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 Total to Date
PMTA Marketing Orders 0 8 8
Refuse to File (RTF) submissions for PMTAs 4 0 4

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 Feb Mar Apr May Jun Jul Aug Sep Oct Nov 2015 Total 
SE Orders   6 6 25 0 125 0 0 98 170 5 435
NSE Orders   3 43 0 11 8 0 2 9 13 23 114
Refuse to Accept (RTA) letters for SE   4 0 0 1 1 6 4 0 0 0 16
Report Withdrawals   95  45 0 3 29 190 2 26 0 29 6 425
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

 

Substantial Equivalence Marketing Orders

FDA Order Letter Date FDA Decision Summary
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  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.

 

 


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Page Last Updated: 12/22/2015
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