In the fall of 2013, Linda Wong, a transplant surgeon in Honolulu, was baffled by the unusual number of patients coming into her hospital with liver failure. Many of them complained of nausea and queasiness; some had jaundice. All told, within a month, eight patients presented with abnormal liver function tests. Two needed urgent transplants. One died.
Wong investigated and ruled out a number of plausible suspects: alcoholism, hepatitis, and Tylenol overdose. All the men and women were young and otherwise healthy — she couldn't figure out what the problem was. But she then asked her patients whether they were taking any over-the-counter supplements.
It turned out that all of them had been using a popular supplement, OxyElite Pro. Instead of helping with muscle building and "fat burning," the pills were poisoning their livers.
Wong called in the local department of health, and then the Centers for Disease Control and Prevention as well as the Food and Drug Administration. These liver problems appeared to be completely preventable — and she wanted to warn the public. Lab tests by the federal health agencies confirmed Wong's suspicions, and eventually the FDA sent a warning letter to the makers of OxyElite Pro, who in turn took the supplement off the market. That was rare: These products don't usually get recalled.
By the end of October 2013, 56 cases of acute liver failure or acute hepatitis nationwide had been linked to OxyElite Pro. That number rose to nearly 100 cases by the following winter, with about half requiring hospitalization.
Now we know that Wong's experience wasn't an isolated case. This week, a new study in the New England Journal of Medicine estimates that supplements cause 23,000 emergency department visits nationwide every year. Of those cases, more than 2,000 are serious enough to warrant hospitalization. That means natural supplements — which are presumed to be safe and very loosely regulated by the FDA — are a much bigger public health problem than anyone realized.
Supplements cause an estimated 2,000 hospitalizations each year
The authors of the NEJM study, a team of researchers at the CDC and FDA, had to get creative to arrive at this national estimate. After all, there's no centralized tracking system for illnesses caused by supplements. So they pored over 10 years' worth of data from 63 representative US hospitals ("sentinel sites" for the federal health agencies), asking staff to review the medical records for every emergency department visit and figure out which ones could be attributed to supplements.
What the authors found was incredible: From 2004 through 2013, an average of 23,000 emergency department visits every year could be attributed to adverse events related to supplements. These visits led to 2,100 hospitalizations annually.
This study allowed the researchers to uncover patterns that had previously been hidden from view. According to their data, herbal supplements — especially those promising to enhance weight loss, energy, and sex drive — accounted for 65 percent of the 23,000 emergency department visits. Micronutrient pills — vitamins and minerals — seemed to be somewhat less problematic, precipitating 30 percent of the visits.
More than 25 percent of the visits were made by young adults ages 20 to 34 (again, products designed to enhance weight loss and energy were most commonly implicated in this group). Another 20 percent of the visits were made by young children who consumed supplements meant for somebody else.
The weight loss and energy pills mostly caused heart-related issues like chest pain and palpitations, as well as dizziness, nausea, and anxiety. Micronutrients usually sickened people by bringing on allergic reactions or getting stuck in people's throats and causing swallowing problems.
There's very little oversight of supplements
About half of Americans report using supplements — from herbals that promise to help you lose weight or boost your energy to vitamins and minerals — with the hopes of improving their health. Supplements are now the most common form of alternative medicine, and spending on them tops $30 billion every year.
Despite their widespread use, supplements undergo limited scrutiny by regulators. The FDA treats them like food — not like drugs — under the Dietary Supplement Health and Education Act of 1994. Supplement manufacturers can basically put whatever claims they want on their bottles, so long as they're honest about their ingredients. There's no requirement to list the amounts of specific ingredients or to warn consumers about potential side effects. What's more, no one checks to make sure these manufacturers are telling the truth about what's in their products before they hit store shelves.
To remove a supplement from the market, the FDA first has to prove that it's not safe — as with the Hawaii case. This is basically the opposite of how pharmaceuticals are regulated. There, drugmakers need to prove their medicines are safe and effective through high-quality scientific studies before they ever reach consumers.
There's also no real monitoring system in place for supplement harms, which means there's been little data on what problems they cause beyond studies of individual pills. Some of the studies that have been conducted found that many popular supplements contain powerful pharmaceuticals (which is illegal) and other disturbing ingredients that consumers would never expect from simply reading the packaging.
The Hawaii tragedy may be more the rule than the exception
The regulatory framework around supplements is based on the presumption that they are safe, explained Pieter Cohen, a Harvard Medical School professor who has studied the supplement industry. "However, if tens of thousands of Americans are ending up in the emergency department every year, then these products are clearly not 100 percent safe and a much more robust regulatory framework is required."
Duffy MacKay, a representative from the Council for Responsible Nutrition, a supplement industry group, said in a statement that the new study proves supplements are indeed safe. "To put this projected number of 23,000 annual emergency room visits into context," MacKay said, "we estimate that far less than one tenth of one percent of dietary supplement users experience an emergency room visit annually."
Of the industry response, Cohen observed, "This is like GM saying, 'Well, thousands of passengers in our cars are hospitalized because of manufacturing problems, but considering how many cars we've sold, we're actually doing great!"
Congress has been slow to update supplement rules here, and the makers of supplements have been forceful in fending off stricter regulations. According to the Economist, the FDA’s Division of Dietary Supplements has a budget of just $5.2 million. By contrast, the supplement industry spends $6 million each year just to lobby Washington.
It's not clear whether reforms will be coming anytime soon. Over the past few decades, a few influential lawmakers — like Sen. Orrin Hatch — who are closely aligned with the supplement industry have successfully squashed bills that would bring supplement regulation closer in line with pharmaceutical regulation. (John Oliver has my favorite explanation of this problem here.)
That may explain why, despite the shocking findings, the researchers on the NEJM study tread lightly and only suggested modest improvements to improve public safety. Dr. Andrew Geller, a medical officer at the CDC's Medication Safety Program and the study's lead author, stressed that parents should treat dietary supplements like pharmaceutical pills, and keep them out of sight and reach of young children.
Geller also suggested that young folks, who seem to favor energy and weight loss boosters, should be aware that these pills can be harmful and cause cardiac problems. He also noted that older people should be aware of the swallowing issues that can arise. "We recommend if you have difficulty swallowing a supplement, talk to your doctor and see if there are other options or supplement pills to take," he advised.
Meanwhile, in an interview, Wong wondered whether the 23,000 figure "vastly underestimates" the problem — since it focused on emergency department visits only and might not account for underreporting by patients and doctors. In the Honolulu case, a lot of the patients sickened by OxyElite Pro were directly admitted to Wong's clinic after seeing their family doctors — so they never visited the emergency room.
"It's a huge cost to society to take care of these people who didn't have to be sick," she said.
Correction: A previous version of this article misstated the size of the supplement industry.