In the past four years, the U.S. Food and Drug Administration (FDA) has received reports of 13 fatalities that cited the possible involvement of 5-Hour Energy, an energy drink containing large amounts of caffeine and other stimulants.
Just weeks earlier, FDA officials acknowledged receiving five fatality reports that mentioned Monster Energy, another energy drink.
According to a New York Times report, some 90 FDA filings since 2009 have mentioned 5-Hour Energy, including at least 30 involving serious injuries such as convulsions, heart attacks and, in one case, a spontaneous abortion.
Products mentioned in FDA reports are not necessarily responsible for the incidents reported, and may not relate to the incident in any way.
In a statement, Living Essentials, the distributor of 5-Hour Energy based in Farmington Hills, Mich., said the product is safe and that the company was “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.”
Monster Beverage of Corona, Calif., producer of Monster Energy, has also issued repeated statements saying its products are safe and were not the cause of health problems in FDA reports.
According to a recent Consumer Reports article, a two-ounce bottle of 5-Hour Energy, referred to as a “shot,” contains about 215 milligrams of caffeine. By comparison, eight ounces of coffee can range from 100 to 150 milligrams depending on how it is made.
The FDA has stated it cannot justify changing regulations on energy products based on current evidence. Complicating matters is the fact that some caffeinated drinks, like Red Bull, are deemed “beverages” and covered by one set of rules, while others, like 5-Hour Energy, are designated as “dietary supplements,” and are covered by other rules.
In an interview with the New York Times, Daniel Fabricant, the FDA’s director of dietary supplement programs, said the agency was investigating fatality reports that cited 5-Hour Energy. He added that Living Essentials had submitted all 13 such reports to the FDA. A law that took effect in late 2008 requires dietary supplement producers to notify the agency when they are made aware of incidents of injury and death involving their products.
The company issued a statement saying that it takes “reports of any potential adverse event tied to our products very seriously,” and that it complied with all FDA reporting requirements.
In a 2011 report, the Substance Abuse and Mental Health Services Administration said that energy drinks were associated with at least 13,000 emergency room visits in 2009.