Short background: Sen. Dick Durbin (D-IL), assistant majority leader, wrote to FDA back in April this year expressing his concerns about the safety of such products and their high caffeine content. He also asked FDA to clarify the regulatory difference between beverages and liquid dietary supplements. In August, FDA replied to Durbin's letter, telling him the data they've studied indicates no additional widespread safety issue with caffeine consumption of energy drinks. The agency also allayed fears certain nutraceutical ingredients in energy drinks, including taurine and gaurana, have not drawn the agency's alarm, but it assured the senator it could and would take action if it feels the need to do so. While FDA seemed to squash safety concerns for energy drinks' caffeine and nutraceutical content, it did assure Durbin it intended to publish a guidance to clarify what the agency considers a beverage vs. a dietary liquid supplement.
Today, Sen. Durbin sent FDA a response letter, which was also signed by Sen. Richard Blumenthal (D-CT), applauding the agency's promise to issue a guidance on beverages vs. supplements, but pushed back on some issues the senators felt FDA failed to addressed. The letter said FDA's reply did not address the issue of stacked caffeine sourcesadding botanical caffeine or stimulant sources to caffeine formulations. Acknowledging FDA's explanation that taurine and guarana are GRAS food additives when used for flavor, the letter asks the agency to explain how it determines when these ingredients are used for flavor and when they are used as actives, especially in products featuring such ingredients, like taurine, prominently on the labeling.
The senators also told FDA its explanation of safe use of caffeine from energy drinks did not adequately address the "unique health risks associated with consuming high levels of caffeine among young people.," who are major consumers of energy drinks, compared the coffee and tea cited as primary caffeine sources in FDA's letter. The senators argued the safety of caffeine consumption should not be based solely on healthy adults, but should include adolescents and children.
Finally, Durbin and Blumenthal confronted FDA on its assertion it has not challenged caffeine in energy drinks because the levels are comparable to prior sanctioned use level of 200 ppm (parts per million). The senators cited a Drug Abuse Warning Network report stating caffeine levels in energy drinks is between 80 and 500 mg per serving, which is far above prior sanctioned use levels. The letter implores the agency to assert its regulatory power on such high-caffeine energy drinks.
The letter to FDA also urged the agency to issue its guidance on beverages vs. liquid supplements as soon as possible.
Durbin is not backing down from his front on energy drinks, and it will be interesting to see where this goes from here, especially considering recent actions by NY and France relative to energy drink safety.