The Scam of Deadly Fitness Supplements
Supplement makers may be headed for jail due to deaths among men and women using their pills. But will anything change?
When Leanne Sparling took the call on June 1, 2011, the voice on the phone told her to pray. It was all she could do to save her son’s life.
That morning, Michael Sparling collapsed during a run with his Army unit at Fort Bliss, Texas, went into cardiac arrest, and was rushed to the hospital. When the commander of the hospital called Leanne, Michael was receiving CPR, but ultimately the doctors failed to resuscitate him. Before noon, he was gone, dead of a heart attack at age 22.
Sparling was shocked, grief-stricken, and confused: Her son had a heart attack? He was fit and active. He played soccer and football during junior high in California, took martial arts lessons with his father, and went snowboarding. But at 145 pounds and standing just under six feet, Michael thought himself small for an infantryman. During basic training at Fort Benning in Georgia, a friend recommended Jack3d, a performance-enhancing supplement from USP Labs. The Dallas-based distributor sold its workout and fat-burning dietary supplements directly to consumers as well as to large retailers like GNC. Roughly four weeks prior to leaving Fort Benning for Fort Bliss, Michael purchased a container of Jack3d powder.
Its name was a play on “jacked,” slang for describing anyone whose muscles call to mind the Hulk’s biceps. Yet its key ingredient, methylhexanamine, was suspect. More commonly known as DMAA, it’s an amphetamine-like stimulant that narrows blood vessels and arteries, causing blood pressure to rise, which in turn gives users a boost of energy. Shortness of breath and a tightening in the chest can also follow.
Such dangers usually don’t slow buyers. Americans spend almost $37 billion on dietary supplements each year, including one-third on products that claim to bulk bodies up or slim them down. And emerging research suggests that many young men may be particularly susceptible to such claims targeting body image insecurities, with new studies reporting teenage boys’ preoccupation with gaining muscle and dropping weight. At the same time, some 23,000 Americans go to the emergency room annually because of dietary supplements.
Nevertheless, Jack3d and OxyElite Pro, its DMAA-laced sister product marketed for weight loss, were huge hits for USP Labs. For several years starting in 2008, they were best-selling workout supplements, making the company more than $400 million.
But money like that can’t last forever — not when you build a supplement empire on misdirection and fraud.
Jack3d and OxyElite Pro formed the basis of a multi-year scheme perpetrated by USP Labs and its manufacturing partner, California-based S.K. Laboratories. Over five years, the two firms imported synthetic ingredients from China using doctored documents. They circumvented United States law governing the production and sale of dietary supplements, and then lied repeatedly about the nature of its supplements to keep the profit machine rolling. A 37-page federal indictment lays out the deception, which came to a close in March after five executives at USP Labs and S.K. Laboratories pleaded guilty to multiple felonies.
(Sentencing was originally scheduled for August, but has since been pushed back until 2020. Delays in sentencing are typical for high-profile cases with multiple defendants, although the presiding judge in the case declined to comment regarding the delay.)
Elemental contacted the lawyers representing the five executives and both companies. Most either did not return an emailed request for comment or declined to comment until sentencing concludes. The lawyer for Matthew Hebert, co-owner of USP Labs, simply referred Elemental to his defendant’s plea agreement. All the plea agreements are public record. The one entered into by USP Labs in the spring came with a number of conditions: The company agreed to close its business within 90 days, forfeit almost $5 million, liquidate its remaining inventory of supplements, and pay a $500,000 fine.
Under U.S. law, supplements are defined as food, and as such, they are exempt from the regulations that govern the safety of prescription drugs. USP Labs exploited this opening to claim to customers, retailers, and the government that the DMAA in its products was safer because it was naturally extracted from geranium plants, even though it was being chemically-produced in Chinese factories.
Undeterred by letters from the U.S. Food and Drug Administration (FDA) warning that they were skirting federal law by selling adulterated products, company executives kept selling DMAA supplements. Only when scrutiny over their use of DMAA became too great did they remove the DMAA — and then merely reformulated their products with other, similarly problematic substances.
