UNDATED (ABC News- JIM AVILA) - The federal government and the New York Attorney General's office are investigating after the Food and Drug Administration received claims that the drink 5-Hour Energy led to 13 deaths and 33 hospitalizations over the past four years.
The popular energy shot – which comes in 2 oz. packages and packs a powerful caffeine punch, equal to two cups of coffee -- led the way in this new and growing energy drink segment over the past eight years. Now government officials are investigating whether the product, made by Michigan-based Living Essentials, does much more.
"If someone is to use multiple cans, now is when we start to see some of the side effects," Dr. Sean Patrick Nord, USC Director of the Section of Toxicology, told ABC News. "You're getting astronomical amounts, 30 to 40 cups of coffee."
The recent FDA filings mark the second time in a month the administration has confirmed it is investigating claims that energy drinks are causing fatal reactions. In October, Monster energy, another popular drink that contains even more caffeine, was allegedly linked to five deaths.
The manufacturers point out that these are just claims, and there is no proven link between the drinks and the deaths.
In a statement overnight, 5-hour Energy said the product is "intended for busy adults." The company says its compact product contains "about as much caffeine as a cup of the leading premium coffee."
During an interview this September, Manoj Bhargava, the founder and CEO of 5-Hour Energy, told ABC News "Nightline" that when used as directed, the caffeine in his product doesn't do any harm.
"It's overblown. When it's in small quantities … It's like this -- water is good, but if you have too much you drown," he said.
Most experts say the fatal dose of caffeine for an adult would be almost impossible to drink – actually 50 to 60 times of what is contained in an energy drink. But critics worry about children with underlying heart problems drinking them, and are warning that energy drinks may be more hazardous than coffee because of the temperature.
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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 to the adverse event being reported, or that any person included in the report caused or contributed to the event.”
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