Guidance, Compliance & Regulatory Information

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Guidance, Compliance & Regulatory Information

Guidance, Regulations & Compliance
Find resources on the legal, regulatory, and policy issues related to tobacco products. For regulatory questions regarding sections 904 and 905 of the act, email

Learn how to legally market, advertise and label new tobacco products – learn more.

  • Tobacco Control Act & Summary
    Read an overview, view an interactive timeline of key Act deliverables, navigate the full Act, and search by topic and audience.
  • 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.
  • Rules & Regulations
    FDA develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act (FD&C Act) or other laws – including the Family Smoking Prevention and Tobacco Control Act – under which FDA operates. FDA regulations have the full force of law.
    Family Smoking Prevention and Tobacco Control Act
  • Compliance & Enforcement
    Learn about compliance check inspections of tobacco product retailers, tobacco warning letters, and civil money penalty complaints.
  • Comment Opportunities
    View the current collection of docket documents open for public comment.
  • Letters to Industry
    Read FDA correspondence documents with industry.

Other Important Guidance, Regulations & Compliance Information

  • View a comprehensive list of all the guidances, rules, and regulations that FDA’s Center for Tobacco products has published to date.
  • View Reports to Congress which provide an assessment of FDA’s effort to implement the Tobacco Control Act.
  • Use the Searchable Tobacco Control Act to help you easily find and access specific information from the law.
  • Download Infographic Timeline with key deliverables, images, and the act’s public health rationale.
  • Search the inspection database to find lists of retailer Warning Letters and Civil Money Penalty Complaints issued by FDA and a list of inspected establishments where no violations were observed in states with FDA tobacco enforcement contracts.