ACSH Testimony at FDA Tobacco Products Scientific Advisory Committee

ACSH testified before the FDA TPSAC on the MRTPA submitted by PMI for their IQOS system
 
 
Hank Campbell at FDA Jan 25 2018
Hank Campbell at FDA Jan 25 2018
 
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WASHINGTON - Jan. 25, 2018 - PRLog -- This morning, American Council on Science and Health President Hank Campbell testified during the US Food and Drug Administration's Tobacco Products Scientific Advisory Committee, which was meeting to approve or deny the modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system, which would allow them to market it as safer than cigarettes.

The committee then voted 8-1 in support of the claim that IQOS "significantly reduces your body's exposure to harmful or potentially harmful chemicals" but determined it is too soon to tell what decrease in morbidity could result.

Mr. Campbell's statement is below:

The American Council on Science and Health was founded in 1978 with the goal of informing the public about real health threats versus health scares. That has always meant separating hazard from risk. We are proud to have promoted the science behind child helmet laws, seat belts and more, but there is no greater achievement we cite than the reduction in smoking in the last 40 years. We were proud to have Dr. C. Everett Koop on our advisory board and he served the public in that capacity because he agreed with our belief that smoking is a "pediatric disease" and if we can stop it in childhood, its incidence will plummet.

Yet we know people engage in risky behavior. Studies have shown that the risk of nicotine causing harm in humans is scant whereas the weight of evidence regarding the harms of cigarettes are well-established. For that reason we want to commend all of you, along with Commissioner Gottlieb and Director Zeller, for refusing to make the perfect the enemy of the good when it comes to smoking cessation and harm reduction. "E-cigarettes" and "vaping" devices may not be perfect but a 95 percent reduction in harm, as Public Health England found in its analyses, will save millions of lives. In countries like Japan, the IQOS system has seen substantially greater uptake from smokers than was found with legacy vaping devices, gums or patches. By now, the data points are in the millions.

We support the IQOS application because data show that switching from cigarettes to the IQOS system accomplishes harm reduction. Since there is no smoke, exposure to deadly and potentially harmful chemicals is mitigated. And since over 70 percent of those who have purchased an IQOS aerosol device in Japan have stopped purchasing cigarettes altogether, its benefits for smoking cessation in America are substantial.

Three benefits for public health

• Obviously, nicotine is addictive, there is no debate on that point, but continuum of risk due to that addiction is an important factor. Our research has found that the marketing and price point PMI proposes for IQOS create a barrier to entry on the demand side whereas laws to prevent minors from purchasing such products prevent supply from easily reaching them. With those factors already in play it would be harmful to human health if the federal government were to create new barriers and provide a benefit if it does not.

• The continuum of risk is also important to consider for the public. Cigarettes are carcinogenic so substantially reduced toxic exposures to non-smokers make sense as well. A nicotine aerosol versus cigarette smoke is orders of magnitude less harmful. FDA agrees with our assessment that IQOS aerosol has a small fraction of Harmful and Potentially Harmful Constituents (HPHCs) compared to cigarette smoke.

• Third is the issue of smoking cessation, which is arguably the most vital area. It is laudable that Philip Morris International wants to exit the cigarette business. In our assessment, one reason IQOS has been successful in smoking cessation is that it mimics much of the physical repetition of cigarettes. The market has borne that out. In Japan, IQOS sales went up 500 percent in a year and now outsell Marlboro.

Concerns

• There will remain some concern about new nicotine addiction and if that creates new cigarette smokers outside the statistical noise range but to-date that has not been the case. The National Academies of Sciences, Engineering, and Medicine analysis of surveys recently expressed concern that vaping with e-cigarettes using diluted nicotine liquid might place young people at a higher risk of becoming smokers but stated conclusively evidence that e-cigarette use is safer than smoking and helps smokers quit. Because IQOS is a commercial product, does not burn and can't be filled with something like a custom liquid, it will be far more difficult for bad actors to place in the hands of underage people.

• The stigmatization of smoking also cannot be understated. Whereas vaping devices look substantially different, IQOS looks too much like a cigarette to appeal to non-smokers, so those use vaping devices and are solely interested in flavors will have no interest in promoting the appearance of smoking. However, there remain concerns about uptake due to its technological appearance. We don't believe the application should be denied because of a small hypothetical risk.

• In a provocative July 2017 JAMA Internal Medicine Research Letter Auer, Concha-Lozano, Jacot-Sadowski, Cornuz, and Berthet posited that IQOS was a tobacco stick "soaked in propylene glycol" producing volatile organic compounds but our examination of their methodology raised concerns about their comparisons between the IQOS aerosol and cigarette smoke.

Conclusion

We can look at every country where smoking cessation has caught on and plot the new diagnoses and COPD issues related to cigarettes as smoking began its heyday, in the 1920s, and  extend those out to now. There will be some slight differences but in all cases the trend is the same and these reduced incidents are beginning to be borne out in positive health outcomes. The elimination of smoking is going to be a giant win for the world's health systems.

While we are proud of our work that has resulted in a decline in smoking in much of the developed world, we want that decline to accelerate, and bring with it more of the public health benefits we have seen, and for that to be possible smoking cessation and harm reduction tools must be diverse and readily available.

For that to continue, the American public needs options. For that reason, we support approval of the MRTP in this instance.

Hank Campbell,

President, American Council on Science and Health (https://acsh.org)

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