Senator Battling FDA Over Energy Drinks

WASHINGTON, D.C.Senator Richard J. Durbin (D, Ill.) has voiced several concerns related to energy drinks and has been going back and forth with FDA on potential measures to tighten their regulation and improve their perceived safety.

This most-recent exchange initiated in April when Durbin sent FDA a letter expressing concerns that arose after he heard about how a 14-year-old girl from Maryland, Anais Fournier, died in Dec. 2011 of a cardiac arrhythmia due to caffeine toxicity after drinking two 24-oz. Monster energy drinks in a 24-hour period. In his April 2, 2012 letter to FDA Commissioner Margaret Hamburg, he cites a recent report by the Substance Abuse and Mental Health Services Administration that outlines potentially serious health risks, noting that the report found between 2005 and 2009 the number of emergency room visits due to energy drinks increased ten-fold, from 1,128 to 13,114 visits.

Durbin writes: A major factor contributing to these hospitalizations is the exceptionally high levels of caffeine in energy drinks. According to the American Academy of Pediatrics, adolescents should not consume more than 100 mg of caffeine daily. One 16 oz. can of Monster contains 160 mg of caffeine, which is equivalent to almost 5 cans of soda. However, this caffeine level does not account for caffeine from additives, like guarana, or ingredients with stimulating properties, like taurine and ginseng.

Consuming large quantities of caffeine can have serious health consequences, including caffeine toxicity, stroke, anxiety, arrhythmia, and in some cases death, writes Durbin. Young people are especially susceptible to suffering adverse effects because energy drinks market to youth, their bodies are not accustomed to caffeine, and energy drinks contain high levels of caffeine and stimulating additives that may interact when used in combination.

Although FDA has the authority to regulate caffeine levels in soft drinks to 0.02% or less, Durbin notes, the fact that energy drinks are classified as dietary supplements removes them from such stipulations (no need for premarket approval or use of exclusively GRAS ingredients). But confusion arises due to the fact that most energy drinks are marketed as conventional foods. If FDA were to determine that energy drinks are, indeed, conventional beverages, they would have regulatory authority over them, Durbin asserts.

I urge the FDA to clarify the definition of conventional foods and its authority to oversee the safety of foods, including energy drinks, containing dietary supplement ingredients, writes Durbin. I also ask the agency to investigate energy drinks like Monster Energy, Rockstar, and Full Throttle to ensure they are not in fact conventional foods, based on the FDAs 2009 Guidance for Industry: Factors that Distinguish Liquid Supplements from Beverages.

I also ask the FDA to enforce its regulatory authority over the caffeine levels in energy drinks, including Red Bull and AMP currently marketed as beverages, and to investigate caffeine levels in energy drinks marketed as supplements, Durbin continues. Finally, I urge the FDA to address the safety concerns posed by additives in energy drinks by requiring manufacturers to provide scientific evidence that ingredients, such as guarana, taurine, and ginseng, are safe for their intended used and when used in combination with other ingredients and caffeine.

On Aug. 10, 2012, Jeanne Ireland, assistant commissioner for legislation, FDA, responded to Durbins letter. She outlines differentiating factors between beverages that are considered conventional foods or dietary supplements, referencingas Durbin didFDAs Dec. 2009 Factors that Distinguish Liquid Dietary Supplements from Beverages draft guidance, noting that FDA is currently preparing a final guidance on this topic to further clarify the differences between conventional beverages and dietary supplements. She notes that, once finalized, this guidance for industry will help FDA and industry draw a line between beverages and liquid dietary supplements. She also points out that Durbins reference to 0.02% or less caffeine in a product (21 CFR 182.1180) applies specifically to cola-type beverages.

Ireland also notes that FDA is following up with the Substance Abuse and Mental Health Services Administration regarding their report to better assess whether any of the incidents cited in the report involved products marketed as dietary supplements and, if so, whether there were adverse event reports sent to FDA on those incidents and determine where gaps in our system may exist

Ireland also wrote that FDA has assessed the amount of caffeine that people in the United States ingest from all sources. She stipulates that the results show, even when the consumption of energy drinks is considered, that most caffeine consumption still comes from coffee and tea, and that levels up to 400 mg per day, for healthy adults, is not associated with general toxicity or other potential health issues. She writes that FDA is currently reviewing safety studies on caffeine and, even though the review is not yet complete, that available studies have not revealed any new or previously unknown risks associated with caffeine consumption.

Dietary supplements are bound by their own set of regulatory stipulations, and Ireland goes on to outline some of these, noting that FDA investigates deviations from code, adverse event reports, etc. And regarding the confusion Durbin cites between liquid dietary supplements and conventional beverages, Ireland references clarifying language from the Dietary Supplement Health and Education Act of 1994but nevertheless acknowledges that FDA must now generally consider multiple factors to determine whether or not a product is represented as a conventional food, and that this is often a difficult task for FDA.

A key point Durbin makes in his original letter is the safety of ingredients like taurine and guarana. In her reply, Ireland notes that taurine is not approved for use in conventional foods, but that the Flavor and Extract Manufacturers Association of the United States considers it GRAS for flavor use. Guarana, she notes, is likewise approved for flavor use. Higher use levels of these ingredientsbeyond what might be considered for flavor usein dietary supplements, she notes, would not be subject to New Dietary Ingredient stipulations due to their probable use as dietary ingredients prior to 1994.

Regarding the tragic death of Anais Fournier, Ireland notes that in the wake of a Serious Adverse Event Report from Monster Energy, FDA medical staff made multiple attempts to contact her mother, but had received limited response and will maintain respect for the familys wishes. FDA also was unable to obtain a copy of her death certificate and received limited information from the doctors who treated Fournier.

Then in Sept., Durbinnow joined with Senator Richard Blumenthal (D, Conn.)saw fit to reply to FDA to further highlight his concerns. While the senators note that they were pleased to learn that FDA intends to release final guidance distinguishing liquid dietary supplements from beverages, Irelands response letter did not address one of our greatest concerns, which include the potential interactions and cumulative effects of additives with stimulant properties in energy drinks with high levels of caffeine. While Irelands response on behalf of FDA touched on the use of taurine and guarana, Durbin and Blumenthal request that FDA provide additional information on the safety of multiple additives with stimulating properties in energy drinks when used in combination with caffeine. They specifically cite Red Bulls label indication that it includes the ingredient taurine prominently on the label next to vitalized body and mind, suggesting that the additive is used for non-flavor purposes.

Durbin and Blumenthals Sept. 11, 2012 letter also notes that FDA neglected to address the safety of health risks posed by caffeine to young peoplethe primary audience for many types of energy drinks. FDAs response letter noted that healthy adults can consume up to 400 mg caffeine per day, but the senator notes the American Academy of Pediatrics recommends that adolescents consume no more than 100 mg of caffeine daily, and that numerous studies cite that young people are especially susceptible to suffering adverse health effects due to consuming large quantities of caffeine. Therefore, the senators urge FDA to include adolescents and children in their assessment of the safety risks posed by consuming high levels of caffeine, such as those in energy drinks.

Durbin, now with support from Blumenthal, are clearly not done with this fight to clear the air regarding energy drinksboth FDAs regulatory stance on these products and their perceived safety.