FDA Calls For Proof Of Alcohol-Caffeine Drinks' Safety

State attorneys general and consumer health groups have criticized the federal government for not regulating the small but fast-growing market of caffeinated alcoholic drinks. Now the federal Food and Drug Administration announces that it's taking its first action on the drinks that are marketed to people in their 20s: Within 30 days, the companies must supply data proving the drinks are "safe" or pull them from the market.

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The makers of alcoholic energy drinks have long insisted their products are safe. Today, they got this message from the Food and Drug Administration: prove it. NPR's Joseph Shapiro reports.

JOSEPH SHAPIRO: Those drinks mix caffeine with malt liquor, then add peach, berry and other sweet fruit flavors. They're popular on college campuses and heavily marketed to 20-somethings. But is this really a good idea to drink something that can get you very drunk and keep you awake at the same time? Now the federal Food and Drug Administration is demanding proof that the products are safe. Joshua Sharfstein is the second-ranking official at the FDA.

Mr. JOSHUA SHARFSTEIN (Food and Drug Administration): The agency has asked nearly 30 manufacturers of caffeinated alcoholic beverages to provide FDA within 30 days the data necessary to demonstrate that caffeine can be safely and lawfully added to alcoholic beverages.

SHAPIRO: The FDA will then consider the response from those companies, as well as other scientific evidence, and then decide whether the drinks can be sold or whether they need to be pulled from the market while the FDA does its own formal review. There's no timetable for how long the FDA takes to decide.

But the FDA got a pause from 19 states' attorneys general. They pursued legal action against the drink makers. Richard Blumenthal is the attorney general for Connecticut.

Mr. RICHARD BLUMENTHAL (Attorney General, Connecticut): No question, this FDA is a different being. It's much more proactive and interventionist when it comes to protecting public health and a major potential ally, rather than an adversary, as the old FDA was.

SHAPIRO: Up until now, those state officials had succeeded in getting two big beer makers to change their products. Last year Anheuser-Busch took the caffeine out of its drink Tilt. And Miller-Coors did the same with Sparks, saying it disagreed with the criticism from the attorneys general, but said they were acting as a responsible company.

Still, as the big beer makers stepped out, smaller ones proliferated. They sell drinks with up to twice or more the alcohol of most beers. Calls to several of the companies were not returned.

Dr. Mary Claire O'Brien at Wake Forest University's School of Medicine studied the use of those drinks by college students.

Dr. MARY CLAIRE O'BRIEN (Wake Forest University): But it's safe to say that a quarter of college drinkers are mixing alcohol with energy drinks, including both pre-mixed products as well as products that they mix themselves.

SHAPIRO: O'Brien's study also found that the drinks encouraged binge drinking and other high-risk behaviors that can lead to car crashes and sexual assaults. She first saw the problem one night working in the emergency room. A college student was brought in so drunk he was nearly comatose. Hours later, when he woke up, he told her hed been mixing caffeine and alcohol.

Dr. O'BRIEN: And I said, why would you want to drink caffeine to stay awake and drink alcohol to make you sleepy? Why would you do that at the same time? He said, oh, so you can drink more and stay up later. And just the light bulb went off. I thought, oh my god, people are not just drinking because they're drinking, they're drinking to party longer, to drink greater quantities for longer periods of time. And exactly what happened to this kid, he had an extraordinarily high level of alcohol in his system.

SHAPIRO: O'Brien thinks the drink makers will have a hard time showing the FDA that their products are safe.

Dr. O'BRIEN: There are no data. I've reviewed the scientific literature. There is not a body of scientific evidence to support that adding caffeine to alcohol is safe. We don't have to prove it's unsafe. They have to prove it's safe. That's the law.

SHAPIRO: O'Brien published her study in 2007. Two other studies found similar results, but since then more and more alcoholic energy drinks have gone on the market.

Joseph Shapiro, NPR News.

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