The Food and Drug Administration has confirmed that it is investigating reports that five people since 2009 may have died after consuming Monster Beverage Corp. drinks.
The probe is based on incident reports that doctors and companies voluntarily submit to the FDA. The FDA told Bloomberg that the incidents are considered to be allegations, and no conclusion is drawn until an investigation is completed.
Last week, the parents of a 14-year-old Maryland teenager, Anais Fournier, filed a civial suit in Calfornia against Corona, Calif.-based Monster, alleging that their daughter died from "caffeine toxicity" after consuming two, 24-ounce cans of Monster energy drinks, according to The Wall Street Journal, which reported that Fournier had a preexisting heart problem.
Monster released a statement saying it does not believe that its drinks are responsible for the teen's death, and is unaware of "any fatality anywhere that has been caused by its drinks." Its labels warn that the drinks aren't recommended for children or those sensitive to caffeine, but do not specify their caffeine content.
Last month, Sens. Dick Durbin (D., Ill.) and Richard Blumenthal (D., Conn.) asked the FDA to investigate the safety of energy drinks, and consider limiting the caffeine allowed in such beverages. Last year, the Substance Abuse and Mental Health Services Administration issued a report showing that emergency-room visits involving energy drinks had increased tenfold between 2005 and 2009.
For regulatory purposes, energy drinks are considered dietary supplements. The FDA said that it continues to evaluate the emerging science on caffeine and other ingredients. It is also working on guidelines relating to dietary supplements and beverages. In 2009, the U.S. Government Accountability Office recommended that the FDA act to take greater oversight of dietary supplements, including energy drinks.
As previously reported, New York attorney general Eric T. Schneiderman issued subpoenas in July to PepsiCo (AMP), Monster Beverage Corp. and Living Essentials (5-hour Energy), asking for information on their marketing and advertising practices, in an investigation of whether their marketing may be deceptive.