In the week before Christmas last year, 14-year-old Anais Fournier went to Valley Mall in Hagerstown, Maryland with some friends. While there she purchased and consumed a 24-ounce can of an energy drink manufactured by the Monster Beverage Corporation. She returned to the mall the next day and consumed another Monster energy drink. Later that evening, while she was watching a movie at home with her boyfriend, she went into cardiac arrest. She died four days later on the day before Christmas Eve. An autopsy concluded that she had died of “cardiac arrhythmia due to caffeine toxicity.”
Thanks to the efforts of her mother to get to the bottom of the matter, Anais’s untimely death may stimulate new efforts to regulate sports drinks and other potentially dangerous dietary supplements and to hold companies accountable in courts of law for their irresponsible marketing strategies.
Anais’s mother was convinced that the Monster energy drinks caused her daughter’s death. Last week, she and Anais’s father filed a lawsuit against the company, and on Monday the New York Times published documents she received in response to her Freedom of Information request for FDA’s adverse event reports on Monster drinks. It turns out that FDA had received reports of five deaths caused by those drinks since 2009. These reports are by no means definitive, and they do not establish a cause-effect relationship between the consumption of highly caffeinated sports drinks and increased mortality risk in humans.
Indeed, it is impossible to tell at this point whether high energy sports drinks are killing teenagers, causing heart attacks, or causing any other maladies in frequent consumers of those drinks. Unlike the manufacturers of drugs and food additives, the manufacturers of dietary supplements are not required to conduct animal and controlled human testing prior to marketing them. Unlike drug manufacturers, they do not need to secure FDA’s approval for the content of the supplements or for the claims made on their labels. So long as they make no claims that they can cure diseases, manufacturers can make bold claims for the performance-enhancing characteristics of dietary supplements without any substantiation whatsoever. And unlike most foods, supplements are not subject to FDA’s nutrition labeling requirements, though they are subject to the Federal Trade Commission’s authority to prohibit false and misleading claims.
The problem is not that dietary supplements fall between the cracks in FDA’s regulatory programs; it is that Congress in 1994 specifically created an exemption from FDA’s regulatory requirements for dietary supplements. With strong financial support from the dietary supplement industry and advocates of health foods and “natural” alternatives to drugs, Congress passed the Dietary Supplement Health and Education Act of 1994, a statute that greatly reduced regulatory oversight over dietary supplements. It left FDA with the power to remove unsafe dietary supplements, but it put the burden of proof on the agency, not the manufacturer.
In the ensuing years, the dietary supplement industry has blossomed into a $25 billion dollar industry. Recently, sales of energy drinks have exploded, and major beverage producers like Coca-Cola and Pepsi have begun to market their own versions. Monster still dominates the market, however, at almost 40 percent of sales, with net sales in the last quarter of $592 million.
Monster energy drinks do not have nutrition labels, but they do contain a box on the back of the cans entitled “Supplement Facts” that provides detailed information on calorie and sodium content and the percentage of normal daily requirements of various vitamins. A separate entry called “Energy blend” lists several enzymes and caffeine, but does not indicate the amount of caffeine per serving. A footnote states that a daily requirement for “energy blend” has not been established. Thus, while the box looks very much like a nutrition label, it does not contain the information that FDA requires on nutrition labels for foods.
In fact, a 24-ounce can of Monster Rehab, the “supercharged” version of Monster’s energy drink, contains 240 milligrams of caffeine. By comparison, FDA limits caffeine in drugs to 200 milligrams per dose, and it limits caffeine in cold drinks (which are regulated as foods) to 71.5 milligrams.
A look at the Monster website reveals why so many healthy teenagers are attracted to highly caffeinated sports drinks. The website features action-packed photos and videos of three things that the company sponsors: high-risk sports, rock bands, and buxom young women.
The description of Monster Rehab boasts that “Monster Extra Strength packs our biggest punch! Call us crazy, but we supercharged our Monster Energy base then injected it with Nitrous Oxide for a unique texture, smooth drinkable flavor and buzz that’s bigger than ever.”
Monster also produces a special blend of caffeine and protein supplement that promises that “after raging all night,” consumers are “always looking fresh poolside the next day.”
Dietary supplement manufacturers support claims like these with only the thinnest sort of scientific evidence. But FTC lacks the resources to challenge such claims because that agency does not have the resources to come up with evidence showing that they are false or misleading.
Worse, if FDA wanted to take an energy drink (or any other dietary supplement) off the market, it would have to collect enough scientific evidence to prove to a court that it was posing a significant or unreasonable risk. The agency has done this on only one occasion -- the notorious dietary supplement ephedra, which killed Baltimore Orioles pitcher Steve Bechler.
The problem with this solution is that FDA is straining mightily within its tight budgetary constraints to regulate drugs and foods over which it clearly has authority. It does not have the resources to investigate, much less prosecute companies that are promoting potentially dangerous products to teenagers.
Ironically, only last month Senators Dick Durbin and Richard Blumenthal sent a letter to FDA asking it to look into the possible toxic interactions of the ingredients of energy drinks and to explore the possible adverse health effects of the high levels of caffeine in energy drinks on children and adolescents.
It is certainly past time for FDA to conduct a thorough inquiry into highly caffeinated energy drinks. Two years ago, the agency caused a stir when it issued warnings to manufacturers of combinations of energy drinks and alcohol. It is time to look into the health effects of energy drinks without alcohol.
But it is even more important that Congress initiate an inquiry into the broader subject of dietary supplements with an eye toward re-regulating risky supplements in the same way that it decided to re-regulate banks under the Dodd-Frank Act.
And while Congress deliberates on the matter, the common law courts can send a powerful message to dietary supplement manufacturers by holding companies liable, where appropriate, for marketing risky products to kids.