Controversy over FDA Regulations for Energy Drinks

energy drinks.pngAdverse event reports submitted voluntarily by doctors and companies recently released by FDA state that the deaths of five people over the past three years may have been linked to drinking Monster Energy, an energy drink containing high levels of caffeine. The reports filed using the Center for Food Safety Adverse Event Reporting System spanned a period from 2004 to June 2012, but all of the deaths occurred in 2009 or later. An FDA spokesperson, Shelly Burgess, stated that energy drink manufacturers are responsible for investigating these accusations and that the FDA is investigating these cases, but has not established a causal link between the deaths and the drinks.

The reports were released through the Freedom of Information Act (“FOIA”) to the mother of a 14-year-old girl who recently died after drinking two 24-oz. Monster Energy drinks in a 24 hours period. The parents of the girl have recently brought survival and wrongful death actions against Monster Beverage Corporation (“Monster Beverage”), the manufacturer of Monster Energy, in the Superior Court of the State of California for the County of Riverside using these reports. According to the complaint filed on October 17, 2012, the two 24-oz cans of Monster Energy consumed by the girl contained 480 milligrams of caffeine or the equivalent amount of caffeine in fourteen 12-oz. cans of Coca-Cola. The girl’s autopsy and death certificate state the cause of death as “cardiac arrhythmia due to caffeine toxicity complicating mitral valve regurgitation in the setting of Ehlers-Danlos syndrome” according to the complaint. Ehlers-Danlos syndrome can affect the body’s connective tissue, including blood vessels.

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Written by Shelly Fujikawa, Ph.D.

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The complaint further asserts that, in addition to caffeine, Monster Energy drinks contain guarana and taurine. Guarana contains caffeine and taurine effects cardiac muscles in a similar way compared to caffeine. Caffeine, guarana, and taurine have also been shown to work synergistically. The complaint also alleges that Monster Beverage “avoided meaningful regulation of its products” by FDA since it classified its drink as a “dietary supplement.” Monster Beverage has denied these allegations responding that “Monster is unaware of any fatality anywhere that has been caused by its drinks.”

While FDA limits the amount of caffeine in soda to 0.02 percent, no limit exists for energy drinks marketed as a dietary supplement such as Monster Energy. Caffeine in energy drinks often ranges from 160 milligrams to 500 milligrams per serving. Senators Dick Durbin, D-Ill. and Richard Blumenthal, D-Conn. have written a letter to FDA requesting regulators to fix the “loopholes” that allow energy drinks to be sold containing high levels of caffeine and other additives. Sales of energy drinks in the United States grew an estimated 16 percent last year to $8.9 billion—-a record level, according to Beverage Digest, a trade publication. Monster Beverage Corporation, the largest U.S. energy drink maker by sales volume, sold about $1.6 billion worth of such drinks last year. Its energy drink sales have tripled since 2006. Emergency room visits involving energy drinks have jumped 10-fold from 2005 to 2009 with 13,114 visits in 2009. Half of these visits were made by 18 to 25 year olds.

Several countries, such as Canada, have started to regulate caffeine levels in energy drinks such as Monster Energy. In addition, Mexico, France, and India have taxed or are contemplating taxing energy drinks to discourage their purchase.

These reports are similar to controversies from several years ago over the Four Loko alcoholic energy drink which contained alcohol, caffeine, taurine, and guarana. Four Loko was involved in several incidents in which people, many of whom were college students, were hospitalized or died. Ultimately, the drink’s manufacturer recalled Four Loko and re-released it without caffeine and various ingredients.