
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?