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HHS/FDA RIN: 0910-AH86 Publication ID: Fall 2018 
Title: Tobacco Product Standard for Nicotine Level of Certain Tobacco Products; Request for Information 

This ANPRM would explain that FDA is considering whether it would be appropriate to develop a product standard that would set a maximum nicotine level in certain combusted tobacco products so that they are minimally addictive.  Such a standard, if ultimately promulgated, could help limit the addictiveness of the most toxic and widely used tobacco products, which would have significant public health benefits for youth, young adults, and adults, as well as potentially vast economic benefits.  This ANPRM would request comments, data, research results, and other information that could inform regulatory actions FDA might take with respect to the nicotine level of certain combusted tobacco products.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 387f(a)(1)    21 U.S.C. 387g(3)   
Legal Deadline:  None
Action Date FR Cite
ANPRM  03/16/2018  83 FR 11818   
ANPRM Comment Period End  07/16/2018 
NPRM  To Be Determined 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Gerie Voss
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373