded to prominence with the help of energy and weight-loss products containing ephedra. Nonetheless, when Owoc saw a federal ban looming—it came in April 2004—he did what anyone who survives in the supplement industry does: He reinvented his business.

A former high school science teacher who began by selling supplements out of the front of his house in 1993, Owoc invested in a 14,000-square-foot plant and churned out Redline, a potent ephedra-free energy and weight-loss drink available not only at GNC and Vitamin Shoppe but also at Wal-Mart and 7-Eleven. Thanks largely to Redline, VPX is doing a nine-figure business and last year expanded, purchasing a 90,000-square-foot facility. Meanwhile, companies with less prescient leadership, like once-mighty Twinlab, which had its chips on ephedra-based Ripped Fuel—a supplement used by Stringer—have suffered a deep decline or even folded.

Owoc survived and is now to the sports-supplement industry what Willy Wonka was to the candy biz: eccentric, bursting with energy (as he sips a VPX BANG!) and in command of a factory full of less-musical Oompa-Loompas who make reality of his imaginative nutritional notions. A drug company, like Pfizer or Merck, typically needs eight years to get a product from the lab to the consumer. In a mere two months, a VPX energy drink can go from Owoc's brain to machines that each churn out 230 bottles a minute—and then to store shelves.

He spends much of his time sampling from a rainbow of liquids. On an afternoon earlier this year, Owoc drew a few cc's of a Day-Glo-red substance into an oral syringe and dropped them into his mouth. The connoisseur of energy drinks clicked his tongue a few times and delivered his verdict. "You gotta go higher on the cinnamon," he told a technician in a shin-length white lab coat, "and more sweetener. And no mint. You're killing me with the mint."

Nearly every energy and weight-loss drink contains some combination of the industry's go-to stimulants: yerba maté, green tea, yohimbine (a stimulant found in yohimbe tree bark) and good old-fashioned caffeine. The amount of each ingredient is part of a secret "proprietary blend," according to labels, though the caffeine content is occasionally listed—a shot glass of Redline, for example, has about as much caffeine as a can of Coke. For Owoc, all the mixing and taste-testing is part of his constant quest to stay ahead of the competition: Get something to market, get it there fast and make sure it tingles. As he puts it, you have to "feel it working."

What you "feel" working with a drink like Redline is thermogenesis, or the production of body heat. Consuming stimulants is like shoveling coal into a locomotive furnace, speeding up the body's metabolism so more energy is burned. One form of thermogenesis is familiar to anyone who has been to a game at Lambeau Field: shivering. The tiny muscle contractions use energy to generate heat and warm the body. "It is a physiological fact that when you shiver, your body releases a large amount of stored body fat in an attempt to bring body temperature back to normal," reads Redline's marketing materials, which play up the product's ability to induce shivering.

For a person drinking a Redline in a gym, however, shivering does generate heat, but it has nothing to do with bringing body temperature back to normal. "Some people get jittery from stimulants," says Judith Alsop, director of the Sacramento division of the California Poison Control System. Alsop says that between 2004 and '06, her office received 10 calls from Redline users reporting symptoms from jitters to vomiting. (Four checked into emergency rooms, but none suffered lasting harm.) VPX says that if people use the drink as indicated, they should experience no adverse reactions.

"They're marketing the side effects as the intended effect, so if someone gets tremors, they think, I'm just shivering and losing weight," says Alsop. Shivering may aid weight loss slightly, but even a tiny increase in body temperature—both from the shaking and increased metabolic rate—can be disastrous during a summer workout. "Football players get on the field at 98 degrees, and it's normal for them to get up to 103 or 104," says Sandra Fowkes-Godek, director of the HEAT Institute at West Chester (Pa.) University. "If they start at 100 or 101 and get to 105, they can have a potentially catastrophic event."

Each eight-ounce Redline bottle notes that one serving is four ounces and has a warning that reads, NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. But such warnings are lost on the prime consumers. As Alsop says, "We've found that young men don't read labels."

How does an idea for a supplement go from the brain of Rene Gonzalez or Jack Owoc to a mall near you?

