In a letter sent to FDA Commissioner Margaret Hamburg on Friday, the senators asked the agency to “take immediate action to address a serious public health issue.”
The letter cites “a November 2011 report by the Substance Abuse and Mental Health Services Administration (SAMHSA), which found a ten-fold increase in emergency room visits due to energy drinks between 2005-2009.” The letter also references reports that link five deaths to consumption of Monster energy drinks, and to reports that some of the products contain more caffeine than listed on the label."
One of those fatalities, a 14-year-old Maryland girl named Anais Fournier, has become the subject of a wrongful death lawsuit filed against Monster Energy by the girl’s parents. The teen died as a result of a heart arrhythmia suffered after consuming two 32-oz. cans of Monster over a 24-hour period. Each beverage contained about 240 mg of caffeine, the complaint states.
Letter echoes earlier versions
The letter references an earlier letter that the two send to FDA, dated Sept. 11, to which FDA has not responded, and the first letter that Sen. Durbin sent earlier this year.
The senators wrote: “As stated in earlier letters, energy drinks contain not only high levels of caffeine, but additives with stimulant properties, such as guarana, taurine, and ginseng. We urge the FDA to assess potential safety concerns posed by multiple additives with stimulating properties in energy drinks when used in combination and with caffeine.”
They went on to state: “Additionally, it is apparent that the FDA needs to examine the impact of energy drink consumption on children and teens. Industry marketing to young people has resulted in heavy consumption of energy drinks by adolescents. Unfortunately, the FDA’s assessment of safe levels of caffeine consumption does not appear to consider divergent consumption patterns for young people compared to adults or recognize differences in safe levels of caffeine consumption for adults compared to children.”
FDA not concerned about caffeine
FDA responded to Sen. Durbin’s first letter, which expressed similar concerns to the latter two. In that response, dated August 10, Jeanne Ireland, Deputy Commissioner, Legislation, stated: “FDA completed an updated assessment of the amount of caffeine that people in the Unites States ingest from all sources. The results show that, even when the consumption of energy drinks is considered, most of the caffeine consumed comes from what is naturally present in coffee and tea.
“For healthy adults, caffeine intake up to 400 mg per day (mg/d) is not associated with general toxicity, cardiovascular effects, effects on bone and calcium balance (with consumption of adequate calcium), changes in adult behavior, incidence of cancer, or effects on male fertility.”
Brewed coffee contains about 135 milligrams of caffeine per 8 ounce serving, while caffeinated soft drinks contain about 35 mg per 12 ounce serving.
FDA indicated that it is continuing to monitor the safety of caffeine, but that “available studies do not indicate any new, previously unknown risks associated with caffeine consumption.”
Call to finalize liquid supplements guidance
The Senators also repeated an earlier call for FDA to finalize its draft guidance on liquid dietary supplements. The letter states that energy drink manufacturers are using the current interregnum to market their products as dietary supplements even though they are packaged and marketed in a manner similar to beverages.
Justin Prochonw, a shareholder in the Colorado law firm Greenberg Traurig and an expert on dietary supplement legislation said in August that he didn’t expect the final version of the liquid dietary supplement guidance to change very much from the current draft version.
“Just because a company labels a product as a dietary supplement doesn’t mean that FDA will consider it a supplement,” he said. “There’s a list of factors that FDA will look at: Are you using words like ‘water’ or ‘juice’ or ‘milk’, in which case this probably puts you closer to a beverage. The serving size and the packaging is also important.”
Prochnow said he thought it is unlikely that caffeine-containing products will be the specific target for action. But he said the other ingredients, such as taurine, guarana, and ginseng, would more likely be the focus of any attack on larger, beverage looking, supplements.