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  1. Market and Distribute a Tobacco Product

Tobacco Product Marketing Orders

On this page:

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 Actions Feb 2014 Oct 2015 Sept 2016 FY 2017 FY 2018 FY 2019 To-Date Total To-Date
PMTA Marketing Orders 0 8 0 0 0 4 12
Refuse-to-File (RTF) 4 0 0 1 0 2 7
Refuse-to-Accept (RTA) 0 0 362 5 0 0 367
Withdrawals 0 0 0 3 0 0 3

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 documents below are some of the reasons why the FDA may refuse to file a new premarket tobacco product application (PMTA) and rationale for for certain postmarket requirements..

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 Actions Oct Nov Dec Jan Feb Mar Apr May June July Aug Sept FY2019
Total-To-Date
SE Orders 13 27 9 29 31 12 39 12 28 8 17 - 225
NSE Orders 48 0 0 0 0 4 9 3 9 6 5 - 84
Refuse-To-Accept (RTA) 0 0 0 8 0 0 0 0 0 2 0 - 10
Withdrawn 10 8 5 6 36 21 34 3 24 29 21 - 197
Total Applications Received 18 42 21 12 4 29 32 7 63 20 18 - 266

SE Actions Oct Nov Dec Jan Feb Mar Apr May June July Aug Sept FY2018
Total-To-Date
SE Orders 11 10 21 6 3 10 17 38 64 40 10 25 255
NSE Orders 1 9 26 3 7 0 2 0 0 15 12 0 87
Refuse-To-Accept (RTA) 0 0 0 0 0 0 0 0 0 0 0 0 0
Withdrawals 10 12 18 3 69 28 26 34 2 13 9 3 227
Total Applications Received 2 9 7 0 20 6 25 10 12 6 7 0 104

SE Actions Oct Nov Dec Jan Feb Mar Apr May June July Aug Sep FY2017
Total-To-Date
SE Orders 0 0 3 0 0 0 2 8 37 0 15 14 79
NSE Orders 7 0 8 0 1 2 1 5 0 6 15 18 63
Refuse-To-Accept (RTA) 1 10 1 0 0 0 0 0 1 2 0 0 15
Withdrawals 7 15 166 13 18 15 17 16 2 29 10 31 339
Total Applications Received 1 1 30 5 15 10 7 3 5 3 10 42 132

SE Final Actions Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec  2016 Total
Full SE Orders 0  0 0 0 3 0 0 0 0 0 0 3 6
Same Characteristic SE Orders 0 0 0 0 3 28 2 8 0 0 0 0 41
Product Quantity SE Orders 0 0 0 0 0 0 0 0 0 0 0 0 0
Full SE Order Rescissions 0 0 0 0 0 0 0 0 0 0 0 0 0
Same Characteristic SE Order Rescissions 0 0 0 0 0 0 0 0 0 0 0 0 0
Product Quantity SE Order Rescissions 0 0 0 0 0 0 0 0 0 0 0 0 0
                           
Full NSE Orders 2  11 0 0 0 0 1 1 0 7 0 8 30
Same Characteristic NSE Orders 0 0 0 0 0 0 0 0 0 0 0 0 0
Product Quantity NSE Orders 0 0 0 0 0 0 0 0 0 0 0 0 0
                           
Full Report Refuse-To-Accepts 4  1 0 244 0 4 0 0 2 1 10 1 267
Same Characteristic Report Refuse-To-Accepts 0 0 0 0 0 0 0 0 0 0 0 0 0
Product Quantity Report Refuse-To-Accepts 0 0 0 0 0 0 0 0 0 0 0 0 0
Full Report Administrative Closures 0 0 0 0 0 0 0 0 0 0 0 0 0
Same Characteristic Report Administrative Closures 0 0 0 0 0 0 0 0 0 0 0 0 0
Product Quantity Report Administrative Closures 0 0 0 0 0 0 0 0 0 0 0 0 0
Full Report Cancellations 0 0 0 0 0 0 0 0 0 0 0 0 0
Same Characteristic Report Cancellations 0 0 0 0 0 0 0 0 0 123  282 0  405
Product Quantity Report Cancellations 0   0 0 0  0  0  0  0  0  0  0  0  0 
                           
Full Report Withdrawals 1 0 48 26 51 23 11 16 28 7 15 166 392
Same Characteristic Report Withdrawals 0 0 4 0 0 4 0 1 0 0 0 0 9
Product Quantity Report Withdrawals 0 0 0 0 0 0 0 8 0 0 0  0  8

