Tobacco Products


To support the public health goals of the Tobacco Control Act, FDA provides guidance to help industry understand and comply with all regulations and the law.

In the table below, search for and download guidance documents that represent FDA’s current thinking on a wide range of tobacco-related issues. Click to sort by title, type of guidance, or date. (You can also access a list of.)

You can also access a list of withdrawn/replaced guidances.

Guidance Documents

Title Type Date
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions Guidance 03/05/15
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 Guidance 09/29/14
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products Guidance 07/16/14
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product Draft Guidance 07/15/14
Civil Money Penalties for Tobacco Retailers - Responses to Frequently Asked Questions Guidance 06/26/14
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Guidance 04/07/14
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent Draft Guidance 02/25/14
Tobacco Retailer Training Programs Guidance 09/04/13
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers Guidance 09/01/13
Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents Guidance 08/21/13
Meetings with Industry and Investigators on the Research and Development of Tobacco Products Guidance 05/24/12
Modified Risk Tobacco Product Applications Draft Guidance 04/03/12
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act Draft Guidance 04/03/12
Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products Guidance 03/30/12
Applications for Premarket Review of New Tobacco Products Draft Guidance 09/27/11
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products Draft Guidance 09/09/11
Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Guidance 05/07/11
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act Guidance 01/31/11
Reports: Demonstrating Substantial Equivalence for Tobacco Products Guidance 01/05/11
Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products Guidance 06/10/10
Tobacco Health Document Submission Guidance 04/20/10
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2) Guidance 12/23/09
Timeframe for Submission of Tobacco Health Documents Guidance 12/21/09
Listing of Ingredients in Tobacco Products Guidance 12/01/09
Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act Draft Guidance 11/27/09
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act Draft Guidance 09/30/09

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Contact FDA

(9am EST-4pm EST)

For General Inquiries:

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002

Page Last Updated: 04/28/2015
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