Tobacco Products

Tobacco Product Marketing Orders

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Different Tobacco ProductsTo legally market a new tobacco product in the United States, you must receive a written order from FDA. FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco. Instead, FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco use causes. There are three pathways to market for tobacco products:  

  • Premarket Tobacco Product Applications
  • Substantial Equivalence
  • Exemption from Substantial Equivalence 

Premarket Tobacco Product Application

Premarket IconMarketing orders are given to Premarket Tobacco Product Applications that have demonstrated that the new tobacco product is appropriate for the protection of the public health, which is determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products, and taking into account the increased or decreased likelihood that:   

  • existing users of tobacco products will stop using such products
  • those who currently do not use tobacco products will start using such products

Summary of Premarket Tobacco Product Application Final Actions 

PMTA Final ActionsFeb 2014Oct 2015Sept 2016FY 2017FY 2018FY 2019 To-DateTotal To-Date
PMTA Marketing Orders0800008
Refuse-to-File (RTF)4001005
Refuse-to-Accept (RTA)00362500367

PMTA Marketing Orders

Marketing Orders are listed by FDA order letter, date, FDA decision summary, environmental assessment (EA), and Finding of No Significant Impact (FONSI).

Explanation of Selected PMTA Decisions

Included in the summary below are some of the reasons why the FDA may refuse to file a new tobacco product application (PMTA).

Substantial Equivalence

Substantial Equivalence is another pathway manufacturers can use to market a new tobacco product, if a new tobacco product meets the following criteria:

  1. It was commercially marketed in the United States after February 15, 2007 but before March 22, 2011; and
  2. A Substantial Equivalence Report was submitted by March 22, 2011.

If both of these criteria are met, then you may continue to market the new tobacco product unless FDA issues an order that the new product is not substantially equivalent to a valid predicate product (commercially marketed in the U.S as of February 15, 2007 or previously found substantially equivalent).

FDA can issue marketing orders for substantially equivalent tobacco products if the new products:

  • have the same characteristics as valid predicate tobacco products, or
  • have different characteristics, but do not raise different questions of public health 

Summary of Substantial Equivalence Actions

SE ActionsOctNovDecJanFebMarAprMayJuneJulyAugSeptFY2019
SE Orders132792931-------109
NSE Orders480000-------48
Refuse-To-Accept (RTA)00080-------8
Total Applications Received184221124-------97
SE ActionsOctNovDecJanFebMarAprMayJuneJulyAugSeptFY2018
SE Orders1110216310173864401025255
NSE Orders19263702001512087
Refuse-To-Accept (RTA)0000000000000
Total Applications Received2970206251012670104
SE ActionsOctNovDecJanFebMarAprMayJuneJulyAugSepFY2017
SE Orders00300028370151479
NSE Orders7080121506151863
Refuse-To-Accept (RTA)110100000120015
Total Applications Received11305151073531042132
SE Final ActionsJanFebMarAprMayJunJulAugSepOctNovDec 2016 Total
Full SE Orders000300000036
Same Characteristic SE Orders000032828000041
Product Quantity SE Orders0000000000000
Full SE Order Rescissions0000000000000
Same Characteristic SE Order Rescissions0000000000000
Product Quantity SE Order Rescissions0000000000000
Full NSE Orders11000011070830
Same Characteristic NSE Orders0000000000000
Product Quantity NSE Orders0000000000000
Full Report Refuse-To-Accepts10244040021101267
Same Characteristic Report Refuse-To-Accepts0000000000000
Product Quantity Report Refuse-To-Accepts0000000000000
Full Report Administrative Closures0000000000000
Same Characteristic Report Administrative Closures0000000000000
Product Quantity Report Administrative Closures0000000000000
Full Report Cancellations0000000000000
Same Characteristic Report Cancellations000000000123 282405
Product Quantity Report Cancellations 00
Full Report Withdrawals1048265123111628715166392
Same Characteristic Report Withdrawals0040040100009
Product Quantity Report Withdrawals00000008008
SE Final Actions JanFebMarAprMayJunJulAugSepOctNovDec2015 Total 
SE Orders 662501250098170525460
SE Order Rescissions 000000000002323
NSE Orders 343011802913230114
Refuse to Accept (RTA) letters for SE 4001164000016
Report Withdrawals 95 450329190226029648473
SE Final ActionsJanFebMarAprMayJunJulAug Sep Oct Nov Dec 2014 Total 
SE Orders005024 78 
NSE Orders0400067125 
Refuse to Accept (RTA) letters for SE0000100016 
Report Withdrawals2675262249 19 223217 301 
SE Final ActionsPre-June 2013JunJulAug Sep Oct Nov Dec 2013 Total 
SE Orders0200438017
NSE Orders0404050013
Refuse to Accept (RTA) letters for SE000000000
Report Withdrawals1327610133171207


