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`Benjamin Levi
`202.997.3711
`blevi@levisnotherly.com
`
`April 27, 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,
`Dkt. No. 337-3447
`
`
`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 Nextera Healthcare (“Nextera”). Latham had full permission to do so and
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`submitted the filing as a courtesy to Nextera.
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`
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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 Nextera received notice of this issue in time to address
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`the concern.
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`The undersigned represents Nextera for purposes of perfecting the filing of its
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`public interest comments. Nextera 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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`

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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, Nextera 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
`____________
`Benjamin Levi
`
`
`
`
`Levi & Snotherly, PLLC 1101 Connecticut Ave., N.W., Suite 450
`Washington, DC 20036
`
`
`

`

`
`
`April 16, 2020
`
`United States International Trade Commission, Washington DC
`
`In the Matter of Certain Tobacco Heating Articles and Components Thereof
`
`Investigation N0. DN 3447
`
`Public interest comment submitted by Clint Flanagan,
`
`M.D., Founder & CEO, Nextera Healthcare
`
`I welcome the opportunity to provide comments to the US.
`
`International Trade
`
`Commission in response to the Public Interest Statement filed on April 9, 2020, by Complainants
`
`RAI Strategic Holdings, Inc.; R.J. Reynolds Vapor Company; and RI. Reynolds Tobacco
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`Company.
`
`I understand that the complainants seek to exclude IQOS heat not burn systems from
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`the US. market and I am concerned that such a ban would have a serious negative impact on the
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`public health and welfare of US. consumers.
`
`As a primary care physician, I routinely see patients who smoke and suffer from chronic
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`illnesses related to their smoking. Without question, the first course of treatment for these patients
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`“is counseling on smoking cessation. We work hard with patients to get them to quit. For a
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`

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`multitude of reasons, however, many patients just cannot or will not stop smoking cigarettes. Even
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`with proper counseling, prescription nicotine replacement therapy, or other methods, some of my
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`patients just can't stop. There are also some who will not stop. They've either made a conscience
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`decision to disregard the risks, or have other behavioral health issues which make quitting less of
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`a priority. Many of them are, of course, self-medicating with nicotine.
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`The truth is that smoking remains the leading preventable cause of premature disease and
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`death in the United States. So, what can we as physicians do for the patients who cannot stop?
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`Primary care physicians and behavioral health specialists are in need of new strategies to help in
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`this effort. That's why I was very pleased to see the Food and Drug Administration take steps to
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`develop a new comprehensive plan for tobacco and nicotine regulation that will recognize that
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`although nicotine is addictive and can be harmful, it certainly is most harmful when delivered
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`through smoke particles in combustible cigarettes.
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`In the New England Journal of Medicine
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`(NEJMQ published August 16, 2017, then-FDA Commissioner Scott Gottlieb wrote:
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`The regulatory framework for reducing harm from tobacco must include nicotine
`— the chemical responsible for addiction to tobacco products — as a centerpiece.
`Nicotine, though not benign, is not directly responsible for the tobacco-caused
`cancer,
`lung disease, and heart
`disease that kill hundreds of thousands of
`Americans each year. The FDA’s approach to reducing the devastating toll of
`tobacco use must be rooted in this foundational understanding: other chemical
`compounds in tobacco, and in the smoke created by combustion, are primarily to
`blame for such health harms.
`
`As Commissioner Gottlieb pointed out in the NEJM, the law provides the FDA with a
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`regulatory tool to do just that. The Family Smoking Prevention and Tobacco Control
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`Act of 2009 lets FDA review scientific evidence behind new tobacco products and also
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`gives the FDA the power to bring potentially reduced risk products to market as long as
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`they are appropriate for the protection of public health.
`
`

