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:
Title
Type
Date
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
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies
Draft Guidance
10/28/20
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised)*
Guidance
10/16/20
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
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)
Guidance
06/11/19
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops
Guidance
03/22/19
Enforcement Policy for Certain Marketed Tobacco Products
Draft Guidance
02/28/19
Use of Investigational Tobacco Products (Revised)*
Draft Guidance
02/20/19
Listing of Ingredients in Tobacco Products (Revised)*
Guidance
11/06/18
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
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments (Revised)*
Guidance
12/07/17
Health Document Submission Requirements for Tobacco Products (Revised)*
Guidance
10/18/17
Prohibition of Distributing Free Samples of Tobacco Products
Guidance
10/11/17
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)*
Guidance
12/15/16
Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (Revised)*
Guidance
12/15/16
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
Guidance
12/12/16
Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016 During the Deeming Compliance Periods
Guidance
10/12/16
“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
Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised)*
Guidance
07/15/16
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
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order
Guidance
08/28/15
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
Guidance
09/29/14
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product
Draft Guidance
07/15/14
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
Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products
Guidance
03/30/12
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products
Draft Guidance
09/09/11
Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
Guidance
01/05/11
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
Additional Resources
Content current as of:
12/08/2021