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What's Up with the FDA and Caffeinated Alcoholic Beverages?

In November, the FDA issued warning letters to four companies that make alcoholic beverages with added caffeine, sometimes referred to as “caffeinated alcoholic beverages.” The letters warned the companies that FDA considers the caffeine added to their malt alcoholic beverages to be an “unsafe food additive.” A food or beverage that contains an unsafe food additive is considered adulterated and, thus, illegal.

Opening a drink canSince the letters were issued, we have received a number of questions about caffeinated alcoholic beverages. Here are answers to three questions we hear frequently:

Q. I thought that caffeine was safe. Why is the FDA saying that it’s an “unsafe food additive?”

A. The lawfulness of a food ingredient is determined in part by how it’s used. If an ingredient hasn’t been approved by FDA for a certain use, the ingredient can be used only if it’s “generally recognized as safe” for that purpose. For example, caffeine is “generally recognized as safe” when it’s used in cola beverages below a certain level. But FDA has not approved caffeine for use in alcoholic beverages, and FDA doesn’t consider the use of caffeine in the products at issue to be “generally recognized as safe.”

Q. Why would caffeine be considered OK in soft drinks but not in these products?

A. Since November 2009, FDA has been looking at whether caffeine added to an alcoholic beverage is lawful. Based on the available scientific research, FDA is concerned about these beverages for several reasons:

  • People drinking these beverages may consume more alcohol—and become more intoxicated—than they realize. That’s because the caffeine masks some of the sensory cues that people use to tell how intoxicated they are (how drunk they feel).
  • People drinking these beverages may think that the caffeine counteracts all the effects of alcohol, but that’s not true. Caffeine does not affect the way the body processes alcohol; it doesn’t “sober you up.” You may feel more alert, but the alcohol still affects your physical coordination and reaction time.
  • People drinking these beverages may be more likely to engage in risky behaviors that may lead to hazardous and life threatening situations. Research suggests that people who drink these beverages area at greater risk of alcohol-related consequences, including alcohol poisoning, sexual assault, and riding with a driver who is under the influence of alcohol.

Q. What about alcoholic beverages that include coffee, such as coffee-based liqueurs?

A. The letters FDA sent last month are not directed at coffee-based liqueurs or similar beverages that contain an ingredient with naturally occurring caffeine. Unlike the products identified in the warning letters, these beverages don’t include caffeine added as a separate ingredient.

For more information on the concerns about caffeinated alcoholic beverages, check these resources:

Tagged: Warning Letters | Recall | Q&A