Jamie D. Underwood
`Direct: +1.202.637.3365
`jamie.underwood@lw.com
`
`April 23, 2020
`
`BY EDIS
`
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, S.W., Room 112
`Washington, DC 20436
`
`555 Eleventh Street, N.W., Suite 1000
`Washington, D.C. 20004-1304
`Tel: +1.202.637.2200 Fax: +1.202.637.2201
`www.lw.com
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`
`Re:
`
`Certain Tobacco Heating Articles and Components Thereof,
`ITC Docket No. 337-TA-3447
`
`Dear Secretary Barton:
`
`Enclosed please find as a courtesy filing the Public Interest Comments of the Reason
`Foundation.
`
`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1047
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1047-001
`
`

`

`5737 Mesmer Ave.
`Los Angeles, CA 90230
`(310) 391-2245
`www.reason.org
`
`Guy Bentley, director of consumer freedom
`Reason Foundation
`April 23, 2020
`
`The Honourable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`Re: ​Certain Tobacco Heating Articles and Components Thereof, DN 3447
`Dear Secretary Barton,
`
`I am writing on behalf of Reason Foundation to voice our concerns over the possible withdrawal
`
`of the IQOS tobacco heating system from the U.S. market. Reason Foundation advances a free
`
`society by developing, applying, and promoting libertarian principles, including individual liberty,
`
`free markets, and the rule of law. These comments are not intended to express a view on the
`
`merits or demerits of the specific claims brought before the International Trade Commission
`
`(ITC). Rather they are restricted to the public health and welfare implications of removing IQOS
`
`from the U.S. market.
`
`Heated tobacco systems are part of a new generation of non-combusted products intended to
`
`give adult smokers the nicotine they desire without generating the smoke that may kill them. By
`
`heating instead of burning tobacco, these products emit much lower levels of harmful toxicants
`
`compared to cigarettes. Combustion at high temperatures causes emissions that expose
`
`cigarette smokers to complex and extremely hazardous chemicals, which when inhaled have
`
`numerous ill effects on the user's health. This problem was articulated by tobacco researcher
`
`Michael Russell who said: "People smoke for the nicotine, but they die from the tar."
`
`Ex. 1047-002
`
`

`

`
`
`5737 Mesmer Ave.
`Los Angeles, CA 90230
`(310) 391-2245
`www.reason.org
`
`
`
`
`
`Because there is no combustion in IQOS, levels of Harmful and Potentially Harmful Chemicals
`
`(HPHCs) in the vapor generated are, on average 54%–99.9% lower than reference cigarettes,
`
`according to an FDA review of independent and industry studies. On January 25, 2018, the
`1
`
`FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) unanimously endorsed the
`
`claim made by Philip Morris International (PMI) that switching completely from cigarettes to
`
`IQOS significantly reduces smokers’ exposure to HPHCs. On April 20, 2019, the FDA
`2
`
`explained its reasoning for approving IQOS for sale: “Following a rigorous science-based review
`
`through the premarket tobacco product application (PMTA) pathway, the agency determined
`
`that authorizing these products for the U.S. market is appropriate for the protection of the public
`
`health because, among several key considerations, the products produce fewer or lower levels
`
`of some toxins than combustible cigarettes.” IQOS has achieved significant success in
`
`international markets, with 14.6 million users, 73% of whom are classified as having “stopped
`
`smoking.” While IQOS has been available in the U.S. for a relatively short time and in few
`
`locations, the initial results are promising, with 40% brand awareness among adult smokers in
`
`Atlanta and more than half of those who try the product proceeding to purchase it.
`
`
`
`There are more than 34 million adult smokers in the U.S., the majority of whom say they would
`
`like to quit. In order to ensure a successful transition away from cigarettes for those who wish to
`
`do so, it is necessary to have a broad and diverse marketplace of safer alternatives. Some
`
`1 Center for Tobacco Products. "Technical Project Lead Review of PMI IQOS Premarket Tobacco
`Application." Food and Drug Administration. 2019. https://www.fda.gov/media/124247/download
`
` Food and Drug Administration. "Summary Minutes of the Tobacco Products Scientific Advisory
`Committee (TPSAC)." Center for Tobacco Products. January 24-25, 2018.
`https://www.fda.gov/media/111455/download
`
`
` 2
`
`Ex. 1047-003
`
`

