Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

 
Docket ID: FDA-2014-N-0189
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of "tobacco product" to be subject to the FD&C Act, and would specify additional restrictions.

RIN: 0910-AG38
Impacts and Effects: International
CFR Citation: Not Yet Determined
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2016
Agenda Stage of Rulemaking: Final Rule
Major Rule: Yes
Legal Authorities: 21 U.S.C. 301 et seq., The Federal Food, Drug, and Cosmetic Act, Pub. L. 111-31, The Family Smoking Prevention and Tobacco Control Act
Legal Deadlines: None
Government Levels Affected: Undetermined
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: Yes
Included in Regulatory Plan: No
Timetable
ActionDateFR Citation
NPRM04/25/201479 FR 23142
NPRM Comment Period Extended06/24/201479 FR 35711
NPRM Comment Period End07/09/2014
NPRM Comment Period Extended End08/08/2014
Final Action05/00/2016
Docket Details open glossary dialog  
Related RINs: None
Short Title: Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Acts
Keyword(s): ctp, ctp20092, 0910-AG38, open, 2014-850, Deeming Tobacco Products To Be Subject to the, Federal Food, Drug, and Cosmetic Act, as Amended, by the Family Smoking Prevention and Tobacco, Control Act, Restrictions on the Sale and, Distribution of Tobacco Products and Required, Warning Statements for Tobacco Products, Final rule, Gerie Voss or Katherine Collins, Office of Regulations, Center for Tobacco Products, 2015-660
Type: Rulemaking
Docket Status: OPEN
Center: CTP
Docket Item Code: N
 

Primary Documents

View All  (12)
Comment Period Closed
Aug 08, 2014 11:59 PM ET
Proposed Rule
Posted: 06/24/2014
ID: FDA-2014-N-0189-20870
Comment Period Closed
Jul 09, 2014 11:59 PM ET
Other
Posted: 06/13/2014
ID: FDA-2014-N-0189-4587
Comment Period Closed
Jul 09, 2014 11:59 PM ET
Proposed Rule
Posted: 04/25/2014
ID: FDA-2014-N-0189-0001
Comment Period Closed
Other
Posted: 06/13/2016
ID: FDA-2014-N-0189-83197
Comment Period Closed
Other
Posted: 06/13/2016
ID: FDA-2014-N-0189-83198

Supporting Documents

View All  (3,828)
Comments Not Accepted
Supporting & Related Material
Posted: 05/27/2016
ID: FDA-2014-N-0189-83193
Comments Not Accepted
Supporting & Related Material
Posted: 05/27/2016
ID: FDA-2014-N-0189-83194
Comments Not Accepted
Supporting & Related Material
Posted: 05/27/2016
ID: FDA-2014-N-0189-83196

Comments

View All  (79,365)

119,031
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Agency Contact
Gerie Voss
Senior Regulatory Counsel
FDA/HHS
ctpregulations@fda.hhs.gov
877 287-1373
301 595-1426 (Fax)
Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue
Silver Spring, MD 20993
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.