(Washington, D.C.) – In response to a series of letters from U.S. Senator Richard Blumenthal (D-Conn.) and U.S. Senator Dick Durbin (D-Ill.), the Food and Drug Administration (FDA) confirmed that they are currently reviewing the safety of energy drinks containing caffeine and other ingredients that act as stimulants and may require regulatory action if evidence of a health risk is found. Since April, both Senators have been calling on the FDA to take action to regulate energy drinks and to investigate the safety of ingredients with stimulant properties in combination with caffeine in energy drinks, particularly as they affect young consumers.
“There is very clearly a lack of understanding about the health effects of energy drinks and their ingredients especially on children and adolescents,” said Blumenthal and Durbin. “I am glad to see that the FDA is undertaking a review but more needs to be done and quickly. For instance, FDA can and should take action now to regulate energy drinks that are marketed as beverages, like Red Bull which has more than the standard of 71 mg of caffeine per 12oz which beverages like Coke and Pepsi are held. I will be calling Commissioner Hamburg for a meeting as soon as possible to review the FDA’s plan.”
In the letter to Blumenthal and Durbin, the FDA states that because energy drinks are new products that have raised safety concerns, they warrant investigation: “New products and patterns of use require us to remain vigilant, and we are working to strengthen our understanding of the nature of ‘energy drinks’ and any causal risks to health”. Blumenthal and Durbin have requested a meeting with FDA Commissioner Margaret Hamburg to further discuss the steps the agency is taking to ensure the safety of these products. They are hopeful the meeting will be scheduled before the end of the year.
The specifics of the FDA’s review of energy drinks are not outlined, but according to the FDA, the review includes examining adverse event reports and consulting with experts outside of FDA to better understand risks posed by energy drinks, additives, and high levels of caffeine consumption in youth. If their review finds safety concerns, FDA will consider regulatory action.
In a September letter, Blumenthal and Durbin asked the FDA to respond to their specific concerns regarding the interaction of ingredients in energy drinks and the effect that the caffeine in energy drinks has on children and adolescents. In April, Durbin sent a similar letter to the FDA Commissioner Margaret Hamburg; however, both Senators felt that the FDA’s response did not fully address the specific concerns that were laid out.
In an October letter, after the FDA revealed an investigation into five deaths that occurred following the consumption of Monster energy drinks, Blumenthal and Durbin challenged the FDA to quickly identify and recommend remedies for weaknesses and loopholes in current law that are exploited by energy drink manufacturers in order to avoid oversight. They also called on the FDA to investigate the interactions between caffeine and stimulants in energy drinks and to assess the health risks associated with caffeine consumption by children and adolescents.
In a November letter, following reports that the FDA has received 13 adverse event reports of fatalities following the consumption of 5-Hour Energy, Blumenthal and Durbin called for a meeting with the FDA Commissioner Margaret Hamburg to discuss the steps the agency is taking to ensure the safety of energy drinks.