Health groups raise important substantive and procedural issues with PM’s application to make reduced exposure claims for IQOS 3

The American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative have submitted a well-conceived public comment to FDA opposing Philip Morris’ request to make “modified exposure” claims about the new IQOS 3.

In addition to providing important information about new studies on IQOS to FDA, the comment raises serious questions about FDA’s process, in which they have allowed Philip Morris to submit a fast-tract “supplemental” Modified Risk Tobacco Product (MRTP) application for IQOS 3 despite the fact that nothing in the FDA law creates such a process and the FDA has not issued a regulation creating such a process. This issue, combined with FDA’s decision to authorize the sale to RJR’s Vuse Solo e-cigarette despite serious problems with the application, raises serious questions about whether the FDA has developed a pro-industry bias rather than prioritizing public health and putting the burden of proof on the tobacco companies..

The health groups raise four important issues in their public comment:
(1) The application itself, and the process used by FDA for review of the application, are inconsistent with the relevant statutory requirements.
(2) FDA must not grant the MRTP application without clarifying whether IQOS 3 includes Bluetooth technology that allows for interaction between the manufacturer and the user, to the detriment of public health.
(3) Granting of the MRTP will extend to a new product the deficiencies in FDA’s grant of an MRTP for IQOS 2.4.
(4) New research and data since FDA’s grant of an MRTP for IQOS 2.4 further support denial of MRTPs for both IQOS 2.4 and IQOS 3.

Their full comment is worth reading:

Click to access tfks-comment-iqos-3-mrtpa_.pdf

The health groups also do a good job of putting FDA’s actions into an international context and pointing out Philip Morris’ misuse of the FDA authorization of IQOS 2.4 in other countries:

Although FDA’s decisions about IQOS are only valid for its marketing in the U.S., the original IQOS marketing order has been used by PMI to mislead consumers and regulators across the globe to believe that FDA has strongly endorsed IQOS. One of the most egregious examples is a flyer about IQOS distributed outside the U.S. by PMI in June, 2019, referencing the marketing order for IQOS 2.4 and featuring CTP Director Mitch Zeller:

In fact, the marketing granted order letter for IQOS 2.4 explicitly informed PM that you [PM] may not make any express or implied statement or representation directed to consumers that conveys, or misleads or would mislead consumers into believing, among other things, that the [IQOS 2.4] products are μapproved by FDA. ́ Certainly, a flyer promoting IQOS with an image of a smiling CTP Director conveys approval of the product.

A study published in October 2021 cited several additional examples of PMI using FDA’s modified risk order to promote IQOS globally…including efforts to minimize government regulation of IQOS. The University of Bath has similarly documented instances where PMI representatives have used FDA’s decision to influence regulations for heated tobacco products in various countries.

Surely, FDA did not intend for its marketing order or modified risk order to mislead consumers or impact regulations in other countries. Thus, in evaluating the IQOS 3 application, it is entirely appropriate for FDA to consider the misuse of its modified exposure order for IQOS 2.4 in other countries. [citations deleted]

It is worth reading the health groups’ comment in the context of the public comments submitted by members of the UCSF TCORS on the IQOS 3 MRTP application:

• IQOS’s appeal to adolescents or young adults, consumer perceptions and the likelihood that the consumers will misunderstand labeling and marketing
• New published research on toxic emissions in IQOS aerosol
• PM underestimates the health impact of IQOS, does not adequately address new published research and information on population health impacts, and does not demonstrate benefits to individual or population health
• IQOS harm to vascular endothelial function
• IQOS risks of immunosuppression and pulmonary toxicity

The UCSF comments reinforce many of the points the health groups raised, particularly highlighting new research in a wide range of issues that Philip Morris ignored.