During the press call on November 13, 2009 FDA provided 3 examples of alcoholic beverages to which caffeine is added, below is one of them. FDA has posted the letters associated with these products on its web site. The inclusion of these examples is not intended to suggest that these products differ in significance from the other beverages identified in the nearly 30 letters FDA has sent to manufacturers as part of its efforts on this issue.
This sample letter was issued on November 13, 2009. See list of manufacturers and additional background information.
November 13, 2009
1106 3rd St. S
La Crosse, WI 54601
Dear Company Official:
The Food and Drug Administration (FDA) is aware that your firm is marketing alcoholic beverages that contain caffeine: Hard Wired and 24/7. The addition of caffeine to these alcoholic beverages raises questions about the regulatory status of these products.
The Federal Food, Drug, and Cosmetic Act's (the Act) definition of food includes articles used for drink for man (Section 201(f)(1) of the Act [21 USC 321(f)(1)]). Therefore, your alcoholic beverages are subject to the Act's pre-market approval requirements for ingredients added to food.
An ingredient added to food is a food additive, unless it is generally recognized as safe or subject to a prior sanction, as discussed below. Food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition (Section 409(b) of the Act [21 U.S.C. 348(b)]). The agency issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be used lawfully (Section 409(c) of the Act [21 U.S.C. 409(c)]). There are no food additive regulations authorizing the use of caffeine in alcoholic beverages.
A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, in pertinent part, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use (Section 201(s) of the Act [21 U.S.C. 321(s)]). Accordingly, for a particular use of a substance to be GRAS, there must be both evidence of safety (the "technical element" of the GRAS standard) and a basis to conclude that this evidence is generally known and accepted by qualified experts. The technical element of the GRAS standard requires that the information about the substance establish that the intended use of the substance is safe, i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. In addition, the data and information to establish the technical element must be generally available, and there must be a basis to conclude that there is a consensus among qualified experts about the safety of the substance for its intended use. GRAS is based on intended use such that a substance may be GRAS for one use but not GRAS for another use (21 CFR 170.30).
Uses of substances that are not GRAS or subject to a prior sanction are subject to the food additive pre-market approval requirements of the Act. An unapproved food additive is deemed "unsafe," and any food that contains an unapproved food additive is deemed adulterated (Sections 409(a), 402(a)(2)(C) of the Act [21 U.S.C. 348(a), 342(a)(2)(C)]). Adulterated foods cannot be legally imported or marketed in the United States. Additional information about the food additive requirements, prior sanction, and the GRAS exemption may be found on FDA's website at http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm.
FDA has provided by regulation that caffeine up to a level of 0.02 percent is GRAS when used in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, this regulation does not confer GRAS status to the use of caffeine in your alcoholic beverages or at higher use levels.
FDA has not made a determination regarding the GRAS status of the use of caffeine in alcoholic beverages, but the agency is not aware of the basis upon which you have or may have concluded that your use of caffeine in an alcoholic beverage is GRAS. Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned. We request that you provide us within 30 days with your rationale, and supporting data and information, for concluding that your use of caffeine in an alcoholic beverage is GRAS or prior sanctioned. The data and information that we are requesting should be sent to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, HFS-200, 5100 Paint Branch Parkway, College Park, MD 20740.
If FDA determines that the use of caffeine in your alcoholic beverages is not GRAS or subject to a prior sanction, FDA will take appropriate action to ensure that these products are removed from the marketplace. It is your continuing responsibility to ensure that the foods you market are in compliance with all applicable legal and regulatory requirements.
Mitchell A. Cheeseman, Ph.D.
Acting Director Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William H. Foster
Assistant Administrator for Headquarters Operations
Alcohol and Tobacco Tax and Trade Bureau
See Caffeinated Alcoholic Beverages for more information.