Advanced technological and scientific solutions require advanced regulatory tools
Offering smoke-free alternatives to adult smokers who would otherwise continue to smoke can have a positive impact on public health. We believe that this approach should be supported by regulators, policy makers, and public health bodies, in addition to existing efforts to prevent smoking initiation and encourage cessation.
Progressive regulatory oversight can protect public health whilst simultaneously ensuring that adult smokers can access smoke-free products as well as accurate and nonmisleading information about them. Access to such information is a common-sense approach to public health.
Regulation should aim to keep up with the pace of technological and scientific innovation and progress. It includes scientifically substantiated smoke-free products which can complement traditional tobacco control measures like prevention and cessation. Regulation should ensure that any commercially available smoke-free product meets specific quality and performance standards, and that robust scientific evidence demonstrates their reduced-risk profile.
Our contributions so far
Our comprehensive body of scientific evidence for our leading smoke-free product, the Tobacco Heating System or THS, has been submitted to regulatory bodies in several countries.
We submitted Modified Risk Tobacco Product Applications (MRTPAs) in December 2016 and Premarket Tobacco Product Applications (PMTAs) in March 2017 to the U.S. Food and Drug Administration (FDA).
We also submitted technical and scientific dossiers to regulatory authorities in several EU member states.
In April 2019, following a rigorous science-based review through the PMTA pathway, the U.S. FDA determined that authorizing THS for the U.S. market is appropriate for the protection of the public health.
In July 2020, the FDA authorized the marketing of the THS as a modified risk tobacco product with reduced exposure information. The agency found that the issuance of the modified risk tobacco product orders with reduced exposure information would be “appropriate to promote the public health and is expected to benefit the health of the population as a whole.”
In January 2025, the FDA authorized the marketing of 20 oral nicotine pouch products, commercialized as ZYN by Philip Morris International, through the PMTA pathway—the first such authorization for oral nicotine pouches in the U.S. market. After an extensive scientific review, the FDA concluded these products meet the regulatory standard of net public health benefit by providing adult smokers and smokeless tobacco users a less harmful alternative.
