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
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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 Spark MD.
`
`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1050
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1050-001
`
`

`

`April 21, 2020
`
`
`
`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
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`Dear Secretary Barton:
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` I write to relay my thoughts regarding the Public Interest Statement that was filed in conjunction
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`with the above-referenced matter at the U.S. International Trade Commission on April 9, 2020. Banning
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`the IQOS heated tobacco system is not in the best interest of U.S. public health. I strongly urge the Trade
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`Commission to allow marketing and sales of IQOS in the United States and would like to explain why
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`this product is important as a public health tool of smoking cessation.
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`I have been a family physician for fourteen years. In that time, I have used many different tools in
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`my efforts to help people quit smoking traditional cigarettes. Notwithstanding my dedication to the task,
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`less than five-percent (5%) of my smoking population has had any real success with cessation. My
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`colleagues would share the same data. Until learning about heat-not-burn products, I had come to accept
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`that smoking cessation was not an area where I was able to offer my patients much in terms of realistic,
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`effective cessation tools.
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`The vast majority of people who smoke are well aware that they should quit. However, cessation
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`options presently available in the United States are woefully inadequate. Nicotine replacements such as
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`lozenges, patches and gum do not replicate, biochemically, the nicotine delivery of a cigarette. Many
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`smokers try them and say, quite uniformly, “they don’t work”. Medications such as Wellbutrin and
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`Chantix can be cost-prohibitive and often cause side effects intolerable to the user. In the U.S, using all
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`1 | Page
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`Ex. 1050-002
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`

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`available options, in the most motivated of people, under the most ideal situation, we have a less than
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`18% cessation rate. The “average” smoker must try to quit an average of eight times before he or she
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`might be successful. In fourteen years, following all training and guidelines and trying every trick I can
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`think of, I have not found a product or strategy that truly helps people transition away from combustible
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`cigarettes and move toward cessation. Our all-or-nothing approach does not accommodate gradual
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`modifications in human behavior that lead to sustained change. Because of this, patients who smoke fail
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`in their cessation efforts time and time again.
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`One of the beautiful things about humans is we often do what feels best right now, not what is in
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`our long-term interest. Solving problems ‘right now’ is one reason all-or-nothing approaches don’t work.
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`With virtually every other detrimental health condition including diabetes, obesity, unprotected
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`intercourse, opiate addiction and many more, we have therapeutic options to help people transition . This
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`has not been the case with smoking. In the U.S, our approach to smoking cessation is akin to telling a
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`person who is one-hundred pounds overweight that they must lose one-hundred pounds. Right now.
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`Offering two behavioral options – continue where you are or modify everything to end-goal right now –
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`sets up a success or failure paradigm that leaves no room for gradual improvement.
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`Incremental change – as with the weight loss metaphor encouraging that even a reduction of
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`twenty-five pounds is a marked health improvement – until recently did not exist as part of our dialogue
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`about smoking cessation. New non-combustible nicotine delivery systems such as heat-not-burn tobacco
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`products offer the possibility of a gradual modification in nicotine exposure and smoking behaviors while
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`a person works toward full cessation.
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` In this way these new products open up an entirely different
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`approach to smoking cessation. Heat-not-burn products provide another option for the U.S. healthcare
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`system, and the physicians within it, to rethink our dialogue around motivational change for our smokers.
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`I was extremely skeptical of heat-not-burn options prior to learning about the research and utility
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`of the IQOS in early 2019. I had never thought about the option of helping smokers in a transitional way.
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`2 | Page
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`Ex. 1050-003
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`

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`After learning about how the IQOS delivers nicotine and reduces a patient’s exposure to the toxic
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`products of combustion released with a traditional cigarette, I had a paradigm shift. It may sound strange,
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`as a physician, to say I became extremely excited about the option to start to work with my patients on a
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`transition away from traditional cigarettes. I became excited to have something new to offer people who
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`have failed every other method of smoking cessation time and again. And I became hopeful, after
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`forty-four years of inhaling my father’s KOOL menthol second-hand smoke, that maybe there was
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`something out there to help him quit, too.
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`I began to think, if I can’t help people quit all the way…can I help them quit part way? Does
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`shifting towards the road of cessation move people through the hardest first part of change? Leading a
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`conversation that looks towards cessation as a matter of incremental change differs from the long-held
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`culture of saying that smoking is deleterious for health and quitting is the only option. The absolutism of
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`that strategy towards cessation has been and remains woefully ineffective. Is continuing a harmful habit
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`that can be modified to be less harmful better than no change at all? As a physician and daughter of a
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`smoker, I think it is.
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`The IQOS allows for a gradual reduction in nicotine and an instant reduction in exposure to the
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`harmful byproducts of traditional cigarette smoke- both for the smoker and the people around him or her.
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`I have discussed the IQOS with patients. Based on the biochemistry of the device, I have been eagerly
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`awaiting this as an effective option to assist my patients in smoking cessation.
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` I purchased an IQOS
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`overseas for my father in 2019. He began using it, was committed, was (after 60 years!) believing he
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`could quit smoking, and then stopped using it because he cannot purchase IQOS compatible supplies
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`where we live in the U.S.
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`Taking away the IQOS - the only novel alternative nicotine product reviewed by the U.S. Food
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`and Drug Administration and found to be appropriate for the protection of public health- would be a
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`massive step backward in U.S smoking reduction. The IQOS is a tool to help patients on the road to
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`3 | Page
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`Ex. 1050-004
`
`

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`behavioral change. It is a tool people can use to improve their quality of life as they work toward ‘perfect’
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`wellness. IQOS has been available, and extremely successful, in dozens of countries for more than three
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`years with many success stories of transition leading to cessation.
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`The medical community in the U.S. desperately needs more options to effectively advocate for
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`change when it comes to traditional smoking. Cessation, while ideal, is not an effective approach
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`straight-out-of-the-gates for virtually any detrimental health condition. Working with people and helping
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`them down a path is what leads to change. Absolute declarations of this-or-that simply don’t work. The
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`IQOS is a novel transitional device, FDA approved after years of thoughtful hard-won research and a
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`necessary tool towards helping smokers transition away from traditional cigarettes. To change the
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`absolutist strategy towards cessation, a wide choice of potentially reduced-risk products is needed.
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`Excluding IQOS as a product available to US smokers would be a step in the wrong direction.
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`Thank you,
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`Julie K. Gunther, MD, FAAFP
`sparkMD, Owner, Physician
`2402 West Jefferson Street
`Boise, Idaho 83702
`drg@sparkmd.com
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`4 | Page
`
`Ex. 1050-005
`
`

`

`
`
`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. 1050-006
`
`