Advisory committee denies PMI first MRTP attempt

The Tobacco Products Scientific Advisory Committee (TPSAC), which advises the U.S. Food and Drug Administration (FDA), has denied the first efforts by Philip Morris International (PMI) to label its iQOS device as a modified-risk tobacco product (MRTP). TPSAC’s denial of the request creates speculation as to how PMI will move forward with introducing the device into the U.S. market.

The FDA must not follow TPSAC recommendations, though historically the regulatory agency has followed the committee’s advice.

According to Bonnie Herzog, senior analyst for Wells Fargo Securities, TPSAC votes have been broadly opposed to PMI’s MRTP application (the majority of the panel has voted “No” in 3 out of 4 questions posed to it so far on health risk/exposure labeling/advertising for iQOS), she does not don’t view today’s events as a total disaster. In a recent email, Herzog writes that “given: (1) much of the panel’s concerns were around how [PMI] worded it’s proposed reduced risk claims and how [PMI] “messages” those claims to the consumer (we’re hopeful there is room for [PMI] & the FDA to work on this); (2) the TPSAC’s recommendation to the FDA is non-binding; and (3) the FDA, we think, seems more supportive of ultimately approving [PMI’s] MRTP application as it is in line with agency’s plan for a comprehensive nicotine strategy. We note, however, the Panel’s seeming dissatisfaction with [PMI’s] data on topics such as youth initiation, impact on vulnerable populations, and in support of some of the claims as currently worded. Therefore, we wouldn’t be surprised if more data/research is requested to more effectively demonstrate the science to support the claim that switching to iQOS from combustible cigs definitively reduces risk of disease & exposure to harmful toxins, i.e., it’s a process! Ultimately we think the chances for the FDA to approve [PMI’s] MRTP are still good but timing is tough to predict.”

These MRTP decisions are not related to PMI’s premarket tobacco product application (PMTA) currently being reviewed by the FDA. An PMTA approval would allow the company to market and sell iQOS in the United States. That decision is expected in February.

Scott D. Ballin, a health policy consultant, told the committee that tobacco and nicotine policies have been at a ‘crossroads’ for a number of years now and given the rapidly changing technological, innovative and competitive environment, has allowed for some serious discussions about what a more modernized regulatory framework can and should look like.

“This is not something unique to tobacco but modernization is routinely carried out by FDA (and Congress) in such areas as drugs, devices, foods, dietary supplements and even cosmetics,” Ballin told the TPSAC. “Consideration of a product like IQOS is just a piece of this new visionary puzzle and which calls for a reassessment of how best to regulate the growing spectrum of products in this rapidly changing environment.”