United States Food and Drug Administration signals ...

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T he United States government has dealt what could be a death blow to caffeinated alcoholic energy drinks that federal officials said can leave people “wide-awake drunk” and more prone to risky behaviour. The premixed caffeine-alcohol com- binations — especially popular with college students and other young peo- ple — should soon be gone from US store shelves in response to warning letters that the US Food and Drug Administration sent to four manufac- turers on Nov. 17, 2010, advising them that the drinks were unsafe and could be subject to seizure (www.fda.gov /Food/FoodIngredientsPackaging/ucm 190366.htm). The FDA said the drinks, which include the popular Four Loko and Joose brands, can mask cues that tell people how drunk they are, and can result in alcohol poisoning, sexual assaults and car accidents. Although the FDA action was not an outright ban, two of the companies that received warning letters said they expected to have all their drinks off store shelves by Dec. 13, 2010, and the other two said they were no longer producing the products. Other manufacturers were expected to quickly follow suit. “It’s definitely the death knell for caffeine in these drinks,” says Michele Simon, research and policy director at the Marin Institute, a private alcohol industry watchdog group. “There’s no question that the FDA has spoken loudly and clearly that caffeine is not a safe additive in alcohol.” While that may not stop young peo- ple from mixing their own caffeine- alcohol concoctions, Simon says, “this is at least one way to make it less easy” for young people to get themselves in trouble with alcohol. The amped-up combination drinks aren’t available in Canada, although retailers often package caffeinated and alcoholic beverages together. Gary Holub, a spokesman for Health Canada, says the Canadian gov- ernment sets tight controls on adding caffeine to food and drinks, and that only natural sources of caffeine are allowed in alcoholic beverages. Pre- mixed alcoholic energy drinks are not approved for sale in Canada (www.hc -sc.gc.ca/ahc-asc/media/ftr-ati/_2010 /2010_83-eng.php). Provincial liquor control boards can even more tightly regulate caffeine in alcoholic drinks. For example, the Liquor Control Board of Ontario allows no more than 30 milligrams of natu- rally occurring caffeine per serving in drinks, says spokesman Chris Layton. With the FDA action imminent, Chicago-based Phusion Projects, which makes Four Loko, announced plans in November 2010 to reformulate the drink and market a noncaffeinated version. The company maintained that Four Loko was safe, but said it was acting “after try- ing — unsuccessfully — to navigate a difficult and politically-charged regula- tory environment at both the state and federal levels” (www.phusionprojects .com/media_reformulation.html). With their large, colourful cans, low cost, fruity flavors and high alcohol content, the caffeine-alcohol drinks have drawn criticism for their appeal to young people. Four Loko, for example, was marketed in 23.5-ounce cans with 12% alcohol by volume, more than twice the concentration of alcohol in regular beer. A single can could contain as much alcohol as four standard 12- ounce beer cans. When caffeine is added to the mix, the drinks “can mask a consumer’s sense of intoxication,” said the US Fed- eral Trade Commission’s Bruce Vladek. “As a result, consumers and particularly young, inexperienced drinkers, may not realize just how impaired they are.” The Federal Trade Commission, acting in concert with the FDA, sent letters to the same four companies warning that their marketing and sale of the drinks could constitute unfair or deceptive advertising (http://ftc.gov /opa/2010/11/alcohol.shtm). News CMAJ United States Food and Drug Administration signals crackdown on caffeinated alcohol drinks © 2011 Canadian Medical Association or its licensors CMAJ, January 11, 2011, 183(1) E47 Several brands of caffeine-alcohol drinks have drawn criticism for masking a consumer's sense of inebriation. © 2011 Jupiterimages Corp.

Transcript of United States Food and Drug Administration signals ...

The United States governmenthas dealt what could be a deathblow to caffeinated alcoholic

energy drinks that federal officials saidcan leave people “wide-awake drunk”and more prone to risky behaviour.The premixed caffeine-alcohol com-

binations — especially popular withcollege students and other young peo-ple — should soon be gone from USstore shelves in response to warningletters that the US Food and DrugAdministration sent to four manufac-turers on Nov. 17, 2010, advising themthat the drinks were unsafe and couldbe subject to seizure (www.fda.gov/Food /FoodIngredients Packaging /ucm190366.htm).The FDA said the drinks, which

include the popular Four Loko and Joosebrands, can mask cues that tell peoplehow drunk they are, and can result inalcohol poisoning, sexual assaults andcar accidents. Although the FDA action was not an

outright ban, two of the companies thatreceived warning letters said theyexpected to have all their drinks off storeshelves by Dec. 13, 2010, and the othertwo said they were no longer producingthe products. Other manufacturers wereexpected to quickly follow suit.“It’s definitely the death knell for

caffeine in these drinks,” says MicheleSimon, research and policy director atthe Marin Institute, a private alcoholindustry watchdog group. “There’s noquestion that the FDA has spokenloudly and clearly that caffeine is not asafe additive in alcohol.”While that may not stop young peo-

ple from mixing their own caffeine-alcohol concoctions, Simon says, “thisis at least one way to make it less easy”for young people to get themselves introuble with alcohol. The amped-up combination drinks

aren’t available in Canada, althoughretailers often package caffeinated andalcoholic beverages together.

