Monday, September 08, 2014

Fascinating Op-Ed in Richmond Times-Dispatch Reveals that Lack of Current E-Cigarette Regulation is the Fault of Anti-Smoking Groups

Revealing an all-but-forgotten piece of legislative and political history, Drs. Alan Blum and Amy Muhlberg provide the "rest of the story" regarding the FDA's failure to regulate electronic cigarettes for the past five years, leading to its inability to develop a sound, coherent, and informed approach to maximizing the benefits while minimizing the risks of these innovative products. Their insightful comments appear in an op-ed piece published in Saturday's Richmond Times-Dispatch.

Drs. Blum and Muhlberg reveal this fascinating piece of history regarding the development of the 2009 Family Smoking Prevention and Tobacco Control Act:

"By 2009, it wasn’t clear if e-cigarettes met the bill’s definition of tobacco products. There were differing opinions among e-cigarette manufacturers about how to proceed, but there was consensus that if e-cigarettes had to be regulated by the FDA, it would be better to be considered a tobacco product than a medical product."

"During the Senate committee debate on the bill, Republican members offered for consideration language that would grant the FDA authority to regulate e-cigarettes as tobacco products and restrict the agency from regulating them as medical products. But the sponsors of the bill and the FDA leadership under the new administration wanted the option to use the FDA’s medical product regulatory authority, so they were not open to including “regulate once but not twice” language. The amendment was withdrawn." ...

"If the FDA had been willing to agree in 2009 that they were tobacco products and not medical products, the agency would have had vast authority over e-cigarettes. For the past five years, the FDA could have acted against adulterated or misbranded products, required manufacturer registration and ingredient-reporting, and inspected manufacturers, among other actions. It’s impossible to know how much ground was lost because of the FDA’s overreaching position that e-cigarettes were possibly medical products."

The Rest of the Story

It is interesting to find out that the "wild, wild West" that anti-smoking groups have complained so much about (i.e., the lack of current regulation of e-cigarettes because they fall into the cracks of the FDA Tobacco Act) is actually their own fault. Had these groups pressured the sponsors of the Tobacco Act to regulate e-cigarettes as tobacco products back in 2009, these products would have been introduced to the U.S. market under a regulated framework, in which, at very least, the FDA would have been able to inform itself about the products by collecting key information, such as ingredients and basic quality control information.

Instead, we are now faced with the "deeming regulations," a disastrous proposal under which most of the existing e-cigarette market may be destroyed and the market essentially handed over to Big Tobacco, which are the only companies large enough to successfully complete the new product applications which will be required for every single e-cigarette product on the market.

This is yet another example of the anti-smoking groups bemoaning a situation for which they are actually responsible. For example, the anti-smoking groups have complained about the menthol loophole, but it was the Campaign for Tobacco-Free Kids and friends which insisted upon this loophole in the first place. The anti-smoking groups complained about the introduction of Marlboro No. 54, but again, it was the Campaign and its friends that made this introduction possible by exempting menthol as the only characterizing flavor allowed in cigarettes.

Now, thanks to Drs. Blum and Muhlberg, we find out that all the complaining by the anti-smoking groups about the "wild, wild West" of e-cigarette marketing in an unregulated environment is bogus, as these groups failed to insist on an amendment which would have regulated e-cigarettes as tobacco products. Instead, these groups - back in 2009 - were actually fighting to get e-cigarettes off the market entirely. Regulating them as tobacco products would have meant institutionalizing their entrance and penetration into the market. It would have risked having these safer products compete with much more hazardous products like regular tobacco cigarettes. And that, by the reasoning of Tobacco-Free Kids and Friends, would have been a disaster.

You see, the goal of the Tobacco Act was not to save lives, but to gain a political victory for the anti-smoking groups. The goal was to put a feather in the cap of the anti-smoking groups' national leaders, rather than to establish a rational, science-based policy designed to reduce cigarette smoking, make cigarettes safer, and promote the public's health.

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