Caffeinated alcoholic beverages may be going the way of Joe Camel. The U.S. Food and Drug Administration has warned four companies that make malt liquors containing caffeine that it considers the caffeine to be "an unsafe food additive."
The letters went to four companies: Charge Beverages Corp., New Century Brewing Co. LLC, Phusion Projects LLC (which does business as the Drink Four Brewing Co.), and United Brands.
The caffeinated malt beverages referenced in these warning letters are
Core High Gravity HG Green
Core High Gravity HG Orange
Four Loko
Joose
Lemon Lime Core Spiked
Moonshot (This product is labeled as "premium beer with caffeine")
Max
The FDA said the manufacturers have failed to show that the direct addition of caffeine to their malt beverages is "generally recognized as safe" by qualified experts. Rather, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.
"Consumers should avoid these caffeinated alcoholic beverages, which do not meet the FDA's standards for safety," says Joshua M. Sharfstein, M.D., FDA's principal deputy commissioner.
The agency has given the firms 15 days to respond to the warning letters and then may proceed to court to stop their sale. In addition, other alcoholic beverages containing added caffeine may be subject to agency action in the future if scientific data indicate that the use of caffeine in those products does not meet safety standards.
A troubling mix
The FDA said that the problem with the drinks is that caffeine can mask sensory cues that people may rely on to determine how intoxicated they are. This means that individuals drinking these beverages may consume more alcohol -- and become more intoxicated -- than they realize.
At the same time, caffeine does not change blood alcohol content levels, and thus does not reduce the risk of harm associated with drinking alcohol.
Studies suggest that drinking caffeine and alcohol together may lead to hazardous and life-threatening behaviors. For example, serious concerns are raised about whether the combination of alcohol and caffeine is associated with an increased risk of alcohol-related consequences, including alcohol poisoning, sexual assault, and riding with a driver who is under the influence of alcohol.
Malt versions of premixed alcoholic beverages come in containers holding between 12 and 32 liquid ounces. Some may also contain stimulant ingredients in addition to caffeine. Their advertised alcohol-by-volume value is as high as 12 percent, compared to standard beer's usual value of 4 to 5 percent.
These alcoholic beverages are available in many states in convenience stores and other outlets. They often come in large, boldly colored cans comparable in size to "tall" cans of beer -- or in containers resembling regular beer bottles.
States approve
Idaho Attorney General Lawrence Wasden called the FDA's action "a significant and necessary step forward in removing these dangerous products from the market." Wasden was one of several state attorneys general who urged the FDA to take action against the drinks.
As a result of action by the state AGs, MillerCoors and Anheuser-Busch have agreed to stop producing caffeinated alcohol beverages but smaller manufacturers have stepped in to fill the gap, producing drinks with alcohol contents as high as 12 percent.
Four Loko was blamed for the hospitalization of 23 students at Ramapo College in New Jersey and to the hospitalization of nine students after a party Central Washington University. Both incidents happened in October and the drink was subsequently banned from both campuses.
The Michigan Liquor Control Commission banned all alcohol-infused energy drinks earlier this month.
Thorough investigation
FDA's action follows an examination of the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consultation with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and a review of information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
"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, Principal Deputy Commissioner. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."
Dangerous drinks
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
The agency said the products named in the warning letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (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 that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.
The agency's action follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.
Positive step
FDA says it is aware that on November 16, Phusion Projects, LLC -- the maker of Four Loko -- announced its intention to remove caffeine and other stimulants from its drinks, and calls the announcement "a positive step."
But the agency notes that it has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product.
Says it will work with Phusion the other manufacturers to assure their products meet safety standards.
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This story includes reporting by James Limbach.
FDA Wants To Decaffeinate Alcoholic Drinks. Agency gives four manufacturers 15 days to respond to warning letters....