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
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
Validation and Verification of Analytical Testing Methods Used for Tobacco Products Draft
12/21/21
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:
11/05/2024
