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A Monster Lurking

Is it time for stronger regulations on energy drinks?

by Joshua Brooks

Published December 12, 2012

A mere glimpse at  the unfortunate forehead placement of a Monster Energy drink tattoo and one can see that the enthusiasm for the drinks has reached critical mass. As with the fictional Brawndo energy drink in the film Idiocracy, devoted consumers and regulators of real life energy drinks alike seem to have taken the slogans at face value (“It’s got electrolytes!). But a recent report from the Food and Drug Administration linking Monster Energy, Rockstar and 5-hour Energy to alleged deaths and ill health effects call into question regulators’ relative nonchalance and consumers’ stimulant-fueled excitement around the beverages, warranting a crackdown.

According to a recent FDA report and other reports, the drinks may be linked to 18 deaths and 150 injuries. Last month, the FDA announced that it plans to investigate multiple claims of deaths, injuries and other health complications, allegedly linked to 5-hour Energy, Monster and Rockstar. 5-hour Energy alone has been linked to heart attacks, convulsions and a miscarriage.

Energy drinks are officially considered food supplements, not beverages by the FDA. Therefore, the drinks are not limited to 70 milligrams of caffeine per 12 ounces of liquid the way soft drinks are. A 16 ounce can of Monster Energy, for example, has about 160 milligrams of caffeine, equivalent to more than four cans of Coca-Cola. A 24 ounce Monster Energy drink contains 240 milligrams of caffeine (about seven cans of Coke).

The FDA did not return a call for comment on whether it plans to more tightly regulate the drinks, but a letter released by the agency shows that it intends to seek advice from outside experts, such as representatives from the Institute of Medicine, to determine whether energy drinks pose risks to teens and people with pre-existing heart conditions or other problems.

Meanwhile, two U.S. senators, Sen. Dick Durban (D-Ill.) and Sen. Richard Blumenthal (D-Conn.), are pushing the FDA to investigate the effects of high caffeine levels in certain energy drinks. Rep. Edward Markey (D-Mass.) has also asked the Federal Trade Commission how the products are marketed.

Studies suggest that the caffeine in energy drinks often exceeds 500 milligrams and can result in caffeine toxicity in children, adolescents and young adults. For pregnant women, caffeine consumption above 200 milligrams increases the risk of miscarriage.

But the effects of highly caffeinated energy drinks, mixed with supplements such as guarana and taurine, are unclear. Since the FDA does not test and regulate these energy drinks the way it does other substances and medical devices, evidence will likely remain scant.

Of course, many think that’s fine, mischaracterizing uncertainty of evidence as a lack of risk and, therefore, a lack of justification for regulation.

The beverage manufacturers have denied that their drinks caused the deaths. And opponents of government regulations see the push to regulate energy drinks as an infringement on consumer freedom, making regulation a bitter concoction.

Such critics believe people should regulate themselves and that government should stay out of their lifestyle choices. Meanwhile, free-market proponents argue that they have every right to satisfy consumer demand within the law.

But the situation is much more complex than this libertarian and industry outlook acknowledges, and a public health response is entirely justified.

One could argue that people are making themselves sick—or dead—by consuming too many of these drinks, but the fact that little oversight is devoted to regulating what’s in the beverages means little is known about their health effects. While these energy drinks are not regulated like drugs, they do contain caffeine, which is considered a drug and a food additive by the FDA.

If submitted to the more rigorous testing drugs face in FDA clinical trials, for example, something like 5-hour Energy drink, which was reportedly linked to 13 deaths, may not hold up. Bristol-Myers Squibb, in contrast, discontinued its clinical trial of a Hepatitis C medication after one death was attributed to the drug.

Granted, the proportion of one death in a smaller clinical trial is likely greater than 13 deaths in an industry that sold approximately 400 million gallons of energy drink in the United States this year, meaning that the overall risk of dying from a drink is probably less than taking a medication tested in a trial during which one patient died.

However, there is the possibility that there are deaths and health complications beyond those we’ve heard about, an idea known as the epidemiological iceberg. In this case, if 18 deaths are the tip of the iceberg, there may be many that are going undetected. That prospect alone warrants the ongoing investigation, particularly for children and people with pre-existing health conditions, such as pregnancy and heart problems.

The FDA investigation may not prove without a reasonable doubt that Monster, Rockstar and 5-hour Energy caused the 18 deaths, particularly after the fact. But policy is often made on the basis of correlation, and if energy drink popularity continues to rise, unforeseen health complications may as well. The investigation is a valuable step forward in regulating questionable high-caffeine food supplements that have long existed in an unchecked category all their own.

Even if the drinks continue to be sold under the same lax regulations, the FDA and state and local public health officials should be able to test the effects energy drinks have and inform others, particularly parents, children and people with pre-existing conditions that there are known risks from excess caffeine. But under stricter regulations, the FDA could mandate clearer, more eye-catching warning messages on cans and packages in order to compete with the flashy marketing of these products.

For moderate coffee drinkers and energy drink consumers, regulating these beverages seems like a slippery slope. But without a reassessment of FDA’s role in regulating their content and a public health response, the growing consumption of beverages that have potentially lethal effects risks drinkers’ lives and health.

Edited by Jordan Lite. Additional research by Larkin Callaghan.

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The views and opinions expressed on this website are solely those of the authors and do not represent those of the Department of Epidemiology, the Mailman School of Public Health, or Columbia University.