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HHS/FDA RIN: 0910-AG39 Publication ID: Spring 2011 
Title: Tobacco Product Substantial Equivalence Exemptions 
Abstract: This rule implements the substantial equivalence exemption provision of the Family Smoking Prevention and Tobacco Control Act. The Secretary may exempt from the requirements relating to demonstration that a tobacco product is substantially equivalent, tobacco products that are modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines the modification would be a minor modification of a tobacco product that can be sold under the law, a report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health, and an exemption is otherwise appropriate. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1107.1   
Legal Authority: 21 USC 371    21 USC 387e    21 USC 387j   
Legal Deadline:
Action Source Description Date
Final  Statutory    07/01/2011 
Timetable:
Action Date FR Cite
NPRM  01/06/2011  76 FR 737   
NPRM Comment Period End  03/22/2011    
Final Action  07/00/2011    
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:
Annette Marthaler
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129,
Silver Spring, MD 20993
Phone:240 753-3043
Email: annette.marthaler@fda.hhs.gov