FDA Warns Makers of Caffeinated Alcoholic Beverages

Published in CSP Daily News

Sends letters to four manufacturers calling products "unsafe"; Phusion removes caffeine

WASHINGTON -- As anticipated, the U.S. Food & Drug Administration (FDA) warned four companies yesterday that the caffeine added to their malt alcoholic beverages is an "unsafe food additive" and said that further action, including seizure of their products, is possible under federal law. Ahead of the announcement, one of the four companies, Phusion Projects LLC, maker of Four Loko, said that it intends to reformulate its products to remove caffeine, guarana and taurine, saying it has taken the necessary steps to do so and is informing its distributors of the plans.

Going [image-nocss] forward, Phusion Projects will produce only noncaffeinated versions of Four Loko, it said.

( Click here for previous CSP Daily News coverage of caffeinated alcoholic beverages.)

The companies receiving warning letters and their products were: Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange and Lemon Lime Core Spiked. New Century Brewing Co. LLC: Moonshot. Phusion Projects LLC (dba Drink Four Brewing Co.): Four Loko. United Brands Co. Inc.: Joose and Max.

Chris Hunter, Jeff Wright and Jaisen Freeman, Chicago-based Phusion Projects' three co-founders and current managing partners, said in a joint statement: "We have repeatedly contended--and still believe, as do many people throughout the country--that the combination of alcohol and caffeine is safe. If it were unsafe, popular drinks like rum and colas or Irish coffees that have been consumed safely and responsibly for years would face the same scrutiny that our products have recently faced."

"In addition, if our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas--the Tobacco Tax & Trade Bureau (TTB)--to have approved them. Yet, all of our product formulas and packaging were reviewed and approved by the TTB before being offered to consumers."

"We are taking this step after trying--unsuccessfully--to navigate a difficult and politically-charged regulatory environment at both the state and federal levels.

"Over the last several months we have been more than willing to talk with regulators and policymakers on the national, state and local levels. Our company has a history of being as cooperative as we possibly can to ensure that our products are consumed safely, responsibly and only by of-age adults.

"We hoped that clear, consistent, industry-wide standards regulating pre-packaged caffeinated alcoholic beverages would be the outcome of these conversations. We also hoped others would share our commitment to transparency and fairness."

The FDA's action follows a scientific review by the agency. It examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.

"FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is 'generally recognized as safe [GRAS],' which is the legal standard," said Dr. Joshua M. Sharfstein, principal deputy commissioner. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said 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.

The agency said the products named in the warning letters are being marketed in violation of the Federal Food, Drug & Cosmetic Act (FFDCA). Each warning letter requests that the recipient inform the FDA in writing within 15 days 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 its reasoning and any supporting information as well.

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.

The FDA's action follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

The agency said that it is aware that on November 16, Phusion Projects announced its intention to remove caffeine and other stimulants from its drinks. "FDA views this announcement as a positive step," it said in a statement. "FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects LLC and the other manufacturers to assure their products meet safety standards."

Click hereto view the FDA's caffeinated alcoholic beverages webpage, including links to the warning letters, more.