Cigarette smoking causes serious disease and is addictive.
For adult smokers who switch to products that do not combust tobacco, it is of paramount importance that these alternatives are scientifically substantiated to present less risk of harm than continued smoking, and that they are developed, tested, and manufactured according to applicable regulations and standards to ensure consistent product integrity and quality.
Developing and commercializing products that meet stringent scientific requirements and technical design criteria are critical to a smoke-free future. By maintaining and continuously improving the reliability of our products while complying with regulations, we reduce waste, protect our reputation, and build brand equity.
Robust quality management systems (QMS) are deployed to cover, control, and improve the entire product development and deployment life cycle. Governance and accountability for consistent product integrity, quality, and reliability sit at the highest senior management levels under the leadership of the Chief Product Officer at PMI, and are guided by our QMS, as well as by other internal and external standards. Work on product integrity and reliability is mainly carried out by teams in our product development, procurement, manufacturing operations, and quality organization departments. Their collective efforts ensure that we preserve quality, from raw material to the retail shelf.
Our approach to product reliability begins during product design inception and continues through manufacturing and final delivery to the end customer. We work with internal and external partners to ensure product quality and reliability. Working with our contracted and qualified suppliers, we secure high-quality raw materials and components, apply robust procurement processes, detailed auditing, and rigorous quality assurance procedures.
We conduct in-depth inspections at every stage of development and production. This rigorous testing regimen guarantees the reliability of our products. Our factories are designed to manufacture our products to the highest quality standards, following the ISO 9001 certification principles. This includes, for example, the careful selection of materials that come into contact with semifinished and finished products during manufacturing and the appropriate training of operators.
Our manufacturing quality management systems are subject to inspection by authorities and certified bodies. Globally, teams of product quality associates ensure that all incoming materials, semifinished components, and finished products across our global footprint meet our quality assurance and quality control standards.
Our quality professionals continuously revise and update our standards to ensure new technologies and innovations are reflected in our QMS processes. We supplement these measures with dedicated third-party quality management programs.
Our product standards apply to all of our products as well as the packaging, storage, and transport of finished goods to ensure that they reach the consumer in proper condition. Packaging has a crucial role to play in this regard and helps ensure the traceability and identification of our products so we can act promptly should issues arise. Packaging is imprinted with unique identifiers that allow us to trace the supply chain journey, from factory to market, enabling backward traceability. If a product quality issue should arise, we can leverage this traceability to investigate problems and undertake any necessary containment actions in an efficient and targeted manner.
We focus on design for sustainability and longevity of our products by embedding eco-design principles across the portfolio. Additionally, we are implementing end-of-life take-back programs and product refurbishment. Read more here.
Our products are manufactured using ingredients compliant with applicable regulatory requirements and with industry and PMI standards. The tobacco used in our heated tobacco products is tested for the presence of crop protection agent residues to ensure it does not exceed permissible levels per industry guidelines. Nicotine and nicotine salts used in e-liquids must satisfy U.S. or European pharmacopoeia specifications. Other ingredients (apart from flavoring extracts from tobacco) are either food grade or satisfy U.S. or European pharmacopoeia specifications. We do not add ingredients classified as carcinogens, mutagens, or reproductive toxicants. Ingredients—and also non-substrate material such as the plastic and other components of cartridges that house the e-liquid and the paper and other components that house the tobacco mixture—are subject to rigorous toxicological risk assessment.
Disclosure of ingredients in our smoke-free products is available in EU member state public health websites, as required under the Tobacco Products Directive.
The electronic devices for our heat-not-burn products are manufactured according to internal standards and ISO 9001 principles and are certified according to applicable regulations and standards. The suppliers of the devices’ electronic parts and components, including batteries, must also operate under these quality standards. Each finished device is subject to rigorous controls before shipment. PMI has established a thorough monitoring process to enable early detection of consumer pain points. We use these insights to improve our products and components.
Heated tobacco units
Heated tobacco units (HTUs) are inserted into the device holder by the consumer. HTUs are composed of a tobacco plug (TEREA consumables also contain a metal susceptor), a hollow acetate tube, a polymer-film filter, a cellulose acetate mouthpiece filter, and filter papers. The uniquely processed tobacco plug is made of a cast leaf blend of high-quality tobacco leaves. Newly introduced LEVIA HTUs substitute tobacco for a nicotine-containing substrate.
The manufacturing of HTUs demands high levels of precision and consistency. We test them for stability, using standard protocols covering a variety of temperature and humidity ranges. The design and packaging aim to preserve product quality and safety in the various conditions to which the product may be subjected (read more on PMIScience.com).
We disclose the ingredients of our heated tobacco units on our website.
E-vapor products
Our non-disposable e-vapor devices use a cartridge, or tank, with nicotine-containing e-liquid. We recognize a trade-off between misuse prevention and recyclability and choose to use closed-tank systems in the development and commercialization of our e-vapor products to prevent misuse. We also test our packaging to ensure compliance with local regulations, including the EU Tobacco Products Directive, and we engage external agencies that test the integrity and safety of our e-liquid packaging.
Swedish Match quality standard
GOTHIATEK® has been Swedish Match's quality standard for the Company’s snus products since year 2000. The uncompromising requirements of this standard are based on decades of research and development, with product safety and consumer protection as the key targets. In cooperation with SIS (Swedish Standards Institute), Swedish Match has refined the standard over the years in terms of structure, scope, limitations, and formulations.
In 2023, PMI began transferring the small portion of oral products PMI produced separate from Swedish Match to the GOTHIATEK® quality management system. This transfer will conclude in the first quarter of 2024, ensuring all oral products follow a consistent, high-quality standard.
Combustible tobacco products
Our combustible tobacco products are also subject to stringent product development controls. We strictly adhere to product specifications and regulations for cigarettes and apply additional internal requirements to ensure the highest quality products. Our ingredients undergo toxicological assessment to ensure their use does not increase the inherent toxicity of cigarette smoke. We disclose the ingredients used in our cigarettes on our website. We keep abreast of changes in regulation and perform further assessments to ensure full compliance with applicable regulations.
For more information on ingredients in our combustible tobacco products, please review EU member state public health websites which are required under the Tobacco Products Directive, to disclose the ingredients.
Nontobacco materials used in our products—e.g., cigarette paper, filters, and packaging materials—also undergo toxicological assessment. In assessing packaging materials, we adhere to the main requirements for food contact materials.
