FDA: Caffeinated Alcoholic Drinks Are Unsafe

Agency Issues Warning About Four Loko and Other Drinks That Mix Caffeine and Alcohol

Medically Reviewed by Laura J. Martin, MD on November 17, 2010
From the WebMD Archives

Nov. 17, 2010 -- Federal officials have warned four companies that caffeine added to some of their alcoholic beverages makes their drinks unsafe and has asked the companies to provide data concerning these safety concerns.

The FDA and the Federal Trade Commission (FTC) issued similar warning letters to these companies:

  • Charge Beverages Corp., of Portland, Ore., which sells Core High Gravity HG Green, Core High Gravity HG Orange, and Lemon Lime Core Spiked.
  • New Century Brewing Co., of Boston, which produces Moonshot.
  • Phusion Projects, based in Chicago, which sells Four Loko.
  • United Brands Co., based in San Diego, which markets Joose and Max.

‘Unsafe’ Food Additives

The FTC says its letters warn that caffeine as used in the companies’ products is an “unsafe food additive” under the Federal Food, Drug and Cosmetic Act (FFDCA).

“Consumers might mistakenly assume that these beverages are safe because they are widely sold,” David Vladeck, director of the FTC’s Bureau of Consumer Protection, says in a news release. “In fact, there is good reason to believe that these caffeinated alcohol drinks pose significant risks to consumer health and safety.”

He says consumers, especially young, inexperienced drinkers, “may not realize how much alcohol they have consumed because caffeine can mask the sense of intoxication.”

The FTC’s statement says the agency “strongly” urges the companies to review the way they are marketing the products and orders the firms to “take swift and appropriate steps to protect consumers.”

Both federal agencies give the companies 15 days to comply with government directives.

Scientific Review of Products

The FDA says its warning letters were sent following a careful scientific review and the examination of peer-reviewed studies on the consumption of alcohol and caffeine.

The FDA says it also consulted experts in the fields of toxicology, neuro-pharmacology, emergency medicine, and epidemiology, and that it also reviewed information manufacturers provided to federal authorities. The FDA also says its investigators performed independent laboratory analysis of the products.

Joshua M. Sharfstein, MD, principal deputy commissioner of the FDA, says the agency rejects the claim made by the companies that “the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe.’”

Rather, he says, evidence exists supporting the federal contention that the caffeinated alcohol drinks “pose a public health concern.”

Concern has been raised before that caffeine can mask some of the cues of intoxication, leading to dangerous and life-threatening situations, the FDA says. It also says its officials believe that the products involved are being marketed in violation of the FFDCA.

Lawmaker Praises Actions of Federal Agencies

Sen. Charles Schumer, D-N.Y., who has been critical of caffeinated alcoholic beverages, says in a news release that the actions of the federal agencies effectively send notice to the companies that their products are unsafe and that such drinks won’t be tolerated.

“Let this serve as a warning to anyone who tries to peddle dangerous and toxic brews to our children, ‘Do it, and we will shut you down,'" Schumer’s statement says.

He says the actions by the federal agencies “should be the nail in the coffin of these dangerous and toxic drinks” and that “parents should be able to rest a little easier knowing that soon their children won’t have access to this deadly brew.”

Schumer says New York’s State Liquor Authority and the state’s largest beer distributors agreed to stop selling the drinks this past week. He also says Oklahoma, Utah, Michigan, and Washington have taken steps to ban the drinks.

Companies Respond

United Brands says in a news release that it is engaging with alcohol regulatory bodies and legislators to provide clarity around the responsible marketing practices of the company. Phusion Projects says in a news release that it will produce only non-caffeinated versions of Four Loko.

Rhonda Kallman, founder and CEO of New Century Brewing, which makes the caffeinated alcoholic beverage Moonshot, tells WebMD she is perplexed by the federal actions and “reeling from the news.”

She says Moonshot contains only a tiny amount of caffeine, much less than the products made by the other three companies.

“I’ve been in the business for 25 years,” she says. “I’m curious about this. There has to be some percentage that works, because caffeinated alcoholic beverages have been around for decades.”

Charge Beverages could not be reached for comment prior to publication time.

Show Sources


Rhonda Kallman, founder and CEO, New Century Brewing.

News release, FDA.

News release, Federal Trade Commission.

News release, Sen. Charles Schumer, D-N.Y.

News release, United Brands.

News release, Phusion Projects.

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