March 25, 2013
Should GNC be liable for selling dangerous supplements?
EVERY morning as she gets dressed for her accounting job, Leanne Sparling hangs her son’s military dog tags and a photograph of him in uniform around her neck. She wears the tags on the outside of her clothes, hoping to prompt strangers to ask about him. “When I do tell them what happened,” she says, “they are in total disbelief.” Her son, Michael Lee Sparling, was a 22-year-old Army private when he died. But he wasn’t killed by a roadside bomb or an ambush in Afghanistan. He collapsed while running in formation for about 10 minutes with his unit at Fort Bliss, Tex., went into cardiac arrest and died later that day, on June 1, 2011. Private Sparling had recently graduated from basic training and was in excellent physical condition. Before the exercise, he had taken the recommended dose of a workout supplement called Jack3d, bought at a GNC store on the base, according to legal filings. Pronounced “jacked,” as in “jacked up,” Jack3d contains a powerful stimulant called dimethylamylamine, or DMAA for short, which some medical experts and health regulators say has similar effects on the body as amphetamines. Among bodybuilders and in the fitness-obsessed culture of the military, Jack3d has acquired a reputation for bolstering workout energy and stamina. The product description on the GNC Web site promises as much: “ultra-intense muscle-gorging strength, energy, power and endurance.” Leanne Sparling and her husband, Michael, blame Jack3d for their son’s death. It is the only way, they say, they can make sense of a healthy young man dying from cardiac arrest. Last month, they filed a wrongful-death lawsuit against USPlabs, the maker of the supplement, and GNC. They argue that the companies sold a defective product and failed to warn about its risks. The case has united some military physicians, professional sports organizations and supplement researchers who say Private Sparling’s death, and reports of at least four others, expose major weaknesses in federal protections for consumers. It also opens a very public challenge to GNC’s image as a trusted supplier to athletes and bodybuilders. The supplement industry is fighting back. Peter B. Hutt, a lawyer representing USPlabs, a Dallas-based company that markets Jack3d and other supplements, says the company is “unaware of anyone that died who has used the product in accordance with the labels’ directions for use.” He adds that there is no evidence that the product caused the deaths that have been reported. “Let me give you an example,” Mr. Hutt says. “Suppose I drank a soda pop and, 15 minutes later, died of a heart attack. Would you say that the caffeine in the soda pop caused my heart attack?” Laura Brophy, a spokeswoman for GNC, said the company did not comment on pending litigation. But in a statement e-mailed to The New York Times two weeks ago, GNC said it had “no reason to believe that DMAA is unsafe.” Although the Defense Department in late 2011 removed products containing DMAA from all stores on military installations, including more than 100 GNC outlets, the GNC statement said the military had “yet to produce any scientific or medical evidence to support a safety concern.” And, in fact, the Food and Drug Administration has not asked manufacturers to recall the products. GNC continues to sell Jack3d in its consumer stores around the country, as well as on its Web site, where the product has been featured this month as a “hot buy.” Federal regulations make supplement manufacturers responsible for ensuring product safety, allowing retailers like GNC to rely on their vendors’ guarantees. On that level, supplement retailers are treated the same as supermarkets. If spinach in the produce aisle arrives at the store contaminated with E. coli, the producer is held responsible, not the grocer. But some industry experts argue that supplement retailers should be held to a higher standard because potential hazards might reside in the very ingredients or formulas of the products sold, not just in contamination or manufacturing error. Some researchers point to workout and weight-loss supplements as categories of particular concern, because they often contain a cocktail of stimulants that can raise blood pressure and heart rate, potentially leading to serious health problems. These experts say supplement retailers should take responsibility for following ingredient research and voluntarily withdraw products as a precaution after safety concerns arise. Right now, “supplement retailers are no different than furniture retailers who sell defective cribs that later have to be recalled,” says Edward Wyszumiala, general manager of dietary supplement programs at NSF International, a nonprofit organization that tests supplements for performance-enhancing substances banned by sports leagues. “They are not being held accountable.” Ms. Sparling says they should be, pointing to Jack3d as a cautionary tale. The assurances from USPlabs and GNC feel