SE Final Actions   Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 Total 
SE Orders   0  6 6 25 0 125 0 0 98 170 5 25 460
SE Order Rescissions   0 0 0 0 0 0 0 0 0 0 0 23 23
NSE Orders   2  3 43 0 11 8 0 2 9 13 23 0 114
Refuse to Accept (RTA) letters for SE   0  4 0 0 1 1 6 4 0 0 0 0 16
Report Withdrawals   95  45 0 3 29 190 2 26 0 29 6 48 473

SE Final Actions Jan Feb Mar Apr May Jun Jul Aug  Sep  Oct  Nov  Dec  2014 Total 
SE Orders 0 0 0  0  4  50 0  0  0  0  24  0  78 
NSE Orders 0 4 0 0 0 0  6 7 1 1  6  0  25 
Refuse to Accept (RTA) letters for SE 0 0 0 0 10 6  0 0  0 0  0  0  16 
Report Withdrawals 26 75 26 22 49  19  22 32 1  7  17  5  301 

SE Final Actions Pre-June 2013 Jun Jul Aug  Sep  Oct  Nov  Dec  2013 Total 
SE Orders 0 2 0 0 4 3 8 0 17
NSE Orders 0 4 0 4 0 5 0 0 13
Refuse to Accept (RTA) letters for SE 0 0 0 0 0 0 0 0 0
Report Withdrawals 132 7 6 10 13 31 7 1 207

 

Note: Information is as of August 31, 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 Letter Date FDA Decision Summary
2018    
SE0001889 October Decision Summary SE0001889
SE0001890 October Decision Summary SE0001890
SE0001891 October Decision Summary SE0001891
SE0001892 October Decision Summary SE0001892
SE0001893 October Decision Summary SE0001893
SE0003304 October Decision Summary SE0003304
SE0003305 October Decision Summary SE0003305
SE0003306 October Decision Summary SE0003306
     
SE0002998 August Decision Summary SE0002998
SE0003000 August Decision Summary SE0003000
SE0003001 August Decision Summary SE0003001
SE0003005 August Decision Summary SE0003005
SE0003006 August Decision Summary SE0003006
SE0003012 August Decision Summary SE0003012
SE0003014 August Decision Summary SE0003014
SE0003015 August Decision Summary SE0003015
SE0003020 August Decision Summary SE0003020
SE0003021 August Decision Summary SE0003021
SE0003022 August Decision Summary SE0003022
SE0003023 August Decision Summary SE0003023
     
SE0003026 July Decision Summary SE0003026
SE0003027 July Decision Summary SE0003027 
SE0003028 July Decision Summary SE0003028 
SE0003029 July Decision Summary SE0003029 
SE0003030 July Decision Summary SE0003030 
SE0003031 July Decision Summary SE0003031 
SE0003032 July Decision Summary SE0003032 
SE0003201 July Decision Summary SE0003201
SE0003204 July Decision Summary SE0003204
SE0003206 July Decision Summary SE0003206
SE0003208 July Decision Summary SE0003208
     
2017    

SE0009624

December

Decision Summary SE0009624

SE0009625

December

Decision Summary SE0009625

SE0009626

December

Decision Summary SE0009626

SE0009627

December

Decision Summary SE0009627

SE0009628

December

Decision Summary SE0009628

SE0009629

December

Decision Summary SE0009629

SE0009630

December

Decision Summary SE0009630

SE0009631

December

Decision Summary SE0009631

SE0009632

December

Decision Summary SE0009632

SE0009634

December

Decision Summary SE0009634

SE0009635

December

Decision Summary SE0009635

SE0009636

December

Decision Summary SE0009636

SE0009637

December

Decision Summary SE0009637

SE0009638

December

Decision Summary SE0009638

SE0009639

December

Decision Summary SE0009639

SE0009640

December

Decision Summary SE0009640

SE0009641

December

Decision Summary SE0009641

SE0009642

December

Decision Summary SE0009642

SE0009643

December

Decision Summary SE0009643

SE0009644

December

Decision Summary SE0009644

SE0009645

December

Decision Summary SE0009645

SE0009646

December

Decision Summary SE0009646

SE0009647

December

Decision Summary SE0009647
     
2016    
SE0000357 October Decision Summary SE0000357
     
SE0002153 July Decision Summary SE0002153
     
SE0002138 February Decision Summary SE0002138
SE0002139 February Decision Summary SE0002139
SE0002140 February Decision Summary SE0002140
SE0002141 February Decision Summary SE0002141
SE0002142 February Decision Summary SE0002142
SE0002143 February Decision Summary SE0002143
SE0002144 February Decision Summary SE0002144
SE0002145 February Decision Summary SE0002145
SE0002146 February Decision Summary SE0002146
SE0002147 February Decision Summary SE0002147
SE0002148 February Decision Summary SE0002148
     
