First Tobacco Product Receives “Reduced Exposure” Authorization

Philip Morris International received the first-ever nod to market a tobacco device that claims to expose users to fewer harmful chemicals than cigarettes, according to the FDA.

The IQOS heated tobacco devices hold disposable tobacco-filled sticks wrapped in paper, which are marketed as Marlboro HeatSticks. They emit a nicotine-containing aerosol and differ from vaping devices, which use liquid.

The FDA said its decision to grant “exposure modification” orders allows the company to claim in ads that the devices provide reduced exposure to tobacco compared with combusted cigarettes. It may state that scientific studies “have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces the body’s exposure to harmful or potentially harmful chemicals.”

Philip Morris is barred from claiming the devices are “safe” or “FDA approved.”

The FDA said there was insufficient evidence to grant the company’s request for “risk modification” orders.

Philip Morris must conduct surveillance to assess the impact of the marketing claim on consumers, including use by young people, and a toxicity study to gauge adverse effects. It must reapply for continued marketing in 4 years.

Some public health advocates have questioned the system’s safety and said it could exacerbate teen tobacco use.

Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said the company’s data show the approved marketing “could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”

Young people “should not start using them,” he added.

The FDA required that the devices only be marketed to adults when it initially okayed their sale in April 2019. The IQOS is 1 of 2 product lines greenlighted as modified risk tobacco products under a pathway established by the 2009 Family Smoking Prevention and Tobacco Control Act. The other is Swedish Match’s smokeless tobacco.