FDA to Look Into Safety of Caffeinated Alcoholic Beverages


FDA to Look Into Safety of Caffeinated Alcoholic Beverages

SILVER SPRING, Md., Nov. 13 /PRNewswire-USNewswire/ — The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic 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, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA’s requirements for use.

In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Click here for more information on the FDA’s Investigation of Caffeinated Alcoholic Beverages


The FDA’s Web site lists the following manufacturers and products as part of the investigation:

Charge Beverages Corporation Products: Liquid Charge, Liquid Core, High Gravity Core

United Brands Company, Inc Products: Joose, Max Vibe, Max Fury, Max Live, 3Sum

Phusion Projects LLC Products: Four, Four Loko, Four Maxed

Point Blank Beverages Co. Products: Torque

Hard Wired Brewing Company, LLC Products: Hard Wired

Mix Master Beverage Co Products: 24/7

Catalyst Beverage Company Products: Catalyst

New Century Brewing Company Products: Moonshot

Melanie Brewing Co Products: Evil Eye

Thomas Creek Brewery, LLC Products: Mobius Lager

Diageo North America, Inc Products: Smirnoff Raw Tea Malt Beverage

Constellation Brands Products: Wide Eye

The P.I.N.K. Spirits Company/Prohibition Beverage Inc Products: P.I.N.K. Vodka, P.I.N.K. Tequila, P.I.N.K. Rum, P.I.N.K. Gin, P.I.N.K. White Whiskey, P.I.N.K. Sake

Delicious Brands Inc. Products: Lotus Vodka

Sovereign Brands Products: 3AM Vodka

Moet Hennessey/Millennium Import LLC Products: Belevedere IX

Shotpak Vodka Products: Gravity Vodka

Wingard USA (Importer) Products: V2 Vodka with Caffeine, Everglo Vodka

LeVecke Corporation Products: Vicious Vodka with Caffeine

Rocktail Drinks/Liquid Manufacturing LLC Products: Slingshot Party Gel

Cold Spring Brewing Company/Atomic Brands Products: A:M Carpe Noctern

808 Spirits Co. Products: 808 Mango Beat

Gaamm Imports Inc. Products: Booya Espresso Silver Tequila with Caffeine

Ithaca Beer Co. Products: Ithaca Eleven Malt Beverage with Coffee

Gluek Brewing Company Products: Gruv Malt Beverage with Guarana

MHW, Ltd and Niche Import Company Products: Agwa De Bolivia

Rizer Spirits Inc Products: XZO Vodka with Caffeine, Taurine, and Guarana