The Food and Drug Administration Wednesday warned four companies that the caffeine blended into their malt-alcohol beverages is an “unsafe food additive” and threatened to take action, including seizure of their products, to halt the sale of the drinks.

A similar warning was issued by the Federal Trade Commission, which said marketing such beverages “may constitute an unfair or deceptive practice.”  

Warning letters were sent to:

• Phusion Projects, which makes the top-selling Four Loko

• United Brands Company Inc., which makes Joose and Max

• Charge Beverages Corp., maker of Core High Gravity HG Green, Core High Gravity HG Orange, and Lemon Lime Core Spiked

• New Century Brewing Co., LLC, which makes Moonshot

The FDA and FTC  gave the companies 15 days to explain in writing what steps they’ll take to remedy their violations.

The FDA acknowledged that on Tuesday, Four Loko maker Phusion Projects said it would remove caffeine and other stimulants from its drinks.  Although the company has not said how quickly it would reformulate, the FDA described the intention “as a positive step.”

Reaction to the federal crackdown was generally positive.  “These products were designed, branded and promoted to encourage binge drinking, and I commend the FDA for acting promptly to curb their sale,” said White House Drug Policy Director Gil Kerlikowske.

But for others, the move came none too soon.  A year ago, 18 state attorneys general had urged the FDA to determine that the use of caffeine in alcoholic beverages is not “generally recognized as safe,” under federal guidelines.

“State attorneys general have long believed that these potentially lethal products were created for those too young to understand the dangers – and that caffeine as an additive was never authorized under laws to protect public health,” Washington State Attorney General Rob McKenna said Wednesday.

Washington, Michigan, Oklahoma and New York recently halted the sale of the drinks and several other states are considering bans.

“State-level product bans will continue to be necessary to get the products off of store shelves,” said Michele Simon, the Marin Institute’s research and policy director and co-author of the watchdog group’s 2007 report, “Alcohol, Energy Drinks, and Youth: A Dangerous Mix.”

Explained Simon,  “States are the primary regulators of alcoholic beverages and have full authority to ban alcoholic energy drinks whether by regulatory or legislative action, or through attorney general enforcement.”

Rep. Rosa DeLauro (D-CT), chairwoman of the FDA and Agriculture Appropriations Subcommittee, noted that caffeinated alcoholic beverages had previously received Generally Recognized as Safe (GRAS) status.


“This case highlights the problems of the GRAS process, and confirms findings by the Government Accountability Office (GAO) that FDA’s oversight of this process is inadequate. Caffeinated alcoholic beverages had been on the market for years before the FDA decision today, and these types of delays in response times is unacceptable,” DeLauro said in a prepared statement.

“It is clear that a better process is needed. I strongly urge the FDA to implement the recommendations outlined in the GAO report to better implement and enforce our product safety standards in a timely, effective manner,” she said. “It is the responsibility of the FDA to protect the American people, and I look forward to their vigilance in restricting these and other unsafe products.”

In its announcement, the FDA said that during its year-long review of the drinks, it examined the published peer-reviewed literature on mixing caffeine with alcohol; consulted experts toxicology, neuropharmacology, emergency medicine, and epidemiology; and reviewed information provided by product manufacturers.

 The agency said it also performed its own laboratory analysis.

“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, principal Deputy Commissioner, in a statement.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

At a news conference, Sharfstein said he wouldn’t characterize the FDA’s action as an outright ban.

United Brands CEO and president Michael Michail said his company would “be reviewing the details of the new guidelines, and will be aligning new FDA rules with the demands of our loyal consumer base.”

But Michael also called the FDA warning “a response to the recent series of health and safety incidents involved with consumption of a competitor’s products”–a reference to Phusion Project’s Four Loko drinks–adding that United Brands was not aware of a single incident of injury or other harm associated with its own products.

FDA said it will work with all the manufacturers to ensure their products meet safety standards.  But the agency also threatened to pursue enforcement, including seizure of the products or an injunction to halt their sale.

Beverage image is from the Food and Drug Administration.