Philip Morris International is seeking approval from the Food and Drug Administration to sell iQOS, a heat-not-burn tobacco product.
An independent advisory committee voted Thursday on whether evidence supports PMI's claims, such as that it cuts the risk for tobacco-related disease. The meeting is part of a process to market iQOS as being less risky than cigarettes.
If this all sounds like a foreign language, here are the basics.
As the name suggests, they heat tobacco but don't burn them. Igniting tobacco causes it to undergo a chemical process that emits toxins in cigarettes.
Unlike e-cigarettes, which use nicotine-laced liquid, heat-not-burn products use real tobacco. They warm tobacco sticks to a temperature that's high enough to release an aerosol but not enough to cause combustion.They may significantly reduce risk while satisfying users' nicotine cravings.
Philip Morris has already launched iQOS in more than 30 markets. Rival British American Tobacco's version, glo, is available in six markets. The company plans to file a substantial equivalence application, a less onerous process, for glo to the FDA this year.
The iQOS tobacco heating system contains three parts: a holder, tobacco stick and a charger.
The pen-like device contains a ceramic and gold plate that heats Philip Morris-branded tobacco sticks up to 350 degrees Celsius. Tobacco in cigarettes burns at temperatures at or greater than 600 degrees Celsius.
The tobacco sticks are designed specifically for the device. In the U.S., PMI wants to offer Marlboro, Marlboro Smooth Menthol and Marlboro Fresh Menthol HeatSticks.
PMI says the product is a closer experience to smoking cigarettes than other alternatives, such as e-cigarettes, because it uses actual tobacco. The company says that could convince adult smokers to switch exclusively to iQOS.
Critics point to e-cigarettes being used in addition to and perhaps even leading users into conventional cigarettes. PMI is quick to note iQOS is not an e-cigarette, and the presence of tobacco may not have the same appeal as fruity, sweet nicotine-laced liquid.
PMI says iQOS is not risk-free, rather it's less risky than conventional cigarettes.
The company stresses quitting smoking is the best way to reduce risk and that iQOS is meant for adult smokers who want to continue using tobacco, not kids or non-smokers. PMI has found exclusively using iQOS significantly lowers users' risk of harm than if they were to continue smoking cigarettes.
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.
The FDA will decide whether iQOS can be marketed as being safer than cigarettes.
Philip Morris outlined its findings this week to an independent committee that made recommendations to the FDA on whether to approve the company's reduced-risk marketing claims.
The committee's decisions are only suggestions, meaning the FDA is not required to follow them. 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.
Even if the FDA rejects PMI's modified-risk application, going through the process may help its application to sell the device. The Tobacco Control Act calls for the FDA to respond to premarket tobacco applications within 180 days. The agency began reviewing PMI's in August, so it could give an answer in February.