Conservative Action Starts Here – bringing you CPAC, Congressional ratings, and principled policy solutions
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`April 22, 2020
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`The Honorable Lisa R. Barton
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`Secretary to the Commission
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`U.S. International Trade Commission
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`500 E Street S.W.
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`Washington, DC 20436
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`Re: Docket No. 337-3447
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`Certain Tobacco Heating Articles and Components Thereof
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`Dear Secretary Burton,
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`The American Conservative Union (ACU) believes in a strongly enforced Intellectual Property (IP) regime
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`that respects innovators, and rewards creators for the fruits of their labor. ACU has worked hard to support
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`positive reforms that strengthen the IP system in the United States and around the world. We believe IP rights
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`are critical to innovating and incentivizing the engine of the American economy.
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`ACU is also in support of the U.S. International Trade Commission (USITC) following normal procedures
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`that follow past precedent with regard to ongoing matters before the commission, which generally favor a
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`gathering facts, examining patents, and adjudicating the legal process before any decision to implement an
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`exclusionary rule is reached by the USITC. Therefore, we support allowing the importation of IQOS to
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`continue as the USITC conducts its proceeding.
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`American Conservative Union
`1199 N. Fairfax Street, Ste. 500 Alexandria, VA 22314
`P: (202) 347-9388 F: (202) 347-9389 ACU@conservative.org
`www.conservative.org Twitter.com/acuconservative Facebook.com/acuconservative
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`Philip Morris Products, S.A.
`Exhibit 1041
`PMP v. RAI
`IPR2020-00919
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`Ex. 1041-001
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`Conservative Action Starts Here – bringing you CPAC, Congressional ratings, and principled policy solutions
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`Finally, ACU believes it is critical that the USITC take into account research done showing potential benefits
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`for consumer choice in the harm reduction space as it relates to IQOS and its authorized sale in the United
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`States. As such, please find attached comments ACU previously filed to the Food and Drug Administration
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`(FDA). These publicly filed comments noted findings of strong compelling public interest in favor of
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`allowing for the approval of IQOS system product applications in the United States.
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`Respectfully,
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`Daniel Schneider
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`Executive Director
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`American Conservative Union
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`American Conservative Union
`1199 N. Fairfax Street Suite 500 Alexandria, VA 22314
`P: (202) 347-9388 F: (202) 347-9389 ACU@conservative.org
`www.conservative.org Twitter.com/acuconservative Facebook.com/acuconservative
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`Ex. 1041-002
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`Conservative Action Starts Here – bringing you CPAC, Congressional ratings, and principled policy solutions
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`September 15, 2017
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`Scott Gottlieb, M.D.
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`Commissioner
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`Division of Dockets Management (HFA-305)
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`Food and Drug Administration
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`5630 Fishers Lane, Room 1061 Rockville, MD 20852
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`Re: Docket No. FDA-2017-D-3001
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`Modified Risk Tobacco Product Applications for IQOS System, 82 Fed. Reg. 27487 (June 15, 2017)
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`Dear Dr. Gottlieb:
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`The American Conservative Union’s mission includes advancing our nation’s founding principles of political
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`liberty and limited government. Because we know that Americans across all income levels and neighborhoods
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`do better under a free enterprise system, ACU defends it from the overreach of the regulatory state as part of
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`our mission. As our organization has repeatedly said: Free enterprise is the only economic system that offers
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`the promise of widespread prosperity and the protection of individual rights. Building on that foundation of
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`responsible, reasonable, and limited government combined with respect for the opportunity for prosperity and
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`respect for the individual, ACU supports allowing for the expansion of the market in the harm-reduction
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`space and urges the FDA to grant Modified Risk Tobacco Product (MRTP) application approval for the IQOS
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`System.
