Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have reportedly called for a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg after reports surfaced that the agency has received adverse event reports indicating that the caffeinated energy supplement 5-Hour Energy® may have been linked to the deaths of 13 people in the past four years. The product has apparently been mentioned in 90 filings submitted to the agency; the reports include more than 30 that purportedly involved serious injuries such as heart attacks, convulsions and a spontaneous abortion.

The senators have questioned the safety of energy drinks in three letters to the agency in recent months; their latest letter states, “[W]e request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients.” The senators also reportedly asked FDA to (i) examine interactions between caffeine and other energy drink stimulants, and (ii) issue final guidance distinguishing between liquid dietary supplements and beverages. FDA has indicated that it is investigating the circumstances of the deaths allegedly involving 5-Hour Energy®, and product distributor Living Essentials issued a statement claiming that the product is safe when used as directed. The company also said that it was “unaware of any deaths proven to be caused by the consumption of 5-Hour ENERGY®.”

Unlike other caffeinated beverages, such as Red Bull® and Monster Energy®, 5-Hour Energy® is sold in a two-ounce bottle, or “shot.” Like the other products, it is not labeled with its caffeine content. Consumer Reports recently indicated that each bottle contains approximately 215 milligrams, compared to eight ounces of coffee which can contain anywhere from 100 to 150 milligrams of caffeine. The product also apparently contains high levels of some B vitamins and taurine. According to an agency spokesperson, Living Essentials submitted the 13 fatality reports as required by a law pertaining to companies marketing energy drinks as dietary supplements. Those companies marketing energy drinks as beverages are not required to submit such reports.

Because some supplement manufacturers may not be aware of their reporting obligations, and because consumers and doctors may be unaware that they can file incident reports with the agency, the FDA data could be inaccurate. For example, while 50,000 products are marketed as dietary supplements or weight loss products, FDA received just 2,000 reports in 2011 of fatalities or serious injuries allegedly involving these categories of products. Yet, the Substance Abuse and Mental Health Services Administration reported 13,000 emergency room visits in 2009 purportedly associated with the consumption and use of these types of products. See The New York Times, November 14, 2012; Living Essentials Response (undated); Law360, November 15, 2012.