The FDA (Food and Drug Administration) has told four drinks companies that adding caffeine to malt alcoholic drinks is an “unsafe food additive”. The FDA Warning Letters added that federal law allows for further action, including confiscation of malt alcoholic beverages with caffeine added. These drinks are a public health concern, the FDA wrote in a communiqué.

The FDA says it looked at studies and peer-reviewed documents about the consumption of alcohol mixed with caffeine, as well as talking to toxicologists, neuropharmacologists, emergency room doctors and epidemiologists. It also examined data provided by drinks makers. Laboratory analyses of alcoholic drinks with caffeine added were also carried out independently by the FDA.

The warning letter was sent to:

  • Charge Beverages Corp., who make Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
  • New Century Brewing Co., who make LLC: Moonshot
  • Phusion Projects, LLC (doing business as Drink Four Brewing Co.), who make Four Loko
  • United Brands Company Inc., who make Joose and Max

Dr. Joshua M. Sharfstein, Principal Deputy Commissioner, said:

    “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. To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Caffeine in alcoholic drinks can mask the effects of alcohol, making drinkers less able to gauge how drunk there are. Reputable studies have indicated that such drinks are linked to a higher likelihood of risky behaviors, which may be dangerous and can even lead to life-threatening events.

The drinks mentioned in the FDA Warning Letters are being sold in violation of the FFDCA (Federal Food, Drug, and Cosmetic Act), the FDA informs.

The four companies that received the Warning Letters have been asked to write back to the FDA within 15 days, explaining what steps they will take to address the violation and make sure it does not happen again.

Any drink maker which thinks its marketing of malted alcoholic drinks with caffeine added do not violate the FFDCA should explain why, with data to back their claim.

The FDA warns that companies which continue selling such products in violation of the Act may face enforcement action, which could include confiscation of the products, or even a court order to stop the company from continuing production until the violation has been remedied.

The FDA added that today’s warning letters follow a November 2009 request to drinks makers to provide safety data on caffeine added to their products.

Phusion Projects’ recent announcement that it will remove caffeine and other stimulants from its beverages is a positive step, the FDA wrote. Phusion Projects makes Four Loko. The FDA would like to know when this will happen.

The FDA concluded that it intends to work with the drinks makers to make sure their products meet safety standards.

In an online communiqué, Phusion Projects announced that it intends to reformulate its drinks to remove caffeine, taurine and guarana across the country. The company added that it will manufacture Four Loko without caffeine.

Chris Hunter, Jeff Wright and Jaisen Freeman, co-founders of the company 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.

    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.

Source: FDA, Phusion Projects.

Written by Christian Nordqvist