News & Events

Guidance, Regulations & Compliance

FDA vigorously enforces the Tobacco Control Act (TCA), which provides FDA with a wide array of powerful regulatory tools to protect the health of all American families.

Use this search tool to 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.

FDA’s regulatory activities include:

  • Setting policy and developing regulations, grounded in science, for the manufacture, distribution, and marketing of tobacco products.
  • Providing clear guidance to the industry to help it thoroughly understand and know its responsibilities under the law.
  • Closely monitoring industry compliance with the law and all regulations, and taking strong corrective action when violations occur.

Scientists working in a lab

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. 


Guidance

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.


Compliance and Enforcement

Retailers play an important role in protecting the health of young people by following the law and refusing to sell cigarettes or smokeless tobacco products to anyone under the age of 18. FDA closely monitors retailers’ compliance with Federal tobacco laws and takes corrective action when violations occur. Learn about compliance inspections, Warning Letters, and Civil Money Penalty (CMP) Complaints.


Letters to Industry

FDA is committed to regular and clear communication with the industry. Search FDA correspondence documents with industry.



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Page Last Updated: 07/15/2015
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