In August 2013, an alarming number of sick people started showing up at the Queen’s Liver Center, in Honolulu. The patients had eyes as yellow as a highlighter pen. Some were disoriented. Dr. Linda Wong, a liver transplant surgeon there, recognized the symptoms: The patients were experiencing acute liver failure.
This was odd. When acute liver failure happens, it’s almost always caused by a virus, or a patient’s boozy bender, or an attempt to OD on Tylenol. But these patients—most of them young, in their 20s and 30s—didn’t fit that description.
At first, Wong wondered if they’d all contracted some rare tropical disease or an infection, but nothing quite fit.
People suffering from acute liver failure go downhill really fast, says Wong, who is also a professor at the University of Hawaii Medical School. Two of the sick people immediately went on a liver transplant list to receive new organs from the mainland. “They had seven days to live,” she recently recalled.
Finally, after months of sleuthing, Wong, her colleagues, and state health officials found the culprit: Most of the patients had been taking OxyELITE Pro, a hugely popular dietary supplement that had been touted for its ability to help consumers lose weight.
In early October, Hawaiian health officials pulled the supplement from store shelves. The problem didn’t end there, however; others were sickened nationwide before the scare was over.
In November, the U.S. Department of Justice announced it had filed criminal charges related to the sale of the products against supplement maker USPlabs LLC and six of its executives: Jacobo Geissler, of University Park, Texas, the CEO of USPlabs; Jonathan Doyle, of Dallas, the company’s president; Matthew Hebert, of Dallas, responsible for product packaging design; Kenneth Miles, of Panama City, Florida, a quality assurance executive; and Cyril Willson, of Gretna, Nebraska, a consultant.
The government also filed charges against SK Laboratories, the lab in Anaheim, California, that manufactured the supplements for USPlabs. It also filed charges against Sitesh Patel, of Irvine, California, the vice president of SK Laboratories.
In addition, USPlabs, Geissler, Doyle, and Hebert are charged with conspiracy to commit money laundering and obstruction of an FDA proceeding.
The indictment alleges that USPlabs billed its ingredients as natural plant extracts, “when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.” (It’s illegal to put substances not found in nature in supplements.) The government alleges that the company covered up its importing of this and other chemicals. According to one email among the companies’ top executives in the indictment, “lol stuff is completely 100 percent synthethic [sic].” What’s more, USPlabs knew the chemical in the Hawaii incident could be toxic to the liver.
Yet after the Hawaii outbreak, the company told the FDA it would stop distributing OxyELITE Pro, “but instead engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyELITE Pro as it could as quickly as possible,” according to the indictment.
“The Company stands firmly behind the safety and integrity of its products,” according to a statement by an attorney for the company. “[T]he Company and its owners vehemently deny that the Company ever attempted to defraud its retail customers or consumers, sold any unsafe products, or engaged in any wrongdoing. They expect to be fully vindicated and look forward to their day in court.”
On the same day the Justice Department announced charges against USPlabs, it also announced that it had recently filed five civil cases against other supplement companies, ranging from a company advertising a product to treat herpes to another selling a product allegedly containing an unsafe food additive called DMAA, an amphetamine-like stimulant. In the past 12 months, the federal government and federal agencies have pursued cases against more than 100 makers and marketers of dietary supplements.
So what does all this mean for consumers, who’ve been baffled in the past few years by news of questionable practices among some supplement makers? Does this crackdown mean a new era of law and order for the chaotic, $38 billion supplements industry?
Don’t bet your Asian ginseng on it yet.
“It really shows what the FDA is up against, because it shows there was a very specific intent to defraud the public and the agency,” says Joshua Sharfstein, a former principal deputy commissioner at the FDA and an associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health, of the USPlabs case. Though the damage occurred two years ago, people are only now being prosecuted, Sharfstein explains. “I think it shows the FDA is determined to do everything it can to protect consumers but that the tools the agency has are very, very hard to use.”
Supplements—vitamins, herbal remedies, amino acids, weight-loss capsules, erection pills, probiotics, protein powders—are huge business in the United States. Roughly 85,000 different products appear everywhere from your corner pharmacy to Walmart to the virtual shelves of the Internet. Roughly half of the U.S. public pops a dietary supplement, according to estimates.
But the industry has a problem. “[S]ubstantial sections of the market for these products remain disorganized, deceptive, and dangerous,” Sharfstein and colleague Akshay Kapoor wrote in the November 2015 issue of the journal Drug Testing and Analysis.
For a culprit, many critics finger the law that regulates supplements: the 1994 Dietary Supplement Health and Education Act. While prescription drugs must prove they are safe before they can be sold, “[a]ll supplements are presumed safe until the U.S. Food and Drug Administration [FDA] proves otherwise,” Pieter Cohen, an assistant professor at Harvard Medical School and an expert on the industry, wrote in a 2014 article in the Harvard Public Health Review. The burden of proof is on the FDA to test and find problems with a supplement, which is expensive and time consuming—and it can be hard to find a problem until after people start leaving a paper trail at hospitals. The upshot: The American consumer is “playing the role of the rat in the laboratory, the guinea pig,” Senator Richard Durbin (D-IL) has said.
Also, unlike prescription drugs, “[y]ou don’t have to prove that your botanical supplement does anything,” says Richard van Breemen, director and principal investigator at the Center for Botanical Dietary Supplements Research at the University of Illinois. Mostly, companies are required to follow some basic manufacturing standards and not make unverified claims to treat disease.
