FDA warns makers of caffeinated alcoholic drinks

NEW YORK Thu Nov 18, 2010 8:20am EST

Phusion Projects LLC's ''Four Loko'' products are seen in this undated handout photo. REUTERS/U.S. Food and Drug Administration/Handout

Phusion Projects LLC's ''Four Loko'' products are seen in this undated handout photo.

Credit: Reuters/U.S. Food and Drug Administration/Handout

NEW YORK (Reuters) - U.S. regulators warned makers of caffeinated alcoholic drinks that their products are unsafe and violate federal laws, following a public outcry and several state bans.

The U.S. Food and Drug Administration sent warning letters on Wednesday to four firms -- Phusion Projects LLC, United Brands Co, New Century Brewing Co and Charge Beverages -- charging that seven of their drinks combining alcohol and caffeine were unsafe.

"(The) FDA has found reason for concern that a number of caffeinated alcoholic beverage products do not meet the legal standard for safety," said FDA Commissioner Margaret Hamburg. "As a result the agency is moving forward on behalf of public health."

The Federal Trade Commission also warned the manufacturers that their marketing may be deceptive or unfair.

"Consumers might mistakenly assume that these beverages are safe because they are widely sold," said David Vladeck, director of the FTC's Bureau of Consumer Protection.

Sweetened drinks with high levels of alcohol and caffeine have grabbed headlines across the country in recent weeks after several incidents involving hospitalization after their consumption. In many cases, the drinkers were underage.

The drinks have already been banned in several states including Washington and Michigan.

Four Loko, one of the most popular of the drinks, comes in fruity flavors and brightly colored cans, similar to nonalcoholic energy drinks, popular with teenagers and young adults. It is 12 percent alcohol, meaning that one 23.5-ounce can is comparable to drinking four or five beers plus a dose of added caffeine, taurine and guarana.

Health experts say mixing alcohol and caffeine is dangerous because the stimulant masks the effects of the alcohol, letting people drink long after they would have otherwise stopped.

FDA's Hamburg said the combined consumption of high levels of caffeine and alcohol led to a state of "wide-awake drunk" and has been linked to alcohol poisoning, automobile accidents and assault.

YEAR-LONG PROBE, TWO-WEEK SOLUTION

Major brewers Anheuser-Busch InBev and MillerCoors stopped making caffeinated alcohol drinks in 2008 amid pressure from state authorities. But smaller companies have filled the gap.

Four Loko maker Phusion Projects said on Tuesday that it would remove stimulants from all its products, ahead of the expected move from the FDA. It said on Wednesday that the caffeine-free versions have received federal approvals and that it is working with state regulators for similar approvals and hopes to have more information in coming days.

United Brands, which makes a similar drink called Joose, said in a statement that it was reviewing the FDA's letter.

"We have complied with all national and state regulations, and will continue to do so," said its CEO, Michael Michail.

Charge Beverages CEO Tim Baggs said the company has already ceased production of caffeinated alcohol drinks, and is just selling through its remaining inventory. He expects the supply to run out in about 2 months.

But Rhonda Kallman, CEO of New Century Brewing, said she was shocked at the warning, since her drink, Moonshot beer, is different than the rest. It is a craft-brewed pilsner with 5 percent alcohol and 69 mg of caffeine, whereas she said the other drinks are sugary, neon-colored and have up to 200 mg of caffeine.

"I was fully hoping and optimistic that the FDA would create some standardization around what is safe in their mind in terms of caffeinated alcohol," said Kallman. "The difficulty for me is if I remove the caffeine, there's no real reason for Moonshot," said Kallman, who co-founded Samuel Adams maker Boston Beer in 1984. She plans to talk to the FDA.

The FDA began probing caffeinated alcohol drinks in November 2009 after requests from several states.

Makers of U.S. food additives and ingredients must prove that their ingredients are "generally recognized as safe" or GRAS, in order to legally sell them. Even though the drinks have been sold legally for years, the FDA said on Wednesday that manufacturers did not prove safety. Therefore, the caffeine in their drinks is "an illegal food additive."

Representative Rosa DeLauro, head of a House panel that oversees the FDA, said this case highlights the problems of the GRAS process and that "these types of delays in response times is unacceptable."

The warning letters give manufacturers 15 days to outline specific action they plan to take. If the steps are insufficient, they risk enforcement action that could include product seizures or an injunction to halt manufacturing.

The FDA said its review is ongoing and may lead to action against other similar products.

White House Drug Policy Director Gil Kerlikowske commended the agencies for acting to curb the sale of drinks he said were "designed, branded and promoted to encourage binge drinking".

"These drinks are especially unhealthy and dangerous because they combine alcohol and caffeine -- and present further concern when used by young people," he said.

But not everyone thinks the solution is a good one.

Jeffrey Parsons, a psychology professor at New York's Hunter College who studies addictions, said making products unavailable often makes them more attractive.

"The use of that type of combination of caffeine and alcohol could actually increase," Parsons said, noting that people can just mix their own drinks, using vodka and an energy drink like Red Bull.

(Additional reporting by Susan Heavey in Washington D.C.; Editing by Lisa Von Ahn, Dave Zimmerman and Carol Bishopric)