Competition from huge and established beverage brands hasn't been able to dent 5-Hour Energy's dominance in the energy-shot segment it created. And criticism of its elixirs by nutritionists and dietitians hasn't been able to slow its sales past the $1-billion-a-year mark.
But here's something that might take a bit of fizz out of 5-Hour Energy: The drinks have been cited in the deaths of 13 people in the last four years, according to reports received by the U.S. Food & Drug Administration. The New York Times reported, "Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion."
The energy shot made by a suburban-Detroit-based company, Living Essentials, has been associated with 92 "adverse-event reports" over that period, including 32 hospitalizations, an FDA spokeswoman told a number of publications. The death reports comprise open cases being investigated by the agency. The FDA stressed that there is no evidence linking the 5-Hour Energy brand to the deaths or hospitalizations, but that the agency continues to investigate the reports.
5-Hour Energy spokeswoman Elaine Lutz said in a statement that 5-Hour Energy takes "reports of any potential adverse event tied to our products very seriously" and that the company complied "with all of our reporting requirements" to the FDA. She also noted that the shots are intended for "busy adults" and that 5-Hour Energy is an effective dietary supplement and not a beverage or energy drink.
On an FAQ section of its website labeled "Myths about 5-hour Energy," the company addresses the "myth" that the brand isn't approved by the FDA, stating "although it may be true that the FDA does not 'approve' 5-hour ENERGY® (just as it does not “approve” the food you buy or eat) the FDA strictly regulates 5-hour ENERGY®."
Living Essentials maintains that the 5-Hour Energy brand, which is also loaded with B vitamins, is for “hardworking adults who need an extra boost of energy,” but it’s “not an energy drink” and isn’t marketed as a beverage, the distributor said. Lutz told reporters it's safe if used as directed: no more than two of the 2-ounce shots a day, each of which contains about as much caffeine as a cup of coffee, and they should not be consumed back to back.
But do consumers read the label, or care? The Associated Press argues that the brand's small size may be contribute to over-consumption beyond the recommended levels: "5-Hour Energy's small size can also be dangerous to consumers with underlying conditions because it's easier to take several of them or mix them with alcohol. Though it is liquid, the 5-Hour Energy 'shot' is marketed not as a drink but as a dietary supplement. FDA regulations require supplement manufacturers themselves to be responsible for products' safety."
Consumer Reports, in examining the levels of caffeine in 27 different energy drinks, found that “The highest amount per serving was 242 milligrams of caffeine in 5-Hour Energy Extra Strength. The lowest was in 5-Hour Energy Decaf, which despite the name carries 6 milligrams of caffeine per serving.”
Energy drinks of all sorts are increasingly a focus of concern of the FDA, activists and lawmakers such as U.S. Senator Dick Durbin, the Illinois Democrat. The caffeine content in the beverages is seen contributing heavily to a huge rise in emergency-room visits over the last several years. Yet as USA Today notes,
The FDA does not regulate caffeine in energy drinks, which can be marketed as dietary supplements. Sen. Richard Blumenthal, D-Conn., says he is concerned about natural ingredients that also act as stimulants in the drinks. Experts say this combination can be risky for people with undiagnosed heart conditions. Soft drinks, on the other hand, are regulated and can have no more than 71.5 milligrams of caffeine in a 12-ounce serving.
Last month, the FDA confirmed that it was investigating reports that five people may have died since 2009 after consuming Monster Energy drinks. Similar to the 5-Hour report, Monster Beverage insisted that its drinks are safe, and the FDA stressed there was no proof linking the drink to the deaths.
This is the kind of development that can prove existential challenges to any brand. Living Essentials, meanwhile, says it's expanding the 5-hour Energy brand by developing other products such as nutrition bars. But there's no escaping a fate tied to 5-Hour Energy — and, now, to a highly involved FDA.