Is the FDA doing enough to keep us safe?

The Food and Drug Administration (FDA) maintains a data base of incidents associated with the products it regulates. However, is simply maintaining the database enough? A recent wrongful death lawsuit involving Monster Energy, a high caffeine drink, illustrates some of the issues.

The FDA received five reports since 2004 of deaths that may have been linked to consumption of Monster Energy. It also lists incidences of abdominal pain, vomiting, tremors and abnormal heart rate and other symptoms associated with the drink. However, a Monster Energy spokeswoman responded that the company was “unaware of any fatality anywhere that has been caused by its drinks.”

A lawsuit was recently filed against Monster Energy by a Maryland mother alleging that her daughter died after consuming the drink and that the manufacturer had failed to adequately warn about its dangers. The Maryland woman obtained the FDA incident reports under the Freedom of Information Act.

A spokesperson for the FDA said that it was the responsibility of the energy drink companies to explore accusations of death and injury related to drink consumption. However, do the companies review the FDA information, or does the FDA monitor the companies’ reviewing efforts? In the case of Monster Energy, the company’s spokeswoman said that they had not received copies of FDA incident filings and did not know whether the company actively monitored the FDA database. She also said the company was unaware of any fatalities except for the death of the Maryland teenager.

Companies are not required to disclose caffeine levels in their beverages. Caffeine can pose risks to those with underlying conditions like heart disorders. The Maryland lawsuit referred to autopsy and medical examiner reports that said the teen had died of “cardiac arrhythmia due to caffeine toxicity” that had exacerbated an existing heart problem.

This summer, the FDA said that there was insufficient evidence to take action on caffeine levels in energy drinks. However, it also noted that it had not yet received medical reports related to the Maryland teenager’s death last December.

Source: New York Times, “Monster Energy Drink Cited in Deaths,” by Barry Meier, Oct. 22, 2012.