WASHINGTON — The Food and Drug Administration announced Wednesday it has sent warning letters to four companies that manufacture drinks containing caffeine and alcohol, stating the beverages do not meet the FDA's standard of safety.
The companies — Phusion Projects, United Brands Co., Charge Beverages Corp. and New Century Brewing Co. — have 15 days to inform the FDA of their plans to bring their products in line with the agency's guidelines, or face further legal action.
"The manufacturers have failed to demonstrate that the addition of caffeine to their beverages is generally recognized as safe, and as a result caffeine is an illegal food additive in these products," said Joshua Sharfstein, principal deputy commissioner with the FDA, during a conference call Wednesday afternoon.
The announcement comes at the end of a yearlong investigation into the drinks and the effect they have on users. Four Loko, the category's top-selling brand, contains 12% alcohol content and as much caffeine as a cup of coffee, and has been linked to several deaths in recent months, prompting a firestorm of public and media attention leading up to today's announcement.
Phusion Projects, the company that manufactures Four Loko, announced yesterday that it plans to remove caffeine and other stimulants from its beverages. It maintains, however, that the product is safe.
The FDA's review, on the other hand, concluded that the combination of alcohol and caffeine is dangerous because it makes drinkers feel less intoxicated than they actually are. This disconnect makes people more likely to engage in drunk driving, unsafe sexual activity and other dangerous behaviors, according to the panel convened by the FDA.
The FDA stated that it chose the four companies because they explicitly advertise the addition of caffeine to their products, and because they are widely available. It encouraged manufacturers of similar products to re-evaluate their operations, as well. In addition, the panel said it was concerned that these alcoholic energy drinks are being marketed to underage drinkers, with advertisements appearing in many youth media outlets.