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                Rules, Regulations and Guidance

Rules, Regulations and Guidance

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          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
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    PrintA New Standard of Effective Regulation

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FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers. Similarly, when developing certain regulations, the law requires FDA to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use.

FDA regulations are based on the laws set forth in the Tobacco Control Act and the Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are also federal laws.

Rules and Regulations

Title
			Type
			DateRequirements for Tobacco Product Manufacturing Practice
			Proposed Rule
			03/10/23Tobacco Product Standard for Menthol in Cigarettes
			Proposed Rule
			05/04/22Tobacco Product Standard for Characterizing Flavors in Cigars
			Proposed Rule
			05/04/22Premarket Tobacco Applications and Recordkeeping Requirements
			Final Rule
			10/05/21Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
			Final Rule
			10/05/21Required Warnings for Cigarette Packages and Advertisements
			Final Rule
			03/18/20Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
			Proposed Rule
			08/15/19Regulation of Premium Cigars
			Advance Notice of Proposed Rulemaking (ANPRM)
			03/26/18Regulation of Flavors in Tobacco Products
			Advance Notice of Proposed Rulemaking (ANPRM)
			03/21/18Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
			Advance Notice of Proposed Rulemaking (ANPRM)
			03/16/18Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products
			Proposed Rule
			01/23/17Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses"
			Final Rule
			01/09/17Refuse to Accept Procedures for Premarket Tobacco Product Submissions
			Final Rule
			12/29/16Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act
			Final Rule
			05/05/16Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
			Final Rule
			05/05/16National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
			Final Rule
			09/24/15Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
			Advance Notice of Proposed Rulemaking (ANPRM)
			07/01/15Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
			Final Rule
			07/10/14Menthol in Cigarettes, Tobacco Products
			Advance Notice of Proposed Rulemaking (ANPRM)
			07/24/13Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
			Established List
			04/03/12Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (Amends Brand Name Provision (1140.16(a))
			Proposed Rule
			11/10/11Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products
			Advance Notice of Proposed Rulemaking (ANPRM)
			09/09/11Exemptions From Substantial Equivalence Requirements
			Final Rule
			07/05/11Required Warnings for Cigarette Packages and Advertisements
			Final Rule
			06/22/11Amendments to General Regulations of the Food and Drug Administration
			Final Rule
			11/30/10Promotion and Advertising Restrictions
			Enforcement Action Plan
			10/01/10Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act
			Advance Notice of Proposed Rulemaking (ANPRM)
			03/19/10Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
			Final Rule
			03/18/10

Additional Resources

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

                                                                                  Content current as of:
      03/08/2023
              
              
Regulated Product(s)
		 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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