It Is Time for The FDA to Regulate “Energy Drinks”

The commercials are catchy and the target audience is ever growing. Who doesn’t want more energy? When you mix those factors with huge profits and a largely unregulated industry, the results can be deadly.

As reported by the Substance Abuse and Mental Health Services Administration, more than 13,000 emergency room visits in 2009 were associated with energy drinks.

The problem begins with the loosely defined term “Energy Drinks”, and the regulation or lack thereof that applies to “Energy Drinks”.

The FDA has the authority to regulate caffeine levels in soft drinks to .02 percent or less of the product – about 71mg in a 12oz soda. The agency also has the authority to regulate additives in beverages to ensure they are safe for their intended use and when used in combination with other ingredients.

Most energy drinks are currently marketed as dietary supplements, therefore they do not need to establish evidence of their products’ safety or adhere to a limit on the level of caffeine. At the same time, many energy drinks come in single-use containers ranging from 8oz to 32oz and are marketed like beverages. The FDA does not define the term “energy drink”; that label is up to manufacturers’ discretion. Thus products like Red Bull, are sold under agency rules governing beverages, while others, like 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing ingredient rules and reporting requirements.

As reported by The New York Times, Federal officials have received reports of 13 deaths over the last four years that cited the possible involvement of 5-Hour Energy. In addition, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion.

Last month, the agency acknowledged it had received five fatality filings mentioning another popular energy drink, Monster Energy.

How much Caffeine are in these products? That’s a good question. 5-Hour Energy does not disclose the amount of caffeine in each bottle, but a recent article published by Consumer Reports placed that level at about 215 milligrams. Along with caffeine, 5-Hour Energy contains other stimulants that contain caffeine or produce similar effects on the cardiac muscles.

By comparison a cup of coffee contains approximately 100 milligrams of caffeine.

I can discuss these products from many different viewpoints, as a consumer of these products, as a Personal Injury Lawyer, and as a Parent. It is the latter that worries me. First and foremost when children see the catchy commercials they think these products are “cool”. Given the immense pressure kids are under to succeed in school, you can see how a child may be drawn to try one of these products. If this product is their first exposure to caffeine, that can be quite a jolt.

On April 4, 2012, Senator Dick Durbin wrote a letter to the commissioner of the FDA for an investigation into energy drinks like ‘Monster Energy’, ‘Rockstar’ and ‘Red Bull’ which contain high levels of caffeine and potentially dangerous ingredients yet are marketed to young people.

The letter was prompted by the death of Anais Fournier, a 14 year old girl from Maryland who died last December of cardiac arrhythmia due to caffeine toxicity after drinking two 24-ounce Monster energy drinks in a 24-hour period.(In 1989, the US Food and Drug Administration (FDA) limited the amount of caffeine in OTC products to a maximum of 200 mg/dose. The ingestion of such concentrated sources of caffeine is the general cause of acute caffeine toxicity.) The two drinks combined are believed to have contained approximately 480 milligrams of known caffeine, the equivalent of almost 14 cans of Coca-Cola.

A lawsuit against the manufacturers and distributors of these products would be based upon the failure to warn of the dangerous side effects, and their failure to remedy a dangerous condition which they knew could cause serious injury and/or death. And that is the exact lawsuit that was filed by Anais’ parents, against Monster Energy for failing to warn about the product’s dangers. The case was filed in California Superior Court (Riverside County). The Case Caption is Wendy Crossland and Richard Fournier, individually and as surviving parents of Anais Fournier v. Monster Beverage Corporation, Case No. RIC 1215551.

From a consumer standpoint, I often use these products, and I am a perfect hypocrite in that sense, but the knowing behavior of these companies that market these products to children is indefensible.