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Rules and Regulations

Rules and Regulations

A 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 Date
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports Proposed Rule 04/02/19
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
Cigarette Packaging and Advertising Compliance Update – Impact of Ongoing Litigation Regulatory Update 02/24/12
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

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