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
`
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`
`Re:
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`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 Dr. Nikan H.
`Khatibi, MD.
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`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
`
`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1044
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1044-001
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`

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`April 18, 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: Investigation No. 337-TA-3447
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`
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`Dear Secretary Barton:
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`I am part of an informal, physician-led group of health professionals devoted to providing
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`patients with devices to help them stop smoking traditional combustible cigarettes. Based on my
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`experience in this area, I would like to offer thoughts regarding a request made by certain Reynolds
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`entities in a Complaint filed with the U.S. International Trade Commission (“Commission”) on April
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`9, 2020. The Reynolds Complainants have asked the Commission to prevent the importation, and
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`thus the availability to Americans, of the IQOS heated tobacco system. I do not believe this serves
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`U.S. public health goals.
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`While the percentage of U.S. smokers has declined in the last half century, smoking remains
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`the number one cause of preventable death, and tens of millions of Americans still smoke. The
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`smoking cessation/reduction tools available to aid physicians in their quest to help patients quit or
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`transition from traditional cigarettes have made some progress. It is time, however, to embrace new
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`solutions.
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`Physicians, and all health professionals, live by the “first do no harm” oath, but complete
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`elimination of risk is very hard in the realm of science, and also in patients’ lives. Reduction of risk is
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`often the best solution. Not all potentially reduced risk smoking alternatives will work on every patient,
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`however. Individual patients will respond differently to various therapeutic approaches. For these
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`reasons, development and access to a range of potentially reduced risk products like IQOS is the key
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`Ex. 1044-002
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`

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`to achieving a meaningful reduction in Americans’ use of traditional cigarettes.
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`As the Surgeon General stated, the death and disease burden of tobacco in this country is
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`overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their
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`use will dramatically reduce this burden. Therefore, a heated tobacco system such as IQOS, which is
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`designed to deliver tobacco without combustion is an important development. Indeed, it should be of
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`the upmost and immediate interest to public health to move current smokers away from combustible
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`cigarettes. Other countries have offered IQOS as a non-combustible tobacco option for years, and with
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`success. For example, a recent paper from the American Cancer Society found that the introduction of
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`IQOS in Japan, the country with the highest number of IQOS users in the world, dramatically reduced
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`cigarette sale in Japan. The researchers found that the decline in cigarette sales increased five-fold
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`following the introduction of IQOS, without increasing the overall sales of tobacco products. IQOS
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`now has almost 14 million users worldwide.
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`In the United States, IQOS has passed through the appropriate regulatory gates by receiving
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`authorization for sale from FDA through the Premarket Tobacco Application (“PMTA”) process. To
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`obtain this type of clearance, an applicant has to show its product is appropriate for the protection of
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`the public health. No other heat not burn product or e-cigarette has been PMTA-authorized. In fact,
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`e-cigarettes have gone largely unregulated. As major concerns mount regarding the rise of youth use
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`of e‐cigarettes and related marketing that targets this vulnerable group, FDA has recognized data
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`showing low youth uptake of IQOS and, through its premarket order, closely restricts and inspects
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`IQOS marketing.
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`The uncertainty and controversy around e-cigarettes and other novel tobacco and nicotine
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`products is unlikely to abate any time soon. Therefore, more than ever, the healthcare providers must
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`rely on FDA’s regulatory review process to ensure that the products that are permitted to be sold on
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`the market meet appropriate regulatory standards. While quitting all tobacco and nicotine use is the
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`best choice for smokers, most smokers are unfortunately unable to achieve abstinence. In this
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`Ex. 1044-003
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`

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`context, the continued availability of FDA-authorized products that have the potential to reduce
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`smoking-related harms is a sensible strategy with a potential to move many more smokers off the
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`nicotine delivery method that is by far the most harmful – lighting tobacco on fire.
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`In sum, IQOS is a non-combustible tobacco delivery system from which millions of
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`Americans could benefit. That possibility goes away, however, should IQOS be banned from the
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`U.S. market. If the United States is serious about reducing traditional smoking rates, it cannot
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`deprive U.S. consumers of this popular, PMTA-cleared option.
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`Regards,
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`Dr. Nikan H. Khatibi, MD
`
`Ex. 1044-004
`
`

`

`
`
`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. 1044-005
`
`