2015    
SE0000925 October Decision Summary SE0000925
SE0010225 October Decision Summary SE0000925
SE0010226 October Decision Summary SE0000925
SE0010227 October Decision Summary SE0000925
SE0010228 October Decision Summary SE0000925
SE0010229 October Decision Summary SE0000925
SE0010230 October Decision Summary SE0000925
SE0010231 October Decision Summary SE0000925
SE0010232 October Decision Summary SE0000925
SE0010233 October Decision Summary SE0000925
     
SE0000276 September Decision Summary SE0000276
SE0000277 September Decision Summary SE0000277
SE0000278 September Decision Summary SE0000278
SE0000281 September Decision Summary SE0000281
     
SE0002648 September Decision Summary SE0002648
     
SE0000515 August Decision Summary SE0000515
     
SE0001079 May Decision Summary SE0001079
SE0003613 May Decision Summary SE0003613
SE0003614 May Decision Summary SE0003614
SE0003615 May Decision Summary SE0003615
SE0003616 May Decision Summary SE0003616
SE0003617 May Decision Summary SE0003617
SE0003618 May Decision Summary SE0003618
SE0003619 May Decision Summary SE0003619
SE0003620 May Decision Summary SE0003620
SE0003621 May Decision Summary SE0003621
     
2014    
SE0000282 August Decision Summary SE0000282
SE0000283 August Decision Summary SE0000283
SE0000284 August Decision Summary SE0000284
SE0000285 August Decision Summary SE0000285
SE0000286 August Decision Summary SE0000286
SE0000287 August Decision Summary SE0000287
SE0000288 August Decision Summary SE0000288
     
SE0003441 February Decision Summary SE0003441
SE0003442 February Decision Summary SE0003442
SE0003443 February Decision Summary SE0003443
SE0003444 February Decision 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 Actions Oct Nov Dec Jan Feb Mar Apr May Jun July Aug Sep Total
EX Orders 1 8 10 7 68 14 6 23 22 19 0 - 178
NEX Orders 0 0 0 1 0 1 0 0 0 4 4 - 10
Refusal-To-Accept (RTA) 0 0 0 2 0 1 4 5 0 9 0 - 21
Withdrawn 0 2 0 0 17 0 0 0 0 0 1 - 20
Total Applications Received 16 21 73 15 27 11 14 40 77 24 4 - 322

Exemption from SE Final Actions Oct Nov Dec Jan Feb Mar Apr May Jun July Aug Sep Total
Exemption from SE Orders 3 7 4 1 0 0 0 2 4 11 16 10 58
Not Exempt from SE Orders 0 0 0 0 0 0 0 2 0 0 0 0 2
Refusal-To-Accept (RTA) Letters for Exemption Requests 0 0 0 0 0 0 0 0 0 0 0 0 0
Withdrawals 1 1 0 0 0 0 0 0 0 0 0 0 2

Exemption from SE Final Actions Oct Nov Dec Jan Feb Mar Apr May Jun July Aug Sep Total
Exemption from SE Orders 0 0 0 0 0 0 0 0 0 0 3 23 26
Not Exempt from SE Orders 0 0 0 0 0 0 0 0 6 0 0 0 0
Refusal-To-Accept (RTA) Letters for Exemption Requests 0 0 0 0 25 0 0 0 0 0 0 0 25
Withdrawals 0 0 0 0 0 0 0 0 6 0 0 0 0

Exemption from SE Final Actions Jan Feb Mar Apr May Jun July Aug Sep Oct Nov Total
Exemption from SE Orders 0 0 0 0 0 0 0 0 0 0 0 0
Refusal-To-Accept (RTA) Letters for Exemption Requests 0 0 0 0 5 0 0 0 0 0 0 5
Withdrawals 0 0 2 0 3 0 0 4 0 0 0 9

Exemption from SE Final Actions Jan  Feb  Mar  Apr  May Jun Jul Aug Sep Oct Nov Total
Exemption from SE Orders 0 0 0 1 0 0 0 0 0 0 0 1
Refusal to Accept (RTA) letters for Exemption Requests 0 0 0 0 9 0 0 0 0 2 3 14

SE Exemption Final Actions Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec  Total
Refusal to Accept (RTA) letters for Exemption Requests 13  1  0  0  0  0  0  0  0  0  0  0  14

SE Exemption Final Actions Jun Jul  Aug  Sep  Oct  Nov  Dec  Total
Refusal to Accept (RTA) letters for Exemption Requests 20 2  0  0  0  0  0  22

Exemption from Substantial Equivalence Marketing Orders

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

Additional Resources