The U.S. Food and Drug Administration yesterday issued an order for makers of drinks like Four Loko to withdraw their products from the market, calling the popular beverages “a public health concern.”
The drinks, heavily marketed to college students, contain caffeine mixed with alcohol.
Although the drinks have become so popular they have even spawned a series of music videos, critics have called the mixtures dangerous.
A number of people have been hospitalized after drinking the so-called energy drinks, and at least one death in New York has been blamed on the beverages.
The drinks contain enough caffeine and alcohol to result in people being “drunk but wide awake” and “virtual zombies,” critics have said.
In a statement issued yesterday, the FDA warned four companies that caffeine added to their malt alcoholic beverages was an “unsafe food additive.” The agency also said further action, including seizure of their products, is possible under federal law.
The companies receiving warning letters and their products are:
- 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 (doing business as Drink Four Brewing Co.): Four Loko
- United Brands Company Inc.: Joose and Max
The companies now have 15 days to respond to the FDA’s letter and explain how they will get the drinks off store shelves.
Makers of one of the most popular of the drinks, Four Loko, denied their drink is unsafe, but have agreed to remove the caffeine content.
The FDA’s action came following a scientific review by the agency.
In conducting the review, the FDA said 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.
The 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,’ 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.”
The agency also said the products named in the warning letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act.
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