The Food and Drug Administration today notified 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,” 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 (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).
FDA has not approved the use of caffeine in alcoholic beverages and
thus 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
The FDA alerted manufacturers to the fact that the agency 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 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 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, 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