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`Benjamin Levi
`202.997.3711
`blevi@levisnotherly.com
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`April 27, 2020
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`VIA EDIS
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`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`Re: Certain Tobacco Heating Articles and Components Thereof,
`Dkt. No. 337-3447
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`Dear Secretary Barton:
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`On Thursday, April 23, 2020, Latham and Watkins LLP (“Latham”) filed timely
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`comments to Complainants’ Public Interest Statement in the above-referenced matter on
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`behalf of the Consumer Advocates for Smoke-free Alternatives Association (“CASAA”).
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`Latham had full permission to do so and submitted the filing as a courtesy to CASAA.
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`On Friday, April 24, 2020, the ITC’s docketing team rejected the filing because a
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`law firm may not file a document on behalf of a person or entity that it does not formally
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`represent. Neither Latham nor CASAA received notice of this issue in time to address the
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`concern.
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`The undersigned represents CASAA for purposes of perfecting the filing of its
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`public interest comments. CASAA respectfully submits that there is good cause for the
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`Commission to accept and consider its public interest filing out of time. The filing, in fact,
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`The Honorable Lisa R. Barton
`April 27, 2020
`Page 2
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`was made in a timely fashion but was rejected based on a technical imperfection in the
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`manner of its filing. Moreover, given the statutory provisions and Commission rules
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`governing consideration of the public interest, it is important that the Commission
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`consider to the greatest extent possible all such submissions. Finally, neither the
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`Commission Staff nor Complainants will be prejudiced by acceptance of the filing at this
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`time, given that it was served on the Commission Staff and Complainants on the day it
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`was originally filed.
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`For the foregoing reasons, CASAA respectfully requests that the Commission
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`accept and consider its public interest submission out of time.
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`Sincerely,
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`/s/ Benjamin Levi
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`Benjamin Levi
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`Levi & Snotherly, PLLC 1101 Connecticut Ave., N.W., Suite 450
`Washington, DC 20036
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`The Consumer Advocates for Smoke-free Alternatives Association
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`www.casaa.org
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`P.O. Box 2991, Plattsburgh, NY 12901
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`202-241-9117
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`April 22, 2020
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`
`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
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`Dear Secretary Barton:
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`The Consumer Advocates for Smoke-free Alternatives Association (CASAA) submits the
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`following comments to the U.S. International Trade Commission (“ITC”) in response to the
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`Public Interest Statement filed on April 9, 2020 in the above-referenced case. Complainants ask
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`the ITC to exclude from the U.S. market all IQOS heat not burn (“HnB”) systems. CASAA
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`believes that such severe measures are inappropriate, would remove choices for consumers
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`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.
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`By way of background, CASAA is a non-profit 501(c)(4) organization with an
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`all-volunteer board and a grassroots membership of more than a quarter of a million individuals
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`from all walks of life. CASAA is a consumer organization, not a trade association or industry
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`representative. CASAA is dedicated to ensuring the availability of reduced harm alternatives to
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`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 2
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`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.
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`CASAA specifically has no comment in connection with the underlying issue of whether
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`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.
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`1. IQOS is used in the U.S. as a reduced risk alternative to smoking.
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`Complainants describe the physical use of IQOS in their complaint, but they give short
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`shrift to discussing the promise that HnB technology holds for people who smoke, and
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`particularly for those who have tried approved smoking cessation products and/or e-cigarettes
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`(sometimes referred to as vapor products) and found them to be an unacceptable low-risk
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`substitute for smoking. IQOS is the only HnB product that has successfully navigated the
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`complicated, expensive, and uncertain premarket tobacco product application (PMTA) process,
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`receiving Food and Drug Administration (FDA) approval to be sold in the U.S. As part of the
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`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
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`levels of some toxins than combustible cigarettes.” 1
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`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
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`smoking.
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`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​.
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`2. Removing IQOS from the marketplace will reduce choices for consumers
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`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 3
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`seeking reduced-risk alternatives to smoking, which is against the public interest.
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`Complainants refer to a broad category of “potentially reduced risk products” they define
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`as “electronic nicotine delivery systems” (ENDS), which they assert includes both HnB
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`(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
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`means that if IQOS is removed from the market, consumers will still have choices. This is, at
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`best, disingenuous.
