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 Applications
  • Substantial Equivalence
  • Exemption from Substantial Equivalence 

Premarket Tobacco Application

Premarket IconMarketing orders are given to Premarket Tobacco 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 Application Final Actions 

PMTA Final ActionsFeb 2014Oct 2015Sept 2016FY 2017FY 2018Total To-Date
PMTA Marketing Orders080008
Refuse-to-File (RTF)400105
Refuse-to-Accept (RTA)0036250367

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 ActionsOctNovDecJanFebMarAprMayJuneJulyAugSeptFY2018
SE Orders11102163-------51
NSE Orders192637-------46
Refuse-To-Accept (RTA)00000-------0
Total Applications Received297012-------30
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, 2018. 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 Marketing Orders

FDA Order LetterDateFDA Decision Summary
SE0000357October 2016Decision Summary SE0000357
SE0002153July 2016Decision Summary SE0002153
SE0002138February 2016Decision Summary SE0002138
SE0002139February 2016Decision Summary SE0002139
SE0002140February 2016Decision Summary SE0002140
SE0002141February 2016Decision Summary SE0002141
SE0002142February 2016Decision Summary SE0002142
SE0002143February 2016Decision Summary SE0002143
SE0002144February 2016Decision Summary SE0002144
SE0002145February 2016Decision Summary SE0002145
SE0002146February 2016Decision Summary SE0002146
SE0002147February 2016Decision Summary SE0002147
SE0002148February 2016Decision Summary SE0002148
SE0000925October 2015Decision Summary SE0000925
SE0010225October 2015Decision Summary SE0000925
SE0010226October 2015Decision Summary SE0000925
SE0010227October 2015Decision Summary SE0000925
SE0010228October 2015Decision Summary SE0000925
SE0010229October 2015Decision Summary SE0000925
SE0010230October 2015Decision Summary SE0000925
SE0010231October 2015Decision Summary SE0000925
SE0010232October 2015Decision Summary SE0000925
SE0010233October 2015Decision Summary SE0000925
SE0000276September 2015Decision Summary SE0000276
SE0000277September 2015Decision Summary SE0000277
SE0000278September 2015Decision Summary SE0000278
SE0000281September 2015Decision Summary SE0000281
SE0002648September 2015Decision Summary SE0002648
SE0000515August 2015Decision Summary SE0000515
SE0001079May 2015Decision Summary SE0001079
SE0003613May 2015Decision Summary SE0003613
SE0003614May 2015Decision Summary SE0003614
SE0003615May 2015Decision Summary SE0003615
SE0003616May 2015Decision Summary SE0003616
SE0003617May 2015Decision Summary SE0003617
SE0003618May 2015Decision Summary SE0003618
SE0003619May 2015Decision Summary SE0003619
SE0003620May 2015Decision Summary SE0003620
SE0003621May 2015Decision Summary SE0003621
SE0000282August 2014Decision Summary SE0000282
SE0000283August 2014Decision Summary SE0000283
SE0000284August 2014Decision Summary SE0000284
SE0000285August 2014Decision Summary SE0000285
SE0000286August 2014Decision Summary SE0000286
SE0000287August 2014Decision Summary SE0000287
SE0000288August 2014Decision Summary SE0000288
SE0003441February 2014Decision Summary SE0003441
SE0003442February 2014Decision Summary SE0003442
SE0003443February 2014Decision Summary SE0003443
SE0003444February 2014Decision Summary SE0003444


Explanation of Selected Not Substantially Equivalent Orders

Included in the summary below are some of the reasons why the FDA concluded that products were Not Substantially Equivalent (NSE) to the predicate products identified in the submissions.

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 SeptFY2018 Total-To-Date
Exemption from SE Orders37410-------15
Not Exempt from SE Orders00000-------0
Refusal-To-Accept (RTA) Letters for Exemption Requests00000-------0
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: 03/23/2018
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