For those familiar with only the press accounts and/or FDA's November 17 new release effectively banning a number of caffeinated alcohol beverages, the detailed analysis can be found in its letter to Phusion Projects, the makers of Four Loko. Here are FDA's main points and conclusions to support its conclusion that "caffeine is an unsafe food additive" in alcohol beverages. Therefore, the beverages to which caffeine has been "directly added" are "adulterated" and "unsafe." Under federal law, the makers were required to prove the added caffeine met its standard of "generally recognized as safe" (GRAS) "under its specific conditions of use" via "consensus among qualified experts" and publicly available "data and information." Net-net: FDA found "a number of experts" had concerns about added caffeine's safety, but no data to prove its safety. Specific concerns included: 1) negative "behavioral effects" in young people; 2) potential "life-threatening
situations" resulting from consumption since caffeine "counteracts some, but not all of alcohols adverse effects"; 3) because of caffeine's masking effect, "naïve" drinkers may consume higher amounts of alcohol in CABs. FDA cited five studies in all to support those concerns. Beyond the product itself, "context" of use is also important. Indeed, FDA seemed equally concerned that CABs "seemingly target the young adult user" and that young adults would be "especially vulnerable" to CABs negative effects.
Phusion had provided some information it believed established Four Loko's safety. But FDA wrote that Phusion's GRAS notice "relies primarily upon safety studies of caffeine alone," not when mixed with alcohol. Phusion had also criticized the "design and interpretation" of some of the studies linking CABs to negative effects, but FDA concluded "the peer reviewed literature as a whole is sufficient to raise, among qualified experts, safety concerns." Then too, FDA found "no studies" or other info to refute the negative effects of the "co-consumption" of alcohol and caffeine.
Many have wondered whether FDA, FTC and/or TTB will use these findings to place limits on other caffeine-alcohol combinations, like coffee or chocolate liqueurs or high-alcohol beers with traces of caffeine. But all of the public statements and letters so far have focused solely on products to which caffeine had been directly added, not where caffeine may be a part of other natural ingredients. In fact, FDA's Q&A document specifically pointed out its action does not apply to coffee-based liqueurs. The young "fan base" of the CABs in question was also a critical factor, given FDA's comments about "context." So far, FDA remains focused on the 4 companies to which it sent letters and has announced no expanded actions.
How Did FDA Conclude Caffeinated Alcohol Beverages Were Unsafe? Broader Implications?
Publishing Info
- Newsletter: Alcohol Issues Insights
- Published: 11/14/2010
- Volume: 27
- Issue #: 11