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New York Times offers tragic cautionary tale about nutritional supplements

jack3d drink
Jack3d contains an amphetamine-like stimulant called dimethylamylamine, or DMAA.

Last weekend’s New York Times offers yet another cautionary tale about the health risks associated with nutritional supplements. This time the focus is on a popular workout supplement called Jack3d, which contains an amphetamine-like stimulant called dimethylamylamine, or DMAA. Such stimulants can cause blood vessels, including arteries, to narrow.

Reporters Natasha Singer and Peter Lattman center their article around the tragic story of a 22-year-old Army private, Michael Lee Sparling. In June 2011, he collapsed and died of cardiac arrest during a military training exercise after taking Jack3d. He had bought the supplement at a GNC store on his base in Fort Bliss, Texas.

Jack3d was also implicated in the death of the 30-year-old woman who collapsed a mile from the finish line of the 2012 London Marathon. Earlier this year, it was reported that the woman had carried a water bottle spiked with Jack3d during the race.

“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,” Singer and Lattman report. The reports included five deaths as well as hospitalizations for heart attacks, heart failure, kidney failure and liver failure.

Banned elsewhere

The U.K.'s drug and medical device watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), order all products containing DMAA removed from the British marketplace to protect public safety. The supplement has been banned in at least six other countries as well.

But not here in the United States. That’s because of a two-decades-old law that essentially protects the supplement industry from having to prove their products’ safety before those products go on the market.

Write Singer and Lattman:

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.”

A pattern of problems

Of course, as the supplement industry points out, just because people die or become ill after taking a supplement, isn’t proof that the supplement caused the death.

As the spokesperson for USPlabs, the Dallas-based company that markets Jack3d, told Singer and Lattman: “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 by heart attack?”

Another industry spokesperson told the reporters that it would be “unrealistic to expect supplements to be 100 percent safe all of the time.”

But consumers should be able to expect that their supplements — whether they contain vitamins, minerals, herbs, botanicals, protein powders or other kinds of ingredients — have been thoroughly and scientifically assessed for safety. That’s not the case.

Write Singer and Lattman:

[T]he 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.

A medicinal ‘flea market’

Dr. Cohen gave Singer and Lattman a metaphor that I believe all consumers — but particularly young men and women who are trying to bulk up or otherwise get into shape — should remember the next time they are tempted to purchase supplements, whether at GNC or anywhere else:

“GNC appears to look like a kind of pharmacy, but in reality it’s more a flea market” where the proprietor does not take responsibility for vendors’ wares, he said. “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 harm.”

You can read Singer and Lattman’s article on the NYTimes website.

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