FDA Orders Safety Review Of Alcoholic Energy DrinksNov 16, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) just notified about 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,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs. According to the FDA, of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.
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). The agency has not approved the use of caffeine in alcoholic beverages; therefore, such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.
For a substance to be GRAS, 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.
The FDA alerted manufacturers to the fact that it is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA 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 was “prior sanctioned.” To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.
The 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 it determines use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, it will take appropriate action to ensure that the products are removed from the marketplace.
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.
The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.
In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.