FDA Review of Heated Tobacco Products: Implications for Innovation Regulation

IQOS MRTP Status Renewal Process

Philip Morris International Inc. (PM) recently presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), an independent panel advising the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). This presentation was part of the FDA’s review process for PMI’s request to continue marketing its IQOS heated tobacco products as modified risk tobacco products (MRTPs) in the U.S.

Key points of the review process:

• The meeting took place on October 7, focusing on IQOS ILUMA, a newer version of previously authorized IQOS models.
• Stacey Kennedy, CEO of PMI U.S., emphasized that the new evidence supports the FDA’s original conclusions leading to IQOS’s MRTP authorization.
• PMI urged the FDA to maintain a timely scientific review process for smoke-free products, noting that IQOS ILUMA has been under review for nearly two years.

IQOS System and Market Performance

IQOS is a heated tobacco system with the following characteristics:

• It heats tobacco without burning it, reducing the production of harmful chemicals.
• The system delivers a taste and ritual similar to smoking, aiding in complete switching from cigarettes.
• As of June 30, 2025, PMI estimates approximately 34 million legal-age consumers worldwide use IQOS.
• Globally, IQOS ILUMA has shown higher rates of complete switching among legal-age adults from traditional cigarettes.

MRTP Renewal Application Details

The application includes:

• Two device versions: IQOS 2.4 and IQOS 3.0 holders and chargers
• Three tobacco consumable variants: Amber HEETS, Green Menthol HEETS, and Blue Menthol HEETS

Original MRTP Status and Claims

The FDA granted MRTP status in 2020, allowing PMI to communicate specific claims to legal-age consumers:

• Reduced production of harmful chemicals
• Reduced exposure when completely switching from conventional cigarettes

Additional Research and Responsible Marketing

During the TPSAC meeting, PMI highlighted:

• Responsible marketing practices
• Additional research showing high levels of complete switching among adult smokers
• Maintained low usage rates among unintended populations

Web3 Insights: Regulatory Lessons for Emerging Technologies

The IQOS review process offers valuable insights for the regulation of innovative technologies in the Web3 space:

1. Rigorous Scientific Review: The FDA’s thorough examination of IQOS demonstrates the importance of robust scientific evidence in regulatory decisions. Web3 projects could benefit from adopting similar evidence-based approaches when seeking regulatory approval.

2. Long-term Monitoring: The ongoing review of IQOS’s MRTP status highlights the need for continuous evaluation of innovative products. This parallels the evolving regulatory landscape in the cryptocurrency sector, where projects may need to adapt to changing requirements over time.

3. Responsible Marketing Practices: PMI’s emphasis on responsible marketing aligns with the growing focus on consumer protection in the Web3 space. Cryptocurrency exchanges and projects could draw lessons from this approach in their user engagement strategies.

4. Balancing Innovation and Regulation: The IQOS case study illustrates the delicate balance between fostering innovation and ensuring public safety. This balance is equally crucial in the Web3 ecosystem, where regulators are grappling with novel technologies and business models.

5. Global Market Implications: With 34 million IQOS users worldwide, the product’s global reach underscores the importance of considering international regulatory frameworks. Web3 projects, operating in a borderless digital environment, face similar challenges in navigating diverse regulatory landscapes.

By examining the regulatory journey of innovative products like IQOS, Web3 stakeholders can gain valuable insights into potential regulatory approaches and prepare more effectively for future compliance challenges.