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 In this section:

                Market and Distribute a Tobacco Product

Market and Distribute a Tobacco Product

                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications Home
          Tobacco Products
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          Market and Distribute a Tobacco Product
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product ApplicationsMarket and Distribute a Tobacco Product Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
  
  					Documents to help reviewers evaluate tobacco product applications. This information adds detail about FDA review processes and regulatory science issues.
	
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    PrintFDA’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

Unique Identification of Portioned Moist Snuff and Snus Products
	Unique Identification of Tobacco ProductsChemistry/Toxicology

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

Engineering Review of Substantial Equivalence (SE) Reports for Originally Regulated ProductsSocial Science

Product Quantity Changes in Substantial Equivalence Reports (SE Reports) for Statutorily Regulated Tobacco Products
	Effects of Tobacco Product Package Shape on Consumer Perceptions, Initiation, and CessationBehavioral and Clinical Pharmacology

BCP Reviews of Characteristic Changes in SE Reports
	BCP Reviews of SE Reports Involving Changes in the Ventilation of Combusted Filtered CigarettesMicrobiology

Substantial Equivalence Reports: Recommended requirements for stability testing of smokeless tobacco productsReviewer Guide**s**

Behavioral and Clinical Pharmacology Guide for SE Reports
	Social Science Reviewer Guide for SE ReportsFDA 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 WebinarsLearn more about the various pathways to market and distribute a tobacco product.

*Documents include the outdated CTP terminology "grandfathered tobacco product." In August 2022, FDA updated the term "grandfathered tobacco product" to "pre-existing tobacco product."

Additional Resources

SE Report Appendices

                                                                                  Content current as of:
      10/25/2019
              
              
Regulated Product(s)
		 TobaccoMarket and Distribute a Tobacco Product

          
                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications
 
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