5-Hour Energy is “unaware of any deaths proven to have been caused” by consuming its top-selling energy shots, distributor Living Essentials has insisted, after the FDA confirmed it has received 92 serious adverse event reports (AERs) citing 5-Hour-Energy in four years, including 33 hospitalizations and 13 deaths.
To put these figures into perspective, company spokeswoman Elaine Lutz told FoodNavigator-USA that the firm now sells more than nine million bottles of 5-Hour Energy every week, and stressed that adverse event reports do not prove causality.
5-Hour Energy: We sell 9 million bottles a week
Each bottle of 5-Hour Energy, which accounted for nine out of every $10 spent in the energy shots category last year, contains “about as much caffeine as a cup of the leading premium coffee”, and contains no herbal stimulants such as guarana or yohimbe, added Lutz in a statement.
However, consumers with caffeine sensitivities “should consult with a physician before taking” or opt for the decaf variant, she said.
“It is not an energy drink, nor marketed as a beverage. In direct contrast to other products on the market, 5-hour Energy is not marketed for use with alcohol... When consumed according to our recommended use guidelines, 5-hour Energy is an effective dietary supplement.
“We recommend on product labels and the website that individuals consume no more than two bottles 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.”
FDA: Energy shots and drinks are not alternatives to rest or sleep
The FDA said it is “continuing to investigate reports of illness, injury or death” from people consuming the shot, but told FoodNavigator-USA that the “existence of an adverse event report (AER) does not necessarily mean that the product identified in the report actually caused the adverse event”.
A spokeswoman added: “FDA as a scientific public health agency must carefully investigate and evaluate all possible causes before deciding whether the product actually caused the medical problem.”
In the meantime, “FDA cautions consumers that 5-Hour Energy and other products marketed as energy shots or energy drinks are not alternatives to rest or sleep”, she said.
Consumers that are concerned “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”, she added.
Broadening the scope of AER reporting would not benefit the industry or consumers
The FDA, which is also investigating reports into fatalities adverse event reports connected to Monster Energy, is under pressure to make adverse event reports about dietary supplements public, although some commentators believe this could prove unduly alarmist and encourage frivolous lawsuits.
Speaking at the Supply Side West show last week, Council for Responsible Nutrition government relations VP Mike Greene said a new Government Accountability Office (GAO) report on AERs would probably be published in late February or early March - and would not likely make pleasant reading for the trade.
While a 2009 GAO report had raised concerns about under-reporting of AERs in the supplement sector, the reason the numbers were so low was a reflection of the overall safety record of dietary supplements, rather than proof that the system wasn’t working, he claimed.
And while it is critical for the FDA to be alerted to serious adverse events linked to supplements, it would not be in the best interests of consumers to broaden the scope of adverse event reporting to include more minor issues, added Patricia Knight, senior policy advisor for the United Natural Products Alliance.
“We’ve pushed back at [previous] attempts to broaden the scope of AER reporting because you just end up with a lot of white noise.”
The American Herbal Products Association (AHPA) said it had not yet reviewed the AERs in question but “notes that AERs report associations only and are not evidence of nor admission of a causal relationship between the product and the adverse events reported.”
Durbin: It’s unclear how the AER system is working in practice
However, Senator Richard Durbin (D-IL) - who has repeatedly raised concerns about energy shots and drinks - has been pushing for greater transparency in the AER reporting system.
In a letter to the Comptroller General of the US sent in November 2011, Durbin said it was “unclear how the AER system is working on practice”, and asked the GAO to explore the number and severity of supplement-related AERs, what steps the FDA is taking to ensure manufacturers are reporting adverse events, and how the agency is using AER data it collates to protect consumers.
Dr Fabricant: ‘Some pretty good indications of under-reporting of adverse events’
Speaking at a webinar on cGMP compliance organized by the Natural Products Association (NPA) in April, FDA dietary supplements division head Dr Dan Fabricant said there were “some pretty good indications” of under-reporting of adverse events .
Moreover, several firms were still failing to provide a domestic address and contact number for consumers to call to report adverse effects, making it doubly unlikely that they were being properly recorded, he claimed.
5-Hour-Energy contains a blend of caffeine, taurine, glucuronolactone, malic acid, N-Acetyl L-tyrosine, L-phenylalanine and citicoline, plus vitamin B12, vitamin B6, folic acid and Niacin.