The U.S. Is Falling Behind as Heated Tobacco Powers a Global Smoke-Free Revolution

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Key Points:

• Global Milestone: Philip Morris International’s flagship heated tobacco product IQOS surpassed $10 billion in annual revenue in 2024, less than a decade after launch – marking a major achievement in the global shift toward smoke-free alternatives.

• Harm Reduction Science: Heated tobacco products (HTPs) reduce harm by heating rather than burning tobacco, producing up to 90 percent fewer toxic compounds than cigarettes. Combustion – not nicotine – is the main source of smoking-related disease.

• Evidence of Reduced Exposure:

  • A 2019 review found HTPs reduced harmful constituents by at least 62 percent versus cigarettes.

  • A 2020 American Cancer Society study linked HTPs to declines in cigarette sales in Japan.

  • The 2022 Cochrane Review and the UK Committee on Toxicity confirm users face far lower exposure to toxicants than smokers.

• Rapid Market Growth: Global HTP sales exploded from 100,000 devices in 2014 to 30 million devices and 125 billion sticks by 2021, with market value soaring to $28.7 billion.

• U.S. Lagging Behind: The FDA has authorized only one HTP – PMI’s IQOS – through its Premarket Tobacco Product Application (PMTA) process. Regulatory delays and outdated standards continue to block adult access to safer alternatives

• Regulatory Delays: PMI’s first IQOS PMTA took 870 days for approval – nearly five times longer than the legal deadline – underscoring the FDA’s broken review process. Despite investing $14 billion in smoke-free R&D, PMI remains one of the few with authorized products.

• Market Barriers: The FDA’s 2007 predicate date means any product introduced after that year must navigate the costly PMTA pathway. As a result, only 81 products have marketing orders, leaving tens of millions of adult smokers without access to reduced-risk options.

• Legal Hurdles: IQOS launched in Atlanta (2019) and Richmond (2020) but was halted in 2021 due to patent disputes. After prevailing in court, PMI relaunched IQOS in Austin, Texas in 2025, signaling a renewed U.S. entry.

• Policy Takeaway: While countries like Japan, Italy, and South Korea are rapidly transitioning away from smoking, the U.S. remains stalled by regulatory gridlock. Policymakers must reform the FDA’s outdated framework to allow innovation, competition, and adult access to cleaner nicotine technologies that can accelerate America’s path to a smoke-free future.

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Philip Morris International (PMI) recently announced that its flagship heated tobacco product (HTP), IQOS, has surpassed $10 billion in annual revenues in 2024, less than a decade after its launch. The milestone was celebrated at an event unveiling a limited edition IQOS Iluma model, underscoring PMI’s global shift toward a smoke-free future. This achievement represents a major step forward in reducing the harms associated with combustible cigarettes through innovative alternatives.

Heated tobacco products like IQOS are reshaping tobacco markets in countries where manufacturers are not obstructed by burdensome regulations. Policymakers in the United States should take notice and examine why American consumers still have access to only one FDA-authorized HTP.

Researchers and tobacco companies have long recognized that it is the smoke, not the nicotine, that causes the most harm from tobacco. Traditional cigarettes contain about 600 ingredients, and when burned, produce more than 7,000 chemicals, including at least 69 known carcinogens. By heating rather than burning tobacco, HTPs eliminate the smoke and drastically reduce exposure to many harmful substances while still delivering nicotine. This technology represents a significant advancement in tobacco harm reduction by producing flavor and nicotine at much lower temperatures than combustion.

Scientific studies have confirmed the lower emissions profile of HTPs. A 2019 review found that compared to cigarettes, modern heated tobacco products reduced harmful and potentially harmful constituents (HPHCs) by at least 62 percent. A 2020 American Cancer Society study noted that HTPs likely contributed to declines in cigarette sales in Japan. The 2022 Cochrane Review concluded there is moderate-certainty evidence that HTP users have lower exposure to toxicants and carcinogens than smokers, and the UK Committee on Toxicity estimates HTP aerosols contain up to 90 percent fewer harmful compounds than cigarette smoke.

The market for heated tobacco has expanded rapidly. In 2014, only about 100,000 HTP devices and 15 million tobacco sticks were sold worldwide. By 2021, those numbers had soared to nearly 30 million devices and over 125 billion sticks, with the market’s retail value jumping from $15.6 million in 2014 to $28.7 billion in 2021. PMI began developing heated tobacco technology in the late 2000s, launching the first IQOS in Italy and Japan in 2014. Since then, the company has released successive generations, including IQOS 3 and IQOS Iluma, while other firms – such as British American Tobacco and Japan Tobacco International – have launched their own versions.

In the United States, the Food and Drug Administration (FDA) has recognized the harm reduction potential of heated tobacco but has so far authorized only one product, PMI’s IQOS, through the premarket tobacco product application (PMTA) process. In April 2019, the FDA issued marketing orders for the IQOS Tobacco Heating System 2.4 and three Marlboro-branded HeatSticks in tobacco and menthol flavors. In 2020, the agency granted a Modified Risk Tobacco Product (MRTP) order allowing PMI to advertise IQOS 2.4 with specific “reduced exposure” statements, though not “reduced risk” claims. Later that year, the FDA authorized IQOS 3 under PMTA, but without MRTP status.

These remain the only modern HTPs authorized for U.S. sale, aside from R.J. Reynolds’ earlier Eclipse product. Like other harm reduction products, HTPs must navigate the FDA’s costly and inefficient PMTA process, which has become a significant barrier to innovation and adult access. PMI’s experience with IQOS illustrates the problem: the company submitted its PMTA for IQOS 2.4 in December 2016, yet the FDA took over 870 days – far beyond the 180-day statutory window – to issue marketing orders. Since 2008, PMI has invested more than $14 billion in research, development, commercialization, and regulatory approvals for its smoke-free portfolio.

Policymakers should recognize the global success of HTPs and the need to modernize U.S. regulation. The FDA has issued only 81 PMTA orders for products it deems “appropriate for the protection of public health,” leaving millions of American smokers and vapers with limited alternatives. Every harm reduction product – from HTPs to e-cigarettes to nicotine pouches – faces the same high-cost PMTA requirement simply because no similar product was on the market before February 2007. This outdated rule leaves more than 30 million adult smokers and 20 million adult vapers underserved.

IQOS’s U.S. rollout further reflects regulatory and legal hurdles. After launching in Atlanta, Georgia in September 2019 and expanding to Richmond, Virginia in 2020, sales were halted in late 2021 following a U.S. International Trade Commission ruling that found IQOS infringed on British American Tobacco patents. PMI appealed and ultimately prevailed when the disputed patents were invalidated, clearing the way for the product’s reintroduction in 2025. PMI relaunched IQOS in Austin, Texas that March, marking its return to the U.S. under PMI’s direct control.

Heated tobacco products are another important tool for achieving a smoke-free future. However, their potential will remain unrealized unless adults can access them and the market is allowed to evolve through competition and innovation. Federal policymakers should reform the existing regulatory process, which continues to hinder progress and limit the ability of adult smokers to transition away from combustible cigarettes.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.