Tuesday, September 14, 2010

FDA's Actions on Electronic Cigarettes Show Absurdity of Entire Tobacco Regulatory Scheme: Asking FDA to Regulate Cigarettes Was a Huge Mistake

The Food and Drug Administration (FDA) used to be responsible for assuring that the food and drugs consumed by Americans are safe. Now, it is also responsible for approving the sale and marketing of products which kill more than 400,000 Americans each year. Although people are dying by the hundreds each day from tobacco products, the FDA has so far taken no action to make cigarettes safer, reduce the number of youths who start smoking, or reduce the number of adults who smoke. While the FDA has comprehensive authority over the production, marketing, and sale of cigarettes, it has taken no actions that have had any effect on improving the public's health by decreasing tobacco-related morbidity or mortality.

In contrast, the FDA has taken significant efforts to remove electronic cigarettes - a much safer alternative to tobacco cigarettes - from the market. The Agency has seized various shipments of electronic cigarettes, threatened to remove electronic cigarettes from the market, warned consumers about the dangers of electronic cigarettes, scared the public into thinking that electronic cigarettes are loaded with carcinogens, convinced many people that all electronic cigarettes contain deadly anti-freeze, and taken other public efforts to highly discourage the use of these products by addicted smokers who would like to quit smoking but have been unsuccessful using other methods (including FDA-approved pharmacotherapy).

The net result is a complete inconsistency and absurdity in the FDA's actions. On the one hand, the agency is approving the sale and marketing of a product that kills hundreds of thousands of Americans each year and has taken no action to significantly reduce the number of cigarette smokers. On the other hand, the agency has threatened to ban a much safer alternative to cigarettes which many ex-smokers are finding useful to keep them off cigarettes and which have greatly improved their health. The agency has also taken efforts which have resulted in encouraging vapers to switch back to regular cigarettes by declaring that they should not use electronic cigarettes at this time.

There is no logical consistency or public health justification for the FDA's actions. Moreover, the agency's actions to date have produced no tangible public health benefits. Even worse, the agency's actions have caused demonstrable public health harm by discouraging many current or potential e-cigarette users from vaping and convincing them to return to cigarette smoking. In other words, the FDA's actions have actually resulted in a prevention of the loss of customers for the tobacco industry.

Philip Morris couldn't be happier with the FDA's actions to date. The agency is protecting the company's dominant market share of the deadliest consumer products on the market and preventing or discouraging the use of a much safer alternative which would otherwise threaten to make a dent in the company's profits.

Big Pharma also couldn't be happier with the FDA's actions, as the agency has protected the pharmaceutical industry's terribly ineffective smoking cessation products from competition from what may just be a much more effective alternative for individuals who want to quit smoking but are having extreme difficulty in doing so.

The only one who hasn't benefited from the agency's actions is the public, which continues to die by the hundreds each day - due not to electronic cigarettes but to the damn real ones.

The Rest of the Story

The rest of the story is that the absurd regulatory system created by Philip Morris, the health groups, and the politicians is nothing more than a huge public scam. The system is set up to make it look like the nation's leading tobacco company, the health groups, and the politicians who supported the law are taking action to protect the public's health and to fight Big Tobacco profits. Instead, the actual effect of the new regulatory system is to make the government a true partner and accomplice in the deaths of hundreds of thousands of Americans each year, to fend off potential less hazardous products that could compete with the market share leaders, and to set up a cozy deal by which existing market share is essentially frozen, existing cigarettes are institutionalized and protected, and new products which could have real public health benefits are thwarted.

The system is working beautifully so far, and the story of the handling of electronic cigarettes under the new regulatory framework is a perfect example. Like clockwork, the FDA has stepped in to protect the deadly cigarette market from potential threats caused by a much safer alternative that has proven to help thousands of smokers to stay off cigarettes or greatly reduce their cigarette consumption.

The status quo is preserved, the profits of Big Tobacco and Big Pharma are protected, yet the one group which is harmed is the public.

Vapers are harmed because they are either deprived of the opportunity to switch to a safer alternative that will improve their health or they are encouraged to return from relatively safe vaping back to very hazardous smoking. Smokers are harmed because they are discouraged from trying a potentially life-saving device and instead, are convinced to keep smoking. Nonsmokers are harmed because instead of benefiting from the absence of secondhand smoke associated with vaping, they continue to be exposed to smoke from smokers who decide, at the advice of the FDA, not to use electronic cigarettes but to stick with their Marlboros. Children are harmed because parents who might otherwise be vaping in the home are now smoking in the home.

There are plenty of politicians and groups which have spoken up to protect the interests of Philip Morris and Big Pharma. But few are speaking up to protect the interests of the public. The Rest of the Story will continue to fight for the welfare of the public, and unlike the politicians and anti-smoking groups which joined hands with Philip Morris in setting up this absurd regulatory scheme, will not be bought off by political or financial interests.

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