SCHUMER, FEINSTEIN, KLOBUCHAR & MERKLEY TELL FDA: ALCOHOLIC 'ENERGY DRINKS,' SUCH AS FOUR LOKO AND JOOSE, MAY BE UNSAFE OR EVEN ILLEGAL--SENATORS URGE AGENCY TO RELEASE FINDINGS ABOUT DRINKS' POTENTIAL DANGERS, ESPECIALLY FOR YOUNG DRINKERS
Drinks Look Nearly Identical to Non-Alcoholic Energy Drinks; Labeling Makes Distinguishing Difficult for Parents, Could be Encouraging Underage Drinking
Drinks Contain Up to Twice the Amount of Alcohol As a Bottle of Beer and High Amounts of Caffeine--Mixing Alcohol and Caffeine Can Be Extremely Dangerous for Teens
FDA Launched Probe Into Drinks' Possible Health Risks Last November, But Has Yet To Make Public Any Findings
Yesterday, U.S. Senators Charles E. Schumer (D-NY), Dianne Feinstein (D-CA), Amy Klobuchar (D-MN) and Jeff Merkley (D-OR) called on the Food and Drug Administration (FDA) to immediately make public its findings from an investigation into possible health risks posed by so-called "energy drinks" that combine alcohol and caffeine. Popular drinks such as Four Loko and Joose look nearly indistinguishable compared to energy drinks, yet contain up to 12% alcohol per volume--or, two to three times the amount of alcohol in one can of beer. In November 2009, the FDA demanded that the makers of these beverages supply information to prove the safety of their product, but the agency has yet to produce a finding.
In a letter to FDA Administrator Dr. Margaret Hamburg, the senators said the 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. They pressed the agency to complete its probe into the drinks and issue a public finding.
"The FDA needs to determine once and for all if these drinks are safe, and if they're not, they ought to be banned," Schumer said. "Caffeine and alcohol are a dangerous mix, especially for young people. Other drink manufacturers have voluntarily stepped back from peddling these products, but certain companies are still out there targeting young consumers. The FDA should make public its findings about the possible safety risks of these drinks immediately."
"Consumers rely on the Food and Drug Administration to evaluate and publicize the safety of the food and beverages available to the public," Klobuchar said. "Caffeine as an additive in alcoholic beverages has never been approved. With recent studies suggesting it might pose a unique safety concern, it's time the FDA publish a policy to inform citizens and protect them from harm."
"Caffeinated alcoholic beverages are being marketed to American youth and present a potential hazard for our young people," Merkley said. "These products deserve careful scrutiny from the FDA to determine whether they are safe to consume."
Caffeinated alcoholic beverages have been around for almost 10 years and, currently, more than 25 brands are sold in a variety of
Caffeinated alcoholic malt beverages such as Four Loko and Joose appear to be created and advertised with teenagers in mind. Their twenty-four ounce cans are designed to appear hip with flashy colors and funky designs that could appeal to younger consumers. With 12% alcohol per volume, these drinks contain more than twice the amount of alcohol than a bottle of beer or a glass of wine. However, the labeling and packaging of these beverages renders them nearly indistinguishable from ordinary energy drinks. Some stores even stock them directly next to other energy drinks causing further confusion for legal and illegal consumers. For example: Four Loko comes in seven different flavors and a vibrantly colored aluminum can with, in their own words, "bright, pop-off-the-shelves, graphics."
In 2008, Anheuser-Busch InBev NV and MillerCoors LLC reformulated caffeinated alcoholic beverages under pressure from several states and regulatory bodies, but smaller companies like the manufacturers of Four Loko and Joose managed to remain unnoticed.
Earlier this month, Schumer pushed the FTC to launch an investigation into these drink manufacturers' marketing practices. The FTC has yet to indicate whether it has acted on that request.
A copy of the Senators' letter to
July 29, 2010
The Honorable Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Dear Commissioner Hamburg,
We write as legislators committed to combating underage drinking and concerned about the lack of guidance from the Food and Drug Administration on the safety and legality of caffeinated alcoholic beverages. It has come to our attention that the FDA has never approved the use of caffeine as an additive for use in alcoholic drinks. We applaud the FDA for taking concrete steps to review this issue and believe that a published policy is necessary. Consumers deserve to hear from the FDA - the agency responsible for protecting the public health by assuring the safety of our food and beverage products - regarding the safety and legality of caffeinated alcoholic beverages.
Recent studies suggest that caffeinated alcoholic beverages do in fact raise unique and disturbing safety concerns - that alcohol mixed with caffeine poses serious health risks, especially for young drinkers. One study found that young drinkers who combine alcohol with caffeine are at increased risk of harm. Specifically, the study found that younger drinkers are twice as likely to be the victim of sexual assault, ride with a drunk driver, and be hurt or injured as a result of their drinking enough to seek medical attention. These findings are alarming, particularly given the skyrocketing popularity of caffeinated alcoholic beverages and the fact that the beverage manufacturers seem to be actively marketing to young and possibly underage drinkers. Under these circumstances, it is imperative that the Food and Drug Administration move expeditiously to issue a decision regarding the safety and legality of these drinks.
We understand that in November 2009, the FDA notified approximately 30 manufacturers of caffeinated alcoholic beverages that it intended to review the safety and legality of their products. The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in alcoholic beverages is "generally recognized as safe" ("GRAS"). As you know, for a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts. We commend the FDA for its actions in pursing this issue, but it has now been seven months since the agency should have received responses from the nearly 30 manufacturers. We respectfully urge the FDA to decide as soon as possible whether the use of caffeine in alcoholic beverages is safe and legal, as well as make public any research or information concerning the safety of caffeinated alcoholic beverages.
Caffeinated alcoholic beverages are heavily marketed in youth-friendly media with youth-oriented graphics and messaging and are readily accessible at retail alcohol outlets such as convenience stores. The Federal Trade Commission previously has been asked to investigate whether such marketing violates any laws enforced by the FTC. We are asking the Food and Drug Administration to do its part and promptly inform consumers whether these beverages are even safe for consumption.
Thank you for your prompt attention to this matter. We look forward to hearing from you.
Sincerely,
Charles
United States Senator United States Senator
Amy Klobuchar Jeff Merkley
United States Senator United States Senator