The US FDA has authorized the marketing of the IQOS Tobacco Heating System (Philip Morris Products) as a modified risk tobacco product (MRTP) because the product exposes users to “considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems” than conventional cigarettes, the agency said in a press release.

However, the FDA emphasized that despite the MRTP label, “these products are not safe nor ‘FDA approved'” but switching from combustible cigarettes could be beneficial. “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to [15 specific] harmful or potentially harmful chemicals,” the agency said in a news release.

The MRTP applies to the IQOS electronic device and three associated Marlboro “heat sticks” (Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks).

The IQOS electronic device generates a nicotine-containing aerosol by heating (not burning) the tobacco-filled sticks wrapped in paper. According to the FDA, heating the tobacco “significantly reduces the production of harmful and potentially harmful chemicals.”

The IQOS system and heatsticks are the second group tobacco products to receive MRTP authorization after a group of smokeless tobacco products were deemed “less harmful” in October 2019. [Read more on the Swedish Match snus products previously designated as MRTP.]

As part of the authorization, Philip Morris Products is required to conduct post-market surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth, the FDA says.

“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products. “Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch. The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth. It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product.”

The company must request and receive authorization from the FDA to continue marketing the products with the same modified exposure information after the initial orders expire in 4 years, the agency noted.