`

`The advent of non—combustible alternative tobacco products does raise
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`significant questions for physicians andtheir patients.
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`If there are products that
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`deliver the nicotine patients crave,
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`in a form that
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`is pleasing to them, with
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`significantly reduced harm to themselves and the rest of the population, then such
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`products could play a significant part in apatient's journey to quitting. Both patients
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`and their physicians, however, will need to look to the FDA to provide an evidence-
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`based review of these products on an ongoing basis to ensure that there aren't any other
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`unintended harms thatmay come as result of a transition from traditional cigarettes.
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`It's also important that the FDA review these products over time to ensure that public
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`health is continually protected.
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`In April 2019, the FDA for the first time authorized one such novel potentially
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`reduced risk non-combustible product — IQOS tobacco heatingsystem —for sale in
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`the United States. In its review of the company's applications, FDA made the
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`following key observations:
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`’
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`FDA's scientific evaluation of the company's applications, peer-
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`reviewed published literature and other sources found that the aerosol
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`produced by the IQOS tobacco heating system contains fewer toxic
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`chemicals than cigarette smoke, and many of the toxins identified are
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`present at lower levels than in cigarette smoke.
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`‘
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`Clinical studies ofup to sixmonths in duration demonstrated improved
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`biomarkers of exposure, which indicates reduced exposure to
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`harmful and potentially harmful constituents. Although these
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`studies did not demonstrate reduction in long-term disease risks, the
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`

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`currently available evidence indicates that smokers of combusted
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`cigarettes who switch completely to IQOS will havereducedtoxic
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`exposures and this is likely to lead to less risk of tobacco-related
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`diseases.
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`IQOS delivers nicotine in levels close to combustible cigarettes
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`suggesting a likelihood that IQOS users may be able to completely
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`transition away from combustible cigarettes and use IQOS exclusively.
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`Available data, while limited, also indicate that few non-tobacco users
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`would be likely to choose to start using IQOS, including youth.
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`IQOS tobacco heating system is fundamentally different from e-cigarettes and
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`combustible cigarettes. A heated tobacco product such as IQOS consists of a heating
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`source and tobacco. The tobacco may be wrapped in paper, which makes it a type of
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`cigarette. However, the tobacco is heated to a lower temperature than a combusted
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`cigarette to create an aerosol that the user inhales. On the other hand, an e—cigarette uses
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`an e-liquid that may contain nicotine, glycerin, propylene glycol, flavorings, and other
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`ingredients. The device has an electric heat source that heats thee-liquid to create an
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`aerosol that the user inhales.
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`Because IQOS uses tobacco and tastes like tobacco, one can expect that millions of
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`smokers in the United States who are looking for a potentially less harmful alternative will be
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`interested in this product. This includes a large segment of the smoker population who have tried
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`e-cigarettes but rejected them, including my patients. Equally, a large portion of e—cigarette users
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`continue to smoke, undermining any potential benefits from switching toe-cigarettes.
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`

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`Finally, issues related to adulterated e-cigarette products, youth initiation, and lack of
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`effective regulatory oversight (no e-cigarette has been reviewed for its public health impact by
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`FDA to date and there is no certainty whether e—cigarettes will be able to meet the public standard
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`mandated by the Tobacco Control Act to continue to be available for sale once FDA begins
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`premarket reviews of the products), make the continued availability of IQOS — the only heat not
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`burn product that has received a premarket order from FDA — critically important to ensure
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`addicted cigarette smokers have a viable offramp from smoking.
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`I expect that the ITC will evaluate these public interest issues carefully. In doing so,
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`however, I urge consideration of the potential ramifications on public health and welfare. Thank
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`you for the critical work that you do.
`
`Sincerely,
`
`fléi/f (/W ”J,
`
`Clint Flanagan, M.D.
`
`Founder & CEO
`
`Nextera Healthcare
`
`North Vista Medical Center
`
`4943 Hwy 52 Ste. 240 Dacono, CO 80514 Phone-303-50l-2600/Fax—877-764-4622
`
`

`

`CERTIFICATE OF SERVICE
`
`It is hereby certified that copies of THIRD PARTY PUBLIC INTEREST COMMENTS
`were served on April 27, 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
`
`
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`
`
`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
`
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`Holdings, Inc., R.J. Reynolds Vapor Company, and
`
`
`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
`
`R.J. Reynolds Tobacco Company
`
`By Email
`dmaiorana@jonesday.com
`rbmccrum@jonesday.com
`separker@jonesday.com
`aminsogna@jonesday.com
`jjnormile@jonesday.com
`
`/s/ Benjamin Levi
`Benjamin Levi
`
`
`
`

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