I read an interesting and eye-opening (no pun intended) article in the New York Times on November 14, 2012 by Barry Meier. The article, entitled “Caffeinated Drink Cited in Reports of 13 Deaths”, discusses the recent disclosure by the U.S Food and Drug Administration (FDA) that it has received numerous reports and filings over the last several weeks of fatalities which are potentially attributable to consumption of caffeinated drinks such as “Five-Hour Energy” and “Monster Energy.” I have seen with my own children (ages 12 and 17) how these so called energy drinks such as Red Bull, Monster Energy and 5 Hour Energy are so readily available to anyone regardless of age with no clear understanding of what is contained in these products. What makes this much more frightening is that according to Beverage Digest, caffeinated beverages are the fastest growing soft drink in the United States with a sales increase of 17% in 2011 to approximately 9 billion dollars!
Apparently, 5 Hour Energy (which is sold in 2 oz. shots) contains approximately 215 milligrams of caffeine, whereas an 8 oz. cup of regular coffee, depending on how it is brewed, can contain from 100 milligrams of caffeine to as much as 165 milligrams in a 8 oz. cup as reported by Consumer Reports.
To be very clear, since 2008 the manufacturers of these energy drinks are required by federal law to report the fatalities and serious injuries they become aware of from consumers, but there is no absolute scientific proof that the products have caused these deaths. What is known is that over the last four years, the FDA has received reports from the distributor of Five Hour Energy, Living Essentials, that 13 people have died and the filings claim that these deaths were caused in some way by the consumption of the product. The FDA has also reported that it is in possession of five fatality filings involving Monster Energy. In 2010, the FDA was notified of 17 fatalities involving some form of weight loss product or dietary supplement. According to the Meier article, since 2009, 5-Hour Energy has been named in approximately 90 filings with the FDA, with one third of those reports involving serious or life-threatening conditions, including heart attacks, convulsions and one spontaneous abortion. Further, the Substance Abuse and Mental Health Services Administration, also a federal agency, reported in 2011 that more than 13,000 emergency room visits in 2009 were related to the consumption of energy drinks.
The FDA regulates products such as Red Bull as beverages, whereas 5- Hour Energy and Monster Energy are regulated as dietary supplements, which complicates rules regarding ingredients and reporting of adverse events.
Living Essentials responded to the reports by indicating that their product is safe when used as intended and denied knowledge of any deaths caused by the use of 5-Hour Energy. Monster Beverage, the manufacturer of Monster Energy, has also denied that their product is responsible for any fatalities and has alleged its products are safe as well. The FDA’s Director of dietary supplement programs Daniel Fabricant, noted on November 14 that the agency was looking into the circumstances of the 13 fatality reports submitted by the distributor of 5-Hour Energy, but that some of the reports might not have sufficient information to determine whether the supplements did in fact contribute to the fatalities.
Manoj Bhargava, the CEO of Living Essentials refused to comment about the fatality filings involving 5-Hour Energy, believing that the New York Times article would leave a negative perception of his product.