Rules, Regulations and Guidance
The Historic Tobacco Control Act
The Tobacco Control Act gave FDA broad authority to regulate the manufacture, marketing, sale, and distribution of tobacco products. FDA is already using its regulatory powers to make important advances in public health.
Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available, and the information on this page will be updated accordingly in a timely manner.
FDA keeps the tobacco industry informed about regulatory issues, including pathways to legally market new tobacco products and proposed restrictions on promotions and labeling. Explore FDA’s current thinking on a wide range of tobacco-related issues, including a searchable list of guidance documents.
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. Learn more about rules and regulations, including a searchable list of final rules, proposed rules, enforcement action plans, regulatory updates, and other vital regulatory information.
Public comments are part of the rulemaking process. FDA uses public dockets announced in the Federal Register to solicit information from all stakeholders on a number of specific issues related to TCA implementation. View the current collection of docket documents open for public comment.
Letters to Industry
FDA is committed to regular and clear communication with the industry. Search FDA correspondence documents with industry.