FDA’s reviewer guides and science policy memoranda provide information about FDA review processes and several regulatory science issues. These documents were developed to assist FDA reviewers with the evaluation of new tobacco product applications. FDA has put these documents on this site in response to public interest, e.g. frequent Freedom of Information Act requests.

Information contained in these documents is subject to change based on advances in policy, the regulatory framework, and regulatory science, and is not binding on FDA or the public. These documents offer a snapshot of FDA’s thinking on certain aspects of tobacco regulatory science at the time the documents were written but do not necessarily represent FDA’s complete or current thinking. These documents should not be used as a comprehensive manual for preparing or anticipating review of tobacco product applications.

General

1. Unique Identification of Portioned Moist Snuff and Snus Products
2. Unique Identification of Tobacco Products

Chemistry/Toxicology

1. SE Review: Toxicological Implications of Fire Standards Compliant (FSC) Paper
2. SE Review: Evaluation of Estimated HPHC Impact of Single Ingredient (saccharides) Pyrolysis
3. SE Review: Evaluation of Multiple Ingredient Changes
4. SE Review: Use of Propylene Glycol in Smokeless Tobacco Products
5. Use of Surrogate Tobacco Products in SE Reports
6. SE Review: Evaluating Carcinogenic HPHC Increases and Assumption of Linearity for Low Dose Extrapolation
7. Use of Cigarette Designer and Other Models to Predict HPHC Yields in SE Reports
8. Effects of Increases of Ammonia and Other Basic Compounds on the Transfer of Free-Base Nicotine to Tobacco Smoke 
9. Equivalence Testing for SE Evaluations
10. Distribution of Menthol in Cigarettes and Smoke Transfer 
11. Use of Reverse Engineering to Reproduce Tobacco Products that are No Longer Manufactured or For Which Characteristics are Not Available
12. Review of Saccharides as Tobacco Ingredients: Effects on Smoke Chemistry 
13. Dissolution as a Critical Comparison of Smokeless Product Performance: SE Requirements and Recommendations for the Review of Dissolution Studies 
14. Harmful and Potentially Harmful Constituent (HPHC) Comparison and Evaluation Procedure for Comparing Two Tobacco Products in the Substantial Equivalence Reports
15. Use of Reference Values in the Toxicological Evaluation of Inhaled Tobacco Products

Engineering

1. Engineering Review of Substantial Equivalence (SE) Reports for Originally Regulated Products

Social Science

1. Product Quantity Changes in Substantial Equivalence Reports (SE Reports) for Statutorily Regulated Tobacco Products
2. Effects of Tobacco Product Package Shape on Consumer Perceptions, Initiation, and Cessation

Behavioral and Clinical Pharmacology

1. BCP Reviews of Characteristic Changes in SE Reports
2. BCP Reviews of SE Reports Involving Changes in the Ventilation of Combusted Filtered Cigarettes

Microbiology

1. Substantial Equivalence Reports: Recommended requirements for stability testing of smokeless tobacco products

Reviewer Guides

1. Behavioral and Clinical Pharmacology Guide for SE Reports
2. Social Science Reviewer Guide for SE Reports

FDA recommends the following tools serve as primary resources for the preparation of SE Reports, requests for Exemption from SE, or Premarket Tobacco Product Applications:

• Rules and Regulations 
• Guidance 
• Compliance Webinars 

Learn more about the various pathways to market and distribute a tobacco product.

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Additional Resources

• SE Report Appendices