Tuesday, April 26, 2011

Consumer Group Praises FDA Concession to Court of Appeals Ruling

On April 25, 2011 the FDA announced its decision to forego petitioning for Supreme Court review of the legal victory won last December by a major electronic cigarette distributor. See, http://www.casaa.org/files/ct%20app%20opinion%20on%20injunction.pdf. "This is a profound landmark in the federal legal definition and regulation of smoke-free tobacco and other nicotine products", stated Yolanda Villa, Legal Director for the Consumer Advocates for Smoke-free Alternatives Association (CASAA).

"With the question of highly restrictive and cost-prohibitive drug product classification finally put to rest in favor of reasonable regulation as an alternative and less hazardous tobacco product, electronic cigarette sales will continue to increase, and many more retailers will probably begin to make them available to their customers", said Ms. Villa.

"The FDA's decision to regulate electronic cigarettes under the Tobacco Act is a great victory for public health," stated Dr. Theresa Whitt, M.D., CASAA Medical Director.

"We estimate that over a million smokers have switched to electronic cigarettes," stated Dr. Whitt. "As a result of avoiding the toxins, carcinogens, and particulates in smoke they are reporting their health has improved. Regulating electronic cigarettes as medical devices would have resulted in these life-saving products being removed from the market, pending lengthy and expensive clinical trials."

Electronic cigarettes (e-cigarettes) are battery-operated devices that heat a liquid solution to create a vapor. Medical experts say that the combination of mimicking the hand-to-mouth action of smoking as well as providing adequate nicotine make the products an acceptable long-term substitute for smoking.

Providing safer long-term substitutes for cigarette smoking is a public health approach referred to as Tobacco Harm Reduction (THR). Dr. Whitt remarked,
"Opponents of the THR approach claim that it delays or prevents nicotine cessation in people who might otherwise quit using nicotine. On the other hand, it is more likely that insisting on nicotine cessation delays or prevents smoking abstinence in people who might otherwise quit smoking."
Dr. Whitt stated that the profile of an e-cigarette user is a middle-aged adult who smoked for decades and tried numerous times to quit smoking, without lasting success. "All of the medically approved smoking cessation treatments require the smoker to give up nicotine as well as smoking," said Dr. Whitt. "The Tobacco Advisory Group of the Royal College of Physicians reported that changes in brain structure and function can impair the ability of smokers to achieve and sustain abstinence. Some smokers may never be able to quit all nicotine use."

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