FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for its use in those beverages. For its part, FTC issued warning letters to the same manufacturers contending that the marketing and sale of the beverages might constitute an unfair or deceptive act or practice in violation of the Federal Trade Commission Act (“FTC Act”). The letters describe scientific and anecdotal evidence of harm associated with the beverages, request prompt corrective action, and give the manufacturers 15 days to respond.
Because alcoholic beverages are food, the use of substances such as caffeine in those beverages is potentially subject to premarket approval under the food additive provisions of the FDC Act unless that use is generally recognized as safe (“GRAS”) or the subject of a prior sanction by the agency. As we noted in a prior blog posting, FDA questioned the regulatory status of the beverages a year ago, and asked manufacturers to provide information demonstrating that the use of caffeine in their beverages is GRAS. One beverage manufacturer submitted a comprehensive response in the form of a GRAS notice providing FDA with a summary of the basis upon which the manufacturer concluded that the use of caffeine as a flavoring ingredient in alcoholic beverages at levels of up to 200 parts per million is GRAS. The manufacturer's conclusion was based upon the consensus opinion of a panel of independent scientific experts that such use is GRAS based on scientific procedures. The safety evaluation described in the GRAS notice focuses primarily on traditional toxicological parameters (e.g., absorption, distribution, metabolism, and excretion; acute and chronic toxicity; and carcinogenicity, genotoxicity, and teratogenic effects). Described as “not related specifically to the safety-in-use of caffeine in alcoholic beverages," the scientific evidence relating to behavioral effects of caffeine and alcohol combined are also briefly discussed in the GRAS notice.
FDA’s warning letter makes clear that the agency finds the pending GRAS notice wanting. FDA faults the manufacturer (and presumably the expert panel) for relying “primarily upon safety studies of caffeine alone (i.e., not in the presence of alcohol),” and for not giving greater consideration to “studies that have reported the adverse behavioral effects elicited by the co-consumption of caffeine and alcohol.” However, neither the FDC Act nor its implementing regulations make clear that the safety evaluation of a substance added to food should include consideration of potential “adverse behavioral outcomes.” Nor is it readily apparent that, in considering whether the use of an ingredient in food is safe, one must consider the potential behavioral impact of packaging and marketing of the finished food. Yet these factors are at the crux of FDA’s conclusion that the use of caffeine in the alcoholic beverages that are intended for adults (> 21 years of age in most states) targeted by the warning letters is not GRAS:
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 (section 201(s) of the Act [21 U.S.C. § 321(s)]). The assessment includes a consideration of the population that will consume the substance (21 CFR 170.30(b); section 409(b) of the Act [21 U.S.C. § 348(b)]). 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 (Bonnie and O'Connell, 2004). FDA is concerned that the young adults to whom these pre-mixed, added 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 (O'Brien et al., 2008; Simon and Mosher, 2007).
To be sure, the potential health risks associated with caffeinated alcoholic beverages posed a thorny challenge for FDA. But in seeking to address those risks, it appears that FDA has broadened the scope of factors that must be considered in evaluating the safety of substances added to food – and thereby introduced an element of uncertainty into the conduct of those evaluations when "behavioral effects” might be at play.
As for the warning letters sent out by FTC, those make clear that the two agencies have been collaborating closely on the matter. FTC’s view that the marketing and sale of the beverages might constitute an unfair or deceptive act or practice in violation of the FTC Act is premised in part on FDA’s finding of adulteration:
The FDA’s warning that caffeine is an “unsafe food additive,” as used in Four Loko, is a relevant consideration in the FTC’s analysis of whether the marketing of caffeinated alcohol products such as Four Loko and Four Maxed is deceptive or unfair under the Federal Trade Commission Act. In the past, the FTC has accorded significant weight to FDA findings regarding product safety and efficacy.
Significant as FDA and FTC’s actions may be, they are only part of the challenge faced by manufacturers of caffeinated alcoholic beverages. A number of states are acting to prohibit the sale of those beverages, and if history is any guide, product liability actions cannot be far behind.