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Smoke-Free Product Standards

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The success of tobacco harm reduction in the United States requires a regulatory framework that allows manufacturers to provide adults who smoke with a portfolio of smoke-free products authorized by the Food and Drug Administration (FDA). To foster innovation and make the Premarket Tobacco Product Application (PMTA) pathway more efficient for smoke-free products, we believe FDA should focus resources on establishing foundational baseline standards for modern oral nicotine pouches, e-vapor, and heated tobacco products.

The science and evidence based product standards below are informed by a review of existing voluntary standards for novel smoke-free products and considered products currently available in the U.S. market. We believe that baseline standards can evolve with product innovation and address critical components of premarket applications like product and design control, chemical and physical characterization, toxicology, risk assessment and product stewardship. Adhering to these types of baseline standards enhances product safety and provides FDA and manufacturers with a more efficient, predictable PMTA process that encourages the development and authorization of potentially reduced risk products.

Reasonable science- and evidence-based standards, combined with a regulatory framework that respects the rights of consumers to access accurate and truthful information that informs product choices, is a critical step in building adult tobacco consumer confidence in smoke-free products and advancing harm reduction.

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Watch as our scientists discuss the benefits of setting baseline product standards that can protect public health and facilitate FDA authorization of reduced harm tobacco products.
  Oral Tobacco Derived Nicotine  Electronic Nicotine Delivery Systems  Heated Tobacco Products 
Nicotine/Nicotine Salts 
  • Pharmaceutical grade
  • Pharmaceutical grade
  • N/A (agricultural product)
Other Ingredients and/or Product Components*
  • Standard toxicological risk assessments
  • Generally Recognized as Safe (“GRAS”) for oral consumption
  • Toxicological risk assessment
  • Full quantitative disclosures of ingredients from suppliers
  • Standard toxicological risk assessments
  • Full quantitative disclosures of ingredients from suppliers
  • Toxicological risk assessment for inhalation (hazard and dose)
  • Standard toxicological risk assessments
  • Full quantitative disclosures of ingredients from suppliers
  • Toxicological risk assessment for inhalation (hazard and dose)
Constituent / Emission Testing
  • Nicotine
  • Others as guided by toxicological risk assessment
  • HPHC testing as recommended in FDA Guidance**
  • Others as guided by ingredient and materials risk assessment**
  • HPHC testing (abbreviated list) as recommended in FDA Draft Guidance++
  • Combustion markers (CO; NO; NOx)
  • Others as guided by ingredient and materials risk assessment
Electrical Components / Batteries
  • N/A
  • Assessment of potential hazards**
  • Certification through industry standard, UL 8139+
  • Assessment of potential hazards
  • Certification through industry standard, UL 8139+
Product Stability
  • Nicotine and nicotine degradants
  • Other analyses as guided by standard toxicological assessment
  • Nicotine and nicotine degradants
  • Other analyses as guided by standard toxicological assessment
  • Other analyses as guided by standard toxicological assessment

* The product standards proposed herein encompass only components that are part of the "tobacco product" as defined by the TCA. They do not reach components that are separate and distinct from the tobacco product.

** FDA Guidance for Industry, Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (June 11, 2019).

+ ANSI/CAN/UL 8139 – Electrical Systems of Electronic Cigarettes and Vaping Devices

++FDA Draft Guidance for Industry, Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act (April 3, 2012).