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`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
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`between these types of products (and, in fact, substantial differences even within the e-cigarette
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`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
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`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
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`differences are substantial enough such that for some people who smoke, e-cigarettes will not
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`be an effective alternative, and HnB technology may be the only product that enables them to
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`make the switch from smoking and to reduce their health risk.
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`Complainants’ assertion also ignores the fact that as a practical matter, the biggest
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`competition for all products in the reduced-risk category are traditional combustible cigarettes.
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`Consumers who cannot find an acceptable low-risk alternative to smoking will likely continue or
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`return to smoking. Consequently, anything that serves to reduce choices will necessarily cause
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`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 4
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`fewer consumers to make the switch and more consumers to keep smoking. In effect, reducing
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`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
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`loss in terms of genuine public health.
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`As noted previously, among the ENDS category that Complainants refer to, IQOS is the
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`only product that has successfully navigated the complicated, expensive, and uncertain PMTA
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`process allowing it to be sold in the U.S. once FDA begins stricter enforcement of the PMTA
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`requirement, which is anticipated to occur sometime later this year. Once FDA begins
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`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
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`acceptable PMTA. Moreover, it will likely be years before another product using HnB technology
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`is available in the U.S. due to the FDA’s lengthy and uncertain PMTA process.
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`Removing IQOS from the market under these circumstances would be unconscionable.
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`3. Removal of IQOS from the U.S. marketplace will discourage diversity in the
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`harm reduction arena, which is against the public interest.
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`As mentioned previously, IQOS is the only product in the ENDS category (as defined by
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`Complainants) that is being marketed under a PMTA. The PMTA process requires a substantial
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`commitment of time, money, and expertise, and there is little certainty in the process. The
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`current PMTA process is daunting, and CASAA is concerned that removal of the only ENDS
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`product with a PMTA will discourage other businesses with ENDS products from filing for
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`PMTAs. From a consumer perspective, it is vitally important that a diversity of products remain
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`on the market, and that cannot happen if businesses are deterred from filing PMTAs.
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`4. Removal of IQOS from the U.S. marketplace will potentially, and negatively,
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`CASAA Comment
`Investigation No. 337-TA-3447
`April 22, 2020
`Page 5
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`impact millions of consumers, not simply those who currently use IQOS.
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`Complainants assert that the requested relief will only affect those consumers who
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`specifically use IQOS. This is simply not true. While it is true that the most immediate impact will
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`be on consumers who currently use IQOS, it completely ignores the substantially larger
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`population of 34 million people in the U.S. who smoke and who may choose to use IQOS in the
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`future. Granting the requested relief would not simply take the product out of the hands of
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`existing consumers, but would deny millions of people in the U.S. who smoke the ability to
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`explore using IQOS as a means of reducing their risk.
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`CASAA understands that there are many factors for the ITC to consider in its evaluation
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`of these public health issues, but CASAA respectfully submits that the harm that would be done
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`to consumers by removing IQOS from the U.S. market is substantial, immediate, and
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`irreparable. We appreciate the opportunity to share our views with the ITC and thank the ITC for
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`its considered review of the issues raised.
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`Respectfully Submitted,
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`Alex Clark
`CEO, CASAA
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`Julia Woessner
`National Policy Director, CASAA
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`CERTIFICATE OF SERVICE
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`It is hereby certified that copies of THIRD PARTY PUBLIC INTEREST COMMENTS
`were served on April 27, 2020 as follows:
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`337-TA-3447
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`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`By EDIS
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`David M. Maiorana
`Ryan B. McCrum
`JONES DAY
`901 Lakeside Avenue
`Cleveland, OH 44114
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`Stephanie E. Parker
`JONES DAY
`1420 Peachtree Street, N.E.
`Suite 800
`Atlanta, GA 30309
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`Holdings, Inc., R.J. Reynolds Vapor Company, and
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`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive
`Suite 1500
`San Diego, CA 92121
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`John J. Normile
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Tel: (212) 326-3939
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`On Behalf of Complainants RAI Strategic
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`R.J. Reynolds Tobacco Company
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`By Email
`dmaiorana@jonesday.com
`rbmccrum@jonesday.com
`separker@jonesday.com
`aminsogna@jonesday.com
`jjnormile@jonesday.com
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`/s/ Benjamin Levi
`Benjamin Levi
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