In the end, dozens of people reported adverse health effects to the FDA after taking USP Labs’ supplements. Two needed liver transplants. Five wound up dead — including Michael Sparling, who used Jack3d every day for one month, up to and including that June morning when his mother learned only prayer might keep him alive. Yet even as the case slowly works its way through the legal system, little has changed in the supplement industry, even in the wake of tragedy. Supplements, still, can be marketed without prior approval, making it virtually impossible to know how a product will affect consumers until after something happens.
“We miss Michael every hour of every day,” says Sparling, eight years after the death of her son. “Until the law changes and there are more regulations, these supplements are a ticking time bomb.”
Although DMAA has existed for more than 60 years, it wasn’t until last decade that the dietary supplement industry began using it in earnest.
Pharmaceutical company Eli Lilly developed DMAA in the 1940s, and in 1948, it was approved for use as a nasal decongestant. By the 1950s, however, doctors were already airing their concerns over associated health risks: panic attacks, seizures, along with increased blood pressure and heart rate. In 1983, the FDA withdrew its approval for DMAA as a prescription drug.
Two decades later, DMAA experienced a renaissance, just as another stimulant was falling from grace. Ephedrine, a plant-based substance, was widely popular in the dietary supplements of the 1990s for its supposed energy-boosting and weight-loss qualities. Yet ephedrine also constricts blood vessels, and studies eventually linked it to high blood pressure and heart attacks. In 2004, after cataloguing 155 deaths related to products containing ephedrine, the FDA banned it.
DMAA took its place. Despite the fact that the approval for DMAA in prescription drugs was withdrawn in 1983, it was still possible for the stimulant to find its way into supplements.
“Because dietary supplements can be marketed without any approval from the FDA, the FDA’s opportunities to identify and address violations of the law are generally limited to actions once a product is already being sold,” says a spokesperson from the FDA.
Under a 1994 amendment to the Federal Food, Drug, and Cosmetic Act — the same amendment that defined supplements as food, not drugs — anything that’s not a vitamin, a mineral, or a botanical is not considered a dietary ingredient. Furthermore, any substance that is not already present in the food supply and not marketed as a dietary ingredient in the United States before 1994 is deemed a “new dietary ingredient.” Yet there’s no safety testing required in humans, even for products containing new ingredients, and the FDA doesn’t approve supplements prior to sale. Instead, the manufacturer is solely responsible for the safety of its products.
It stands to reason that it might have been quite difficult, then, for DMAA to make its way into supplements. But a single study published in 1996, in a now-defunct scientific journal, concluded that DMAA was present in geranium oil, a common botanical used in cosmetics. As it relates to the interpretation of the rules and regulations of the FDA, the supplement industry seems to take the broadest possible interpretation. According to Dr. Pieter Cohen, a Harvard Medical School professor who studies dietary supplements,: supplement makers generally think that if they find a substance present in food or a botanical, they can synthetically produce it and sell it to people.
“That’s clearly selling something like a drug — but, at the same time, bypassing the FDA,” Cohen says.
Thanks to that single 1996 study, DMAA was deemed a natural product; not illegal from a dietary standpoint, in other words. For USP Labs, it was an opportunity too good to pass up.
As early as 2008, USP Labs co-founders Jacobo Geissler and Jonathan Doyle were looking for a competitive edge in the marketplace. They surmised that the ingredients chosen for its supplements could set its products a cut above a crowded industry: an estimated 85,000 dietary supplements are currently available. That’s when Sitesh Patel came calling.
Patel was the vice president of the supplement-manufacturing company S.K. Laboratories in Anaheim, California. In the dietary supplement industry, it’s common for sellers like USP Labs to outsource manufacturing of the actual supplements to an outside company. In this case, that was Patel, who began telling Geissler and Doyle about DMAA that year. To his credit, Geissler, the CEO, had his doubts. (Any quotes attributed to principals from USP Labs or S.K. Laboratories in this article come from the indictment released by the federal Department of Justice.)
