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  1. Rules, Regulations and 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.

To search for a guidance related to tobacco or other cross-Center guidances:

Note: The definition of “tobacco product,” where included in the text of FDA regulations, has been updated to reflect the statutory amendments to include products that contain nicotine from any source. FDA has made these conforming changes to its regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022 (the Appropriations Act), which amended the term “tobacco product” in the FD&C Act. Revisions to FDA’s guidances to reflect the updates are ongoing.

Title Type Date
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
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) Guidance 07/09/21
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised) Guidance 07/09/21
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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