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
`
`FIRM / AFFILIATE OFFICES
`Beijing
`Moscow
`Boston
`Munich
`Brussels
`New York
`Century City
`Orange County
`Chicago
`Paris
`Dubai
`Riyadh
`Düsseldorf
`San Diego
`Frankfurt
`San Francisco
`Hamburg
`Seoul
`Hong Kong
`Shanghai
`Houston
`Silicon Valley
`London
`Singapore
`Los Angeles
`Tokyo
`Madrid
`Washington, D.C.
`Milan
`
`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 TechFreedom.
`
`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1051
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1051-001
`
`

`

`
`
`I.
`
`IQOS Technology is Innovation with Public Health Benefits
`
` The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
` Re: In the Matter of Certain Tobacco Heating Articles and Components Thereof,
`Investigation No. 337-TA-3447
` Dear Secretary Barton:
`
`I am grateful for the opportunity to submit this public interest statement In the Matter of
`Certain Tobacco Heating Articles and Components. TechFreedom is a post-partisan think tank
`dedicated to promoting the progress of technology that improves the human condition. To this end,
`we seek to advance public policy that makes experimentation, entrepreneurship, and investment
`possible, and thus unleashes the ultimate resource: human ingenuity.
`Traditional cigarettes are a known hazard to health, but the risks stem mainly from chemicals
`produced through the process of combustion. Products that heat nicotine solutions or tobacco, such
`as the IQOS, deliver nicotine without combustion and, as a result, lack most of the harmful and
`potentially harmful elements of traditional tobacco. Heat-not-burn alternatives provide
`substantially less hazardous options for individuals wishing to consume nicotine with an
`experience similar to smoking. In 2014, the FDA’s research determined, “the inhalation of nicotine
`(i.e. nicotine without the products of combustion) is of less risk to the user than the inhalation of
`nicotine delivered by smoke from combusted tobacco products.”1
`1 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family
`Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required
`Warning Statements for Tobacco Products 81 FR 28973 (May 10, 2016), available at
`https://www.gpo.gov/fdsys/pkg/FR-2016-05-10/pdf/2016-10685.pdf.
`
`
`
`
`
`1
`
`Ex. 1051-002
`
`

`

`
`
`The history of technology is full of examples where innovation moves consumers toward safer,
`more effective, and more user-friendly options. We’ve seen innovations in public health elsewhere,
`as telemedicine has increased access to medical services especially right now as our country is
`grappling with an unprecedented challenge of a pandemic. There is drone delivery being developed
`globally to help reach the most vulnerable population. Apple and Google are on track to release a
`privacy minded contract tracing tool to help reopen America.2 These advances bypass conventional
`outmoded paradigms and create new ones, and they have occurred in all aspects of American life.
`In his seminal 1976 British Medical Journal article, the late Professor Michael Russell noted that,
`“people smoke for nicotine, but they die from the tar.”3 Yet, over 35 years later, smoked tobacco is
`still the primary source of nicotine and by far the largest cause of preventable death and disease.4 In
`an effort to stem such preventable deaths and to create a “smoke-free future,” Philip Morris
`International (PMI) has introduced a new device in the U.S. utilizing a “heat-not-burn” (HNB)
`technology, which will significantly reduce the release of the chemical compounds as compared to
`the smoke created by the fire from conventional cigarettes. Results in other countries using IQOS
`are positive. Since IQOS was launched in the UK last December, for example, about 70% of people
`that use it are able to give up conventional cigarettes.5
`Despite the benefits, only about 22% of all U.S. smokers have made the switch to healthier
`alternatives, suggesting that a large majority of the estimated 36.5 million current smokers in the
`2 Kaveh Waddell, Apple, Google Could Alert You to Coronavirus Exposure, Consumer Reports, (April 10, 2020),
`https://www.consumerreports.org/coronavirus/apple-google-could-alert-you-to-coronavirus-exposure/.
`3 M.A.H. Russell, Low-tar Medium Nicotine Cigarettes: A New Approach To Safer Smoking, 1430 British Medical
`Journal 1976; 1431 (1976), http://www.bmj.com/content/bmj/1/6023/1430.full.pdf.
`4 Centers for Disease Control, Smoking & Tobacco Use, Fast Facts, Diseases and Death (Nov. 16, 2017),
`https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm.
`5 Reuters Staff, Tobacco group Philip Morris sees iQOS as key to smokeless future in UK REUTERS(June 30, 2017),
`https://www.reuters.com/article/us-philipmorris-britain/tobacco-group-philip-morris-sees-iqos-as-key-to-smokeless-
`future-in-uk-idUSKBN19L1DU.
`
`
`
`
`
`2
`
`Ex. 1051-003
`
`