Geissler considered DMAA a “questionable powder,” which made him concerned about importing large quantities of it from China. He told Patel that the “last thing” he wanted for USP Labs was for the company to show up “on the FDA radar.” Geissler had previously been under the microscope of law enforcement: In 2003, he was indicted on a controlled substance charge and placed under community supervision for possessing anabolic steroids.
And yet both Geissler and Doyle recognized that selling natural, plant-based substances would be easier than selling supplements filled with synthetic stimulants. That’s because regulatory bodies like the FDA, as well as retailers like GNC, would be less likely to raise questions. They landed on a workaround: Use fraudulent documents to ensure that any synthetic DMAA the companies imported was mislabeled as an extract from the geranium plant — not only on the shipping packaging, but also on containers of Jack3d and OxyElite Pro.
In the dietary industry, companies rely on certificates of analysis. Each certificate of authenticity, or COA, is essentially a guarantee from the ingredient provider certifying that what’s being shipped has been tested to ensure it is what the COA says it is. So if shipped DMAA is synthetic, the associated COA will say so.
USP Labs and S.K. Laboratories doctored their COAs instead. “Have your supplier create a COA like this,” wrote Patel in a September 2008 email to Geissler and Doyle, USP Labs’ presidents. Patel provided almost word-for-word the text they used to create the fake COA that allowed them to import chemically-produced DMAA for years.
In November 2008, USP Labs released Jack3d; the following November, it came out with OxyElite Pro. An old description of Jack3d on GNC’s website says the supplement “produces an intense sensation of drive, focus, energy, motivation, and awareness,” along with “rapid increases in strength, speed, power, and endurance.” Supplement retailers are not bound by federal law to ensure product safety; they take the claims that manufacturers make at face value, and assume those manufacturers aren’t being unscrupulous. (GNC did not return an emailed request for comment. However, in 2016, the global supplement retailer agreed to pay $2.25 million as part of a non-prosecution agreement struck with the U.S. Department of Justice, thereby ending its liability for selling OxyElite Pro in its stores in 2013.)
But doctored labels covered both products, portraying the DMAA ingredient inside as having been extracted from the “geranium stem,” a blatantly false statement. In that very instant, both USP Labs and S.K. Laboratories had broken the law — by using fake COAs and false labels, they were participating in a conspiracy to introduce misbranded food into the United States.
What was even more brazen is that they bragged about it. In an email Patel sent to Geissler and Doyle in May 2009, he wrote, “lol stuff is completely 100% synthethic [sic].” He was referring to the imported DMAA. The federal indictment says that in September 2010, S.K. Laboratories received documents claiming that 1,000 kilograms of synthetic DMAA being shipped was instead “Geranium Flower Powder Extract.”
By 2010, DMAA was facing scrutiny. The World Anti-Doping Agency had always prohibited DMAA because it’s a stimulant, but added it as an official example of a banned substance that year. The following year, in partnership with botanical researchers at the University of Mississippi, the U.S. Anti-Doping Agency tried deriving DMAA as an extract from geranium — and, crucially, couldn’t do it. By the end of 2011, following the deaths of two soldiers who used Jack3d — one of them being Michael Sparling — the U.S. Department of Defense removed all DMAA-laced products from stores on military bases.
In April 2012, the FDA sent its first warning letter to USP Labs, claiming that Jack3d and OxyElite Pro were adulterated products while citing product labeling that called DMAA a “dietary ingredient.” The company responded by sending back two self-funded studies purporting to show that trace amounts of DMAA were derived from samples of geranium plants.
Dietary supplements containing DMAA grew in popularity, even as the FDA, prominent organizations, and academia raised questions about the stimulant. By 2012, DMAA was available in more than 200 supplements being sold in the United States.
That supplements might contain cautionary ingredients is usually not at the forefront of the minds of buyers — especially men. Behind the seemingly jocular chants of “sky’s out, thighs out” and asseverations about “bro-tein” lies a growing body of psychological research showing that men are more concerned with their body image than ever before.
