FDA To Look Into Safety of Caffeinated Alcoholic Beverages

The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

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

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.

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

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Drug Legalization Would Be 'Catastrophe', Says Ex-White House Drug Spokesman Bob Weiner; Drugs Have Not 'Won The War'; Op-ed Letter in New York Times

/PRNewswire/ -- Former White House Drug Policy Spokesman Robert Weiner is attacking the arguments of the most recent drug legalization advocates: "They invite a catastrophe of greater drug use, car crashes, school and work dropouts, hospital emergency room cases, and crime including domestic violence and date rape."

Weiner, the spokesman for the White House National Drug Policy Office from 1995 to 2001, states in an op-ed letter today in the New York Times:

"Legalization would be a catastrophe. (Some) use the analogy of legal alcohol. But we have an estimated 15 million alcoholics in this country and 5 million drug addicts; do we want the 5 to become 15?

"Parents, police and the American people know that taking away the incentive of the normative power of the law would increase drug use and related car crashes, school dropouts and work absences. That is why the law has remained in place.

"Hospital emergency rooms would be flooded, and crime would return to the crisis levels of the 1970s and '80s, when drug use was at its highest. Domestic violence and date rape would be substantially higher. The majority of arrestees in 10 major American cities recently tested positive for illegal drugs, a remarkable indicator of a link between drugs and crime.

"I disagree with those who assert that drugs have 'won the war.' With a comprehensive anti-drug strategy in place, involving foreign policy, enforcement, education, treatment, prevention and media, America's overall drug use has declined almost by half in the past three decades -- from 14.1 percent of the population in 1979 to 8.3 percent now -- who used drugs in the past month. In addition, cocaine use, including crack -- the source of much of the former record-high violent crime numbers -- is down 70 percent. Want to go back?

"The new director of the Office of National Drug Control Policy, R. Gil Kerlikowske, and another recent drug czar, Gen. Barry McCaffrey, are both correct that we must remove the phrase 'war on drugs' and fight drugs like a cancer, which can be managed and treated."

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