FDA, FTC Target Alcoholic Energy Drinks

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) simultaneously notified makers of popular caffeinated alcoholic beverages that such products are unsafe, unapproved, and misleadingly marketed, The Washington Post reported Nov. 17.

Large brewers like Anheuser-Busch and MillerCoors stopped selling similar caffeinated alcoholic beverages in 2008, after several states’ attorneys general argued that they were unsafe and were inappropriately marketed to young people.

Smaller companies stepped into the breach, marketing drinks such as Core High Gravity, Moonshot, Four Loko, Joose, and Max. The drinks have become popular with young people, especially on college campuses, where they have been dubbed “blackout in a can.”

In Nov. 2009, the FDA sent a letter to about 30 manufacturers of these drinks, stating that the addition of caffeine to alcoholic drinks had not been approved and that it would evaluate its safety. It asked the drink makers to submit information on the safety of caffeine as a food additive.

On Nov. 17, 2010, the FDA notified four companies — Charge Beverages Corporation, New Century Brewing, Phusion Projects Inc., and United Brands Company, Inc. — that the addition of caffeine to their alcohol drinks was unapproved and unsafe, effectively making the manufacture and distribution of caffeinated alcoholic beverages illegal.   

“There is evidence that the combinations of caffeine and alcohol in these products pose a public health concern,” said Dr. Joshua Sharfstein, deputy commissioner at the FDA.

The FDA's letters cited recent scientific studies showing that when combined, alcohol and caffeine posed an elevated risk to the health and safety of consumers, especially younger drinkers. In response to criticisms of that research made by United Brands and Phusion Projects, FDA officials wrote that, “[T]here are currently no studies or other information that refute the safety concerns or otherwise affirmatively establish the safety of caffeine directly added to alcoholic beverages.”

Simultaneously, the Federal Trade Commission warned the four companies that their marketing practices for the drinks were potentially deceptive.

“Consumers might mistakenly assume that these beverages are safe because they are widely sold,” said the FTC's Director of the Bureau of Consumer Protection, David Vladeck. “In fact, there is good reason to believe that these caffeinated alcohol drinks pose significant risks to consumer health and safety. Consumers — particularly young, inexperienced drinkers — may not realize how much alcohol they have consumed because caffeine can mask the sense of intoxication.”

The FDA's letters made no mention of recent incidents in four states where young adults were hospitalized or died after consuming caffeinated alcoholic beverages. The FTC letter explicitly cited the incidents as a factor in its decision. 

Manufacturers were given 15 days to act, or face seizure of their products or even a court order barring them from selling it. 

A day ahead of the FDA and FTC's announcements, on Nov. 16, Phusion Projects Inc. said that it would remove all additives, including caffeine, from its product Four Loko, according to The Boston Globe.

The founders of Phusion Projects stated in a press release that they “still believe, as do many people throughout the country – that the combination of alcohol and caffeine is safe,” citing commonly-consumed drinks like rum and cola, or Irish coffee. The press release did not mention the hospitalization incidents that have been linked to the consumption of caffeinated alcoholic beverages.

Phusion Projects' founders added, “[I]f our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas – the Tobacco Tax and Trade Bureau (TTB) – to have approved them.”

The FDA acknowledged the TTB approvals in its Nov. 17 letters to all four companies, but stated that the matter was unrelated to the need to have food additives approved by the FDA under the Federal Food, Drug, and Cosmetic Act.