Guidance

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.

In the table below, download guidance documents that represent FDA's current thinking on a wide range of tobacco-related issues.

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Validation and Verification of Analytical Testing Methods Used for Tobacco Products	Draft Guidance	12/21/21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

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