thin to her. She knows that the F.D.A. sent warning letters last April to 10 companies, including USPlabs, that made supplements containing DMAA. Regulators said that they had no evidence that the stimulant was a legitimate dietary ingredient and that it often increased blood pressure, potentially increasing the risk of heart attacks. She also knows that numerous sports associations, including the World Anti-Doping Agency and Major League Baseball, have banned DMAA under its alternate name, methylhexaneamine. Considering all of that, Ms. Sparling is fierce in her condemnation of GNC for continuing to sell Jack3d. “I feel they have a responsibility because they sell it and they back it,” she says. Her son’s death has transformed Ms. Sparling, who lives with her husband and their three younger children in a gated community outside Sacramento, into a kind of Erin Brockovich, challenging performance-enhancing supplements. “They just think they are too big and everybody’s afraid of them,” she says of GNC. “They think I will just go away. Unfortunately for them, I won’t go away.” MORE than half of American adults take some kind of supplement – a multivitamin, protein powder, a calcium pill. In 2011, Americans spent an estimated $30 billion on such products, according to Nutrition Business Journal, a market research firm. In fact, supplements have become something of a commodity, proliferating in supermarkets and sold in bulk at Costco. GNC has differentiated its business by marketing itself as an upscale wellness brand and, perhaps more crucially, as a mecca for gym rats. It has become the largest specialty supplements retailer by far, with more than 8,100 retail locations globally. With marketing slogans like “Live Charged” and “Live Amped,” and its own Pro Performance line of sports supplements, GNC had about $2.4 billion in revenue last year, with sports nutrition products the largest segment: about 43 percent of sales. The Pro Performance brand alone brings in nearly $300 million. “Due to our cutting-edge product development,” the company said in a recent news release, “we now have 27 percent of the fast-growing sports nutrition business.” GNC started during the Great Depression as a Pittsburgh health food store called Lackzoom, whose signature product was yogurt. The company first went public in 1980. Over the last 25 years, three private equity firms and a European company have owned it. The buyout firm Ares Management and the Ontario Teachers’ Pension Plan bought GNC for $1.65 billion in 2007. The two funds took it public in 2011, then continued to reduce their ownership stake in subsequent share sales. Ares and Ontario Teachers made more than four times their investment, according to a person briefed on the sale. Since GNC’s 2011 initial public offering, its stock price has doubled, and it now has a market capitalization of about $4 billion. As the industry leader, GNC is at the center of a debate over the regulation of supplements, and the vulnerability of consumers to potentially hazardous products. Although supplement packages carry official-looking ingredient labels, the manufacturers are not as tightly regulated as pharmaceutical companies. Under a 1994 federal law, supplement makers must submit some kind of safety data to the F.D.A. if they plan to introduce new ingredients to the market. And manufacturing-practice rules require them to make sure their products contain only the ingredients listed on the labels, with no hidden substances. But, unlike drug makers, supplement makers are not required to prove that their products are safe and effective on humans. Nor do they have to get federal approval before selling their products. That means it is up to the F.D.A. to identify any risky supplements from among the estimated 85,000 on the market, and to prove that they are adulterated or present health hazards. A result is that untested and potentially harmful ingredient combinations can easily end up on store shelves, says Amy Eichner, special adviser on drugs and supplements at the United States Anti-Doping Agency, the anti-doping association for American Olympic athletes. “No consumer can ever know what’s inside a bottle,” Dr. Eichner says. “We advise our athletes that all supplement use is at their own risk.” According to the GNC Web site, the company requires vendors who wish to place new products in stores to submit an application that includes a product sample, pricing recommendations and a marketing budget. GNC also has a medical advisory board of physicians who help guide the development of new products, the site says. For some GNC-branded sports supplements, the company works with an independent testing company to certify that the products do not contain substances banned by the World Anti-Doping Agency. But GNC declined to answer questions about whether the company requires vendors to provide ingredient and product safety data for their supplements or to certify that those products are free of banned substances. In response to reporters’ questions, Greg Miller, a spokesman for GNC, said in an e-mail that the company “sells legal products that are widely available at a variety of retailers” and that the products “comply with all relevant regulatory guidelines.” He referred questions about ingredient safety to supplement manufacturers. A large majority of supplements are safe, says Steve Mister, president of the Council for Responsible Nutrition, an industry trade group, noting that only a small number of people, out of millions of users, report health problems. Some people have allergies or idiosyncratic reactions to certain supplements, just as some people react badly to certain foods or medications, he says, and that is why many retailers, including GNC, have agreements with vendors to indemnify them should a product turn out to be defective or harmful. “I think it’s unrealistic to expect supplements to be 100 percent safe all of the time,” Mr. Mister says. Consumer advocates argue that the regulatory system gives retailers no incentive to ensure the safety of third-party products. If a supplement turns out to pose health risks, retailers can simply replace it with a reformulated product or a new brand, with little consequence, says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who studies supplement safety. That is what has happened in previous cases involving products made by third-party vendors. GNC and other retailers marketed StarCaps, a popular weight-loss product, as a natural supplement containing papaya enzymes. The product was recalled in 2008 after the F.D.A. said the capsules contained bumetanide, a prescription diuretic that can cause severe dehydration and low blood pressure. StarCaps is no longer on the market. Next came Hydroxycut, a popular line of fat-burning and energy-boosting products that have been a mainstay of GNC’s weight-loss business. In 2009, the F.D.A. issued a warning, saying it received 23 reports of health problems, including liver failure, in people who used the supplements. The distributor agreed to recall the products, and the Hydroxycut line has since been reformulated; GNC sells some of those products. Now GNC finds itself responding to concerns about the safety of DMAA products like Jack3d. In each case, a GNC representative has defended the company with nearly identical phrasing, explaining in e-mails to The Times that GNC is “simply the retailer” and, like all retailers, relies upon “representations and contractual warranties made by the vendor that the products are safe.” Other major retailers, including the Vitamin Shoppe, have sold the same items. The Vitamin Shoppe also continues to sell Jack3d, but GNC has more than 10 times the number of outlets in the United States, and thus the market power to turn products by niche manufacturers into national best sellers. “GNC appears to look like a kind of pharmacy, but in reality it’s more of a flea market,” Dr. Cohen says, where the proprietor does not take responsibility for vendors’ wares. “If people viewed it as more of a flea market, they would understand that there are random people selling pills that don’t do much of anything, and occasionally might hurt.” In a conference call with investors in February 2012, Joseph Fortunato, the GNC chief executive, noted how quickly the assortment of workout supplements changes. In response to a question from an analyst about how the DMAA issue had affected sales, Mr. Fortunato held up the company’s turnaround cycle as reassurance that the negative publicity over products like Jack3d was of little financial concern. “You guys know this industry,” Mr. Fortunato said. “It’s a churn industry as far as products go. Things come, things go very quickly. When something goes, something replaces it very quickly.” BEFORE Leanne Sparling walked into a GNC store in a mall not far from her family’s house, she tucked her son’s dog tags underneath her sweater set. Ever since her son died, Ms. Sparling has kept an eye on the marketing of Jack3d by dropping into local GNC outlets. “I just go in to see if it is still on the market,” she says. Bypassing the shelves of vitamins and protein bars, Ms. Sparling headed directly for the locked shelf displaying the original Jack3d and a new formulation, Jack3d Micro, which does not contain DMAA. When a young sales associate came over, Ms. Sparling asked about Jack3d. He told her it was a “high energy” workout product and recommended that she buy the Micro as well as the original and “stack them” together. He also recommended that Jack3d not be taken after 2 p.m., as he said it could interfere with sleep. DMAA has a short track record as a dietary supplement. Eli Lilly, the pharmaceutical company, first developed it in the 1940s as an inhaled drug for nasal congestion. A council of the American Medical Association recommended discontinuing the use of the drug in patients who experienced side effects like tremors, headaches and nervousness. In the 1980s, Lilly voluntarily removed the product from the market. Patrick Arnold, an organic chemist who had developed designer steroids for the Bay Area Laboratory Co-Operative, known as Balco, is credited with reintroducing DMAA as a supplement in 2005, according to his Web site. The stimulant was trademarked under the name Geranamine. Mr. Arnold was convicted in 2006 for his role in the Balco case, the government investigation into steroid use by elite athletes. Since then, DMAA has been included in dozens of supplements, and the makers of those products contend that the stimulant qualifies as a dietary ingredient because they say it can be found in geranium grown in a particular area of China. Representatives of the United States Anti-Doping Agency and others dispute this contention. Health regulators in at least seven countries have effectively banned supplements containing DMAA. Denmark and Sweden, for example, have declared the ingredient “not appropriate for human consumption due to its associated health risks.” In the United States, the F.D.A. received about 80 reports from January 2009 through mid-February this year of health problems in people who took DMAA supplements, according to documents obtained this month by The Times under the Freedom of Information Act. Among the reports, there were accounts of five deaths: three of people who used Jack3d; one of a person who took OxyElite, a fat-burning product also made by USPlabs; and one of a person who used both products. Other reports cited hospitalizations for heart attacks, heart failure, kidney failure and liver failure. Federal regulators caution that these anecdotal cases do not prove a causal link between the products and the health problems that were reported. Most of the companies that received F.D.A. warning letters about DMAA last April have since stopped making the products in question or have reformulated them without the stimulant. USPlabs, the maker of Jack3d, however, contended in its response to regulators that the substance was both safe and legal. The dispute between the agency and the company is continuing, with health regulators saying the products are adulterated and USPlabs saying they are not. “No information has been submitted to show that this is a lawful dietary ingredient,” says Daniel Fabricant, the director of the F.D.A.’s division of dietary supplement programs. “No one has officially notified the agency that this is safe under reasonable conditions of use.” Mr. Hutt, the lawyer for USPlabs, says that the company has made three submissions to the agency about DMAA’s safety and regulatory status, and that it has financed substantial safety testing of the products. But Dr. Cohen of Harvard, who is also an internist at the Cambridge Health Alliance, says some of those studies suggested that the stimulant was problematic. One published study, for instance, reported that four out of six people assigned to take OxyElite Pro dropped out of the experiment after experiencing problems like sleeplessness, inability to focus, nausea, headaches and jitters. RETAILERS, however, feel that they can safely continue to sell these supplements unless the F.D.A. takes further action, like banning DMAA or starting a product recall, says Mr. Mister of the Council for Responsible Nutrition. After the F.D.A. warnings, Bodybuilding.com, one of the country’s largest online sellers of supplements, decided to stop selling the stimulant. The company is not exactly a model of industry best practices. Last year, a former president of the company pleaded guilty to a misdemeanor criminal charge that the site had sold anabolic steroids illegally in the guise of dietary supplements. But Bodybuilding.com has since stepped up its compliance and decided to withdraw Jack3d, despite the fact that DMAA products accounted for millions of dollars in sales. “Our top priority is the safety of our customers,” says Bill Carter, the general counsel at Bodybuilding.com. “People are more important than money.” GNC’s response to the F.D.A. warning was very different in tone. The company first issued a statement in April 2012, saying the industry was “adamantly opposed” to the agency’s position. “As a company, we are completely opposed to this unilateral, factually and legally unfounded action by the F.D.A.,” the statement said, “and we believe the large consumer base that has safely used products containing DMAA in millions of doses will also oppose it.” Seven months later, in a conference call with investors, Mr. Fortunato, the GNC chief executive, responded to an analyst’s question about whether “the issue” with pre-workout products had run its course. In that response, Mr. Fortunato seemed to indicate that GNC was phasing out products like Jack3d. “The pre-workout issue is behind us,” he said. “We continue to move out products that we think may still cause a problem down the road, if somebody has decided to get back on that horse again. But that’s diminished so much for us, and we’ve replaced it. And we did a fantastic job of transitioning that business.” Last