The short but lucrative era of combining alcoholic drinks with caffeine is coming to a close. The Food and Drug Administration announced today it is giving 30 days' notice to makers of alcohol energy drinks that they have to pull their products from the market unless they can provide evidence of their safety.
It is not expected that FDA will accept any evidence produced.
"The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible," said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.
The advent us such drinks was an offshoot of the innovative energy drinks category. In this case, high-caffeine drinks met alcohol, under the same operating procedure that has historically led inebriated people to consume coffee before heading home.
Of added concern to the functional beverage category is whether this constitutes a shot over the bow of the high-caffeine energy drinks — as well as energy shots — category.
In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.
In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages. The group expressed concern that "stimulants such as caffeine appear to mask the intoxicating effects of alcohol, which may lead to increased risk-taking and other serious alcohol-related problems. We ask the FDA to use its authority under the Food Drug and Cosmetics Act to cause the immediate removal of AEDs (alcoholic energy drinks) from the marketplace."
FDA released the names of the 30 manufacturers of caffeine/alcohol combination beverages, with evocative product names such as Liquid Charge, Torque and Hard Wired.
In one of the letters, Mitchell A Cheeseman, PhD, acting director of the Office of Food Additive Safety Center for Food Safety and Applied Nutrition at the FDA, explained its position: "FDA has provided by regulation that caffeine up to a level of 0.02 percent is GRAS when used in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, this regulation does not confer GRAS status to the use of caffeine in your alcoholic beverages or at higher use levels.
"FDA has not made a determination regarding the GRAS status of the use of caffeine in alcoholic beverages, but the agency is not aware of the basis upon which you have or may have concluded that your use of caffeine in an alcoholic beverage is GRAS. Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned. We request that you provide us within 30 days with your rationale, and supporting data and information, for concluding that your use of caffeine in an alcoholic beverage is GRAS or prior sanctioned.
"Other products containing added caffeine may be subject to agency review if the available scientific data and information indicate that added caffeine may pose a safety concern, or is being unlawfully used, under the conditions of its use in other products."
The FDA's decision regarding the regulatory status of caffeine added to various alcoholic beverages will be "a high priority" for the agency.
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