Q&As on Caffeine in Alcoholic Beverages

Q1. What action is FDA taking?

A1. On November 12, 2009, the Food and Drug Administration (FDA) notified nearly 30 manufacturers of certain alcoholic beverages containing added caffeine that it intends to look into the safety and legality of their products. FDA requested that each manufacturer provide its rationale, and supporting data and information, for concluding that its use of caffeine in an alcoholic beverage is GRAS or prior sanctioned.

Q2. Under what authority is FDA taking this action? What is the manufacturer's responsibility to ensure that its product is safe?

A2. Under the Federal Food, Drug, and Cosmetic Act (the Act), a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, is Generally Recognized As Safe (GRAS), or is subject to a prior sanction. A food that contains an unapproved food additive is deemed adulterated under Section 402 of the Act; adulterated foods are subject to agency enforcement actions, including seizure.

The burden is on the manufacturer to ensure that products the firm markets are safe and otherwise in compliance with applicable laws. 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 subject to a prior sanction by FDA. By law, any person can make a GRAS determination but that determination must meet the GRAS criteria for safety and general recognition.

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 are no food additive regulations that permit the addition of caffeine, at any level, in alcoholic beverages.

FDA is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS. To be GRAS, the use of caffeine in alcoholic beverages must satisfy the following two conditions: (1) caffeine is safe for use in alcoholic beverages based on publicly available scientific evidence; and (2) there is a consensus among qualified experts regarding the safety of caffeine for this use.

Q3. What happens if the industry doesn’t share its data in the next 30 days? What options are available to FDA?

A3. If FDA determines that the use of caffeine in an alcoholic beverage is not GRAS or subject to a prior sanction, FDA has a range of regulatory options available to it, from the issuance of a warning letter to seizure. It is the manufacturer’s continuing responsibility to ensure that the foods they market are in compliance with all applicable legal and regulatory requirements. FDA intends to exercise all options that are appropriate for the product in question.

Q4. Has FDA ever asked manufacturers to present their data to support that a use is GRAS or prior sanctioned?

A4. FDA informally asks manufacturers to support their determination that a substance is GRAS for its intended use. A less frequent occurrence is where FDA formally asks for support about a GRAS determination. An example of a formal request would be a warning letter dated June 4, 2001, wherein we asked the manufacturer to provide its data to support its determination that Echinacea was GRAS or prior sanctioned for use in conventional foods.

Q5: Is it okay to continue drinking these products?

A5. Irrespective of how these products are marketed, it is important to remember that these are alcoholic beverages and consumers should heed the Surgeon General’s warning on these products and drink them responsibly. Should FDA determine these products are not lawful, the agency will take appropriate action to protect the public heath.

Q6. Will other caffeine-related products be next?

A6. At this time, the FDA is focusing its attention on products in which caffeine has been intentionally added to alcoholic beverages by the manufacturers. Other products containing added caffeine may be subject to agency review if the available scientific data and information indicate that added caffeine may pose a safety concern, or is being unlawfully used, under the conditions of its use in other products. The manufacturer’s continuing responsibility includes marketing products with ingredients that are safe for their intended use, and are otherwise in compliance with the law.

Q7. Does FDA even have authority over alcohol products? Isn’t that TTB?

A7. The Alcohol and Tobacco Tax and Trade Bureau (TTB) of the U.S. Department of Treasury enforces the provisions of the Federal Alcohol Administration Act. Under this authority, TTB regulates the labeling and advertising of alcoholic beverages, among other things. TTB also enforces provisions of the Internal Revenue Code of 1986 related to Distilled Spirits, Wines, and Beer. 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 includes alcoholic beverages. See 21 U.S.C. 321(f) and 21 CFR Part 170.3 (n)(2). As such, alcoholic beverages are subject to the FFDCA adulteration and misbranding provisions, and implementing regulations, related to food. Among other things, a food is adulterated under section 402 of the FFDCA if it was produced, packed, or held under insanitary conditions; if it contains any poisonous or deleterious substance which may render the food injurious to health; or if it contains an unapproved food additive. FDA has authority to initiate seizure of adulterated foods, including alcoholic beverages, and to seek to enjoin the introduction of such products into interstate commerce (see MOU 225-88-2000 – http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm).

Q8. Why didn’t FDA ask Anheuser-Busch and MillerCoors for similar information when they had caffeinated alcoholic beverages on the market?

A8. In the past year, Anheuser-Busch and MillerCoors reformulated their popular drinks, Tilt, Bud Extra, and Sparks, removing the added caffeine and agreed not to produce any caffeinated alcoholic beverages in the future.

Q9. What type of evidence is required for GRAS status? Will FDA consider evidence beyond what the manufacturer provides?

A9. 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)). And, as noted, the safety must be generally recognized; that is, the evidence supporting safe use is generally known, and accepted, by qualified experts. Additionally, GRAS status may be achieved based on history of use.

Yes, FDA will consider all of the data and information available to the agency related to the specific use of the food ingredient.

Q10. What about coffee-based liqueurs?

A10. This FDA action is not directed at products that are flavored with coffee. The beverages that are the subject of FDA’s request for information are characterized by the intentional addition of caffeine to alcoholic beverages by the manufacturer.

Q11. What's the difference between a drink that combines alcohol and cola and a beverage that contains alcohol and caffeine?

A11. Cola is a carbonated beverage made up of many ingredients, including caffeine. The addition of caffeine to cola-type beverages up to certain levels is GRAS. Consumers may themselves choose to add cola to alcoholic beverages according to their preferences. The beverages that are the subject of FDA’s request for information are characterized by the intentional addition of caffeine to alcoholic beverages by the manufacturer.

Q12. How was the group of manufacturers and products selected and if you identify others will they get the same letter?

A12. The list of manufacturers was provided to FDA in a letter from the co-chairs of the National Association of Attorneys General Youth Access to Alcohol Committee. At this point, FDA has no information regarding any additional products, other than the original list.

Q13. What will you do if you hear nothing after 30 days?

A13. If FDA determines that the use of caffeine in an alcoholic beverage is not GRAS or subject to a prior sanction, FDA has a range of regulatory options available to it, ranging from the issuance of a warning letter to seizure. It is the manufacturer’s continuing responsibility to ensure that the foods they market are in compliance with all applicable legal and regulatory requirements. FDA intends to exercise all options that are appropriate for the product in question.

Q14. What's the general timeframe you are thinking for evaluating the manufacturer’s information that the addition of caffeine in an alcoholic beverage is GRAS or prior sanctioned?

A14. The FDA intends to evaluate the information submitted by the manufacturers and other available scientific evidence as soon as possible in order to determine whether caffeine can be safely and lawfully added to alcoholic beverages. The timeframe is difficult to predict and it will depend on the amount and quality of data and information that the FDA receives from manufacturers and that are otherwise available to the agency and upon the complexity of scientific issues that may be encountered in the course of its review. The FDA’s decision regarding the regulatory status of caffeine added to various alcoholic beverages will be a high priority for the agency; however, a decision regarding the use of caffeine in alcoholic beverages could take some time.

Q15. What will happen after you make that determination?

A15. This will depend on the outcome of FDA’s review of the available data and information pertinent to this use of caffeine. For example, if the FDA determines that such use of caffeine is unsafe based on the totality of the evidence, it could move swiftly to remove these products from the market as has been suggested by the Attorneys General. Alternatively, the agency might conclude that such use meets the GRAS standard and take no further action.

From FDA