WEDNESDAY, Nov. 17 (HealthDay News) -- The U.S. Food and Drug
Administration on Wednesday told makers of caffeinated alcoholic
beverages that the caffeine in their products has been deemed an
"unsafe food additive," and the drinks can no longer be sold in
their current form.
In warning letters to the companies, the agency said the four
firms risked further action, including seizure of their
"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, the agency's principal deputy commissioner. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."
"I wouldn't characterize this as an outright ban," Sharfstein added at a news conference. "These are warning letters that these products are adulterated, and do not meet our standards for safety."
The drinks -- marketed under such names as Four Loko, Joose,
Lemon Lime Core Spiked, and Moonshot -- have become popular with
young adults, and have left dozens of people sick or hospitalized.
Several states have banned the drinks, which can have alcohol
levels as high as 12 percent, according to federal officials.
FDA officials said the caffeine in the drinks can make it hard
for consumers to gauge their level of intoxication. And
peer-reviewed studies have suggested that consumption of the
beverages can lead to "risky behaviors" and "life-threatening
situations," the agency said.
The announcement comes amid a growing backlash against the
so-called energy drinks -- sometimes called "blackout in a can" --
that blend caffeine and alcohol. Such beverages are becoming
increasingly popular with college students and even children. The
drinks are regularly consumed by 31 percent of 12- to 17-year-olds
and 34 percent of 18- to 24-year-olds, the U.S. Centers for Disease
Control and Prevention estimates.
In a news release Thursday, the FDA said the products cited in
the warning letters are "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 violations persist, it said it could take
additional steps including "seizure of the products or an
injunction to prevent the firm from continuing to produce the
product until the violation has been corrected."
The warning letters stemmed from an FDA safety review of the
drinks that was launched in the fall of 2009 in response to
concerns of several states attorneys general.
The FDA said the companies that received the warning letters and
their products are:
Meanwhile, the maker of Four Loko said Tuesday that it would
remove caffeine and other stimulants from its four different
flavors of alcoholic drinks. Four Loko has up to 12 percent alcohol
in a 23.5-ounce can, according to published reports.
Four Loko's manufacturer, Chicago-based Phusion Projects,
insists that the drinks are safe. But, in a statement posted on the
company's Web site, it said it was removing the caffeine "after
trying unsuccessfully to navigate a difficult and politically
charged regulatory environment at both the state and federal
The company said it doesn't agree that mixing caffeine and
alcohol is inherently unsafe. "We have repeatedly contended -- and
still believe, as do many people throughout the country -- that the
combination of alcohol and caffeine is safe. If it were unsafe,
popular drinks like rum and colas or Irish coffees that have been
consumed safely and responsibly for years would face the same
scrutiny that our products have recently faced," the Web site
According to the CDC, caffeinated alcoholic beverages can have
alcohol levels that range from 5 percent to 12 percent, compared to
4 percent to 5 percent for beer.
People who consume alcohol mixed with energy drinks are three
times more likely to binge drink than drinkers who do not mix
alcohol with energy drinks. And drinkers who consume alcohol-laced
energy drinks are about twice as likely as drinkers who do not
report mixing alcohol with energy drinks to report being taken
advantage of sexually, to report taking advantage of someone else
sexually, and to report riding with a driver who was under the
influence of alcohol, according to the CDC.
Sharfstein was joined at the news conference by U.S. Food and
Drug Administration Commissioner Dr. Margaret Hamburg, as well as
representatives from the Alcohol and Tobacco Tax and Trade Bureau,
the Bureau of Consumer Protection, the U.S. Centers for Disease
Control and Prevention, and state attorney generals from Washington
To learn more about caffeinated alcoholic beverages, visit the
U.S. Centers for Disease Control and
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