FDA Declares CABs Unsafe

FILED NOVEMBER 17, 2010

Beer Business Daily

November 17, 2010

FDA Declares CABs Unsafe


Dear Client:

It's official. The FDA has declared caffeinated alcohol unsafe. According to a statement on their website, the FDA today warned Charge Beverages Corp (producers of Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked), New Century Brewing (Moonshot), Phusion Projects (Four Loko) and United Brands Co (Joose and Max) that "the caffeine added to their malt alcoholic beverages is an 'unsafe food additive' and said that further action, including seizure of their products, is possible under federal law." No mention of caffeinated spirits was made.

Following a scientific review conducted by the agency, they did 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 FDA said the products named in the warning letters "are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA)." Each letter requests that the recipient inform the FDA in writing within 15 days of the specific steps they are taking "to remedy the violation and prevent its recurrence." These companies also have the option to present reasoning and supporting information if they do not believe their products are in violation of the FFDCA.

And if the FDA believes the violation continues to exist, they "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 until the violation has been corrected."

Recall Phusion Projects announced yesterday they have taken the necessary steps to reformulate their products to remove caffeine, guarana and taurine nationwide. "Going forward, Phusion will produce only non-caffeinated versions of Four Loko," they said.

The FDA commended Phusion, saying they view this "announcement as a positive step," but have "not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product." And finally, "FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards."

WHAT'S NEXT? Now it's expected that the FTC will send a letter to manufacturers, notifying them "that they are engaged in the potential illegal marketing of unsafe alcoholic drinks," according to New York Senator Charles Schumer announcement yesterday. So we wait.

Meanwhile, lots of people of legal drinking age are saying on Facebook that they are going to load up on Four Loko before it leaves shelves. We will see how the other manufacturers respond.


Until tomorrow, Harry

"Always be honest and sincere. If you can fake that, you got it made."
-Woody Allen

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