Recent Action Against Caffeinated Alcoholic Beverage Manufacturers Highlights The Dual Jurisdiction Of FDA and TTB In Federal Labeling Issues
On November 17, 2010, the FDA issued warning letters to four companies that manufacture caffeinated alcoholic beverages. The FDA declared that the caffeine added to the companies malt alcoholic beverages is an “unsafe food additive” and therefore their products are considered adulterated under section 402(a)(2) of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 342(a)(2). A copy of the FDA press release can be read at: FDA press release on caffeinated alcoholic beverages.
As a result of this determination, the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) of the U.S. Department of the Treasury, formerly known as the ATF, announced on November 18th that the caffeinated alcoholic beverages were also mislabeled under the Federal Alcohol Administration Act (“FAAA”). These recent actions highlight the interrelated roles and dual jurisdiction of the FDA and TTB in the regulation of alcoholic beverages.
TTB is tasked with enforcing the labeling provisions of the Federal Alcohol Administration Act found at 21 U.S.C. § 205(e). However, while TTB regulates the labeling of alcoholic beverages, it is the FDAs responsibility to evaluate the safety of ingredients added to alcoholic beverages, pursuant to the FDAs authority under the FDCA. Therefore, while a manufacturer may receive a certificate of label approval (“COLA”) from the TTB for its alcoholic beverage, a COLA does not constitute a determination that the product complies with the FDCA, including a determination of whether the product is adulterated because it contains an unapproved food additive.
The dual relationship between the FDA and TTB in regards to alcoholic beverages stems from a 1987 Memorandum of Understanding entered into by both agencies that is still in effect today. Under the Memorandum of Understanding, TTB is the agency with regulatory control over alcoholic beverages but FDA has authority regarding determinations of the safety of food additives used in making alcoholic beverages. The FDA also has the power to determine whether an alcoholic beverage is adulterated. A copy of the Memorandum of Understanding is available on TTBs website at: TTB-FDA Memorandum of Understanding.
In a special edition newsletter posted November 18, 2010, TTB described the inter-agency relationship in regards to alcoholic beverages as follows:
This topic highlights the fact that FDA does have jurisdiction over certain aspects of alcohol beverages. TTB enforces the provisions of the Federal Alcohol Administration Act. Under this authority, TTB regulates the labeling and advertising of alcohol beverages to ensure that labels and advertisements provide consumers with adequate information about the identity of the product and to prevent consumer deception. TTB also enforces provisions of the Internal Revenue Code of 1986 related to the production and taxation of distilled spirits, wines, and beer. Under these authorities, TTB reviews formulations for various alcohol beverages and nonbeverage products that contain alcohol. FDA enforces the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). The definition of “food” under the FFDCA includes “articles used for food or drink” and thus also includes alcohol beverages. Under this law FDA is responsible for determining the safety of food products and additives used in the production of alcohol beverages and nonbeverage products that contain alcohol including authority over adulterated alcohol beverages.
The TTB newsletter can be read in full at: TTB November 18 Newsletter.
For more information on labeling issues under the FDCA or the FAAA, please contact us at firstname.lastname@example.org.