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January 26 2018

Testimony Before FDA Advisory Committee

by Julie Gunlock

Yesterday, I provided testimony to the Tobacco Products Scientific Advisory Committee (TPSAC), which is an advisory panel to the US Food and Drug Administration. TPSAC convened January 24-25 to consider whether Philip Morris should be allowed to claim that its new product, called iQOS--an electronic cigarette device, can reduce the risk of tobacco-related diseases compared with traditional combustible cigarettes.

 

 

 

 

Testimony of Julie Gunlock

Tobacco Products Scientific Advisory Committee (TPSAC) Hearing

Washington, DC

January 25, 2018

Good morning and thank you for allowing me to speak today.

My name is Julie Gunlock

I’m a Senior Fellow at the Independent Women's Forum, which is a research and educational institution located in Washington, DC that is run and staffed entirely by women.

Perhaps, therefore, it makes sense that I’m going to focus my remarks on women and specifically the fact that women have a far more difficult time than men quitting traditional, combustible cigarettes.

I’m sure you’re all aware of the study that was published in Journal of Neuroscience by researchers at Yale University that found that when men smoke, the number of nicotine receptors in the brain increased.

But this wasn’t true for women, who, while smoking, had the same number of nicotine receptors as nonsmokers.

Those results suggest that, neuro-biologically, men are more responsive to the nicotine in a cigarette, whereas women tend to be rewarded more by the “cues” of smoking, like the smell and taste of the smoke (and as a women, I would add this non-scientific observation that women might also be attracted to the appetite suppressing qualities of cigarettes). 

So, why does this relate to the matter at hand?

Well, as you all know, currently, the FDA only approves nicotine-replacement therapies—such as patches and gum—to help people quit smoking.

Clearly, this study demonstrates that women need treatment options other than nicotine replacements, such as those that help replace other cravings—like the taste and smell of traditional cigarettes and the hand-to-mouth habits associated with smoking.

Similarly, researchers at the University of Montreal found that women’s menstruation cycle increases neural activity related to cravings, which often hamper a female’s attempt to quit traditional cigarettes. As we all know, it’s a scientific fact, that men do not have a menstruation cycle, and as such, don’t have to deal with the added monthly cravings.

Other studies have shown women have much more severe symptoms of withdrawal then men, and that women are more likely then men to begin smoking again when faced with stress and anxiety.

In an interview with National Public Radio, Carolyn Mazure, a professor of psychology at Yale School of Medicine explained that, "Women often report smoking is helpful in reducing negative mood, even enhancing positive mood, managing the stress of daily life and also managing appetite and weight gain...” adding that they are “…looking to cigarettes to help them with those different situations, and as a consequence, it is often more difficult for women [than for men] to give up their cigarettes."

Clearly, the FDA does not intend to punish women, simply for their gender.

Yet, that is precisely what’s going to happen if women are limited to smoking cessation products that biologically cannot provide them with the help they need to quit traditional cigarettes.

For this reason, IWF strongly urges this committee and ultimately the FDA to approve new and innovative e-cigarette products that will help women quit smoking.

Thank you.

 

 

Independent Women's Forum is an educational 501(c)(3) dedicated to developing and advancing policies that aren’t just well intended, but actually enhance people’s freedom, choices, and opportunities. IWF is the sister organization of the Independent Women’s Voice.​
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