Government Rule & Regulation Of Building Construction
Rules and Regulations
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 |
| 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
- View a comprehensive list of all rules, regulations, and guidances we have published to date.
Source: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/rules-and-regulations
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