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 TobaccoIndustryQuestions@fda.hhs.gov.
- 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.
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.
- 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.