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FDA to Examine the Safety of Caffeinated Alcoholic Beverages

On Nov. 13, 2009, the Food and Drug Administration (FDA) sent letters notifying nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

"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," says Joshua Sharfstein, M.D., principal deputy commissioner of food and drugs.

As many as 26 percent of U.S. college students use the combination of caffeine and alcohol, according to the few studies on this topic.

Under the Federal Food, Drug and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed "unsafe" and is unlawful unless

  • its particular use has been approved by FDA regulation,
  • the substance is subject to a prior sanction, or
  • the substance is “generally recognized as safe” (GRAS)

For a substance to be generally recognized as safe, there must be

  • evidence of its safety at the levels used, and
  • a basis to conclude that this evidence is generally known and accepted by qualified experts

To date, FDA has approved caffeine only as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. The agency has not approved caffeine for use at any level in alcoholic beverages; therefore, these beverages can be lawfully marketed only if their use is subject to a prior sanction or if their use is GRAS.

FDA alerted manufacturers that it is considering whether caffeine can lawfully be added to alcoholic beverages. The agency noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.

FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, major brewers 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 alcohol beverages in the future.

The U.S. Treasury Department’s Tax and Trade Bureau, which has primary responsibility for regulating alcoholic beverages, requires that alcoholic beverages contain only ingredients that satisfy FDA’s requirements for use.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: November 13, 2009

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