Since the launch of IQOS in 2014, the heated tobacco product (HTP) market has expanded rapidly, now valued at over $30 billion. The sector has evolved significantly over the past decade, with innovations spanning electronic, aerosol, and carbon-based products. As the industry continues to grow, particularly in the US and China, regulatory scrutiny and technological advancements are shaping its trajectory.
The origins of HTPs date back to the 1980s, when major tobacco companies sought alternatives to traditional cigarettes. RJ Reynolds (RJR) developed the Premier, a device using a charcoal tip to heat a tobacco plug. But its poor taste and smell led to its swift withdrawal. RJR refined the concept into the Eclipse in 1996, which remained available until 2014. Similarly, Philip Morris International (PMI) introduced the Accord, featuring a battery-powered heating element. Despite its advanced design, including electric heating and parental locks, it was discontinued, followed by the unsuccessful Heatbar.
The breakthrough came in 2014 with PMI’s IQOS 2.2, developed after a $6 billion investment. IQOS allowed controlled heating of tobacco to optimise nicotine delivery while minimising toxicant exposure. In 2019, it received Premarket Tobacco Authorisation (PMTA) in the USA, followed by Modified Risk Tobacco Product (MRTP) designation in 2020, permitting PMI to market it as reducing exposure to harmful chemicals.
Subsequent improvements, including the transition from blade technology to induction heating with the IQOS Iluma, have enhanced user experience by reducing maintenance and improving battery life. Future innovations are expected to focus on sustainability, digital integration, and enhanced convenience. However, regulatory uncertainties, particularly flavour bans, could impact product development.
Regulatory landscape
HTP regulation varies globally, influenced by national tobacco control strategies. The UK aims to become smoke-free by 2030, enforcing strict laws such as prohibiting tobacco sales to individuals born after 1 January 2009. While vaping regulations have tightened, including bans on single-use vapes and restrictions on nicotine strength, HTPs face lighter regulation compared to traditional cigarettes.
In contrast, the USA has a rigorous seven-module PMTA process, requiring comprehensive documentation on product composition, manufacturing, toxicology, and public health impact. Some countries, including Australia, India, and Mexico, have banned HTPs entirely. Meanwhile, the EU’s Tobacco Products Directive 2 (TPD2) offers a simpler regulatory path, requiring a six-month notification period before market entry via the European Common Entry Gate (EU-CEG). Companies must disclose product composition, emissions data, toxicity studies, and consumer research to assess smoking cessation potential.
Broughton, a regulatory consultancy specialising in PMTA Module 3, assists manufacturers in compiling essential product descriptions and emissions data. Its automated toxicology data tool, Tox HQ, facilitates toxicological and pharmacological assessments to meet regulatory requirements efficiently.
Testing and compliance
Ensuring HTP compliance demands rigorous testing. Toxicological assessments examine ingredient safety, emissions, thermal degradation, and long-term toxicity. Laboratories must adhere to ISO 5501-1:2024 standards for sample storage and ISO laboratory conditions to maintain data integrity. Tools like Tox HQ streamline risk assessments and regulatory documentation submission, expediting the approval process.
With nearly two decades of experience in regulatory consultancy and nicotine product testing, Broughton is positioned to assist manufacturers in navigating evolving HTP regulations and accelerating market entry. As the sector advances, collaboration with regulatory experts remains crucial for sustained growth and compliance.
