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.