What FDA’s Action on Caffeinated Alcoholic Beverages Could Mean for GRAS

By Ricardo Carvajal –

When FDA sent letters to manufacturers of caffeinated alcoholic beverages asking them to furnish evidence supporting a conclusion that the use of caffeine in an alcoholic beverage is generally recognized as safe (GRAS) or prior sanctioned, the agency allowed 30 days for a response.  The 30-day deadline expires on December 13, and anyone with an interest in the future of FDA’s voluntary GRAS notification program should pay close attention to what comes next. 

The FDCA excepts from regulation as a food additive the use of a substance that is GRAS.  This means that a manufacturer can determine GRAS status and proceed to market without seeking FDA’s approval and without notifying the agency.  FDA operates a voluntary GRAS notification program pursuant to a proposed rule that was published in 1997.  FDA’s administration of that program, and the adequacy of its oversight of GRAS substances more generally, is the subject of an ongoing Government Accountability Office (GAO) review.  The GAO is expected to issue its report in January.  Depending on its content, that report could well rekindle debate over whether the GRAS exception affords manufacturers too much flexibility in introducing new uses of substances into the food supply.  Given the possibility that major food safety legislation could be debated and enacted in 2010, it is not unthinkable that any perceived weaknesses in FDA’s oversight of GRAS substances could quickly rise on the Congressional agenda.

This brings us back to caffeine in alcoholic beverages.  Should the manufacturers' evidence of GRAS status prove insufficient, a robust regulatory response by FDA could help preserve the status quo by confirming that FDA has both the will and requisite authority needed to prevent abuse of the GRAS exception.  A lax response by the agency could let loose the hounds of reform.  We’ll keep an eye on this one.