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FDA Tells Nearly 30 Makers of Caffeinated Alcoholic Drinks to Provide Safety Evidence

Nov. 13, 2009 -- The FDA today told nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

The FDA is giving those companies 30 days to provide evidence that caffeine can safely be added to alcoholic drinks.

The FDA has not approved the use of caffeine in alcoholic beverages. Those drinks can be legally marketed if the addition of caffeine is considered to be "generally recognized as safe," which requires the sort of evidence that the FDA is requesting.

The FDA notes that in the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages -- Tilt, Bud Extra, and Sparks -- and agreed not to produce any caffeinated alcoholic beverages in the future.

In late September, the FDA received a letter from 18 state attorneys general and one city attorney expressing concerns about caffeinated alcoholic beverages.

"The concern they're expressing is that caffeine stimulates people to drink more," Joshua Scharfstein, MD, the FDA's principal deputy commissioner, said in a news conference.

"Another sentence that's in their letter is that 'Being wide awake and drunk at the same time increases the risk of engaging in several forms of violent or other high-risk physical behaviors that can cause injury.' That's not FDA saying that; that's the nature of the concern that we've heard and that's why we are interested in understanding more," Scharfstein said.

The FDA also released a questions-and-answers statement about caffeinated alcoholic beverages that urges people to remember that, "irrespective of how these products are marketed, it is important to remember that these are alcoholic beverages and consumers should heed the Surgeon General's warning on these products and drink them responsibly. Should the FDA determine these products are not lawful, the agency will take appropriate action to protect the public health."

Today's FDA action only applies to alcoholic drinks in which the manufacturer has intentionally added caffeine. It doesn't apply to nonalcoholic caffeinated beverages.

But the FDA notes that it may review other products containing added caffeine if it finds a safety or legal issue when used with other products.

Here is the full list of companies that got today's FDA letter:

  • Charge Beverages Corporation (products: Liquid Charge, Liquid Core, High Gravity Core)
  • United Brands Company, Inc. (products: Joose, Max Vibe, Max Fury, Max Live, 3Sum)
  • Phusion Projects LLC (products: Four, Four Loko, Four Maxed)
  • Point Blank Beverages Co. (product: Torque)
  • Hard Wired Brewing Company, LLC (product: Hard Wired)
  • Mix Master Beverage Co. (product: 24/7)
  • Catalyst Beverage Company (product: Catalyst)
  • New Century Brewing Company (product: Moonshot)
  • Melanie Brewing Co. (product: Evil Eye)
  • Thomas Creek Brewery, LLC (product: Mobius Lager)
  • Diageo North America, Inc. (product: Smirnoff Raw Tea Malt Beverage)
  • Constellation Brands (product: Wide Eye)
  • The P.I.N.K. Spirits Company/Prohibition Beverage Inc. (products: P.I.N.K. Vodka, P.I.N.K. Tequila, P.I.N.K. Rum, P.I.N.K. Gin, P.I.N.K. White Whiskey, P.I.N.K. Sake)
  • Delicious Brands Inc.(product: Lotus Vodka)
  • Sovereign Brands (product: 3AM Vodka)
  • Moet Hennessey/Millennium Import LLC (product: Belevedere IX)
  • Shotpak Vodka (product: Gravity Vodka)
  • Wingard USA (Importer) (products: V2 Vodka with Caffeine, Everglo Vodka)
  • LeVecke Corporation (product: Vicious Vodka with Caffeine)
  • Rocktail Drinks/Liquid Manufacturing LLC (product: Slingshot Party Gel)
  • Cold Spring Brewing Company/Atomic Brands (product: A:M Carpe Noctern)
  • 808 Spirits Co. (product: 808 Mango Beat)
  • Gaamm Imports Inc.(product: Booya Espresso Silver Tequila with Caffeine)
  • Ithaca Beer Co. (product: Ithaca Eleven Malt Beverage with Coffee)
  • Gluek Brewing Company (product: Gruv Malt Beverage with Guarana)
  • MHW, Ltd and Niche Import Company (product: Agwa De Bolivia)
  • Rizer Spirits Inc. (products: XZO Vodka with Caffeine, Taurine, and Guarana

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