iQOS meeting big moment for Philip Morris International and Altria

Akio Kon | Bloomberg | Getty Images

The Philip Morris International Inc. iQOS electronic cigarette, including packs of Marlboro HeatStick.

The company has already launched iQOS in more than 30 markets, including Japan, where it has become wildly popular. Analysts see an enormous opportunity for iQOS the U.S.

The Centers for Disease Control and Prevention estimates there are 36.5 million adults currently smoke cigarettes. Among all U.S. adult smokers, nearly 70 percent say they want to quit, according to the CDC.

Under FDA Commissioner Scott Gottlieb, the FDA has adopted the idea that nicotine products live on a continuum of risk, with smoke particles in combustible cigarettes being the most harmful. PMI will try and convince the committee that iQOS falls on the other side of the spectrum, while noting the product is not risk-free.

Altria, which would receive sole distribution rights in the U.S., is expected to lay out its plan to market and sell iQOS if it’s approved. It has already shared some details of its plans. The company will need to try and quell worries about how it will convince adult smokers to switch from cigarettes, while avoiding attracting people who don’t use cigarettes, including kids and teens.

The Campaign for Tobacco-Free Kids urged the FDA on Monday to address how youths will perceive the risk of iQOS and the potential for youths to start using tobacco with it. The group was responding to the FDA’s review of iQOS published Monday ahead of the hearing.

The FDA’s review of iQOS identified lower levels of toxic chemicals than cigarettes. It could not say that using the device led to a decreased risk of illnesses associated with smoking because doing so would require a longer study.

Even if the advisory committee suggests the FDA approve PMI’s modified risk tobacco product application, the FDA is not guaranteed to follow the recommendation. The timing of the agency’s ultimate decision is unclear. Some have suggested May, which would mark one year since the FDA said it would review the application.

PMI has another application under FDA review that would simply allow iQOS to be sold in the U.S, without the lower-risk claims. The Tobacco Control Act calls for the FDA to respond to premarket tobacco applications within 180 days. It began reviewing PMI’s in August, so a decision could come in February.