WASHINGTON - The Food and Drug Administration is investigating reports of 13 deaths possibly linked to so-called "energy shots" and cautioning consumers to talk to their doctors before they take them or other energy drinks.
The agency has received 92 reports that cite illnesses, hospitalizations and deaths after consumption of a product marketed as 5-Hour Energy. The FDA has also received reports that cited the highly caffeinated Monster Energy Drink in five deaths and one non-fatal heart attack.
Agency officials said the reports to the FDA from consumers, doctors and others don't necessarily prove that the drinks caused the deaths or injuries, but said they are investigating each one. In a statement, FDA officials said they will take action if they can link the deaths to consumption of the energy drink. Such action could include forcing the company to take the drinks, often found at convenience store checkout counters, off the market.
FDA spokeswoman Shelly Burgess said the agency is cautioning consumers that these "energy shots" or "energy drinks" are not alternatives to rest or sleep.
"If someone is thinking about taking one of these products, they should consult with their health care provider to ensure that there are no underlying or undiagnosed medical conditions that could worsen as a result of using them," Burgess said.
The agency doesn't individually regulate caffeinated drinks or supplements such as the energy shots but can take action if they are proven to do harm. Makers of caffeinated alcoholic drinks took those products off the market in 2010 after the FDA sent the companies warning letters saying that combinations of caffeine and alcohol in the drinks was a public health concern and could lead to alcohol poisoning, car accidents and assaults.
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.
A spokeswoman for the company that makes the product, Michigan-based Living Essentials, LLC, says 5-Hour Energy is a "compact-sized energy shot intended for busy adults -- it is not an energy drink, nor marketed as a beverage."
Elaine Lutz said the company is not aware of any deaths proven to have been caused by their product. She said the company's website advises consumers to drink no more than two bottles of the shots per day, spaced several hours apart, and for new consumers to drink half a bottle to start.
The New York Times first reported that 13 deaths were linked to 5-Hour Energy.
The company that distributes 5-Hour Energy released this statement:
The following response can be attributed to Elaine Lutz, Living Essentials, LLC distributor of 5-hour ENERGY ® :
“5-hour ENERGY ® is a compact-sized energy shot intended for busy adults; it is not an energy drink, nor marketed as a beverage.
“5-hour ENERGY ® is marketed to hardworking adults who need an extra boost of energy. The dietary supplement has no sugar, contains only four calories and no herbal stimulants, like guarana or yohimbe. 5-hour ENERGY ® contains about as much caffeine as a cup of the leading premium coffee.
“In direct contrast to other products on the market, 5-hour ENERGY ® is not marketed for use with alcohol, nor do we condone its consumption with alcoholic beverages.When consumed according to our recommended use guidelines, 5-hour ENERGY ® is an effective dietary supplement, although individual results may vary.
“We recommend on product labels and the 5-hour ENERGY ® website that individuals consume no more than two bottles of 5-hour ENERGY ® shots per day, spaced several hours apart. We also recommend individuals new to 5-hour ENERGY ® try half a bottle to start, wait 10 minutes and consume the rest later. Consumers who have caffeine sensitivities should consult with a physician before taking, and can consider the “decaf” version. Consumers are also instructed to use or discard any remaining product within 72 hours (three days) after opening.
“Living Essentials LLC, distributor of 5-hour ENERGY ®, takes reports of any potential adverse event tied to our products very seriously. We fully comply with all of our reporting requirements. Living Essentials, LLC is strictly regulated by and complies with DSHEA (Dietary Supplement Health and Education Act) as regulated by the U.S. Food and Drug Administration (FDA) and the FDA’s current Good Manufacturing Practice regulations.
“Living Essentials, LLC is unaware of any deaths proven to have been caused by the consumption of 5-hour ENERGY ®.
“It is important to note that submitting a serious adverse event report to the FDA, according the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed