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Tobacco Products-Related Citizen Petitions

A citizen petition is a way for individuals, regulated industry representatives, or consumer groups to petition FDA to issue, amend, revoke a regulation, or to take other administrative action. The requirements for a citizen petition are set out in 21 CFR 10.30.

Additional information about citizen petitions can be found on Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions.  

The table below contains tobacco products-related citizen petitions received by FDA. You can search for petitions by specific text or refine your results by using the search box or filters. All links will redirect you to the docket in regulations.gov.

Docket# Petitioner Description Receipt
Date
Response
Date
Response
FDA-2024-P-2126 Innevape, LLC Restricted: Confidential Business Information 2024/05/01 - -
FDA-2024-P-1030 William Drake Request that the FDA test for and, if found, to publicize and make broadly known the presence and concentrations of any residues of pesticide chemicals found in the Certified 1R6F Kentucky Reference Cigarettes that FDA distributes to researchers and research institutions worldwide for purposes of conducting tobacco and tobacco product-related research. 2024/02/28 - -
FDA-2023-P-5234 Bill Drake Request that the FDA act immediately to test the tobacco components of
all IQOS products, whether currently authorized by FDA or in process with FDA, for the presence of pesticide residues and, if pesticide residues are detected, to immediately release these results to the public in full and transparent fashion and to immediately initiate further testing.
2023/11/27 - -
FDA-2023-P-4440 Bill Drake Request that the Secretary initiate a Health Hazard Evaluation of the Swisher Sweets brand of little cigars for possible widespread DDT contamination. 2023/10/09 2024/04/04 Tentative
FDA-2023-P-2633 Mod Fuel Restricted: Confidential Business Information 2023/06/26 2023/12/19 Tentative
FDA-2023-P-2225 Energy Marketers of America (EMA)

Request that the FDA publish a list by brand and category of (i) electronic nicotine delivery systems (ENDS) and other deemed tobacco products with tobacco-derived nicotine that were on the market as of August 8, 2016, and (ii) ENDS and other deemed tobacco products with nicotine not derived from tobacco that were on the market as of April 14, 2022, that indicates whether each of those products:

  • Has received a marketing granted order;
  • Has received an MDO that has been stayed by a court or FDA, rescinded by FDA, or vacated by a court; and/or
  • Has a timely filed premarket tobacco product application (PMTA) pending and is not subject to one of FDA’s enforcement priorities identified in FDA’s Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (rev. Apr. 2020).
2023/06/01 2023/12/12 Tentative
FDA-2023-P-1784 Brava Ventures LLC Restricted: Confidential Business Information 2023/05/04 2023/10/26 Tentative
FDA-2023-P-1477 Alt Zero, Inc. Restricted: Confidential Business Information 2023/04/13 2023/09/25 Tentative
FDA-2023-P-1271 NicQuid, LLC Restricted: Confidential Business Information 2023/04/03 2023/09/25 Tentative
FDA-2023-P-1230 Nicholas Phillips, et al. Request that FDA (1) Assert powers given by the Special Rule for Cigarettes in the TCA and prohibit the sale, manufacture, distribution, and transportation of commercial filtered cigarettes; (2) Seize current commercial filtered cigarettes to prevent their distribution and eventual pollution of countries with developing tobacco control regulations; (3) Act proactively against the industry’s future tobacco and nicotine products and their associated health issues and waste streams; (4) Establish penalties against the industry for their known and continued sale of cigarettes with characterizing flavors beyond the Special Rules enactment in TCA of 2009; (5) Encourage Congress to ratify the World Health Organization Framework Convention on Tobacco Control; (6) Prohibit Menthol as a Characterizing Flavor; (7) Extend the Special Rule for Cigarettes to Cover all Tobacco Products.
 
