SPECIAL EDITION NEWSLETTER for November 18, 2009
In the TTB Newsletter, we compile the top TTB news of the week and other helpful information about the Bureau and the Federal alcohol and tobacco laws and regulations we enforce. Please send any questions and/or comments to Executive Liaison for Industry Matters (IndustryLiaison@ttb.gov) and/or (StateLiaison@ttb.gov).
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Caffeinated Alcohol Beverages
On November 13, 2009, the Food and Drug Administration (FDA) published a news release titled FDA to Look Into Safety of Caffeinated Alcoholic Beverages. The FDA also posted on its Web site, www.fda.gov, additional information about recent FDA activity regarding alcohol beverages to which caffeine is added, including copies of letters it sent to nearly 30 manufacturers of caffeinated alcohol beverages. The letters put these manufacturers on notice that the FDA intends to look into the safety and legality of their products. These actions followed a meeting held in August, 2009, when several State Attorneys General met in TTB headquarters with both TTB and FDA to express their view that caffeinated alcohol beverages pose health and safety hazards to consumers.
The FDA news release and the letters to producers of caffeinated alcohol beverages have generated a number of inquiries to TTB. TTB has been working with and consulting FDA on this matter for a number of years, most recently in response to the State Attorneys General inquiry.
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.
In 1987 TTB's predecessor agency, ATF, entered into a Memorandum of Understanding (MOU) with FDA that clarifies each agency's authority and responsibility with respect to alcohol beverages. This MOU is still in force today. The MOU acknowledges that TTB is the agency with a system of specific statutory and regulatory controls over alcohol beverages and that FDA has authority regarding determinations of the safety of the food additives used to make alcohol beverages and over making determinations about when an alcohol beverage is considered adulterated.
Further, the MOU outlines various procedures designed to bring about efficient communication and exchanges between the two agencies regarding adulterated alcohol beverages and ingredients that pose a public health problem. TTB consults regularly with FDA on the status of ingredients proposed to be used to make alcohol beverages to ensure that the resulting product will comply with all applicable statutes.
TTB followed the procedures set out in the MOU and consulted with FDA about the addition of caffeine to alcohol beverages during collaborations spanning many years. During that time, FDA did not raise objections to the addition of caffeine to alcohol beverages within the limitations of 200 parts per million. This is the limit set by FDA regulations for the addition of caffeine to cola products. In 2008, in response to concerns raised by the State Attorneys General and others, TTB asked FDA to clarify its position with regard to the levels, if any, at which caffeine may safely be added to alcohol beverages. We look forward to resolution of this issue.
It has been TTB's consistent position that our approval of either beverage or nonbeverage alcohol formulas does not affect an industry member's obligation to comply with the FFDCA. If new information comes to light regarding the suitability of a food additive, TTB follows the procedures in the MOU and works in coordination with FDA to ensure that alcohol beverages that pose a public health or safety problem are removed from the marketplace.
TTB will continue to evaluate alcohol formulas and labels on a case-by-case basis while FDA completes its inquiry into the addition of caffeine to alcohol beverages. We will continue to apply the standards we have used in the past unless we are notified by FDA in the future that those standards are no longer appropriate. If FDA determines that caffeine is not a suitable food additive for use in alcohol beverages TTB will coordinate with FDA following the guidelines set out in the 1987 MOU to take appropriate action.
If you have any further questions about this issue, please contact Susan Stewart Evans, Executive Liaison for Industry Matters, at industryliaison@ttb.gov or 202-453-2142.