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U.S. Department of Health and Human Services

Tobacco Products

FDA Tobacco Regulations Resources

 

Regulations and guidances are mechanisms through which CTP implements the authorities laid out in the Tobacco Control Act.  CTP stakeholders are urged to share information about – and submit responses to – relevant dockets for guidances and regulations.  These public dockets are the official mechanism for the FDA and the Center to hear from stakeholders. By participating in this process, State, Local, Tribal and Territorial stakeholders are playing a critical role in the implementation of the Tobacco Control Act. 

 

How do Dockets, Guidance, Laws and Regulations Differ? 

 

Regulations.gov 

 

Federal Register 
  • The Federal Register (FR) is the official daily publication of notices of Federal agencies and organizations, proposed rules, final rules, and other such regulatory action, as well as Executive Orders and Presidential documents.  
  • The FR also provides several tools to increase understanding of the corresponding tools and processes. 
  • Stakeholders should monitor the FR to learn of CTP regulatory developments from public dockets to upcoming meetings of the TPSAC.  

 

Unified Agenda  

The Unified Agenda of Federal Regulatory and Deregulatory Actions (also known as the semi-annual regulatory agenda) is published in the spring and fall of each year. Since 1978, Federal agencies have been required by Executive orders to publish agendas of regulatory and deregulatory activities. The Regulatory Plan, which is published as part of the fall edition of the Agenda, identifies regulatory priorities and contains additional detail about the most important significant regulatory actions that agencies expect to take in the coming year.  The following represents FDA’s most current Regulatory Agenda.