2023/03/31 2023/09/25 Tentative
FDA-2023-P-0172 Lucy Goods, Inc. Restricted: Confidential Business Information 2023/01/13 2023/07/13 Tentative
FDA-2023-P-0430 RAI Services Company Request that FDA adopt a new enforcement policy directed at illegally marketed disposable electronic nicotine delivery system ("ENDS") products. 2023/02/06

1. 2023/08/04
2. 2023/11/14

1. Tentative
2. Denied
FDA-2022-P-2483 Vapor Vapes, Inc Request that FDA (1) amend the regulation pertaining to the export of tobacco products, namely, 21 C.F.R. §1.101(b), (2) issue a guidance document for industry for tobacco product inspections at manufacturing facilities that are engaged, in whole or in part, in the manufacture of tobacco products for export, and (3) issue an update to FDA’s
Investigations Operations Manual (IOM) regarding inspections of manufacturers that export a tobacco product.
2022/10/06 2023/03/31 Tentative
FDA-2022-P-1211 American Vapor
Manufacturers
Request that the (1) FDA CTP Office of Compliance and Enforcement (“OCE”) permit the continued marketing and sale of such synthetic nicotine e-liquids to adults for the duration of the Agency’s full scientific review (i.e., until FDA reaches a final marketing authorization determination) of their respective applications; (2) the FDA CTP Office of Science (“OS”) allow manufacturers of these products to continue to submit additional data and amend their applications, as the time provided (60 days between March 15, 2022, and May 14, 2022) was simply insufficient to prepare all of the product-specific data FDA requires PMTAs contain including, in some cases, long-term (6 months+) clinical or longitudinal evidence. 2022/06/16 2023/02/02 Denied
FDA-2021-P-0157 Fresh Farms Request the (FDA) to modify or withdraw its decision to issue a Refuse-to-Accept (RTA) letter. Stay of Action Petition asking that the RTA be stayed pending the outcome of the CP. 2021/02/03 2021/08/02 Tentative
FDA-2021-P-0032 Angela Bryan Request the FDA to enact a law entitled the “Mommy I Can’t Breathe Act of 2021”. 2021/01/05 2021/05/04 Denied
FDA-2020-P-1797 Cream Vapor LLC Request the FDA for a 180-day extension of the September 9, 2020 deadline for filing Premarket Tobacco Product Applications (PMTA). 2020/08/24 2021/02/12 Denied
FDA-2020-P-1052 National Tobacco Reform 
Initiative Department 
of Psychiatry &
Behavioral Sciences
Request FDA to take actions its regulation of tobacco products, including that FDA modify its regulatory framework through the lens of the continuum of risk while also recommending a modernization of the TCA. 2020/03/06 2020/08/18 Tentative
FDA-2019-P-5922 Respira
Technologies Inc.
Request the following:  1) establish a nicotine standard for ENDS products; 2) establish a product standard for  ENDS products that limits exposure to HPHCs and other known toxins; 3) establish standardized warnings and HPHC Fact Panels for ENDS products and heated tobacco products; 4) impose marketing restrictions on ENDS products; 5) establish a voluntary, fast track pathway for the approval of ENDS products; and 6) require manufacturers of approved ENDS products to periodically submit post-market reports to FDA. 2019/12/16 2020/05/05 Tentative
FDA-2017-A-6853 NJOY LLC; et. al. Request advisory opinion stating Prop 65 warnings and other warnings mandated by state law for ENDS are preempted by FD&C Act and/or FDA regulations. Federalism, preemption, warning labels. 2017/12/08 2018/06/04 Tentative
FDA-2017-P-3065 NJOY LLC; et. al. Request to issue a revised guidance document extending the compliance periods for the filing of premarket submissions for newly deemed "new tobacco products" that were on the U.S. market as of August 8, 2016, to no earlier than 24 months from FDA's publication of final guidance or regulation describing the recommended or required contents of premarket submissions for the applicable category of tobacco products; and Issue a revised guidance document that provides for the continued marketing of a product that is the subject of a timely filed premarket submission under the revised compliance policy throughout the entire period of the Agency's review (not limited to 12 months).     2017/05/12 2017/11/02 Closed
FDA-2014-N-0189 Center for 
Regulatory 
Effectiveness;
and J.C. Newman Cigar Company
Request that FDA incorporate in its rule an administrative petition process for legacy cigar manufacturers to avoid closure. 2016/06/07 2016/08/25 Closed
FDA-2015-P-1279 Cigar Rights
of America
Request that the FDA exempt premium cigars from any finalized Deeming regulation. 2015/04/22