Note: Information is as of February 28, 2019. The data provided on this page is produced on an ongoing basis and is subject to change due to updates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

FDA works expeditiously to post all relevant documents for SE marketing orders. Please note that before these documents can be posted they must be redacted in accordance with applicable statutes and regulations and reviewed to ensure compliance with Section 508, which requires that all website content be accessible to people with disabilities. This review time may vary based on the content of each document.

Substantial Equivalence Actions

Common Issues Found in Substantial Equivalence Reports

To help companies prepare a substantial equivalence (SE) report for submission and to avoid common deficiencies that may result in an unfavorable decision on an application, the FDA has posted appendices (organized by product type) containing common issues found in previous SE reports.

FDA Order LetterDateFDA Decision Summary
SE0003026JulyDecision Summary SE0003026
SE0003027JulyDecision Summary SE0003027
SE0003028JulyDecision Summary SE0003028
SE0003029JulyDecision Summary SE0003029
SE0003030JulyDecision Summary SE0003030
SE0003031JulyDecision Summary SE0003031
SE0003032JulyDecision Summary SE0003032



Decision Summary SE0009624



Decision Summary SE0009625



Decision Summary SE0009626



Decision Summary SE0009627



Decision Summary SE0009628



Decision Summary SE0009629



Decision Summary SE0009630



Decision Summary SE0009631



Decision Summary SE0009632



Decision Summary SE0009634



Decision Summary SE0009635



Decision Summary SE0009636



Decision Summary SE0009637



Decision Summary SE0009638



Decision Summary SE0009639



Decision Summary SE0009640



Decision Summary SE0009641



Decision Summary SE0009642



Decision Summary SE0009643



Decision Summary SE0009644



Decision Summary SE0009645



Decision Summary SE0009646



Decision Summary SE0009647

SE0000357OctoberDecision Summary SE0000357
SE0002153JulyDecision Summary SE0002153
SE0002138FebruaryDecision Summary SE0002138
SE0002139FebruaryDecision Summary SE0002139
SE0002140FebruaryDecision Summary SE0002140
SE0002141FebruaryDecision Summary SE0002141
SE0002142FebruaryDecision Summary SE0002142
SE0002143FebruaryDecision Summary SE0002143
SE0002144FebruaryDecision Summary SE0002144
SE0002145FebruaryDecision Summary SE0002145
SE0002146FebruaryDecision Summary SE0002146
SE0002147FebruaryDecision Summary SE0002147
SE0002148FebruaryDecision Summary SE0002148
SE0000925OctoberDecision Summary SE0000925
SE0010225OctoberDecision Summary SE0000925
SE0010226OctoberDecision Summary SE0000925
SE0010227OctoberDecision Summary SE0000925
SE0010228OctoberDecision Summary SE0000925
SE0010229OctoberDecision Summary SE0000925
SE0010230OctoberDecision Summary SE0000925
SE0010231OctoberDecision Summary SE0000925
SE0010232OctoberDecision Summary SE0000925
SE0010233OctoberDecision Summary SE0000925
SE0000276SeptemberDecision Summary SE0000276
SE0000277SeptemberDecision Summary SE0000277
SE0000278SeptemberDecision Summary SE0000278
SE0000281SeptemberDecision Summary SE0000281
SE0002648SeptemberDecision Summary SE0002648
SE0000515AugustDecision Summary SE0000515
SE0001079MayDecision Summary SE0001079
SE0003613MayDecision Summary SE0003613
SE0003614MayDecision Summary SE0003614
SE0003615MayDecision Summary SE0003615
