Advancing regulatory frameworks for smoke-free products

How are smoke-free products regulated in the United States? 

In the U.S., the regulatory pathway for smoke-free products is overseen by the Food and Drug Administration (FDA). To gain FDA authorization for commercializing novel tobacco products, including smoke-free products, manufacturers must submit a Premarket Tobacco Product Application (PMTA) to demonstrate the product is appropriate for the protection of public health. In addition, they can apply for a Modified Risk Tobacco Product (MRTP) order, under which the FDA assesses whether the product will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. Companies that obtain MRTP authorization for their products are required to conduct postmarket surveillance and studies to determine the impact of the modified risk order on consumer perception, behavior, and health. The results of these studies must be submitted to the FDA annually and enable a review of the accuracy of the determinations upon which the modified risk order was based. 

Snus, sold under the General brand name by Swedish Match USA, Inc. (now a subsidiary company of Philip Morris International [PMI]), became the first smoke-free tobacco product to receive both PMTA and MRTP authorizations in November 2015 and October 2019, respectively. As a result, the eight authorized snus products may be marketed in the U.S. with the following reduced-risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

The Tobacco Heating system (THS) 2.2, commercialized as IQOS by PMI, was the first HTP to receive FDA authorization under both PMTA (April 2019) and MRTP (July 2020) pathways. With its MRTP authorization, the following statements could be used in consumer communications in the U.S. market:

• “The IQOS system heats tobacco but does not burn it.
• This significantly reduces the production of harmful and potentially harmful chemicals.
• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.” 

In January 2025, the FDA authorized the marketing of 20 oral nicotine pouch products, commercialized as ZYN by PMI’s subsidiary Swedish Match USA, Inc., 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 by providing adult smokers and smokeless tobacco users a less harmful alternative.

The FDA’s review process for the above products was comprehensive, encompassing various aspects of product development and testing, from product quality and aerosol characterization to potential health effects and appeal to nonsmokers and youth. This underscores the FDA’s commitment to ensuring that smoke-free products meet stringent scientific standards to protect public health.

How are smoke-free products regulated in the European Union?

In the EU, the regulatory framework for tobacco products is primarily governed by the Tobacco Products Directive (TPD) 2014/40/EU.

Under Article 19 of the TPD, manufacturers and importers must notify the competent authorities in EU Member States of any novel tobacco product they intend to market at least 6 months prior to commercialization. This notification must include detailed product description, usage instructions and comprehensive information on ingredients and emissions, as specified in Article 5 of the TPD.

This regulatory framework aims to ensure that novel tobacco products undergo rigorous assessment to safeguard public health while providing transparent information to regulatory bodies and the public.

View PMI’s scientific dossier for THS, which was submitted in compliance with the EU TPD and includes results from the assessment program for THS as of May 2016.

Greece: An example of smoke-free product regulation in the European Union

Greece is one EU country that has decided to integrate tobacco harm reduction into its tobacco regulatory framework. In July 2020, the Greek government enacted Law 4715/2020 Article 36 (in Greek), making Greece the first EU Member State to permit scientifically substantiated claims related to the reduced health risks of smoke-free alternatives.

This decision aligns with Greece’s National Action Plan Against Smoking, which supports the implementation of its anti-smoking law (L. 4633/2019) by promoting health, protecting nonsmokers from secondhand smoke, supporting smoking cessation, and regulating novel smoke-free tobacco products. This regulatory approach reflects Greece's commitment to tobacco harm reduction while ensuring public health protection.

Beyond the United States and Europe: Smoke-free product regulation in New Zealand 

While the U.S. and EU have made important strides in regulating smoke-free products, learnings from other regions, like New Zealand, offer valuable insights for shaping effective tobacco harm reduction policies. 

The future of smoke-free product regulation

The future of smoke-free product regulation appears promising for public health, with growing acknowledgement of the potential benefits of alternatives like HTPs, e-vapor products, and oral options, such as nicotine pouches and snus. Developing policies that evolve with technological advancements and that are grounded in scientific evidence could further improve public health alongside existing tobacco regulation policies.