`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 Nextera
`Healthcare.
`
`Respectfully submitted,
`
`//s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1045
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1045-001
`
`
`
`April 16,2020
`
`United States International Trade Commission, Washington DC
`
`In the Matter of Certain Tobacco Heating Articles and Components Thereof
`
`Investigation No. 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.; RJ. Reynolds Vapor Company; and RJ. Reynolds Tobacco
`
`Company.
`
`I understand that the complainants seek to exclude IQOS heat not burn systems from
`
`the US. market and I am concerned that such a ban would have a Serious negative impact on the
`
`public health and welfare of US. consumers.
`
`As a primary care physician, I routinely see patients who smoke and suffer from chronic
`
`illnesses related to their smoking. Without question, the first course of treatment for these patients
`
`is counseling on smoking cessation. We work hard with patients to get them to quit. For a
`
`EX. 1045-002
`
`Ex. 1045-002
`
`
`
`multitude ofreasons, however, many patients just cannot or will not stop smoking cigarettes. Even
`
`with proper counseling, prescription nicotine replacement therapy. or other methods, some of my
`
`patients just can't stop. There are also some who will not stop. They've either made a conscience
`
`decision to disregard the risks, or have other behavioral health issues which make quitting less of
`
`a priority. Many of them are, of course, self-medicating with nicotine.
`
`The truth is that smoking remains the leading preventable cause of premature disease and
`
`death in the United States. So, what can we as physicians do for the patients who cannot stop?
`
`Primary care physicians and behavioral health specialists are in need of new Strategies to help in
`
`this effort. That's why I was very pleased to see the Food and Drug Administration take steps to
`
`develop a new comprehensive plan for tobacco and nicotine regulation that will recognize that
`
`although nicotine is addictive and can be harmful, it certainly is most harmful when delivered
`
`through smoke particles in combustible cigarettes.
`
`In the New England Journal of Medicine
`
`jflEJM} published August 16, 2017', then-FDA Commissioner Scott Gottlieb wrote:
`
`The regulatory framework for reducing harm from tobacco must include nicotine
`w 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
`
`regulatory tool to do just that. The Family Smoking Prevention and Tobacco Control
`
`Act of 2009 lets FDA review scientific evidence behind new tobacco products and also
`
`gives the FDA the power to bring potentially reduced risk products to market as long as
`
`they are appropriate for the protection of public health.
`
`I‘J
`
`EX. 1045-003
`
`Ex. 1045-003
`
`
`
`The advent of non-combustible alternative tobacco products does raise
`
`significant questions for physicians andtheir patients.
`
`If there are products that
`
`deliver the nicotine patients crave,
`
`in a form that
`
`is pleasing to them, with
`
`significantly reduced harm to themselves and the rest of the population, then such
`
`products could play a significant part inapatient‘s journey to quitting. Both patients
`
`and their physicians, however, will need to look to the FDA to provide an evidence-
`
`based review of these products on an ongoing basis to ensurethattherearen't any other
`
`unintended harms thatmay come as result of a transition from traditional cigarettes.
`
`It's also important that the FDA review these products over time to ensure that public
`
`health is continually protected.
`
`In April 2019, the FDA for the first time authorized one such novel potentially
`
`reduced risk non-combustible product — IQOS tobacco heatingsystem —for sale in
`
`the United States. In its review of the company‘s applications, FDA made the
`
`following key obselvations:
`
`'
`
`FDA‘s scientific evaluatiou of the company's applications, peer-
`
`reviewed published literature and other sources found that the aerosol
`
`produced by the IQOS tobacco heating system contains fewer toxic
`
`chemicals than cigarette smoke, and many of the toxins identified are
`
`present at lower levels than in cigarette smoke.
`
`Clinical studies ofupto sixmonths induration demonstrated improved
`
`biomarkers of exposure, which indicates reduced exposure to
`
`harmful and potentially harmful constituents. Although these
`
`studies did not demonstrate reduction in long-term disease risks, the
`
`EX. 1045-004
`
`Ex. 1045-004
`
`
`
`currently available evidence indicates that smokers of combusted
`
`cigarettes who switch completely to IQOS will havereducedtoxic
`
`exposures and this is likely to lead to less risk of tobacco—related
`
`diseases.
`
`'
`
`IQOS delivers nicotine in levels close to combustible cigarettes
`
`suggesting a likelihood that IQOS users may be able to completely
`
`transition away from combustible cigarettes and use IQOS exclusively.
`
`‘
`
`Available data, while limited, also indicate that few non-tobacco users
`
`would be likely to choose to start using IQOS, including youth.
`
`IQOS tobacco heating system is fundamentally different from e-cigarettes and
`
`combustible cigarettes. A heated tobacco product such as IQOS consists of a heating
`
`source and tobacco. The tobacco may be wrapped in paper, which makes it a type of
`
`cigarette. However, the tobacco is heated to a lower temperature than a combusted
`
`cigarette to create an aerosol that the user inhales. On the other hand, an e-cigarette uses
`
`an e-liquid that may contain nicotine, glycerin, propylene glycol, flavorings, and other
`
`ingredients. The device has an electric heat source that heats thee-liquid to create an
`
`aerosol that the user inhales.
`
`Because IQOS uses tobacco and tastes like tobacco, one can expect that millions of
`
`smokers in the United States who are looking for a potentially less harmful alternative will be
`
`interested in this product. This includes a large segment of the smoker population who have tried
`
`e-clgarettes but rejected them, including my patients. Equally, a large portion of e-cigarette users
`
`continue to smoke, undermining any potential benefits from switching toe-cigarettes.
`
`EX. 1045-005
`
`Ex. 1045-005
`
`
`
`Finally, issues related to adulterated e-cigarette products, youth initiation, and lack of
`
`effective regulatory oversight (no e-cigarette has been reviewed for its public health impact by
`
`FDA to date and there is no certainty whether e-cigarettes will be able to meet the public standard
`
`mandated by the Tobacco Control Act to continue to be available for sale once FDA begins
`
`premarket reviews of the products), make the continued availability of IQOS fl the only heat not
`
`burn product that has received a premarket order from FDA — critically important to ensure
`
`addicted cigarette smokers have a Viable offramp from smoking.
`
`I expect that the ITC will evaluate these public interest issues carefully.
`
`In doing so,
`
`however, I urge consideration of the potential ramifications on public health and welfare. Thank
`
`you for the critical work that you do.
`
`Sincerely,
`
`Krfl fl/fiwng 54%
`
`Clint Flanagan, MD.
`
`Founder & CEO
`
`Nextera Healthcare
`
`North Vista Medical Center
`
`4943 Hwy 52 Ste. 240 Dacono, CO 80514 Phone-303-50] -2600/Fax-877-764—4622
`
`EX. 1045-006
`
`Ex. 1045-006
`
`
`
`
`
`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. 1045-007
`
`