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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, search for and download guidance documents that represent FDA's current thinking on a wide range of tobacco-related issues. Click to sort by title, type of guidance, or date. You can also access a list of withdrawn/replaced guidances.

Title Type Date
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
Modifications to Compliance Policy for Certain Deemed Tobacco Products Draft Guidance 03/13/19
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised)* Guidance  03/08/19
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised)* Guidance  03/08/19
Enforcement Policy for Certain Marketed Tobacco Products Draft Guidance 02/28/19
Use of Investigational Tobacco Products (Revised)* Draft Guidance 02/20/19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
Applications for Premarket Review of New Tobacco Products Draft Guidance 09/27/11
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

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