`

`
`
`U.S. do not view e-cigarettes, which have been around for some time, as an attractive alternative.
`According to one study, the principle reason for smokers not wanting to switch was because, in
`their view, e-cigarettes were less pleasurable than traditional cigarettes.6 This is the appeal of PMI’s
`IQOS system: giving the user a taste and experience closer to smoking than other products could
`entice those stubborn smokers to switch to healthier alternatives. Also appealing to current
`smokers is the fact that the IQOS system delivers nicotine levels comparable to traditional
`cigarettes.7 Evidence shows that this is true, as PMI reports that there are nearly 14 million IQOS
`users worldwide8
`Most critically, by heating rather than burning the tobacco, the IQOS system dramatically
`reduces the harmful chemicals ingested. In traditional cigarettes, the lit end can reach 1600˚
`Fahrenheit; at such extreme temperatures, the breakdown of tobacco leaf also causes the release of
`what the FDA calls “harmful or potentially harmful constituents” (HPHCs) — the likely causes of
`smoking-related diseases.9 The IQOS system avoids the combustion altogether by heating the
`tobacco at a much lower temperature, which keeps many of the chemical reactions that release the
`HPHCs from occurring.10 This reduces the release of HPHCs overall and thus reduces the incidence
`of smoking-related diseases.11
`
`
`6 McKeganey N. & Dickson T., Why Don’t More Smokers Switch to Using E-Cigarettes: The Views of Confirmed Smokers,
`International Journal of Environmental Research and Public Health, 2-12 (2017),
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486333/pdf/ijerph-14-00647.pdf.
`7 Philip Morris Int’l, Summary of Modified Risk Tobacco Product Application 5 (May, 2017),
`http://pmiscienceusa.com/wp-content/uploads/Brief-Summary-of-PMIs-MRTP-Application-May-2017.pdf [hereinafter
`MRTP Summary].
`8 Philip Morris Int’l, 2019 Fourth-Quarter and Full-Year Results 19 (February 6, 2020),
`https://philipmorrisinternational.gcs-web.com/static-files/156f7310-3ff7-4a6d-890f-3a7f663fee81.
`9 Id. at 2 (citing Department of Health and Human Services, Surgeon General's Report: How Tobacco Smoke Causes
`Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease (2010)).
`10 Id.
`11 Id.
`
`
`
`
`
`3
`
`Ex. 1051-004
`
`

`

`
`
`II.
`
`Excluding IQOS from the Market Would Stifle Innovation and Put
`Public Health in Jeopardy
`
`Currently IQOS is the only FDA authorized heated tobacco product that has been through FDA’s
`PMTA review process. Mitch Zeller, the director of CTP, noted that the PMTA process is a “critical
`part of our mission to protect the public…and to reduce tobacco-related disease and death,” and
`that the review process made certain the IQOS’ heat-not-burn technology is appropriate for the
`protection of the public health due to the product’s potential to “completely move adult smokers
`away from use of combustible cigarettes.”12
`
`As we move into this second section, it is important to remember that in July of 2017, the FDA
`announced a new comprehensive plan for tobacco and nicotine regulation. One element of this plan
`centered on fostering innovation that could lead to less harmful tobacco products, with the goal of
`achieving the public health benefits that would accrue if users of combusted tobacco products
`switch to novel, non-combusted forms of nicotine delivery.
`The marketing order issued for IQOS authorized immediate commercial distribution of the
`product, subject to ongoing post-market oversight by FDA and the discretion to withdraw the
`marketing order upon a determination that continued marketing of IQOS is no longer appropriate
`for the protection of public health.
`Decisions about product circulation in the market should be adopted and implemented in a
`manner that is consistent with their overarching objective: to strengthen the economy and give
`consumers choice. Removing IQOS will hurt both the consumers and the economy on many levels.
`12 Press release, FDA Permits sale of IQOS Tobacco Heating System through premarket tobacco product application
`pathway, FDA, (April 30, 2019), available at https://www.fda.gov/news-events/press-announcements/fda-permits-sale-
`iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway.
`
`
`
`
`
`4
`
`Ex. 1051-005
`
`

`

`
`
`First of all, excluding a product from the market that is the only currently authorized heated
`tobacco product that has been through FDA’s PMTA review process would stifle innovation and
`could discourage others from filing in an already precarious regulatory environment.
`Second, the availability of “choice” has always been the guiding star in FDA’s harm reduction
`goals. There is a big difference between e-cigarettes and heated tobacco products. They are not
`substituting for each other. Consumers want a variety of choices, and many prefer heated tobacco
`to e-liquid or other oral products.
`
`
`
`
`
`
`Third, exclusion of IQOS from the market – in effect – will compel consumer use and public
`exposure to cancer-causing tobacco products.
`
`
`
`
`Fourth, if IQOS is removed there will an economic impact that will cause a loss of jobs in the
`agriculture community and suppliers and stores who sell IQOS. Taking into account the state of the
`American economy as we fight the deadly COVID-19 virus, we just can’t afford this.
`
`
`Excluding IQOS from the market would flatly ignore years of valuable research into the benefits
`of harm reduction tools that achieve better public health outcomes. Such an approach is inconsistent
`with America’s track record as a home to enlightened policies concerning industrial oversight.
`Sincerely,
`/s/ Ashkhen Kazaryan
`
`Director of civil liberties and Legal Research
`Fellow
`TechFreedom
`
`III. Conclusion
`
`
`
`
`
`
`
`5
`
`Ex. 1051-006
`
`

`

`
`
`CERTIFICATE OF SERVICE
`
`337-TA-3447
`
`It is hereby certified that copies of PUBLIC INTEREST COMMENTS were served on
`April 23, 2020 as follows:
`
`
`By EDIS
`
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`David M. Maiorana
`Ryan B. McCrum
`JONES DAY
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`Stephanie E. Parker
`JONES DAY
`1420 Peachtree Street, N.E.
`Suite 800
`Atlanta, GA 30309
`
`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive
`Suite 1500
`San Diego, CA 92121
`
`John J. Normile
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Tel: (212) 326-3939
`
`On Behalf of Complainants RAI Strategic
`Holdings, Inc., R.J. Reynolds Vapor Company, and
`R.J. Reynolds Tobacco Company
`
`
`
`
`By Email
`dmaiorana@jonesday.com
`rbmccrum@jonesday.com
`separker@jonesday.com
`aminsogna@jonesday.com
`jjnormile@jonesday.com
`
`
`
`/s/ Erika J. Weinstein
`Erika J. Weinstein
`LATHAM & WATKINS LLP
`
`
`
`
`
`Ex. 1051-007
`
`