Center for Tobacco Products’ Regulation and Guidance Policy Agenda

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On this page:

• Regulations: Current Priorities
• Regulations: Longer-term Priorities
• Guidance Documents: Current Priorities

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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

• Tobacco Product Standard for Menthol in Cigarettes 
• Tobacco Product Standard for Characterizing Flavors in Cigars
• Tobacco Product Standard for Nicotine Level of Certain Tobacco Products
• Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
• Administrative Detention of Tobacco Products   
• Requirements for Tobacco Product Manufacturing Practice

Longer-term Priorities 

• Investigational Tobacco Product Applications
• Nicotine Toxicity Warnings
• Establishment Registration and Product Listing for Tobacco Products
• ENDS Safety Standards, Including Standards for Toxicants and Impurities in Nicotine, Propylene Glycol, and Vegetable Glycerin Used in E-Liquids; Tobacco Product Standards
• Modified Risk Tobacco Product Applications

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