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 Actions Feb 2014 Oct 2015 Sept 2016 Total To-Date
PMTA Marketing Orders 0 8 0 8
Refuse-to-File (RTF) 4 0 0 4
Refuse-to-Accept (RTA) 0 0 362 362
Withdrawals 0 0 0 0

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 Final Actions

SE Final Actions Jan 2017 Total To-Date
Full SE Orders 1 1
Same Characteristic SE Orders 0 0
Product Quantity SE Orders 0 0
Full SE Order Rescissions 1 1
Same Characteristic SE Order Rescissions 0 0
Rescissions 0 0
Product Quantity SE Order Rescissions 0 0
     
Full NSE Orders 0 0
Same Characteristic NSE Orders 0 0
Product Quantity NSE Orders 0 0
     
Full Report Refuse-To-Accepts 0 0
Same Characteristic Report Refuse-To-Accepts 0 0
Product Quantity Report Refuse-To-Accepts 0 0
Full Report Administrative Closures 0 0
Same Characteristic Report Administrative Closures 0 0
Product Quantity Report Administrative Closures 0 0
Full Report Cancellations 0 0
Same Characteristic Report Cancellations 0 0
Product Quantity Report Cancellations 0 0
     
Full Report Withdrawals 8 8
Same Characteristic Report Withdrawals 0 0
Product Quantity Report Withdrawals 5 5
SE Final Actions Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec  2016 Total
Full SE Orders 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 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 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  282 405
Product Quantity Report Cancellations  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 8
SE Final Actions   Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 Total 
SE Orders   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   3 43 0 11 8 0 2 9 13 23 0 114
Refuse to Accept (RTA) letters for SE   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 50 24  78 
NSE Orders 0 4 0 0 0 6 7 1 25 
Refuse to Accept (RTA) letters for SE 0 0 0 0 10 0 0 16 
Report Withdrawals 26 75 26 22 49  19  22 32 17  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 January 17, 2017. 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 Letter Date FDA Decision Summary
SE0000357 October 2016 Decision Summary SE0000357
     
SE0002153 July 2016 Decision Summary SE0002153
     
SE0002138 February 2016 Decision Summary SE0002138
SE0002139 February 2016 Decision Summary SE0002139
SE0002140 February 2016 Decision Summary SE0002140
SE0002141 February 2016 Decision Summary SE0002141
SE0002142 February 2016 Decision Summary SE0002142
SE0002143 February 2016 Decision Summary SE0002143
SE0002144 February 2016 Decision Summary SE0002144
SE0002145 February 2016 Decision Summary SE0002145
SE0002146 February 2016 Decision Summary SE0002146
SE0002147 February 2016 Decision Summary SE0002147
SE0002148 February 2016 Decision Summary SE0002148
     
SE0000925 October 2015 Decision Summary SE0000925
SE0010225 October 2015 Decision Summary SE0000925
SE0010226 October 2015 Decision Summary SE0000925
SE0010227 October 2015 Decision Summary SE0000925
SE0010228 October 2015 Decision Summary SE0000925
SE0010229 October 2015 Decision Summary SE0000925
SE0010230 October 2015 Decision Summary SE0000925
SE0010231 October 2015 Decision Summary SE0000925
SE0010232 October 2015 Decision Summary SE0000925
SE0010233 October 2015 Decision Summary SE0000925
     
SE0000276 September 2015 Decision Summary SE0000276
SE0000277 September 2015 Decision Summary SE0000277
SE0000278 September 2015 Decision Summary SE0000278
SE0000281 September 2015 Decision Summary SE0000281
     
SE0002648 September 2015 Decision Summary SE0002648
     
SE0000515 August 2015 Decision Summary SE0000515
     
SE0001079 May 2015 Decision Summary SE0001079
SE0003613 May 2015 Decision Summary SE0003613
SE0003614 May 2015 Decision Summary SE0003614
SE0003615 May 2015 Decision Summary SE0003615
SE0003616 May 2015 Decision Summary SE0003616
SE0003617 May 2015 Decision Summary SE0003617
SE0003618 May 2015 Decision Summary SE0003618
SE0003619 May 2015 Decision Summary SE0003619
SE0003620 May 2015 Decision Summary SE0003620
SE0003621 May 2015 Decision Summary SE0003621
     
SE0000282 August 2014 Decision Summary SE0000282
SE0000283 August 2014 Decision Summary SE0000283
SE0000284 August 2014 Decision Summary SE0000284
SE0000285 August 2014 Decision Summary SE0000285
SE0000286 August 2014 Decision Summary SE0000286
SE0000287 August 2014 Decision Summary SE0000287
SE0000288 August 2014 Decision Summary SE0000288
     
SE0003441 February 2014 Decision Summary SE0003441
SE0003442 February 2014 Decision Summary SE0003442
SE0003443 February 2014 Decision Summary SE0003443
SE0003444 February 2014 Decision 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 Actions Jan  2017 Total-To-Date
Exemption from SE Orders 0 0
Refusal-To-Accept (RTA) Letters for Exemption Requests 0 0
Withdrawals 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  14
SE Exemption Final Actions Jun Jul  Aug  Sep  Oct  Nov  Dec  Total
Refusal to Accept (RTA) letters for Exemption Requests 20 22

Exemption from Substantial Equivalence Marketing Orders

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

 


This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco.

Page Last Updated: 05/08/2017
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