Guidance Related to Tobacco Products

To support the public health goals of the Tobacco Control Act, FDA provides guidance to help industry understand and comply with all regulations and the law.

The guidance documents in the table below represent FDA's current thinking on a wide range of tobacco-related issues.

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Guidance Summary	Status	Date
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization	Final	05/12/26
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk	Draft	03/11/26
Validation and Verification of Analytical Testing Methods Used for Tobacco Products	Final	01/07/25
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements	Final	09/13/24
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)	Final	09/13/24
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised)	Final	09/13/24
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised)	Final	10/17/23
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (Revised)	Final	10/17/23
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)	Final	08/31/23
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments (Revised)	Final	03/31/23
Health Document Submission Requirements for Tobacco Products (Revised)	Final	03/31/23
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised)	Final	03/17/23
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) (Revised)	Final	03/17/23
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops (Revised)	Final	03/17/23
Prohibition of Distributing Free Samples of Tobacco Products (Revised)	Final	03/17/23
Listing of Ingredients in Tobacco Products (Revised)	Final	03/17/23
Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products (Revised)	Final	03/17/23
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order (Revised)	Final	03/17/23
Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised)	Final	09/07/22
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies (Revised)	Final	08/23/22
Tobacco Product User Fees: Responses to Frequently Asked Questions	Final	12/08/21
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised)	Final	04/30/20
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products	Final	11/26/19
Enforcement Policy for Certain Marketed Tobacco Products	Draft	02/28/19
Use of Investigational Tobacco Products (Revised)	Draft	02/20/19
Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco	Final	08/09/18
Compliance Policy for Required Warning Statements on Small-Packaged Cigars (Revised)	Final	08/09/18
Submission of Warning Plans for Cigars (Revised)	Final	08/09/18
Tobacco Retailer Training Programs (Revised)	Final	08/09/18
Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (Revised)	Final	12/15/16
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act (Revised)	Final	08/31/16
Tobacco Product Master Files	Final	05/05/16
Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products	Final	05/05/16
Small Entity Compliance Guide: National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions	Final	10/26/15
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent	Final	09/11/15
Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents	Final	08/21/13
Modified Risk Tobacco Product Applications	Draft	04/03/12
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	Draft	04/03/12
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products	Draft	09/09/11
Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products	Final	06/10/10
Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco	Final	05/07/10
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2)	Final	12/23/09
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act	Draft	09/30/09

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You can also access a list of withdrawn/replaced guidances.

Where Can I find More Information About Tobacco-Related Guidance?

The Center for Tobacco Product's website includes resources to help you learn more about tobacco product regulations depending on your interest, such as: