`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 Consumer
`Advocates for Smoke-free Alternatives Association.
`
`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1042
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1042-001
`
`
`
`
`The Consumer Advocates for Smoke-free Alternatives Association
`
`www.casaa.org
`
`P.O. Box 2991, Plattsburgh, NY 12901
`
`202-241-9117
`
`
`
`
`
`
`
`
`April 22, 2020
`
`
`VIA EDIS
`
`The Honorable 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, Investigation No. 337-TA-3447
`
`Dear Secretary Barton:
`
`
`The Consumer Advocates for Smoke-free Alternatives Association (CASAA) submits the
`
`following comments to the U.S. International Trade Commission (“ITC”) in response to the
`
`Public Interest Statement filed on April 9, 2020 in the above-referenced case. Complainants ask
`
`the ITC to exclude from the U.S. market all IQOS heat not burn (“HnB”) systems. CASAA
`
`believes that such severe measures are inappropriate, would remove choices for consumers
`
`seeking a low-risk alternative to smoking, and would give a competitive advantage to high-risk
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`traditional cigarettes, all of which work against the public interest and genuine public health.
`
`By way of background, CASAA is a non-profit 501(c)(4) organization with an
`
`all-volunteer board and a grassroots membership of more than a quarter of a million individuals
`
`from all walks of life. CASAA is a consumer organization, not a trade association or industry
`
`representative. CASAA is dedicated to ensuring the availability of reduced harm alternatives to
`
`
`
`Ex. 1042-002
`
`
`
`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 2
`
`
`smoking and to providing smokers and non-smokers alike with honest information about those
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`alternatives so that they can make informed choices.
`
`CASAA specifically has no comment in connection with the underlying issue of whether
`
`or not there has been patent infringement. CASAA speaks only on the issue of the necessity of
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`ensuring that IQOS remains available for consumer purchase and use in the United States.
`
`1. IQOS is used in the U.S. as a reduced risk alternative to smoking.
`
`Complainants describe the physical use of IQOS in their complaint, but they give short
`
`shrift to discussing the promise that HnB technology holds for people who smoke, and
`
`particularly for those who have tried approved smoking cessation products and/or e-cigarettes
`
`(sometimes referred to as vapor products) and found them to be an unacceptable low-risk
`
`substitute for smoking. IQOS is the only HnB product that has successfully navigated the
`
`complicated, expensive, and uncertain premarket tobacco product application (PMTA) process,
`
`receiving Food and Drug Administration (FDA) approval to be sold in the U.S. As part of the
`
`PMTA process, FDA concluded that marketing IQOS is “appropriate for the protection of the
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`public health because, among several key considerations, the products produce fewer or lower
`
`levels of some toxins than combustible cigarettes.” 1
`
`IQOS is not simply another tobacco product. IQOS allows consumers to replace their
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`smoking habit with HnB technology, thereby lowering their exposure and risk as compared to
`
`smoking.
`
`1 “FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application
`pathway,” Food and Drug Administration News Release, April 30, 2019,
`https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-th
`rough-premarket-tobacco-product-application-pathway.
`
`Ex. 1042-003
`
`
`
`2. Removing IQOS from the marketplace will reduce choices for consumers
`
`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 3
`
`
`seeking reduced-risk alternatives to smoking, which is against the public interest.
`
`Complainants refer to a broad category of “potentially reduced risk products” they define
`
`as “electronic nicotine delivery systems” (ENDS), which they assert includes both HnB
`
`(specifically, IQOS, since it is the only HnB product currently available in the U.S.) and
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`e-cigarettes. Complainants assert that the existence of other products in the ENDS category
`
`means that if IQOS is removed from the market, consumers will still have choices. This is, at
`
`best, disingenuous.
`
`While it is sometimes convenient to talk about e-cigarettes and HnB, both of which are
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`lower risk than smoking, as a cohesive ENDS product class, there are substantial differences
`
`between these types of products (and, in fact, substantial differences even within the e-cigarette
`
`product category). These differences in form factor, design, and patterns of use are important
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`because they allow consumers to find products that work for them as an acceptable and
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`effective reduced-risk alternative to smoking. Specifically, IQOS heats tobacco, while
`
`e-cigarettes heat a liquid. For the consumer, e-cigarettes and HnB provide very different
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`experiences in terms of, among other things, the nicotine delivery, taste and aroma. These
`
`differences are substantial enough such that for some people who smoke, e-cigarettes will not
`
`be an effective alternative, and HnB technology may be the only product that enables them to
`
`make the switch from smoking and to reduce their health risk.
`
`Complainants’ assertion also ignores the fact that as a practical matter, the biggest
`
`competition for all products in the reduced-risk category are traditional combustible cigarettes.
`
`Consumers who cannot find an acceptable low-risk alternative to smoking will likely continue or
`
`return to smoking. Consequently, anything that serves to reduce choices will necessarily cause
`
`Ex. 1042-004
`
`
`
`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 4
`
`
`fewer consumers to make the switch and more consumers to keep smoking. In effect, reducing
`
`choices for consumers in the ENDS category protects the competitive advantage that
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`combustible tobacco products currently enjoy over low-risk nicotine products, which is a huge
`
`loss in terms of genuine public health.
`
`As noted previously, among the ENDS category that Complainants refer to, IQOS is the
`
`only product that has successfully navigated the complicated, expensive, and uncertain PMTA
`
`process allowing it to be sold in the U.S. once FDA begins stricter enforcement of the PMTA
`
`requirement, which is anticipated to occur sometime later this year. Once FDA begins
`
`enforcement, consumer choice in the ENDS category will be dramatically reduced to perhaps
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`only a handful of products that will gain a temporary delay in enforcement due to filing an
`
`acceptable PMTA. Moreover, it will likely be years before another product using HnB technology
`
`is available in the U.S. due to the FDA’s lengthy and uncertain PMTA process.
`
`Removing IQOS from the market under these circumstances would be unconscionable.
`
`3. Removal of IQOS from the U.S. marketplace will discourage diversity in the
`
`harm reduction arena, which is against the public interest.
`
`As mentioned previously, IQOS is the only product in the ENDS category (as defined by
`
`Complainants) that is being marketed under a PMTA. The PMTA process requires a substantial
`
`commitment of time, money, and expertise, and there is little certainty in the process. The
`
`current PMTA process is daunting, and CASAA is concerned that removal of the only ENDS
`
`product with a PMTA will discourage other businesses with ENDS products from filing for
`
`PMTAs. From a consumer perspective, it is vitally important that a diversity of products remain
`
`on the market, and that cannot happen if businesses are deterred from filing PMTAs.
`
`Ex. 1042-005
`
`
`
`4. Removal of IQOS from the U.S. marketplace will potentially, and negatively,
`
`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 5
`
`
`impact millions of consumers, not simply those who currently use IQOS.
`
`Complainants assert that the requested relief will only affect those consumers who
`
`specifically use IQOS. This is simply not true. While it is true that the most immediate impact will
`
`be on consumers who currently use IQOS, it completely ignores the substantially larger
`
`population of 34 million people in the U.S. who smoke and who may choose to use IQOS in the
`
`future. Granting the requested relief would not simply take the product out of the hands of
`
`existing consumers, but would deny millions of people in the U.S. who smoke the ability to
`
`explore using IQOS as a means of reducing their risk.
`
`CASAA understands that there are many factors for the ITC to consider in its evaluation
`
`of these public health issues, but CASAA respectfully submits that the harm that would be done
`
`to consumers by removing IQOS from the U.S. market is substantial, immediate, and
`
`irreparable. We appreciate the opportunity to share our views with the ITC and thank the ITC for
`
`its considered review of the issues raised.
`
`
`
`Respectfully Submitted,
`
`Alex Clark
`CEO, CASAA
`
`
`
`Julia Woessner
`National Policy Director, CASAA
`
`
`
`
`
`Ex. 1042-006
`
`
`
`
`
`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. 1042-007
`
`