Last November, the FDA notified nearly 30 manufacturers of alcoholic beverages containing added caffeine that it intends to look into the safety and legality of their products. The FDA requested that each manufacturer provide its rationale, and supporting data and information, for concluding that its use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned, within 30 days of the notice.
The Pittsburgh Post-Gazette published a follow-up report on the FDA's inquiry today. Nearly a year later, 19 of the 27 companies have responded, including some who asked for more time. Apparently, the FDA is still evaluating this issue "as quickly as possible" but "a decision regarding the use of caffeine in alcoholic beverages could take some time."
An ingredient added to food (other than dietary supplements) is a food additive, which requires pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition. However, a substance is exempt from the definition of a food additive (and exempt from pre-market approval) if it is GRAS.
For a particular use of a substance to be GRAS, there must be both (1) evidence of safety, and (2) a basis to conclude that this evidence is generally known and accepted by qualified experts.
Doctors and state attorney generals have presented their "anti-GRAS" studies showing that those who use caffeinated alcohol beverages drink more often, binge drink more often and are more likely to engage in risky behavior such as driving with a drunk driver.
It would be interesting to see the outcome of this case as well as the basis of these manufactures' GRAS determination, if any. Rum and Coke, anyone?