A study published by the Journal of the International Society of Sports Nutrition in 2014 found that two-thirds of teenage boys are preoccupied with losing weight and gaining muscle, and are turning to protein powders and nutritional supplements to do it. As the authors wrote, “[T]hese substances may act as a gateway for the use of drugs and illegal substances to enhance appearance or sports performance.” One year later in 2015, at a meeting of the American Psychological Association, the question was posed more starkly: Is overuse of workout supplements an “emerging eating disorder for men”? A June 2019 study reported that 22% of young men — compared to 5% of young women — reported partaking in disordered eating behaviors to bulk up, such as eating more or different food, using supplements, or taking steroids.
Getting ripped, getting big, lifting weights, gaining muscle: On an individual level, it can be a worthwhile, healthy pursuit. In the aggregate, it seems, it’s making men ingest supplements that they think will give them an added edge in the gym.
As the inclusion of DMAA in workout supplements increased coming into this decade, USP Labs was doing its best behind the scenes to support its own statements about the DMAA in Jack3d and OxyElite Pro — statements the company knew were not true.
Beginning in 2010, USP Labs went on the offensive, looking to quell controversy over the stimulant. Geissler and Doyle had help from two other USP Labs associates: co-owner Matthew Hebert, who focused on packaging design, and former co-owner Cyril Willson, who coordinated scientific research. The indictment says that Willson (who used the fake name Erik White publicly) went online to attack competitors whom USP Labs believed were spearheading negative press about DMAA. Meanwhile, Hebert lied to retailers by telling them the DMAA in his company’s products was a natural extract from the geranium plant. In late 2010, Geissler and Doyle perjured themselves during a lawsuit involving a professional athlete who took Jack3d and subsequently failed a drug test: They said the DMAA in their product was sourced naturally from geraniums.
Still, USP Labs continued searching for other ingredients to mix into its products as a fail-safe should the company need a DMAA replacement.
In December 2011, the same month the U.S. Department of Defense removed all DMAA-contained products from U.S. military bases, Geissler emailed a Chinese chemical seller with instructions on how to mislabel a shipment of nine different chemicals: “Please send as Green coffee samples and send them all together… And don’t label the individual bags. Label as green coffee sample 1, 2, 3, etc.”
Having finally stripped DMAA from its supplements, USP Labs confronted a fresh problem: Its new formulations, did not sell as well in the new year. So Geissler sought once again to reformulate OxyElite Pro, this time by adding as an ingredient an extract from a Chinese herb called cynanchum auriculatum. USP Labs thought the extract might promote weight loss. According to the indictment, both Geissler and Willson, the brains of the company’s scientific research wing, knew of one study showing that cynanchum auriculatum actually led to liver toxicity.
In August 2013, OxyElite Pro Advanced Formula, containing the compounds aegeline and cynanchum auriculatum, hit store shelves. Just one month later, the trail of deception left by USP Labs finally caught up with it.
Dr. Linda Wong knew something was wrong. For Wong, the director of the liver transplant program at The Queen’s Medical Center in Honolulu, Hawaii, an unusual year would be one where she saw two people with acute liver failure. But by September 3, 2013, she was seeing the fourth patient with acute liver failure in almost as many weeks. The common thread among her patients: They were all taking OxyElite Pro.
Wong notified the Hawaii Department of Health the following week. Soon officials from the FDA and the Centers for Disease Control were also involved in a rapid effort to understand whether these instances of liver failure could be traced back to this one dietary supplement.
They quickly had an answer. These mounting cases of liver failure seemed to coincide with the timeframe during which the “Advanced Formula” of OxyElite Pro was available on store shelves in Hawaii. From January to September 2013, an average of 6,912 containers of weight-loss supplements were sold per month; 43% of that total was OxyElite Pro.
USP Labs got one thing right: Its reformulation of one of its popular supplements was selling like gangbusters.
Unfortunately for the people taking the supplement, they endured dark urine, yellowing of the skin, loss of appetite, and fatigue. Eventually, Wong and the team identified 44 cases of acute liver failure with mysterious origins dating back to April 2013. Of those 44 cases, 36 involved people who had taken OxyElite Pro. Two people required liver transplants. One person died.