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`American Conservative Union
`1199 N. Fairfax Street Suite 500 Alexandria, VA 22314
`P: (202) 347-9388 F: (202) 347-9389 ACU@conservative.org
`www.conservative.org Twitter.com/acuconservative Facebook.com/acuconservative
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`Ex. 1041-003
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`Conservative Action Starts Here – bringing you CPAC, Congressional ratings, and principled policy solutions
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`Innovation spurs the free-market economy and the power of consumer choice drives innovation. ACU
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`believes that there is a limited role for the government to ensure that certain products meet basic standards,
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`regulators should not be in the business of preventing consumers from making their own choices when it
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`comes to harm reduction products they prefer or want to try.
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`The IQOS System offers a new choice for Americans who may be seeking to make a change in their health,
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`habits, and daily lives. The product is new to the United States, but it is becoming more recognized around the
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`world as 32 countries (including Japan, Australia, and countries in the EU) have approved IQOS already.
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`With many parts of the world allowing for this new choice on the marketplace, the answer for the FDA is a
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`simple one: don’t hinder innovation by overstepping the regulatory reach in contradiction of consumer
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`choices.
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`In the past decade, the market for tobacco products has undergone a number of changes. New technologies are
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`making it possible for innovation to move what was once a limited environment for consumer choice, into a
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`brand new space altogether with harm-reduction now playing a significant role in how the market looks.
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`On IQOS specifically, the product is giving consumers in other countries a new choice, and the initially
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`numbers on IQOS are encouraging from a free-market, consumer-driven, and liberty-minded perspective.
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`Since the product was introduced in 2014 (initially in Japan) nearly 3 million adult smokers worldwide have
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`made the decision to stop smoking and switch to IQOS. Specifically, in Japan, the industry volume of
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`cigarettes and other heated tobacco products has declined by 3% since IQOS hit the market. These trends are
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`a great example of how innovation can help to expand markets, enhance consumer choice, and benefit public
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`health; all things the FDA should work to advance here in the United States.
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`American Conservative Union
`1199 N. Fairfax Street Suite 500 Alexandria, VA 22314
`P: (202) 347-9388 F: (202) 347-9389 ACU@conservative.org
`www.conservative.org Twitter.com/acuconservative Facebook.com/acuconservative
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`Ex. 1041-004
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`Conservative Action Starts Here – bringing you CPAC, Congressional ratings, and principled policy solutions
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`The precedent for seeing this shift in consumer choice, driven largely by innovation, has been evident with the
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`growth of the E-Cigarette industry. Surveys from The BMJ of smoking-cessation rates from 2014 to 2015
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`showed that “65 percent of e-cigarette users had tried to quit smoking, versus 40 percent of people who
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`smoked but didn’t use e-cigs. About 8 percent of e-cig users succeeded in quitting for at least three months,
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`compared to about 5 percent of non-users.” The numbers from the survey show that overall, about 350,000
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`people have quit smoking due to the switch to e-cigarettes.
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`In closing, while there is certainly a legitimate role for the FDA to play in making sure that certain products
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`coming onto the market are safe for use, the agency should never prevent an individual from being offered the
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`chance to use a product that may in fact be a safer alternative than what is currently available. Innovation has
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`driven consumers into new markets, with more choices that can reduce harm and broaden the amount of
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`options individuals have available to them, this is a good thing and the FDA should continue to bolster efforts
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`that build on innovation and expand free-markets for consumers. The IQOS represents a new alternative for
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`individuals who smoke cigarettes but wish to change their habit (for whatever reason) and IQOS can be a
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`safer option if health and harm reduction is a factor in the consumer’s choice.
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`Respectfully,
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`Daniel Schneider
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`Executive Director
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`American Conservative Union
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`American Conservative Union
`1199 N. Fairfax Street Suite 500 Alexandria, VA 22314
`P: (202) 347-9388 F: (202) 347-9389 ACU@conservative.org
`www.conservative.org Twitter.com/acuconservative Facebook.com/acuconservative
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`Ex. 1041-005
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