November 16/Washington/States News Service -- In response to complaints from 18 attorneys general and one city attorney that alcohol-infused energy drinks cause dangerous behavior and injury, the Food and Drug Administration has challenged makers of those drinks to prove that their beverages are safe.

The FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages last week that it will begin investigating 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," said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Under the Federal Food, Drug and Cosmetic Act, a substance added intentionally to food is deemed "unsafe" and therefore 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).

The FDA has not approved the use of caffeine in alcoholic beverages and therefore, it can only be lawfully marketed if its use is subject to a prior sanction or is GRAS (for the latter, this evidence must be generally known and accepted by qualified experts).

The FDA said that it is unaware of the basis upon which manufacturers may have concluded that adding caffeine to alcoholic beverage is either sanctioned or is GRAS. To date, the FDA has approved caffeine as an additive in soft drinks in concentrations no greater than 200 parts per million. It has not approved caffeine for use in alcoholic beverages.

The FDA has requested that the companies respond within 30 days. If it determines that the use of caffeine is not GRAS or prior sanctioned, it will take action to remove the drinks from the marketplace.

Earlier this year, Anheuser-Busch and Miller discontinued their caffeinated alcoholic beverages and agreed to not produce any in the future.  

From the November 23, 2009, Prepared Foods E-dition