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FDA issues warning letters to four producers of caffeinated alcoholic beverages


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FDA issues warning letters to four producers of caffeinated alcoholic beverages

2010-11-18 02:53:55 GMT+7 (ICT)

WASHINGTON D.C. (BNO NEWS) -- The U.S. Food and Drug Administration (FDA) on Wednesday issued warning letters to four companies that produce caffeinated alcoholic beverages as caffeine is an unsafe food additive.

FDA warned that if the companies continue to manufacture these beverages, which present a public health concern, further action will be taken, such as seizing their products under federal law.

The companies that received the warning letters are Charge Beverages Corp; New Century Brewing Co.; Phusion Projects (doing business as Drink Four Brewing Co.) and United Brands Company Inc. The companies manufacture the drinks Core High Gravity HG, Core High Gravity HG Orange, Lemon Lime Core Spiked, Moonshot, Four Loko, and Joose and Max.

"These products are designed, branded, and promoted to encourage binge drinking, and I commend the FDA for acting promptly to curb their sale," said White House Drug Policy Director Gil Kerlikowske. "These drinks are especially unhealthy and dangerous because they combine alcohol and caffeine – and present a further concern when used by young people."

The warnings were determined following a scientific review by the FDA which 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 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 combination of caffeine and alcohol in these products pose a public health concern."

On Tuesday, U.S. Senator Charles Schumer announced in advance that the FDA will ban caffeinated alcoholic drinks after ruling that caffeine is an unsafe food additive to alcoholic beverages.

Senator Schumer pressured for months to have the drinks banned due to serious risks to consumer health and safety. According to the Senator, the ruling will serve as a warning to any company that attempt to sell dangerous and toxic drinks to the American people, in particular children.

FDA further informed that the products mentioned in the warning letters were being marketed in violation of the Federal Food, Drug, and Cosmetic Act. The companies have to inform the agency, within 15 days, about the specific steps that will be taken to remedy such violation and prevent its recurrence.

Companies can also present a reasoning and supporting information on its products it they believe the drinks do not violate the act. If the violation persists, the FDA 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.

Also on Tuesday, Phusion Projects announced its intention to remove caffeine and other stimulants from its Four Loko drinks. The FDA said that it was a positive step but has not received an official announcement from the company.

In New York, the State Liquor Authority agreed to stop selling the dangerous drinks in the state this past week. In addition, Oklahoma, Utah, Michigan and Washington also banned the drinks as well as a number of colleges.

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-- © BNO News All rights reserved 2010-11-18

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FDA warned that if the companies continue to manufacture these beverages, which present a public health concern, further action will be taken, such as seizing their products under federal law.

Another sign of the federal government moving their goalposts and extending their power.

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