FDA Sends Warning to Companies Who Make Caffeinated Alcoholic Drinks

A few weeks ago, the FDA sent warning letters 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 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.”

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

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.

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 that it would remove stimulants from all its products, ahead of the expected move from the FDA. United Brands, which makes a similar drink called Joose, said in a statement that it was reviewing the FDA’s letter.

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.

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.

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