`

`5737 Mesmer Ave.
`Los Angeles, CA 90230
`(310) 391-2245
`www.reason.org
`
`smokers succeed using traditional nicotine replacement therapy while others use e-cigarettes.
`
`Unfortunately, a majority of the public is under the mistaken impression that e-cigarettes are just
`
`as or more dangerous than combustible cigarettes, which is deterring many smokers from
`
`switching. Heated tobacco products provide important option for smokers who have failed to quit
`
`using other tools or find current alternatives unappealing.
`
`The availability of IQOS can assist in driving down U.S. cigarette sales, just as it has in other
`
`markets. A study conducted by the American Cancer Society (ACS) examined changes in
`
`Japan's cigarette sales from the time IQOS was launched in 2014 to 2018. During this period,
`
`there were no other major changes to Japan's tobacco policy. Before the introduction of IQOS,
`
`cigarette sales were declining at 1.8% per year. After the introduction of IQOS, cigarette sales
`
`declined at 9.5% per year. The authors concluded that "The introduction of IQOS likely reduced
`
`cigarette sales in Japan." Fortunately, IQOS has very little appeal to minors. According to
`3
`
`surveys of 64,000 Japanese students, conducted by Prof. Y Osaki of Tottori University, Medical
`
`School, youth use of heated tobacco is close to zero. The percentage of high schoolers who
`4
`
`had used a heated tobacco product at least once in the past month between December 2017
`
`and February 2018 was 0.9% and daily use was 0.1%. As part of its decision to approve IQOS
`
`for sale, FDA also imposed stringent marketing restrictions to prevent youth access and
`
`3 Stoklosa, M., Z. Cahn and A. Liber, et al. "Effect of IQOS introduction on cigarette sales: evidence of
`decline and replacement." Tobacco Control. June 17, 2019.
`https://tobaccocontrol.bmj.com/content/early/2019/06/11/tobaccocontrol-2019-054998
`
`4 Kumamaru, Hiroya. “Update on Current Status in Japan on Tobacco Harm Reduction.” Global Nicotine
`Forum. June, 2019. https://gfn.net.co/downloads/2019/presentations/Hiroya_Kumamaru.pdf
`
`Ex. 1047-004
`
`

`

`5737 Mesmer Ave.
`Los Angeles, CA 90230
`(310) 391-2245
`www.reason.org
`
`exposure. In conclusion, we urge you to consider the detrimental impact removingl IQOS would
`5
`
`have on reducing tobacco related harms.
`
`Sincerely,
`
`Guy Bentley
`Director of consumer freedom, Reason Foundation
`
`5 Food and Drug Administration. “FDA permits sale of IQOS Tobacco Heating System through premarket
`tobacco product application pathway.” April 30, 2019.
`https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobaccoheating-system-thr
`ough-premarket-tobacco-product-application-pathway
`
`Ex. 1047-005
`
`

`

`CERTIFICATE OF SERVICE
`
`It is hereby certified that copies of PUBLIC INTEREST COMMENTS were served on
`April 23, 2020 as follows:
`
`337-TA-3447
`
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`By EDIS
`
`By Email
`dmaiorana@jonesday.com
`rbmccrum@jonesday.com
`separker@jonesday.com
`aminsogna@jonesday.com
`jjnormile@jonesday.com
`
`David M. Maiorana
`Ryan B. McCrum
`JONES DAY
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`Stephanie E. Parker
`JONES DAY
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`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive
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`John J. Normile
`JONES DAY
`250 Vesey Street
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`Tel: (212) 326-3939
`
`On Behalf of Complainants RAI Strategic
`Holdings, Inc., R.J. Reynolds Vapor Company, and
`R.J. Reynolds Tobacco Company
`
`/s/ Erika J. Weinstein
`Erika J. Weinstein
`LATHAM & WATKINS LLP
`
`Ex. 1047-006
`
`