A New Standard of Effective Regulation
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
Date
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
Additional Resources
Content current as of:
10/04/2021