November 15, 2012
Federal Regulator Confirms Reports Of 5-Hour Energy Drink Linked To Deaths
[WATCH VIDEO: Tom Costello Reports On Energy Drink Deaths]
Lawrence LeBlond for redOrbit.com - Your Universe Online
This marks the second time in recent weeks that the FDA has cited energy drinks associated with consumer deaths. Last month, the regulatory agency received reports of five fatalities stemming from the immensely popular, caffeine-packed Monster Energy drink.
Shelly Burgess, a spokeswoman for the FDA, said that since 2009, 5-Hour Energy drink has been mentioned in no less than 90 reports, including more than 30 involving serious or life-threatening injuries. Such injuries have been heart attacks, convulsions, and even a spontaneous abortion, as shown in records reviewed by the NY Times.
While both 5-Hour Energy and Monster Energy drinks have been highlighted in such reports, it in no way definitively makes them responsible for the deaths or injuries. Reports of this nature can be fragmentary in nature and be extremely difficult to investigate. The reports only state that these caffeine drinks were associated in some way to the incidences.
Living Essentials of Farmington Hills, Michigan, the company that produces 5-Hour Energy, in a statement obtained by the NY Times, said it was “unaware of any deaths proven to be caused by the consumption of [the energy drink].”
“When consumed according to our recommended use guidelines, 5-Hour Energy is an effective dietary supplement, although individual results may vary,” the statement said.
The company said it “takes reports of any potential adverse event tied to our products very seriously. We fully comply with all of our reporting requirements.” It added that it is “strictly regulated” by the FDA and its subsidiaries.
Highly-caffeinated beverages are becoming the fastest-growing soft drink in the US, with sales increasing 17 percent in just the last year to around $9 billion, according to data from Beverage Digest.
Along with the increase in usage has come the increase in hospitalizations as well. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), more than 13,000 ER visits were linked to energy drinks in 2009 alone.
But Living Essentials spokeswoman Elaine Lutz said 5-Hour Energy “is not an energy drink”–the so-called shot comes in a small bottle that holds less than 2 ounces.
Daniel Fabricant, director of the FDA´s division of dietary supplement programs, said the agency was looking into the 13 death reports citing 5-Hour Energy. He said that while medical information in such reports could rule out the energy drink as the root cause of death, some reports may not have sufficient evidence to make that call, and to determine what role, if any, the drink played in the incidences.
Fabricant said all 13 fatality reports mentioning 5-Hour Energy had been submitted to the FDA by Living Essentials. He noted that producers of dietary supplements, since 2008, are required by law to notify the FDA when they become aware of a death or serious injury that may be related to their products.
Two energy drink makers, Red Bull and Coca-Cola, responded to a NY Times query, which asked several companies if they had received reports linking their products to fatalities or serious injury. Both companies said they were unaware of any such reports.