week, however, Mr. Miller, the GNC spokesman, said that the company had no plans “at this time” to stop selling DMAA products like Jack3d. Indeed, Ms. Sparling continues to find Jack3d on her expeditions to various GNC outlets. After leaving the GNC store near Sacramento, she rejoined her husband, who was waiting by the family’s car in the mall parking lot. Ms. Sparling was incensed that the store not only continued to sell the product, but was also promoting it as “hot.” “I feel like they are laughing at my boy dying,” she said. In January, a coroner in Britain cited DMAA in the death of a 30-year-old runner, Claire Squires, who took Jack3d at the London Marathon last year, according to news reports in Britain, and collapsed late in the race. In his report, the coroner wrote that DMAA “on the balance of probabilities, and in combination with extreme physical exertion, caused cardiac failure which resulted in her death.” Mr. Sparling, standing in the parking lot looking back at the store, said he did not understand how GNC could maintain it had no evidence that the stimulant posed health risks. “How can they say they didn’t know?” he asked. IN high school, Michael Sparling studied military history. Then he announced to his family that he wanted to enlist in the Army. Initially, his mother wasn’t so keen on the idea. “I love our military,” she said, sitting on a leather couch in the family’s den, reminiscing with her husband and Michael’s younger siblings. “But for my own selfish reasons, I didn’t think I could be a military mom.” After graduating from high school, Michael worked for several years at a local sporting goods store. But when he turned 21 and still seemed set on a military career, his family supported his decision. In early 2011, he went to basic training at Fort Benning, Ga. He wrote his family cheerful letters, with enthusiastic descriptions of military life. “Christopher! You always put on a good Super Bowl party. I’m sorry I missed it, Little Brother,” he wrote in a letter to his family in February 2011. “But I’m a little busy shooting M4s at expert levels, blowing stuff up, kicking in doors and working out constantly.” He added, “Anyways, I have to go clean my rifle real well so nothing bad happens on qualification tomorrow.” Michael Sparling was athletic. He played soccer and football in junior high school, took up snowboarding and trained in the martial art of ninjutsu with his father. But at 5-foot-10 and about 145 pounds, Michael arrived at basic training feeling that he was on the small side for an infantryman, his parents say. A friend, they say, recommended that he try Jack3d. “He thought it would be good for him – it would help his performance, it would kind of bulk him up a little bit,” his mother recalled. By the time he left for his station at Fort Bliss, his parents say, he had been taking it for about a month. His father spoke with him the night before he was to meet his unit for the first time. “He was hoping to make a good impression,” Mr. Sparling says. The next morning, Ms. Sparling received a message to call the base. Her son had collapsed during a training run with his unit and had gone into cardiac arrest. The doctor asked whether her son took any drugs or supplements. Ms. Sparling says she replied that he had just started taking Jack3d, and she told the doctor that she would take the next plane to be at her son’s bedside. “He said: ‘Ma’am, you don’t understand what I am saying. Your son is in cardiac arrest. We are performing CPR.’ And I said: ‘What are you telling me?’Ã‚Â ” Ms. Sparling recounted. She paused to catch her breath. “He said: ‘Ma’am, I’m telling you you need to pray.’Ã‚Â ” At 11:17 a.m., Michael Sparling was pronounced dead. His parents arrived at the base the next day. “We understood the risks of him joining the military, the risk of the car pulling up in front of our house to let us know that our boy died overseas,” Ms. Sparling says. “But we were not prepared for a telephone call saying your son has collapsed. Who dies of a heart attack at 22?” IN December 2012, a team of military and civilian medical experts published an article in a scientific journal, Military Medicine, describing the cases of two soldiers who had died after taking DMAA supplements. One of the reports described an unnamed 32-year-old African-American woman who had developed shortness of breath during a two-mile fitness test. Her heart stopped beating, and she went into a coma and died several weeks later. The other case report, about an unnamed “22-year-old male infantry soldier who was in excellent physical condition,” described how the man had collapsed while running with his unit outdoors in 75-degree weather, went into cardiac arrest and died at a hospital the same day after failed resuscitation attempts. Presumably, that was Michael Sparling. The authors reported that toxicology tests had identified DMAA in the blood of both soldiers, and called it an “ingredient of concern.” Although these descriptive reports are not proof