Companies that outsource manufacturing, as Gonzalez's does, are in the vast majority, and they usually rely on the manufacturer to obtain ingredients. Those that make their own products, such as VPX, order most of their raw materials from abroad, often from Asia.

Materials from overseas arrive with a certificate of validation from the exporter. "[But] you have to treat that like just a piece of paper some guy in China wrote something on," says Patrick Arnold, who before he rose to fame as the BALCO chemist, popularized the andro supplement that was in McGwire's locker in 1998. Says Arnold, "If you are serious about quality control, you have to test everything."

Some manufacturers, like VPX, rigorously screen the raw materials they receive; others trust the suppliers, at the consumer's risk. Balanced Health Products, the manufacturer of StarCaps, said its supplement was probably contaminated by raw materials imported from Peru. "Like any business, there are companies you can trust to do the testing and those that you cannot," says Arnold.

Once the materials are in hand, a large manufacturer, like VPX, can decide what to mix together and call a supplement. Gonzalez's options, on the other hand, are more limited. Because the size of his order won't be large enough to warrant its own production run from the manufacturer, he can only commission a so-called "me-too" product, essentially a copy of an existing supplement in the marketplace that he then brands with his label.

To make a brand rise above the crowd, though, a company can't just churn out another basic creatine or whey protein. It takes a different formula, or the real jackpot: the inclusion of a novel ingredient. It is during the race to create something new, when supplement makers spend hours poring over science and nutrition journals—sometimes using themselves and their coworkers as guinea pigs for experimental formulas—that they're likely to jump the gun and embrace ingredients that have proved neither safe nor effective.

A few years ago supplement makers turned ecdysterone, an insect development hormone, into all the rage. The leap that companies made was spelled out in the ecdysterone information page at, the leading online-only supplement purveyor: "Could there be some correlation between insects' superior strength ratio and this compound? What would the effects be on vertebrates such as mammals? If we had the proportionate strength of an ant, for example, we could easily pick up a car." A article by a former chief of research for a major nutrition company called ecdysteroids the "Steroidal Holy Grail."

Except ecdysterone doesn't have any effect on humans. "Studies in my lab have shown that ecdysteroids are completely innocuous in mammals," says Ronald M. Evans, a professor at the Salk Institute for Biological Studies in San Diego. "Spinach, for example, is loaded with [ecdysteroids], but these molecules provide no muscle-building properties in humans."

Instances in which supplement makers have moved faster than science, or dodged it entirely, abound. For example:

• A 2003 study claimed that an extract of brown seaweed binds to and blocks myostatin, a protein that tells muscles when to stop growing. Companies such as Biotest and Champion Nutrition rushed brown-seaweed-extract supplements to market. After two later studies debunked the seaweed-as-muscle-builder theory, Tim Ziegenfuss, one of the authors of the pro-seaweed study and now a Biotest scientist, conceded in an online interview with the website Testosterone Muscle that "the science was just so promising that we just didn't follow the process like we usually do in terms of stringent testing.... [The supplement companies] were in too big a hurry to get it to market."

• Some oral spray or liquid products claim to contain human growth hormone. Whether they do or do not is unimportant, since HGH is a very large molecule that is not effective unless taken by injection and can be legally obtained only with a prescription.

• Ginseng has been used in China for thousands of years, as many supplement makers will inform a consumer looking for a boost in the gym or on the field. But a few well-designed scientific studies, according to UC Berkeley's Wellness Guide to Dietary Supplements website, have found no proof that ginseng enhances energy levels or athletic performance.

• Almost every sports-supplement store sells products that contain the steroid prohormone DHEA, which is legal but banned by the NCAA, the NFL, the NBA and WADA. DHEA is marketed for everything from muscle growth and fat loss to antiaging. Levels of DHEA in the body do decline with age, but in scientific studies on thousands of senior citizens, supplemental DHEA failed to improve muscle mass or brain function. Studies have, however, documented side effects, including facial hair growth in women and breast enlargement and elevated blood pressure in men, in addition to a number of dangerous interactions for those also taking prescription drugs.

No comments: