Rules, Regulations, and Guidance Related to Tobacco Products
On this page:
- What is the Tobacco Control Act and What Does It Do?
- What Guidance Has FDA Issued Related to Tobacco Products?
- What Rules and Regulations Has FDA Issued Related to Tobacco Products?
- How Do I Comment on Proposed Rules, Regulations, or Guidance Related Tobacco Products?
- How Do I Search Letters to Industry
What is the Tobacco Control Act and What Does It Do?
The Family Smoking Prevention and Tobacco Control Act gave FDA broad authority to regulate the manufacture, marketing, sale, and distribution of tobacco products. FDA uses its regulatory authorities to make important advances in public health.
Use the Tobacco Control Act Table of Contents to review the different parts of the law.
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.
What Guidance Has FDA Issued Related to Tobacco Products?
FDA issues guidance to help tobacco industry and others stay informed and up-to-date on the agency’s current thinking related to tobacco regulation, 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 and the Center for Tobacco Products’ policy agenda of guidance documents that are in development or planned for development.
What Rules and Regulations Has FDA Issued Related to Tobacco Products?
FDA develops rules and regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Tobacco Control Act. FDA regulations have the full force of law.
The agency provides a searchable list of final and proposed rules, enforcement action plans, regulatory updates, and other details related to FDA’s regulation of tobacco products, as well as a policy agenda of rules documents that are in development or planned for development.
FDA Tobacco Rulemaking 101 - How does FDA make rules about tobacco products?
FDA also periodically issues an updated, comprehensive, list of all rules, regulations, and guidances we have published to date.
To assist the public in better understanding the processes for which rules are made, FDA created an explainer video that provides a visual of the steps FDA uses to develop rules based on the laws set forth in the FD&C Act or other laws – including the Family Smoking Prevention and Tobacco Control Act – under which FDA operates.
How Do I Comment on Proposed Rules, Regulations, or Guidance Related Tobacco Products?
Public comments are part of the rulemaking process. FDA uses public dockets announced in the Federal Register to solicit information from all industry, other interested groups, and the public on draft guidance, proposed regulatory actions, rules, and other topics related to the regulation of tobacco products.
Find the current collection of dockets that are open for public comment on the Submit Comments on Tobacco Regulatory Activities page.
How Do I Search Letters to Industry?
FDA is committed to regular and clear communication with industry. FDA's Center for Tobacco Products sends letters to industry to provide updates, help industry understand FDA regulations and policies, and request information. Search FDA correspondence documents with industry.