San Francisco City Attorney Dennis Herrera is stepping up his campaign to stop alcoholic drink makers from adding in caffeine and some of those other chemicals that help you party the night away. So the FDA is taking action right now.
Remember getting loaded and showing off your orange tongue in the minivan? Those days are gone:
Sisters doing it for themselves. Click for full-on girl power, courtesy of rOOkrOc
Remember the “Sparks Girls” and the “Sparkitects” with their cans that were designed to look like batteries complete with anode plus signs? They’re gone too:
These are the drinks that might need to get reformulated soon:
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.
Hard Wired Brewing Company, LLC
Products: Hard Wired
Mix Master Beverage Co
Catalyst Beverage Company
New Century Brewing Company
Melanie Brewing Co
Products: Evil Eye
Thomas Creek Brewery, LLC
Products: Mobius Lager
Diageo North America, Inc
Products: Smirnoff Raw Tea Malt Beverage
Products: 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.
Products: Lotus Vodka
Products: 3AM Vodka
Moet Hennessey/Millennium Import LLC
Products: Belvedere IX
Products: Gravity Vodka
Wingard USA (Importer)
Products: V2 Vodka with Caffeine, Everglo Vodka
Products: Vicious Vodka with Caffeine
Rocktail Drinks/Liquid Manufacturing LLC
Products: Slingshot Party Gel
Cold Spring Brewing Company/Atomic Brands
Products: A:M Carpe Noctern
808 Spirits Co.
Products: 808 Mango Beat
Gaamm Imports Inc.
Products: Booya Espresso Silver Tequila with Caffeine
Ithaca Beer Co.
Products: Ithaca Eleven Malt Beverage with Coffee
Gluek Brewing Company
Products: Gruv Malt Beverage with Guarana
MHW, Ltd and Niche Import Company
Products: Agwa De Bolivia
Rizer Spirits Inc
Products: XZO Vodka with Caffeine, Taurine, and Guarana
Read all about it, after the jump:
Herrera, AGs Persuade FDA to Investigate Alcoholic Energy Drinks
Manufacturers have 30 days to prove the caffeine in their products is ‘Generally Recognized As Safe’ or prior sanctioned
SAN FRANCISCO (Nov. 13, 2009)— City Attorney Dennis Herrera today joined 18 state attorneys general in applauding the Food and Drug Administration’s recognition of the potential harm to the public from alcoholic energy drinks (AEDs) and its decision to request manufacturers of these products provide the agency with support for the claim that the use of caffeine and other stimulants in alcoholic beverages is Generally Recognized As Safe (GRAS) under FDA regulations.
On Sept. 25, Herrera and the attorneys general sent a letter to the FDA urging the federal agency to examine the health and safety hazards posed by AEDs. In a supporting letter submitted by Herrera and the Attorneys general to the FDA, scientists and medical professionals who conducted research in this area concluded that the use of caffeine and other stimulants as additives to alcoholic beverages pose serious public health and safety risks and that there is no evidence to support the claim that caffeine is GRAS for use in alcoholic beverages. The researchers point to recent studies that confirm caffeine appears to mask, but not reduce the intoxicating effects of alcohol. This may lead to increased risk-taking and other serious alcohol-related problems such as driving under the influence, violence, sexual assault, and suicide.
In response to the FDA’s announcement today, City Attorney Herrera issued the following statement:
“I am gratified to see the FDA is making this issue a priority. Beverages that combine caffeine and alcohol create ‘wide-awake drunks’ who pose a great danger to themselves and others. We hope the companies that produce these drinks and target youth with their products will take the responsible step and remove these dangerous products from the marketplace immediately.”
City Attorney Herrera has a long-standing concern regarding alcoholic energy drinks. Last year, Chicago-based brewing company MillerCoors stopped producing all caffeinated alcoholic beverages, including its flagship product “Sparks,” following an agreement reached by the City Attorney and 13 state attorneys general. Alcoholic energy drinks are pre-mixed sweetened beverages that combine alcohol with high levels of caffeine (and, often, guarana, taurine, ginseng and other ingredients associated with non-alcoholic energy drinks).
For more information regarding today’s FDA announcement, please visit:
And here’s the letter the beverage makers are now getting from the Feds:
Caffeinated Alcoholic Beverages Sample Letter # 2
Gaamm Imports, Inc.
10 Fairway Drive, Suite 122
Deerfield Beach, FL 33441
Dear Company Official:
The Food and Drug Administration (FDA) is aware that your firm is marketing an alcoholic beverage that contains caffeine: Booya Espresso Silver Tequila with Caffeine. The addition of caffeine to this alcoholic beverage raises questions about the regulatory status of this product.
The Federal Food, Drug, and Cosmetic Act’s (the Act) definition of food includes articles used for drink for man (Section 201(f)(1) of the Act [21 USC 321(f)(1)]). Therefore, your alcoholic beverages are subject to the Act’s pre-market approval requirements for ingredients added to food.
An ingredient added to food is a food additive, unless it is generally recognized as safe or subject to a prior sanction, as discussed below. Food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition (Section 409(b) of the Act [21 U.S.C. 348(b)]). The agency issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be used lawfully (Section 409(c) of the Act [21 U.S.C. 409(c)]). There are no food additive regulations authorizing the use of caffeine in alcoholic beverages.
A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, in pertinent part, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use (Section 201(s) of the Act [21 U.S.C. 321(s)]). Accordingly, for a particular use of a substance to be GRAS, there must be both evidence of safety (the “technical element” of the GRAS standard) and a basis to conclude that this evidence is generally known and accepted by qualified experts. The technical element of the GRAS standard requires that the information about the substance establish that the intended use of the substance is safe, i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. In addition, the data and information to establish the technical element must be generally available, and there must be a basis to conclude that there is a consensus among qualified experts about the safety of the substance for its intended use. GRAS is based on intended use such that a substance may be GRAS for one use but not GRAS for another use (21 CFR 170.30).
Uses of substances that are not GRAS or subject to a prior sanction are subject to the food additive pre-market approval requirements of the Act. An unapproved food additive is deemed “unsafe,” and any food that contains an unapproved food additive is deemed adulterated (Sections 409(a), 402(a)(2)(C) of the Act [21 U.S.C. 348(a), 342(a)(2)(C)]). Adulterated foods cannot be legally imported or marketed in the United States. Additional information about the food additive requirements, prior sanction, and the GRAS exemption may be found on FDA’s website at http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm.
FDA has provided by regulation that caffeine up to a level of 0.02 percent is GRAS when used in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, this regulation does not confer GRAS status to the use of caffeine in your alcoholic beverages or at higher use levels.
FDA has not made a determination regarding the GRAS status of the use of caffeine in alcoholic beverages, but the agency is not aware of the basis upon which you have or may have concluded that your use of caffeine in an alcoholic beverage is GRAS. Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned. We request that you provide us within 30 days with your rationale, and supporting data and information, for concluding that your use of caffeine in an alcoholic beverage is GRAS or prior sanctioned. The data and information that we are requesting should be sent to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, HFS-200, 5100 Paint Branch Parkway, College Park, MD 20740.
If FDA determines that the use of caffeine in your alcoholic beverage is not GRAS or subject to a prior sanction, FDA will take appropriate action to ensure that this product is removed from the marketplace. It is your continuing responsibility to ensure that the foods you market are in compliance with all applicable legal and regulatory requirements.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William H. Foster
Assistant Administrator for Headquarters Operations
Alcohol and Tobacco Tax and Trade Bureau
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