CASAA to FDA’s TPSAC: PMI’s modified risk claims should go further!

Full text of statement below.

Please note that a portion of our statement was omitted during the presentation due to time constraints. In the interest of transparency, we have included the omitted COI statement here.

January 25, 2018

Testimony Delivered to FDA Tobacco Product Scientific Advisory Committee (TPSAC)

RE: PMI IQOS Modified Risk Tobacco Application

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Members of the committee,

Good morning and thank you for the opportunity to speak with you today. My name is Alex Clark and I am the executive director of The Consumer Advocates for Smoke- free Alternatives Association. We are a 501(c)(4) nonprofit consumer organization with a membership of more than 200,000 consumers from all walks of life.

[[Original text not included in presentation due to time constraint]

By way of information, CASAA accepts donations from many sources and has no financial or policy agreements with industry stakeholders. In 2017, CASAA received a one-time, completely unrestricted contribution from Philip Morris International. CASAA’s policy for allocating resources is that all contributions are used for efforts that will maximize consumer access to and awareness of low-risk, smoke-free nicotine and tobacco products.]

I am here today to express CASAA’s support for PMI’s MRTP application as we agree that IQOS marketing should accurately inform consumers of the relative low risk of using this heat-not-burn tobacco product.

CASAA believes that consumers deserve honest and accurate risk communication about the products they use so they can make informed choices.

However, our support for PMI’s applications is not without concern. Specifically, we draw attention to the statement that  “scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco related diseases.”

In our written comment we provide a footnote to this statement expressing our objection to the use of the term “tobacco related disease.”

To echo the recent statements made by Director Zeller and Commissioner Gottlieb regarding nicotine, CASAA believes that we must update the language we use to discuss the harms of smoking.

Broadly referring to the health consequences of smoking as “tobacco related harm” misinforms the public by wrongfully implying that all tobacco products carry the same risks as smoking. It is imperative that we have a constructive conversation about the relative risks of nicotine delivery products and consistency in our communications about the risks of consuming different tobacco products.

To underscore this point, the other statements that PMI is seeking approval for are consistent among one another in their focus on the fact that IQOS reduces the production of and exposure to harmful and potentially harmful constituents. PMI is not seeking approval to market IQOS as an alternative to low-risk products like smokeless tobacco, vapor products, or other smoke-free nicotine products. Therefore, marketing claims should not reference an outdated and politically motivated understanding of tobacco related harm. IQOS is a lower-risk alternative to smoking and marketing statements should narrowly focus on this fact.

CASAA strongly recommends that PMI amend the their proposed marketing language to read “smoking related diseases” and  that FDA allow this small but vital change.

We also question the wisdom of PMI’s self-imposed prerequisite that a consumer must be a smoker in order to purchase IQOS. It is unclear from the application materials whether or not IQOS might provide a protective or deterrent effect for at-risk never-smokers or former smokers who might relapse. CASAA believes that enforcing a “smoker test” may ignore a small but not insignificant group of consumers who are (for whatever reason) contemplating starting smoking and should have access to low-risk products instead of feeling that smoking is their only option.

Again, thank you for the opportunity to speak with you today and we urge the committee to issue a favorable recommendation to FDA regarding approval of PMI’s MRTP applications for the IQOS System.

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• Meeting materials for this TPSAC meeting are available here.