Phusion Projects to Produce Only Non-Caffeinated Version of Four Loko; F.D.A. Issues Warning Letters

CHICAGO -- On the heels of the Food and Drug Administration making a decision about the safety of consumption of alcoholic energy drinks, Phusion Projects, makers of the Four Loko beverage which has come under fire over the past several months, released a statement on its Web site, Nov. 16.

Moving forward Phusion will produce only non-caffeinated versions of Four Loko, the company stated.

In the statement, Chris Hunter, Jeff Wright and Jaisen Freeman, Phusion's three co-founders and current managing partners said: "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 and 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."

The reformulation of its products will remove caffeine, guarana and taurine from the Four Loko product line, the company stated, also adding that Phusion is informing its employees and distributors of the plans.

The co-founders also added: "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.

By taking this action today, we are again demonstrating leadership, cooperation and responsible corporate citizenship."

Phusion stated it has a history of making concessions, pointing out that it added multiple additional label warnings to its cans; alcohol-by-volume warnings are in a font as large is allowed by law; and, where required, reduced alcohol content product versions are available for sale. Phusion has also worked with distributors on appropriate ways to stock and market its product, providing point-of-sale information and the importance of asking for ID and "includes warnings and labels on its cans that go above and beyond what the federal government requires."

On Wednesday, CNN.com reported that the F.D.A. alerted the manufacturers of seven caffeinated alcoholic beverages that their drinks are "a public health concern" and that it will not allow the beverages to stay on the market in their current form. The companies have 15 days to reformulate their products of face possible seizure under federal law, CNN.com stated.

"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," Dr. Joshua Sharfstein, the agency's principal deputy commissioner told reporters. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."

While Phusion Projects was among the seven companies issued the warning, the six other companies include: San Diego, California-based United Brands, which manufactures the Joose and Max brands; Portland, Oregon's Charge Beverages Corp., which sells Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked; and New Century Brewing of Boston, Massachusetts, which makes Moonshot, CNN.com reported.

"As we stated yesterday [November 16] we have stopped the production and shipment of all our products containing these ingredients," Phusion Projects said in a released statement after the F.D.A. decision was handed down. "We will continue to work closely and cooperatively with national and state regulators."