“Their lives were completely disrupted by this. It was horrible,” Wong says.
In October 2013, the FDA issued another warning letter to USP Labs, this time about the aegeline in its reformulations of OxyElite Pro. The ground was shifting beneath the company’s feet. Because of the outbreak of liver failure, FDA officials were conducting emergency inspections of USP Labs’ facilities in Dallas as well as S.K. Laboratories’ operations in Anaheim. On October 8 — the same day the Hawaii Department of Health asked retailers to voluntarily pull OxyElite Pro from their shelves — USP Labs told the FDA it would stop all distribution of its OxyElite Pro supplements, its final diversion.
Instead of halting distribution, Geissler, Doyle, and co-owner Hebert worked the phones to sell as much OxyElite Pro as possible, lest the FDA seize the company’s remaining stockpile. They sold by phone, the indictment says, “in order to avoid creating a paper trail.”
One month later, on November 6, the FDA sent USP Labs a voluntary recall letter. In the world of dietary supplements, this is the first measure taken: The company is given a chance to remove any and all products on its own. In the same letter, the FDA threatened to order USP Labs to cease distribution of OxyElite Pro supplements. Several days later, the federal agency announced that USP Labs agreed to recall OxyElite Pro.
Two years later, in November 2015, Geissler, Doyle, Hebert and Willson, along with Patel of S.K. Laboratories, were charged by the U.S. Department of Justice as members of a criminal conspiracy to introduce misbranded food into interstate commerce. Later that same month, GNC announced it was suspending all sales of USP Labs products “in the best interest of our customers.”
Jack3d and OxyElite Pro are just two examples of adulterated substances — dietary supplements that include active drugs in a purportedly botanical concoction.
From 2007 to 2016, the FDA identified 746 brands of supplements that were adulterated. Yet the agency’s hands are somewhat tied when it comes to getting adulterated products removed from the market. Usually it involves warning letters and voluntary recall notices, as in the case of USP Labs. But these steps are not overly effective: Just 360 of those 746 adulterated supplements were removed from the market.
“People see them in the store and think they’re going to build muscle and burn fat. It sounds exciting, but these things are not well-tested,” says Wong. “The most harmful ones are the ones that say they’re for weight-loss and fat-burning.”
FDA enforcement actions are also down so far during the Trump administration. According to a report published in Science in July, the agency sent 1,033 warning letters from January 2017 through May 2019, compared to 1,532 from January 2013 through May 2015.
The simple truth is that the dietary supplement industry is a veritable Wild West. According to the 1994 amendment to the Federal Food, Drug, and Cosmetic Act of 1938, supplement makers have to submit safety information to the FDA if they plan to introduce new dietary ingredients to the market — and, of course, their products must contain only the ingredients listed on the labels. But USP Labs is a case study in just how easy it is to go around the system.
What’s more, supplement makers don’t have to demonstrate that their supplements are safe for human consumption. The burden of proof, in fact, is on the FDA: According to the law, the agency has to pull together enough evidence to show that a supplement is adulterated, and only “if there is inadequate information to provide reasonable assurance that such an ingredient does not present a significant or unreasonable risk of illness or injury.” In the case of ephedrine, the precursor to DMAA, the FDA logged 62,000 consumer complaints — and those 155 deaths — before the stimulant was banned.
“Supplements should not be classified as a subcategory of food as they are currently,” says Harvard’s Cohen. “And there needs to be more rules regarding the safety of what’s included. It has to be crystal clear that the law can’t be misinterpreted to introduce novel drugs and supplements.”
One suggestion Cohen has: Make supplement makers register their products with the FDA prior to selling them.
For now, people like Leanne Sparling await final sentencing. Willson and Hebert face up to three years in federal prison, while Doyle and Geissler could be sentenced to five years. Patel faces six years in federal prison.
The possibility of prison time, however, is just grim satisfaction to Sparling and her husband.
“The people who ran the company will be out of jail in a few years and go about their lives as normal,” she says. “We were given a life sentence.”