FDA Scientific Committee Says IQOS is Too Risky

The FDA may allow Philip Morris to sell IQOS in the U.S., but it won’t be with the unconditional blessing of the agency’s scientific advisers.

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) voted on several questions related to the heat-not-burn (HNB) tobacco product Thursday, and with one exception found that it didn’t meet the burdens of proof needed to be granted “Modified Risk Tobacco Product” (MRTP) status.

That doesn’t mean that the FDA won’t approve IQOS for sale. TPSAC merely serves an advisory function. In fact, no product has ever received modified risk approval. The last application, by Swedish Match for eight of its snus smokeless tobacco products, was denied despite decades of scientific evidence proving snus to be massively safer than smoking.

IQOS, which PMI already sells in more than two dozen countries, heats “sticks” of actual tobacco to produce a smoke-free vapor. It is available only in plain tobacco and menthol flavors — which is probably a selling point to the FDA, which has expressed concerns about vaping e-liquid flavors being attractive to youth. According to PMI, smokers in some countries — especially Japan — are switching to IQOS in large numbers.


“Modified risk” is the more difficult of the two pathways to FDA marketing approval for tobacco products. Unlike the Premarket Tobacco Application (PMTA) path, MRTP requires the manufacturer to prove to the FDA that the product is less risky to public health than cigarettes. PMI filed MRTP and PMTA applications last year. If approved, the product will be sold in the U.S. by Altria.

The committee heard public testimony Thursday morning, including comments in support of approval from Gregory Conley of the American Vaping Association and CASAA executive director Alex Clark. Clark reminded the committee that IQOS should be compared to smoking, not all tobacco products.

Arguing against approval, Matthew Myers from the Campaign for Tobacco-Free Kids actually claimed that IQOS looks like a JUUL vape, which he says is the most popular e-cigarette for kids. “It is designed in exactly the way that would appeal to young people,” Myers told the committee.

The committee then deliberated publicly and voted on the questions it was assigned to answer, based on the 75-page briefing document produced by the agency. That document summarizes reams of research data provided to the FDA by PMI.

The FDA will decide in the coming months whether to heed the advice of its scientific advisers, or overrule their judgements and grant a marketing order for IQOS. The question manufacturers of low-risk nicotine products — including vaping manufacturers — are asking is, if Philip Morris can’t receive FDA approval after spending a reported $3 billion on research, what hope do smaller companies have?

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Jim McDonald