Tobacco Products

Rules & Regulations

The decisions made by FDA in the regulation of tobacco products are grounded in science.


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. 


Search for Information about Rules and Regulations

Sort by type, title, or date.

Title Type Date
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
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 Proposed Rule 04/25/14
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions Proposed Rule 01/23/14
Menthol in Cigarettes, Tobacco Products Advanced 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
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products Proposed Rule 05/31/13
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products; Extension of Comment Period Advanced Notice of Proposed Rulemaking (ANPRM) 12/06/11
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
Promotion and Advertising Restrictions Enforcement Action Plan 10/31/11
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products Advanced 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
Outdoor Advertising Provision Advanced Notice of Proposed Rulemaking (ANPRM) 03/19/10
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Final Rule 03/18/10

Share this page Share this page on FacebookTweet this pageEmail this page


 

 

Contact FDA

1-877-CTP-1373
1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002

Page Last Updated: 03/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.