1. 2015/09/16
2. 2016/05/09

1. Tentative
2. Closed

FDA-2013-P-1127 Tobacco Control
Legal Consortium;
et. al.
Request the Agency to assert jurisdiction over and regulate the manufacturing, marketing, sale, and distribution of certain non-cigarette tobacco products, also known as "other tobacco products" (OTPs). 2013/09/09

1. 2014/03/06
2. 2016/05/09

1. Tentative
2. Granted

FDA-2013-P-0435 Tobacco Control
Legal Consortium;
et. al.
Request urging FDA to take immediate action to prohibit menthol as a characterizing flavoring in cigarettes and cigarette smoke. 2013/04/12

1. 2013/10/18
2. 2021/04/29

1. Tentative
2. Granted

FDA-2013-P-0285 Collective public
health officials
and advocacy
organizations
Request implementation of a track and trace system to monitor manufacturing and the flow of tobacco products from production through distribution to retail outlets. 2013/03/11 2013/09/06 Tentative
FDA-2013-P-0280 R J Reynolds Tobacco
Company; American
Snuff Company, LLC;
and Santa Fe Natural Tobacco Co.
Request that the Secretary assess user fees in a manner that no manufacturer or importer of tobacco products is required to pay such fees in an amount greater than its actual market share-based percentage. 2013/03/07 2013/07/11 Granted
FDA-2012-P-0695 Lorillard Tobacco Company Request the Agency to announce a policy of enforcement discretion with respect to the premarket approval requirements of section 910(a) of the FDCA for new tobacco products first introduced into the U.S. commerce after March 22, 2011, or modified in certain ways after that date, so long as the manufacturer has submitted a report under section 9050) of the FDCA (an SE Report) at least 90 days before introducing the new product into the market. 2012/06/27

1. 2012/12/26
2. 2013/10/18

1. Tentative
2. Denied

FDA-2011-P-0623-0001/CP International Premium
Cigar, and Pipe
Retailers Association
Request to issue regulations that define a "traditional large and premium cigar" and then exempt traditional large and premium cigars from further regulations by FDA. 2011/08/24

1. 2011/12/05
2. 2016/05/09

1. Tentative
2. Granted

FDA-2011-P-0573-0001/CP RJ Reynolds Request to initiate a rulemaking procedure to adjust the text of a smokeless tobacco (“ST”) product warning label statement. 2011/07/29 2015/05/11 Denied
FDA-2011-P-0356-0001/CP Center for Tobacco Regulation, University of Maryland School of Law; et. al. Request to assert jurisdiction over cigars and subject cigars to certain sales and distribution regulations that apply to cigarettes and smokeless tobacco. 2011/05/10

1. 2011/10/26
2. 2016/05/09

1. Tentative
2. Granted

FDA-2010-P-0532 BBK Tobacco & Foods Request the Food and Drug Administration to refrain from taking any form of administrative or enforcement action against Flavored Paper sold separately, and find that the Act does not authorize the regulation of Flavored Paper. 2010/10/04

1. 2011/07/15
2. 2016/08/18

1. Tentative
2. Denied

FDA-2010-P-0376 Rousseau Research,
Inc., and 
ETOBACCO LLC
Request a ban on free samples, price discounts, and marketing contracts that penalize distributors/retailers who sell MRTPs and potential MRTPs; issuance of a product standard for d-alpha Tocopherol levels ; and recognition of E brand cigarettes as a potential MRTP.

2010/07/09

1. 2011/07/15
2. 2013/12/06

1. Tentative
2. Denied

FDA-2010-P-0149 House of Oliver Twist Request an exemption from certain label requirements for the Oliver Twist Chewing Tobacco Bits Products package. 2010/03/16 2011/07/15 Denied
FDA-2009-P-0359 National Coalition
of Associations of
7-Eleven Franchises –
New England 7-11
Franchise Owners
Association
Request to implement new section 907(a)(1) of the Federal Food, Drug and Cosmetic Act and for enforcement discretion for cigarette products not expressly identified on the label or in labeling as containing a fruit, candy, herb or spice as characterizing flavor until implementing regulations can be promulgated. 2009/07/29 2009/09/22 Denied

 

 
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