Due to the growing popularity of alcoholic beverages containing
caffeine, the Food and Drug Administration recently notified nearly 30
manufacturers of caffeinated alcoholic drinks that it intends to look
into the safety and legality of their products.
This comes after the FDA received a letter from 18 Attorneys General
and one city attorney in late September expressing concerns about
caffeinated alcoholic beverages.
"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.
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
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 qualified experts.
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