Tobacco Products

Rules, Regulations and Guidance

Man and woman in lab coats

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. 


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. 

Comment Opportunities

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.

Page Last Updated: 03/30/2018
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