`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
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`Dear Secretary Barton:
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`Enclosed please find as a courtesy filing the Public Interest Comments of the Smoke-Free
`Alternatives Trade Association.
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`Respectfully submitted,
`
`/s/ Jamie D. Underwood
`
`Jamie D. Underwood
`of LATHAM & WATKINS LLP
`
`Enclosure
`
`cc:
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`Service List
`
`Philip Morris Products, S.A.
`Exhibit 1049
`PMP v. RAI
`IPR2020-00919
`
`Ex. 1049-001
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`Smoke-Free Alternatives Trade Association
`1155 F Street NW
`Suite 1050
`Washington, DC 20004
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`Docket No. 3447
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`April 20, 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
`
`
`
`Dear Secretary Barton:
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`
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`
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`Re: Certain Tobacco Heating Articles and Components Thereof
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`The Smoke-Free Alternatives Trade Association (“SFATA”) submits the
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`following comments to the U.S. International Trade Commission (“ITC”) in response to
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`the Public Interest Statement filed on April 15, 2020, in the Federal Registry, Volume 85
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`No. 73. Complainants ask the ITC to issue a limited exclusion order, cease and desist
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`orders and other requirements, during the 60-day Presidential Review period pursuant to
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`19 U.S.C. 1337(j). The request would affect the U.S. market on all IQOS heat not burn
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`(“HNB”) systems.
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`SFATA believes that while electronic cigarettes and vapor products provide
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`significant harm reduction products in the battle against death and disease from smoking,
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`HNB systems also offer significant alternatives to traditional combustible tobacco
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`products, including cigarettes. Additionally, this measure would harm competitive
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`conditions in the United States for smoke free alternative products, frustrate choices for
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`Docket No. 3447
`
`
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`1
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`Ex. 1049-002
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`Smoke-Free Alternatives Trade Association
`1155 F Street NW
`Suite 1050
`Washington, DC 20004
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`consumers who want to switch from using cigarettes and stifle innovation in a space that
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`has the potential to save many lives.
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`SFATA, a 501(c)(6) organization, is a national trade association of businesses that
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`work in, or in service of, the electronic vapor products industry, including manufacturers,
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`distributors and retailers. SFATA’s core mission is to advocate for a reasonably regulated
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`U.S. marketplace which allows its member companies to provide smoke-free reduced
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`harm alternative products to smoking adult consumers, while promoting a positive and
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`truthful public image for vapor products and educating businesses and policy makers
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`regarding our industry.
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`Factors influencing Remedial Order That are in Accordance with Public Interest
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`SFATA cannot comment on the underlying merits of the allegations in the above
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`referenced litigation. Nevertheless, SFATA recognizes there is a strong public interest in
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`protecting intellectual property rights and strongly recommends that members utilize this
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`tool in their own businesses. The protection of intellectual property rights provides
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`businesses with a climate of predictability, encourages innovation, investment and the
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`exchange of technology and property rights. While these allegations made by the
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`complainants are significant, SFATA cannot support the removal of the subject HNB
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`products by the ITC.
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`Docket No. 3447
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`2
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`Ex. 1049-003
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`Smoke-Free Alternatives Trade Association
`1155 F Street NW
`Suite 1050
`Washington, DC 20004
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`Exclusion of HNB Products Would Frustrate Market Conditions for Consumers
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` The electronic vapor industry considers the subject IQOS products to be
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`competition to its inhalable vapor products. At its core, the electronic vapor industry has
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`always recognized the issue that combustible tobacco products pose significant health
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`issues to the consumer in the long term. With this in mind, not all consumers find
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`electronic vapor products to be an acceptable alternative to conventional smoking.
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`However, heated tobacco products, including HNB products, hold promise for Americans
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`who are trying to quit/reduce traditional cigarette smoking. SFATA therefore believes
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`there is a strong need for a ready availability of several alternative products to help
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`smokers in accomplishing their goal, including IQOS. The ITC removing IQOS
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`products from the U.S. market will severely limit smokers who have already found such
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`products to be an aid to reducing/quitting cigarettes. While one HNB tobacco product
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`has undergone the FDA’s Substantial Equivalence (“SE”) process, only IQOS has been
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`authorized by the FDA through the Pre-Market Tobacco Application (“PMTA”) pathway,
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`which requires a finding that the product is appropriate for the protection of public health.
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`
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`PMTA clearance is required for any new HNB tobacco product, and that process
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`could take years to complete, exclusion would result in one product only be available for
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`an indeterminate period. Further, having no choice in HNB tobacco products could
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`increase prices, causing many tobacco users to return to traditional cigarettes or turning to
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`the black market.
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`Docket No. 3447
`
`
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`3
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`Ex. 1049-004
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`Smoke-Free Alternatives Trade Association
`1155 F Street NW
`Suite 1050
`Washington, DC 20004
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`SFATA believes that consumer choice is at the heart of the solution in helping
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`smoking adults’ transition to alternative products that potentially provide for harm
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`reduction. Every consumer is different, and thus no one particular flavor or product is the
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`sole solution to helping consumers transition away from combustible tobacco. In
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`addition, reducing the U.S. market to a single supplier would foster the very monopolistic
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`practices Congress and the ITC have sought to prevent.1
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`Exclusion of IQOS Would Stifle Innovation in the Reduced Risk Product Space
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`
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`Encouraging the development of non-combustible products would stimulate
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`innovation in a space that has the potential to save many lives. As more Americans than
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`ever seek to quit traditional cigarette smoking, companies and individuals interested in
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`creating innovative alternative tobacco products are weighing the costs/benefits of
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`participating in the U.S. market. In SFATA’s view, if the U.S. market continues to be too
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`expensive and uncertain, it will reduce the probability that companies will attempt to
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`keep their current products on the market as well as bring new products to market. IQOS
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`has undergone the FDA’s robust review process. Excluding a product already authorized,
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`with the potential to help millions of smokers, even if temporarily, sends the wrong
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`public health message and stifles the introduction of new solutions. Policies encouraging
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`
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`1 See Certain Automatic Crankpin Grinders, Inv. No. 337-TA-60, Alberger, Bedell, and Stern
`Comm’n Op. at 18 (Dec. 1979).
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`Docket No. 3447
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`4
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`Ex. 1049-005
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`Smoke-Free Alternatives Trade Association
`1155 F Street NW
`Suite 1050
`Washington, DC 20004
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`the availability of affordable health innovations is central to the FDA’s mission – and one
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`the ITC should support.
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`SFATA respectfully requests that the ITC weigh these public interest harms when
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`assessing whether public interest issues should be delegated to the assigned
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`Administrative Law Judge. SFATA appreciates the ITC’s attention to this matter.
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`Respectfully submitted,
`
`Mark Anton
`Executive Director
`
`
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`Docket No. 3447
`
`
`
`5
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`Ex. 1049-006
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`
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`
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`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
`
`
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`
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`Ex. 1049-007
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`