November 17, 2010
FDA issued warning letters to four makers of caffeinated alcoholic malt beverages. See questions and answers below.
What action is FDA taking?
FDA is issuing Warning Letters to four manufacturers of caffeinated alcoholic beverages. All of these products are alcoholic malt beverages to which caffeine has been directly added as an ingredient. The manufacturers and their products are:
FDA is issuing the Warning Letters because the Agency’s position is that the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA).
The agency has not approved the use of caffeine in alcoholic beverages at any level, and based on the information FDA has reviewed, the agency does not consider the use of caffeine in the beverages listed above to be generally recognized as safe (GRAS). The Warning Letters should not be interpreted to mean that FDA considers other alcoholic beverages to which caffeine has been directly added to be in compliance with the law.
- Charge Beverages Corporation, which makes “Core High Gravity HG Green,” “Core High Gravity HG Orange,” and “Lemon Lime Core Spiked;”
- New Century Brewing Company, LLC, which makes “Moonshot;”
- Phusion Projects, LLC (doing business as Drink Four Brewing Company), which makes “Four Loko;” and
- United Brands, which makes “Joose” and “Max.”
What are the next steps?
Each Warning Letter lists the violation that FDA has identified and requests that the recipient respond in writing within 15 days and inform FDA of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present that reasoning and any supporting information as well.
If the violation continues to exist, FDA may pursue an enforcement action, including seizure of the violative product or an injunction to prevent the firm from continuing to produce the product until the violations have been corrected.
Under what authority is FDA issuing these Warning Letters?
FDA is issuing the four Warning Letters under its authority to implement the Federal Food, Drug, and Cosmetic Act (the FFDCA). Under the FFDCA, a substance added to food (such as caffeine added to an alcoholic beverage) is deemed an "unsafe food additive" and is unlawful unless its particular use has been approved by FDA, is the subject of a prior sanction, or is generally recognized as safe (GRAS). A food that contains an unsafe food additive is deemed adulterated under Section 402(a)(2) of the FFDCA [21 U.S.C. 342(a)(2)]; adulterated foods are subject to agency enforcement actions, including seizure.
The FDA has only listed caffeine as GRAS as an ingredient for use in cola-type beverages in concentrations of no greater than 200 parts per million. There is no food additive regulation that permits the addition of caffeine, at any level, to an alcoholic beverage. Based on the information FDA has reviewed, the agency does not consider the use of caffeine in the products listed above to be GRAS.
What is a manufacturer's responsibility for ensuring that its products are safe?
A manufacturer is responsible for ensuring that the products it markets are safe and otherwise in compliance with applicable laws.
Regarding caffeinated alcoholic beverages, FDA has not issued a food additive regulation to approve the use of caffeine in alcoholic beverages, and FDA is not aware of a basis to conclude that this use of caffeine is GRAS or is the subject of a prior sanction. By law any person may make a GRAS determination, but that determination must satisfy the legal criteria for general recognition of safety.
Why is FDA concerned that caffeine directly added to alcoholic beverages may not be safe?
Based on its review of the published scientific literature, FDA believes that there are insufficient publicly available data and information relating to the safety of alcoholic beverages with added caffeine to form the basis of a consensus among qualified experts that the beverages at issue in these Warning Letters are safe. FDA is concerned about the safety of alcoholic beverages with added caffeine because published peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations. Caffeine appears to mask some of the sensory cues an individual might normally rely on to determine his/her level of intoxication. The scientific literature suggests that individuals drinking such beverages may consume more alcohol per drinking occasion, a situation that is particularly dangerous for naïve drinkers.
The Centers for Disease Control and Prevention has released a fact sheet on caffeinated alcoholic beverages. It is online at http://www.cdc.gov/alcohol/fact-sheets/cab.htm
Will FDA take action against other products containing added caffeine?
At this time, the FDA is sending Warning Letters to four manufacturers of alcoholic malt beverages to which caffeine has been directly added as an ingredient. Other alcoholic beverages containing added caffeine may be subject to agency action in the future if the available scientific data and information indicate that the use of caffeine in those products is not GRAS. A manufacturer is responsible for ensuring that its products, including the ingredients of its products, are safe for their intended use and are otherwise in compliance with the law.
Does this action apply to coffee-based liqueurs?
No. These Warning Letters are not directed at alcoholic beverages that only contain caffeine as a natural constituent of one or more of their ingredients, such as a coffee flavoring. The alcoholic beverages that are the subject of FDA's Warning Letters are malt beverages to which the manufacturer has directly added caffeine as a separate ingredient.
What happened when Anheuser-Busch and MillerCoors marketed caffeinated alcoholic beverages in 2008?
Anheuser-Busch and MillerCoors reformulated their products ("Tilt," "Bud Extra," and "Sparks") by removing the added caffeine and agreed not to produce any caffeinated alcoholic beverages in the future.
What type of evidence is required for GRAS status?
For a substance to be considered GRAS, there must be both technical evidence of safety 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. This determination of safety includes, among other things, a consideration of the probable consumption of the ingredient, the cumulative effect of the ingredient in the diet, and other safety factors, which are generally recognized as appropriate by qualified experts (see 21 CFR 170.3 (i)(1), (2), (3)). Furthermore, as noted, the safety must be generally recognized; that is, the evidence supporting safe use must be generally known and accepted by qualified experts. In general, the evidence used to demonstrate that the use of a substance is GRAS must be the result of scientific procedures; however, for substances that were used in food before January 1, 1958, experience based on common use in food can also be used to establish safety. In either situation, the evidence needs to be generally known and accepted by qualified experts as demonstrating the safety of the intended use of the substance.
For More Information
Serious Concerns Over Alcoholic Beverages with Added Caffeine
Consumer Update, 11/17/2010
Caffeinated Alcoholic Beverages