The report, which appears in the latest issue of The DAWN (Drug Abuse Warning Network) Report, says energy drink related visits to emergency rooms in the US doubled from 10,068 in 2007 to 20,783 in 2011.
Of the 2011 energy-drink-related visits, 58% involved energy drinks alone, it claims, while in the remaining 42% of cases, patients reported that they had consumed a combination of energy drinks and alcohol, illegal drugs or prescription medication.
This data, it argued, “validates claims that energy drinks can be dangerous when used alone or in combination with other drugs or alcohol”.
Report reflects no medical finding or diagnosis that consumption of energy drinks was the reason for the ER visit
However, Monster - which was one of 14 firms to receive a letter from Senators Dick Durbin, Richard Blumenthal and Rep. Edward Markey last week asking them to qualify the safety and labeling of their energy products - says the report's authors have added two and two together and made five.
In a statement issued Friday, Monster said the report was “highly misleading and does not support any conclusion that energy drinks are unsafe for consumers”.
It added: “[It] does not provide enough information to determine the nature of patients' complaints, the amount of caffeine consumed from all sources, or whether there was any connection between the complaints and the consumption of an energy drink.
“[It also] reflects no medical finding or diagnosis that consumption of energy drinks was, in fact, the reason for the patient's emergency room visit.
A 16oz can of Monster Energy contains half the caffeine of a 16oz cup of coffeehouse coffee
Meanwhile, “Any causal connection between energy drink consumption and ER visits is further substantially weakened by the existence of other factors more likely to have been responsible for the patients' medical issues, such as the use of pharmaceuticals, alcohol or illegal drugs, which was reported by 42% of patients", said Monster.
The report also falsely claimed that energy drinks typically contain more caffeine than coffee, which is not true, said Monster: “A 16-ounce can of Monster Energy contains roughly half the caffeine of a 16-ounce cup of coffeehouse-brewed coffee.”
Monster: if we chose to do so, we could re-categorize Monster Energy as a food
This is not the first time Monster has felt compelled to defend its products in public, and deny claims by Senator Dick Durbin and others that it is marketing its products as supplements when they should be marketed as conventional beverages (which are subject to different rules).
Speaking at the firm’s Q3, 2012 results in November, chief executive Rodney C. Sacks said: “Our products could be labeled and sold as foods if we chose to do so… All of the ingredients in our products at current levels are either FDA approved food additives or are GRAS… and are therefore permissible for inclusion in and labeling as foods.
“We are confident that if we chose to do so, we could re-categorize Monster Energy drinks as a food.”
Addressing a recent lawsuit filed against the company following the death of Anais Fournier, who suffered a cardiac arrhythmia after drinking two 24oz (710ml) cans of Monster Energy in 24-hours, Sacks added: “The allegations in that lawsuit… are false and totally baseless and are not supported by either the science or the facts.
“The autopsy report reveals that a caffeine blood level was not performed and that her death was natural and associated with a pre-existing heart condition which by itself increased her risk of cardiac arrhythmia and sudden death.”
Liquid confusion: Where does a liquid supplement end and a beverage begin?
The distinction between liquid dietary supplements and conventional beverages has come under scrutiny in recent years, following a 2009 guidance document from the FDA which argued that if a product is packaged like a drink and looks like a drink, it should be marketed as one.
This matters because if firms are selling a conventional food or drink - as opposed to a dietary supplement – then novel ingredients including herbals and other botanicals must be either approved food additives or Generally Recognized as Safe (GRAS) for their intended use.
Currently, several firms are marketing liquid supplements that are arguably in breach of this guidance, but could not easily switch to a beverage classification because they contain ingredients that are not GRAS.
How much caffeine is allowed in beverages? It depends, says the FDA…
Similarly, the rules governing how much caffeine is allowed in conventional beverages vs supplements are also different, although this is something of a grey area.
An FDA spokesman said: “Under FDA’s regulations, the addition of caffeine up to 200ppm [71mg/12oz] in cola-type soft drinks is considered GRAS."
But does this limit apply to other non-cola-type beverages such as energy drinks?
Yes and no, says the FDA: “Although this regulation specifies the level of caffeine in cola-type beverages that is GRAS, it does not automatically preclude other uses of caffeine from being considered GRAS, nor does it automatically give GRAS status to other uses.”
Click here to read the letter sent to Monster by Senators Dick Durbin, Richard Blumenthal and Rep. Edward Markey.
Click here to read our coverage of the DAWN report on energy drinks and ER visits.