Gary Holub, a spokesman forHealth Canada, says the Canadian gov-ernment sets tight controls on addingcaffeine to food and drinks, and thatonly natural sources of caffeine areallowed in alcoholic beverages. Pre-mixed alcoholic energy drinks are notapproved for sale in Canada (www.hc-sc.gc.ca/ahc-asc/media/ftr-ati/_2010/2010_83-eng.php). Provincial liquor control boards can

even more tightly regulate caffeine inalcoholic drinks. For example, theLiquor Control Board of Ontario allowsno more than 30 milligrams of natu-rally occurring caffeine per serving indrinks, says spokesman Chris Layton. With the FDA action imminent,

Chicago-based Phusion Projects, whichmakes Four Loko, announced plans inNovember 2010 to reformulate the drinkand market a noncaffeinated version.The company maintained that Four Lokowas safe, but said it was acting “after try-ing — unsuccessfully — to navigate adifficult and politically-charged regula-tory environment at both the state and

federal levels” (www.phusion projects.com/media_reformulation .html).With their large, colourful cans, low

cost, fruity flavors and high alcoholcontent, the caffeine-alcohol drinkshave drawn criticism for their appeal toyoung people. Four Loko, for example,was marketed in 23.5-ounce cans with12% alcohol by volume, more thantwice the concentration of alcohol inregular beer. A single can could containas much alcohol as four standard 12-ounce beer cans.When caffeine is added to the mix,

the drinks “can mask a consumer’ssense of intoxication,” said the US Fed-eral Trade Commission’s Bruce Vladek.“As a result, consumers and particularlyyoung, inexperienced drinkers, may notrealize just how impaired they are.”The Federal Trade Commission,

acting in concert with the FDA, sentletters to the same four companieswarning that their marketing and saleof the drinks could constitute unfair ordeceptive advertising (http://ftc.gov/opa/2010/11/alcohol.shtm).

NewsCMAJ

United States Food and Drug Administration signalscrackdown on caffeinated alcohol drinks

© 2011 Canadian Medical Association or its licensors CMAJ, January 11, 2011, 183(1) E47

Several brands of caffeine-alcohol drinks have drawn criticism for masking a consumer'ssense of inebriation.

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Before the federal government acted,at least four states moved to ban thedrinks after a number of cases in whichunderage drinkers were hospitalized.In 2009, a group of state attorneys

general had asked the FDA to reviewthe safety of the drinks, saying thatthere was an emerging consensus thatthe caffeine-alcohol combination“poses a serious public health threat.”The attorneys general successfullypressed Anheuser-Busch and Miller-Coors to halt production of caffeinatedenergy drinks in 2008.Former Maine attorney general

Steve Rowe, a leader in that effort,welcomed the FDA’s action but saysthe government will have to remain

vigilant to ensure the drinks aren’treplaced by other unsafe concoctionsor deceptive marketing practices. Henoted that there are other stimulantsbesides caffeine.“I hope it’s the end of these, but I

remain skeptical,” he said.The private Washington, DC-based

Center for Science in the Public Interestsaid that even if caffeine is taken out ofthe mix, government regulators at thefederal, state and local levels still havemore work to do to address the market-ing of high-alcohol drinks in kid-friendly flavours like watermelon andblue raspberry.“The idea of marketing sweet alco-

holic beverages to young people to get

them to drink is something that shouldworry most parents,” says David Schardt,the center’s senior nutritionist. “But atleast it doesn’t pose the hazard that thecaffeinated products did, in which kidsdidn’t realize how much they were ine-briated or impaired. We’re back to a situ-ation where young kids drink a lot.”In addition to Phusion Projects, the

warning letters went to Charge Bever-ages Corp., maker of Core High Grav-ity, Core Spiked and El Jefe carbonatedmalt beverages; New Century BrewingCo., maker of Moonshot; and UnitedBrands, maker of Joose. — NancyBenac, Washington, DC

CMAJ 2011.DOI:10.1503/cmaj.109-3775

E48 CMAJ, January 11, 2011, 183(1)