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Guidance

Search for and download guidance documents representing FDA’s current thinking on particular subjects with information to assist in understanding and complying with relevant regulations and laws. You can click to sort by Category, Title, Type or Date.

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You can also access the list of Withdrawn/Replaced Guidances.

Title	Type	Date
Civil Money Penalties for Tobacco Retailers - Responses to Frequently Asked Questions	Draft Guidance	02/08/13
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers	Guidance	11/21/12
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Modified Risk Tobacco Product Applications	Draft Guidance	04/03/12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Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act	Draft Guidance	04/03/12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
Required Warnings for Cigarette Packages and Advertisements	Guidance	10/24/11
Applications for Premarket Review of New Tobacco Products	Draft Guidance	09/27/11
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions	Draft Guidance	09/22/11
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products	Draft Guidance	09/09/11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
Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007	Draft Guidance	04/22/11
Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents [Revision to Draft Guidance]*	Draft Guidance	03/23/11
“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
Tobacco Retailer Training Programs	Draft Guidance	07/16/10
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
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments	Guidance	11/12/09
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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