This fact was discovered by a Maryland mother who requested to see reports of adverse health effects linked to Monster products after her daughter died in late 2011 hours after consuming the company’s energy drinks.
The information – provided to the mother upon request by the U.S. Food and Drug Administration – revealed that five deaths and one non-fatal heart attack have occurred after consumption of Monster Energy drinks since 2004 (FDA confirmed these statistics for Food Safety News).
The parents of 14-year-old Anais Fournier, who suffered cardiac arrest hours after drinking the second of two Monster Energy drinks in 24 hours, filed suit against Monster Beverage Corporation Friday, claiming that its beverages contributed to their daughter’s death.
According to the complaint – filed in California Superior Court – the cause of Anais’ death was determined to be “cardiac arrhythmia due to caffeine toxicity complicating mitral valve regurgication in the setting of Ehlers-Danlos syndrome.”
Ehlers-Danlos syndrome is an inherited condition usually marked by loose joints and skin that bruises easily, according to the National Institute of Health.
Monster Beverage Corp.’s stock sunk by 14 percent Monday after the suit against the company was announced and reports of the five deaths following consumption of its drinks hit the media. By the end of the trading day the company had lost all of the gains it’s made this year.
FDA says the fact that people have died after eating these energy drinks does not necessarily prove a connection between the beverage and death.
“As with any reports of a death or injury the agency receives we take them very seriously and investigate diligently,” said Shelly Burgess, a representative for FDA’s Department of Health and Human Services, in an emailed statement to Food Safety News. “Under the law, Adverse Event Reports serve as a signal to FDA and do not prove causation between a product or ingredient and an adverse event.”
According to the government’s Drug Abuse Warning Network, hospital visits involving energy drink consumption rose sharply from 1,128 visits in 2005 to 16,053 visits in 2008. That number fell back a bit to 13,114 visits in 2009.
Under current FDA policy, the amount of caffeine in a “cola-type” drink does not have to be marked on the beverage’s label when it’s present at concentrations below .02 percent. The agency considers the ingredient to be “Generally Recognized as Safe,” or GRAS, in at this level.
Energy drinks are often exempt from this .02 percent rule, as they are marketed as dietary supplements rather than “cola-type” drinks.
Monster Energy drinks contains 80 milligrams of caffeine per 8 ounces, according to the Mayo Clinic. This translates to .035 percent. Anais Fournier consumed 48 ounces of Monster drinks, containing about 480 mg of caffeine, over the 24 hour period before she went into cardiac arrest, according to the complaint.
Following Anais’s death, Senator Dick Durbin (D) of Illinois wrote a letter to FDA asking that the agency investigate energy drinks with potentially dangerous levels of caffeine, along with the reaction between caffeine and other ingredients in these products.
“If the FDA makes a determination that energy drinks are beverages with high levels of caffeine and additives that raise safety concerns, the agency would have the authority to limit the level of caffeine and require the manufacturers to provide scientific evidence that ingredients such as guarana, taurine, and ginseng are safe for their intended use and in combination with caffeine and other energy drink ingredients,” wrote Durbin.
“The distinction between dietary supplements and foods with dietary ingredient additives is not always clear, leaving room for some food and beverage products to be marketed as dietary supplements in order to circumvent the safety standards required for food additives,” the letter continues. “I urge the FDA to clarify the definition of conventional foods and its authority to oversee the safety of foods, including energy drinks, containing dietary supplement ingredients.”
Some experts have concluded that caffeine should not be considered GRAS, even in cola-type beverages.
In an opinion last updated in 2011, FDA’s Select Committee on GRAS Substances found that “it is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.”
“FDA continues to evaluate the emerging science on a variety of ingredients, including caffeine,” Burgess said in her response to Food Safety News.
“It is important to remember that caffeine occurs in many places in the diet (i.e. coffee, chocolate, etc.) FDA considers exposure to any ingredient in its totality and from any and all sources in the diet.”© Food Safety News