Perils of energy drinks kept out of view by law
The disclosure this week that the deaths of five people since 2009 may be linked to a popular energy drink has revealed major gaps in the way federal regulators and companies monitor product safety.
Food and Drug Administration officials say that they are aggressively investigating the death reports, which are associated with Monster Energy, a highly caffeinated beverage. And its producer, the Monster Beverage, insists its products are safe, adding that it was unaware, apart from one fatality report, of other filings about deaths and serious injuries linked to its drinks.
But while the FDA regularly makes adverse event reports about drugs and medical devices publicly available, it does not do so for dietary supplements like energy drinks. The result was that consumers had no way of knowing of the complaints about Monster Energy drinks before incident reports were released by the FDA in response to a formal Freedom of Information Act request.
Also, while supplement makers have been required since late 2007 to alert the FDA of possible productrelated deaths and injuries, Monster Beverage submitted just one such report to the agency over the past four years, agency officials said. Wendy Crossland with a picture of her daughter, Anais Fournier, in Hagerstown, Md. Crossland has filed a lawsuit against Monster Beverage for the death of Fournier, who died in December of a heart arrhythmia after drinking large cans of Monster Energy on two consecutive days.
But the recently released FDA documents show that over that time, the agency received some 20 other filings about Monster Energy from consumers, doctors and others that included reports of another four deaths as well as life-threatening injuries.
The fact that the FDA receives a report of a fatality or an injury linked to a drug, medical device or dietary supplement does not mean the product was at fault. But Sen. Richard Durbin, D-Ill., who sponsored the law that requires supplement producers to file such reports, said the agency needs to both enforce it and make the filings available to consumers.
“The reality is that the FDA has not done its job,” Durbin said.
Since mandatory reporting started in 2007, the only report of an adverse event submitted by Monster Beverage to the FDA involved the highly publicized death last year of a Maryland teenager, Anais Fournier, Burgess said.
The girl’s mother, Wendy Crossland, also filed an incident report with the FDA; the additional Monster Energy-related reports came to light when she sought such filings under the Freedom of Information Act.
She has sued the company, which says its product played no role in the teenager’s death.