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 2015Total to Date
PMTA Marketing Orders088
Refuse to File (RTF) submissions for PMTAs404

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 ActionsJanFebMarAprMayJunJulAugSepOct2015 Total 
SE Orders662501250098170430
NSE Orders34301180291391
Refuse to Accept (RTA) letters for SE40011640016
Report Withdrawals95 450329190226029419
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


Substantial Equivalence Marketing Orders

FDA Order LetterDateFDA Decision Summary
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 ActionsJan Feb Mar Apr MayJunJulAugSepOctNovTotal
Exemption from SE Orders0001000000-1
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.



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Page Last Updated: 11/24/2015
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