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  1. Rules, Regulations and Guidance

Center for Tobacco Products’ Regulation and Guidance Policy Agenda


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CTP’s policy agenda outlines rules and guidance documents that are in development or planned for development. This agenda will be updated annually. The center will also periodically assess this agenda and prioritize, reprioritize, and when appropriate, deprioritize certain activities to reflect its recent activities, decisions, and desired future outcomes along with the current state of the tobacco marketplace. This process will be guided by the best available science, strict adherence to the law, and our fundamental mission to protect and promote the public health.

This agenda does not create a legal obligation on FDA to: implement any regulation or guidance; adhere to schedules in this publication; or to confine their activities to the items that appear within it. FDA may withdraw any item on this agenda, and may issue or propose other regulations or guidances not included in this agenda, consistent with applicable law. FDA may take action on any item in the agenda before or after any dates listed.

Regulations

Current Priorities

Longer-term Priorities 

Guidance Documents

Current Priorities 

  • Tobacco Product Standard for Menthol in Cigarettes - Small Entity Compliance Guidance 
  • Tobacco Product Standard for Characterizing Flavors in Cigars - Small Entity Compliance Guidance
  • Civil Money Penalties for Regulated Tobacco Entities 
  • Tobacco Product Test Methods Validation and Verification and Recordkeeping for Analytical Methods (VRAM) Final Guidance
 
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