that the stimulant directly caused the deaths, the authors concluded that the health problems that “developed in these two cases are in line with what could be expected of DMAA” alone or in combination with other ingredients like caffeine. Mr. Hutt, the lawyer for USPlabs, said, “Obviously when that happens with soldiers, it’s a horrible tragedy, but they were doing extreme training.” He added, “Without taking any substance, that kind of training can cause death.” The authors of the journal article, however, wrote, “The fact that at least two previously healthy soldiers died after ingesting a product marketed as a dietary supplement that contained DMAA raises questions.” They added, “This entire scenario is reminiscent of ephedra.” More than a decade ago, military physicians and researchers started seeing serious health problems among service members who had used weight-loss supplements containing ephedra, a stimulant that has been associated with heart attacks, strokes and deaths. The main branches of the military removed ephedra products from stores on military installations worldwide in 2001 and 2002, several years ahead of the F.D.A.’s nationwide ban of the supplement. Last year, some military physicians and researchers began warning that DMAA might pose similar health risks. By mid-2011, Jack3d, OxyElite Pro and other weight-loss and workout products containing DMAA had become best sellers in post exchange stores and GNC outlets on bases. Reports of health problems associated with the products also increased. Although the products may not have directly caused the injuries, the undersecretary of defense for personnel and readiness issued a directive at the end of 2011 requiring the removal of all DMAA supplements from on-base stores, pending a safety review. The military doesn’t take such action lightly. Fitness is not only a requirement for military personnel; it’s also one of the main leisure pursuits on base. About one-quarter of military personnel take performance-enhancing or weight-loss supplements, according to a Defense Department study, and some people use three or more products. At least a few physicians in the military say they now believe that bases should not sell any kind of performance-enhancing or weight-loss supplements because they often contain combinations of stimulants and other ingredients that could pose health risks. “We are selling truckloads of these supplements in our military exchange system,” says Col. Erin P. Edgar, command surgeon of the United States Central Command at MacDill Air Force Base, Fla. “I noticed that it was causing morbidity and, in one case, I saw a soldier who died after taking supplements. My suggestion is that we should not be selling these on the shelves of our military post exchanges.” He emphasizes that these are his own opinions based on experience as a military physician. Colonel Edgar, who is responsible for Defense Department medical policy in the Middle East, says the supplements need to be vetted for safety. “I think we are just starting to get a feel for them,” he says. “It was kind of a black box until the military stepped up, particularly with DMAA, and started looking at it.” IN New York, State Senator Jeffrey D. Klein, a Democrat representing parts of Westchester County and the Bronx, is starting to look at DMAA, too. He recently introduced a bill to ban the sale of DMAA supplements in the state. This month, he invited supplement researchers to Albany to discuss workout products. The Sparlings, who are starting an educational foundation in their son’s name to teach students, parents and coaches about sports nutrition supplements, also participated. Mr. Klein took particular aim at retailers, saying that he wanted to ban the sale of supplements containing DMAA in New York in part because retailers, in his view, have failed to protect consumers by withdrawing the products of their own accord as a precaution. “You are in the business of selling ‘healthy’ products to consumers,” Mr. Klein said. “I think you have a duty, before you put it on your shelves, to ensure that it’s not dangerous.” Mr. Mister, the president of the supplement industry group, calls the senator’s bill “a rush to judgment” without “access to all the information that F.D.A. has.” The evidence of health risks with DMAA seems suggestive, but it may not be conclusive to F.D.A. regulators. What seems clear to some researchers and local legislators, however, is that the imprimatur of the nation’s largest supplement retailer is not an automatic guarantee of workout supplement safety. Ms. Sparling, for one, is determined to take that message to the public. In Albany, dog tags visible, she adjusted her microphone and proceeded to recount her son’s life and death to the assembled legislators. “As you consider the legislation before you,” she said, “I implore you to imagine your son or daughter going into a GNC and buying a supplement that they have been told is natural and safe, and tragically find out that it is not.”