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Tobacco Products
Guidance, Compliance & Regulatory Information
Resources on legal, regulatory, and policy issues related to tobacco products. The Family Smoking Prevention and Tobacco Control Act was signed on June 22, 2009.
For regulatory questions regarding sections 904 and 905 of the act, email TobaccoIndustryQuestions@fda.hhs.gov.
Regulatory Submissions can be mailed to:
Center for Tobacco Products
Food and Drug Administration
Attn: Document Control Center
9200 Corporate Boulevard
Rockville, MD 20850
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Guidance Documents
Draft Guidance for FDA and Tobacco Retailers: Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers Draft Guidance for Industry: Tobacco Retailer Training Programs Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products Draft Guidance for Industry and FDA Staff: “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents Guidance for Industry and FDA Staff: Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Final Guidance for Industry: Tobacco Health Document Submission Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act Final Guidance for Industry: Listing of Ingredients in Tobacco Products Draft Guidance for Industry: Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Timeframe for Submission of Tobacco Health Documents Guidance to Industry and FDA Staff: General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2)
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Regulatory Information
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Letters to Industry
Letter to Commonwealth Brands, Inc., Promotional Materials Disseminated Through the Company’s Website Letter to Industry Regarding New Health Warnings Required By Amendments to the Smokeless Tobacco Act Letter to Tobacco Manufacturers on Tobacco Products Labeled or Advertised with the Descriptors “Light,” “Low,” “Mild,” or Similar Descriptors Letter to Retailers on Tobacco Products Labeled or Advertised with the Descriptors “Light,” “Low,” “Mild,” or Similar Descriptors Letter to Philip Morris USA, Inc., Marketing Marlboro Lights Cigarettes with an Onsert Letter: Request for Submissions Related to Menthol Letter to Industry on Cigarettes Containing Certain Characterizing Flavors Letter to Tobacco Control Groups on Cigarettes Containing Certain Characterizing Flavors Letter to Industry on Dissolvable Smokeless Tobacco Products (Star Scientific, Inc) Letter to Industry on Dissolvable Smokeless Tobacco Products (R.J. Reynolds Tobacco Company) Letter to States Regarding Competitive RFP to Enforce Certain Provisions of the Tobacco Control Act and Implement Regulations
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