SE0003616MayDecision Summary SE0003616
SE0003617MayDecision Summary SE0003617
SE0003618MayDecision Summary SE0003618
SE0003619MayDecision Summary SE0003619
SE0003620MayDecision Summary SE0003620
SE0003621MayDecision Summary SE0003621
SE0000282AugustDecision Summary SE0000282
SE0000283AugustDecision Summary SE0000283
SE0000284AugustDecision Summary SE0000284
SE0000285AugustDecision Summary SE0000285
SE0000286AugustDecision Summary SE0000286
SE0000287AugustDecision Summary SE0000287
SE0000288AugustDecision Summary SE0000288
SE0003441FebruaryDecision Summary SE0003441
SE0003442FebruaryDecision Summary SE0003442
SE0003443FebruaryDecision Summary SE0003443
SE0003444FebruaryDecision Summary SE0003444


Exemption from Substantial Equivalence

FDA may consider a tobacco product that is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive for exemption from demonstrating substantial equivalence if:

  • The product is a modification of another tobacco product and the modification is minor;
  • The modifications are to a tobacco product that may be legally marketed under the FD&C Act;
  • A Substantial Equivalence Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health;
  •  The modified tobacco product is marketed by the same organization as the original product; and,
  • An exemption is otherwise appropriate

Before legally marketing your product, you must obtain written notification that FDA has granted the product an exemption from demonstrating substantial equivalence. In addition, at least 90 days before commercially marketing the product, you must submit a report notifying FDA of your intention to do so and establishing that your product is covered by a granted exemption. (See 21 CFR 1107.1 and Section 905(j) of the FD&C Act.)

Exemption from Substantial Equivalence Final Actions

Exemption from SE Final ActionsOct Nov Dec Jan Feb Mar Apr May June July Aug SeptFY2019 Total-To-Date
Exemption from SE Orders1810762-------88
Not Exempt from SE Orders00010-------1
Refusal-To-Accept (RTA) Letters for Exemption Requests00020-------2
Exemption from SE Final ActionsOct Nov Dec Jan Feb Mar Apr May June July Aug SeptFY2018 Total-To-Date
Exemption from SE Orders37410002411161058
Not Exempt from SE Orders0000000200002
Refusal-To-Accept (RTA) Letters for Exemption Requests0000000000000
Exemption from SE Final ActionsOct Nov Dec Jan Feb Mar Apr May June July Aug Sep2017 Total-To-Date
Exemption from SE Orders000000000032326
Not Exempt from SE Orders0000000060000
Refusal-To-Accept (RTA) Letters for Exemption Requests000025000000025
Exemption from SE Final ActionsJan Feb Mar AprMayJunJulyAugSepOctNovTotal
Exemption from SE Orders000000000000
Refusal-To-Accept (RTA) Letters for Exemption Requests000050000005
Exemption from SE Final ActionsJan Feb Mar Apr MayJunJulAugSepOctNovTotal
Exemption from SE Orders000100000001
Refusal to Accept (RTA) letters for Exemption Requests0000900002314
SE Exemption Final ActionsJan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total
Refusal to Accept (RTA) letters for Exemption Requests13 14
SE Exemption Final ActionsJunJul Aug Sep Oct Nov Dec Total
Refusal to Accept (RTA) letters for Exemption Requests2022

Exemption from Substantial Equivalence Marketing Orders

Marketing orders are listed by FDA order letter, date, and FDA decision summary.






Page Last Updated: 04/09/2019
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