FDA approves renewed authorization for IQOS and HEETS

The U.S. Food and Drug Administration (FDA) has approved the renewal of previously granted modified risk tobacco product (MRTP) orders for two versions of Philip Morris International’s (PMI) IQOS device and three variants of tobacco sticks marketed under the HEETS brand.

According to PMI, the decision allows the company to continue communicating reduced-exposure information to U.S. adults aged 21 and older who smoke conventional cigarettes.

The agency concluded that renewing the MRTP authorizations for IQOS and HEETS is appropriate for the promotion of public health and is expected to benefit the health of the population as a whole, taking into account both tobacco users and those who do not currently use tobacco products.

PMI U.S. Chief Executive Stacey Kennedy said the company remains the only one in the United States to have obtained and retained modified-risk authorization for heated tobacco products, and that it believes science-based alternatives can help adult smokers move away from combustible cigarettes.

She said the FDA’s latest decision reflects both the strong scientific evidence supporting IQOS and the company’s commitment to responsibly offering smoke-free alternatives to adults.

In its decision, the FDA reiterated that even without the completion of long-term epidemiological studies, the available scientific evidence indicates that measurable and substantial reductions in morbidity or mortality among individual tobacco users are reasonably likely.

The IQOS 2.4 system became the first heated tobacco product authorized under the FDA’s MRTP pathway in 2020, after receiving initial market authorization in 2019 through the premarket tobacco product application process. The IQOS 3.0 system received initial market authorization in 2020 and MRTP status in 2022.

The company said the FDA is continuing to review premarket applications for IQOS ILUMA.

PMI believes that, given the strength of the application package and its demonstrated track record in helping adult smokers switch to better alternatives, the review deserves to be expedited.

Materials submitted as part of PMI’s MRTP application state that the IQOS system generates an aerosol containing significantly lower levels of harmful or potentially harmful chemicals than cigarette smoke.

The company notes that no tobacco product is risk-free, but says a growing body of real-world evidence from markets including Japan shows that the availability of heated tobacco products is associated with a meaningful decline in cigarette consumption.

Heated tobacco products such as IQOS heat tobacco rather than burn it. PMI says this significantly reduces the formation of harmful chemicals produced by combustion, while still providing real tobacco taste and nicotine satisfaction.

PMI U.S. said it is focused on offering better alternatives to conventional tobacco products to America’s 45 million adult nicotine users, including about 25 million people who still smoke cigarettes.

According to the company, PMI has invested more than $16 billion globally since 2008 in the development, scientific substantiation and commercialization of innovative smoke-free products for adults who would otherwise continue to smoke.

PMI entered the U.S. market after acquiring Swedish Match in 2022, strengthening what it describes as its global leadership position in smoke-free products.

PMI said its goal is for all adults who would otherwise continue smoking either to quit nicotine altogether or switch completely to scientifically substantiated smoke-free products as soon as possible. The company believes regulatory policies and decisions can significantly accelerate the pace and scale of that transition.