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.
Search Tobacco-Related Guidance Guidance Summary Status Date Validation and Verification of Analytical Testing Methods Used for Tobacco Products Final 01/07/2025 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
How Do I Search for a Tobacco-Related Guidance or Cross-Center Guidance? 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:
Content current as of:
01/06/2025
