In 2017, the Food and Drug Administration ("FDA") announced the Comprehensive Plan for Tobacco and Nicotine Regulation1 that included recognition of a continuum of risk among various nicotine-containing products. Then-FDA Commissioner Gottlieb stated FDA policy should "move addicted smokers down that continuum of risk to these less harmful [innovative] products."2 For tobacco harm reduction to be successful, we must first have a diverse marketplace of FDA-authorized potentially reduced risk products ("RRPs").

Science- and evidence-based regulation, including product standards, may accelerate market authorization of RRPs and thereby benefit public health. We have developed recommended product standards for potentially RRP categories, including Oral Tobacco Derived Nicotine ("OTDN") products, Heated Tobacco Products ("HTPs"), and Electronic Nicotine Delivery Systems ("ENDS").

These proposed product standards, informed by science- and evidence-based product stewardship principles, should evolve with product innovation and emphasize product safety, as well as achievable and efficient authorization pathways. In creating this framework, we conducted an extensive review of existing voluntary standards for novel RRPs and considered products currently marketed in the United States. It was not our intent to create a universal product standard for every possible iteration of every product. Instead, our proposal seeks to identify foundational product standards for each RRP category with a focus on product safety and quality.

  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

At Altria, our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. Reasonable science- and evidence-based RRP 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 RRPs and advancing harm reduction.

We encourage FDA to lead a national dialogue with all stakeholders to develop and implement product standards for RRP categories.


1See Press Release, FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death (July 27, 2017), available at https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regulatory-plan-shift-trajectory-tobacco-related-disease-death; FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan-tobacco-and-nicotine-regulation; Scott Gottlieb & Mitchell Zeller, Perspective, A Nicotine-Focused Framework for Public Health, New Engl. J. Med., 2017; 377:1111-1114. DOI: 10.1056/NEJMp1707409.

2Remarks by Scott Gottlieb, M.D., Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), available at https://www.fda.gov/news-events/speeches-fda-officials/protecting-american-families-comprehensive-approach-nicotine-and-tobacco-06282017.

* 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).