Rules and Regulations Related to Tobacco Products

What Rules and Regulations Exist for Tobacco Products?

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. These regulations are also federal laws.

FDA also regularly issues guidance about tobacco product regulation to assist industry with the requirements set forth in the rules and regulations below. CTP's policy agenda outlines rules and guidance documents that are in development or planned for development.

---

List of Rules and Regulations Related to Tobacco Products

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

---