No wonder the public is confused: According to studies, most consumers incorrectly think the government vets supplements before they appear on shelves. One survey even found that many doctors also (wrongly) believe the same thing.
But as the industry has flourished, so have abuses. The Government Accountability Office found in 2012 that one in five supplements sold for weight loss or immune system support included prohibited disease-related claims on their labels.
Yet misleading claims are only one problem. An even larger problem is what that bottle, pill, powder, or capsule contains. Last February, the attorney general of New York State ordered retailers like Target, GNC, and Walmart to stop selling certain popular products such as echinacea, ginseng, and others after a DNA study requested by the attorney general’s office found that, overall, only about 20 percent of the store-brand herbal supplements actually had the plant in them that they advertised.
Instead, researchers found that the supplements contained everything from houseplant (dracaena) to asparagus. The work was similar to 2013 findings by Canadian researchers. In that study, a supplement labeled as St. John’s wort, for instance, actually contained a plant known to be a powerful laxative.
While they sound funny—who cut my arnica with baking soda?!—this kind of adulteration can be deadly. Last year, an infant at a Connecticut hospital died when doctors gave the child a popular probiotic supplement that was later found to be contaminated with a mold.
Swapping out one ingredient for another isn’t the only problem. Natural ingredients listed on a label haven’t always been fully tested on humans and might have ill effects, say health officials. For instance, yohimbe, an African shrub that’s found in many weight-loss supplements, can cause elevated blood pressure or panic attacks, Cohen wrote last year.
Then there’s the issue of synthetic chemicals turning up in supplements, as is alleged in the indictments against USPlabs, SK Laboratories, and its executives.
Hundreds of products have been spiked with illegal pharmaceuticals, the FDA has said—from Viagra knockoffs slipped into a sexual-enhancement supplement to a prescription statin put into a red yeast rice.
Earlier this year, Cohen and his colleagues said they had found a synthetic amphetamine called BMPEA in more than half of U.S.-sold supplements that were labeled as containing Acacia rigidula—products with names like JetFuel and Yellow Scorpion. BMPEA isn’t found in nature and isn’t allowed in supplements. Its safety in humans hasn’t been studied. It has long been banned by the World Anti-Doping Agency. Since 2010, several athletes have tested positive for it, including an Olympic canoeist who claimed he had inadvertently consumed the substance in a supplement. Canada pulled products containing BMPEA from store shelves late last year. Yet the FDA sent warning letters to companies just last April, though its own study found BMPEA in products as early as 2013.
Why did the FDA move so slowly? Critics cite varying reasons, including the fact that for the past several years, top former executives from the supplements industry have run the FDA’s division that oversees that industry.
Young athletes are a big audience for many of these supplements, which has researchers worried. As many as 18 percent or more of strength supplements are contaminated with stimulants and/or anabolic-androgenic steroids, Travis Tygart, CEO of the US Doping Agency wrote in the November issue of Drug Testing and Analysis. Side effects of some of the additives in sports supplements aren’t well known, but there could be long-term problems. Earlier this year, researchers linked long-term use of bodybuilding supplements to testicular cancer.
Given all this, it’s perhaps also not surprising that supplements cause more than 23,000 emergency room visits each year, according to a study published in October in the New England Journal of Medicine. More than one in four of those ER visits are by otherwise healthy young adults, often using products related to energy or weight loss, said co-author Andrew Geller, a medical officer in the Medication Safety Program at the CDC’s Division of Healthcare Quality Promotion. As much as 20 percent of severe liver damage caused by drugs is now believed to be caused by supplements, as the OxyELITE Pro case underscored.
So, is there a way forward?
Last April, attorneys general called on Congress to begin more robust FDA oversight of the herbal supplements industry. That followed a deal struck between New York State’s attorney general and nutrition giant GNC to put in place a nationwide program—the first in the United States—to ensure the purity of its supplements.
Senator Durbin and Senator Richard Blumenthal (D-CT), meanwhile, have proposed legislation that would “give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health benefit claims.” So far, though, the bill has gone nowhere.
Everyone wants the few bad actors who blacken the eye of the entire supplements industry put out of business, according to Duffy MacKay, a naturopath and senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, an industry group. “The supplement industry is willing to embrace transparency, is willing to stand by its products,” MacKay says. But he called any effort to have drugs undergo the same pre-market approval that drugs do “a deal-breaker.” “It’s not appropriate to use a drug model to regulate dietary supplements,” he says.
Perhaps there’s a middle path forward where everyone can win, says Sharfstein, the former principal deputy commissioner at the FDA, whose new article with Kapoor in Drug Testing and Analysis is titled “Breaking the Gridlock.” Their argument is to focus on what everyone can agree to, which means making supplements safe. To do this, they suggest several reforms: One is to mandate that every product be registered with the FDA before selling it. “That way, if a company tries to sell a product on the side, the agency can immediately take it off the market without having to do complicated testing.” Right now, the feds have no idea what’s out there. Next, standardize production so that consumers can be certain what is in every pill, powder, and capsule. Finally, bolster the FDA’s oversight powers.
But in the meantime, consumers need to take more responsibility, says Wong, the surgeon who first noticed the problems with OxyELITE Pro.
“If it’s too good to be true,” she says of supplements, “it probably is.”