U.S. Senators Tell FDA Alcoholic Energy Drinks ‘Unsafe and Possibly Illegal’

Marin Institute campaign makes progress

Senators Charles E. Schumer (D-NY), Dianne Feinstein (DCA), Amy Klobuchar (D-MI), and Jeff Merkley (D-OR) have joined forces in a recent letter to the U.S. Food and Drug Administration (FDA) calling on the agency to “immediately make public its findings from an investigation into possible health risks posed by so-called ‘energy drinks’ that combine alcohol and caffeine.”

The senators also say that “alcoholic energy drinks appear to be marketed to underage teens, misleading parents and law enforcement by designing labels and containers so the products resemble non-alcoholic energy drinks.” The senators want the FDA to complete its investigation and issue a report of the findings to the public.

Back in November of 2009 the FDA announced it was investigating the safety and legality of alcoholic energy drinks. It sent letters to nearly 30 manufacturers of alcoholic energy drinks (also known as caffeinated alcoholic beverages) demanding that these manufacturers produce evidence within 30 days that their products were safe and indicated that the FDA would take appropriate regulatory action, including possible product seizures if these manufacturers could not provide adequate proof of safety. However, to date, no further action has been taken by FDA, which makes the senators’ letter all the more important.

The Marin Institute in California has been at the forefront of the fight to get potentially dangerous alcoholic energy drinks off the market and commended the FDA last year for its actions in 2009. The Marin also recently thanked Senator Schumer for his earlier letter to the Federal Trade Commission on this issue. The Marin says it hopes that the addition of three more U.S. senators in this call to action will encourage the FDA to take action to remove these potentially dangerous products from the market place once and for all.

Subsequently, the FDA issued warning letters to four makers of caffeinated alcoholic beverages stating that these beverages present a public health concern.

The letter warned the four companies that the caffeine added to their malt alcoholic beverages was an “unsafe food additive” and it said that further action, including seizure of their products, was possible under federal law.

FDA’s action follows a scientific review by the Agency. FDA examined the published peerreviewed literature on the coconsumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.

“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and lifethreatening situations.

The agency said the products named in the Warning Letters were being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.