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                Rules, Regulations and Guidance

Rules, Regulations and Guidance

                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
          Tobacco Products
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          Rules, Regulations and Guidance
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    PrintTo 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:

Go to Search for FDA Guidance Documents
	Scroll down to Guidance Document Search
	Filter by FDA Organization, Center for Tobacco Products
	Use other filters, as needed
	You can also access a list of withdrawn/replaced guidances.**Note:** The definition of “tobacco product,” where included in the text of FDA regulations, has been updated to reflect the statutory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
			DateDemonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions **(Revised)**
			Guidance
			10/17/23Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 **(Revised)**
			Guidance
			10/17/23Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers **(Revised)**
			Guidance
			08/31/23Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments **(Revised)**
			Guidance
			03/31/23Health Document Submission Requirements for Tobacco Products **(Revised)**
			Guidance
			03/31/23FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements **(Revised)**
			Guidance
			03/17/23Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) **(Revised)**
			Guidance
			03/17/23Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops **(Revised)**
			Guidance
			03/17/23Prohibition of Distributing Free Samples of Tobacco Products **(Revised)**
			Guidance
			03/17/23Listing of Ingredients in Tobacco Products **(Revised)**
			Guidance
			03/17/23Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products **(Revised)**
			Guidance
			03/17/23Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order **(Revised)**
			Guidance
			03/17/23Meetings with Industry and Investigators on the Research and Development of Tobacco Products **(Revised)**
			Guidance
			09/07/22Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies **(Revised)**
			Guidance
			08/23/22Validation and Verification of Analytical Testing Methods Used for Tobacco Products
			Draft Guidance
			12/21/21Tobacco Product User Fees: Responses to Frequently Asked Questions
			Guidance
			12/08/21Submission of Plans for Cigarette Packages and Cigarette Advertisements **(Revised)**
			Guidance
			07/09/21Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide **(Revised)**
			Guidance
			07/09/21Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization **(Revised)**
			Guidance
			04/30/20Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products
			Guidance
			11/26/19Enforcement Policy for Certain Marketed Tobacco Products
			Draft Guidance
			02/28/19Use of Investigational Tobacco Products **(Revised)**
			Draft Guidance
			02/20/19Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
			Guidance
			08/09/18Compliance Policy for Required Warning Statements on Small-Packaged Cigars **(Revised)**
			Guidance
			08/09/18Submission of Warning Plans for Cigars **(Revised)**
			Guidance
			08/09/18Tobacco Retailer Training Programs **(Revised)**
			Guidance
			08/09/18Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions **(Revised)**
			Guidance
			12/15/16Investigational 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
			08/31/16Tobacco Product Master Files
			Guidance
			05/05/16Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
			Guidance
			05/05/16Small Entity Compliance Guide: National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
			Guidance
			10/26/15Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent
			Guidance
			09/11/15Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product
			Draft Guidance
			07/15/14Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
			Guidance
			08/21/13Modified Risk Tobacco Product Applications
			Draft Guidance
			04/03/12Reporting 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
			04/03/12Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products
			Draft Guidance
			09/09/11Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
			Guidance
			01/05/11Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
			Guidance
			06/10/10Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
			Guidance
			05/07/10General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors **(Edition 2)**
			Guidance
			12/23/09The 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

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	View a comprehensive list of all rules, regulations, and guidances we have published to date

                                                                                  Content current as of:
      10/17/2023
              
              
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		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
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