Is the FDA Banning Drinks or Censoring Speech?


Today, as expected, the Food and Drug Administration announced that Four Loko violates the Food, Drug, and Cosmetic Act because the caffeine in it is not "generally recognized as safe" (GRAS) in this context. In addition to Phusion Products, the Chicago-based company that produces Four Loko (which has already said it will no longer make the drink with caffeine), the FDA is sending warning letters to just three other companies: United Brands of La Mesa, California, which makes Joose, a direct Four Loko competitor; Oregon's Charge Beverages, which makes Core, a similar product; and Boston's New Century Brewing Company, which makes Moonshot, a light lager with added caffeine. By contrast, Michigan's list (PDF) of newly forbidden "alcohol energy drinks" includes 55 product varieties made by 10 companies. Moonshot did not make the list, although a beer brewed with the caffeine-containing herb yerba maté did (to the consternation of its brewer).

The concerns expressed in the FDA's warning letters are familiar:

Reports in the scientific literature have described behavioral effects that may occur in young adults when energy drinks are consumed along with alcoholic beverages….Studies suggest that the combined ingestion of caffeine and alcohol may lead to hazardous and life-threatening situations because caffeine counteracts some, but not all, of alcohol's adverse effects….Because caffeine alters the perception of alcohol intoxication, the consumption of pre-mixed products containing added caffeine and alcohol may result in higher amounts of alcohol consumed per drinking occasion, a situation that is particularly dangerous for naive drinkers.

So why just these four companies? One criterion seems to be that they directly add caffeine to malt beverages, as opposed to using ingredients (such as coffee or yerba maté) that happen to contain caffeine (although that exception also would apply to guarana, one of the caffeine sources in Four Loko). The warning letters refer to "caffeine that has been directly added to an alcoholic beverage and packaged in combined caffeine and alcohol form." But the main factor distinguishing the companies that made the FDA's list from the ones that didn't is marketing (citations omitted):

GRAS status is not an inherent property of a substance, but must be assessed in the context of the intended conditions of use of the substance. The assessment includes a consideration of the population that will consume the substance. Therefore, the scientific data and information that support a GRAS determination must consider the conditions under which the substance is safe for the use for which it is marketed. Reports in the scientific literature have raised concerns regarding the formulation and packaging of pre-mixed products containing added caffeine and alcohol. For example, these products, presented as fruity soft drinks in colorful single-serving packages, seemingly target the young adult user. Furthermore, the marketing of the caffeinated versions of this class of alcoholic beverage appears to be specifically directed to young adults. FDA is concerned that the young adults to whom these pre-mixed caffeine and alcohol products are marketed are especially vulnerable to the adverse behavioral effects associated with consuming caffeine added to alcohol, a concern reflected in the publicly available literature.

In short, a caffeinated alcoholic beverage targeted at "young adults" is "adulterated," while exactly the same beverage targeted at middle-aged drinkers is not. The FDA is not really banning drinks; it is censoring speech.

In the April issue of Reason, Greg Beato argued that the message sent by Four Loko's marketing, as opposed to the caffeine in the can, was the real source of controversy.