HealthSpeak: Thank you for not regulating

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March 13, 2007

Thank you for not regulating

by Peter Pitts

Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.

Pending legislation (Kennedy-Cornyn and Waxman-Davis) aims to give the FDA broad authority over tobacco products, providing the agency with oversight over virtually every aspect of tobacco company operations. The knee-jerk reaction is "great!" But, when you ask ""Would such legislation result in fewer smokers and reduced death and debilitation from tobacco? the answer is very unclear -- with the weight of logic and evidence saying otherwise.

For example, proposed legislation would set a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.

Or consider this, adult smoking has been declining since 1997 -- due to a number of things including clean air laws, media campaigns, and youth access programs. Who did these things? Largely the states. If FDA became the nation's tobacco czar, it would become difficult if not impossible to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.

And then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Let me put it this way -- none. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current PDUFA-IV negotiations, you have to ask yourself if this is really the way we want to be going.

So, when you consider all of these issues (and there are many others) the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.

So, for now, thank you for not regulating.

Posted by peterpitts at March 13, 2007 06:45 AM