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 | Filing Date |
Response Date |
Response |
|---|---|---|---|---|---|
| FDA-2023-P-1784 | Brava Ventures LLC | Restricted: Confidential Business Information | 2023/05/05 | - | - |
| FDA-2023-P-1477 | Alt Zero, Inc. | Restricted: Confidential Business Information | 2023/04/17 | - | - |
| FDA-2023-P-1271 | NicQuid, LLC | Restricted: Confidential Business Information | 2023/04/04 | - | - |
| 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. |
2023/04/03 | - | - |
| FDA-2023-P-0172 | Lucy Goods, Inc. | Restricted: Confidential Business Information | 2023/01/17 | - | - |
| 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. | 2023/02/07 | - | - |
| 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 | - | - |
| 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. | 2022/06/17 | 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). | 2020/08/25 | 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. | 2020/03/09 | 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. | 2017/12/13 | 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). | 2017/05/15 | 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. | 2016/06/08 | 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 |
1. Tentative |
| 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 |
1. Tentative |
| 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. | 2013/04/03 |
1. 2013/10/18 |
1. Tentative |
| 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 |
1. Tentative |
| 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 |
1. Tentative |
| 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 |
1. Tentative |
| 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 |
1. Tentative |
| 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 |
1. Tentative |
| 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 |