Tobacco Product Marketing Orders

Tobacco Product Marketing Orders

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On this page:

• Premarket Tobacco Product Applications
• Substantial Equivalence
• Exemption from Substantial Equivalence

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To 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 

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Premarket Tobacco Product Application

Marketing 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	0	5
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).

• PMTA Marketing Orders

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..

• Refuse To File Determinations
• Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing, and Promotion

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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

FY 2019

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	-	-	-	-	-	160
NSE Orders	48	0	0	0	0	4	9	-	-	-	-	-	61
Refuse-To-Accept (RTA)	0	0	0	8	0	0	0	-	-	-	-	-	8
Withdrawals	10	8	5	6	36	21	34	-	-	-	-	-	120
Total Applications Received	18	42	21	12	4	29	32	-	-	-	-	-	158

FY 2018

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

FY 2017

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

Calendar Year 2016

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

Calendar Year 2015

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

Calendar Year 2014

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

Pre-June 2013 to December 2013

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 April 30, 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

• Substantial Equivalence Marketing Orders
• FY2018 Provisional SE Products Removed from Review (CSV - 71KB)

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.

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Provisional Not Substantially Equivalent Orders

FDA Order Letter	Date	FDA Decision Summary
2018
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
SE0006259	July	Decision Summary SE0006259
SE0006260	July	Decision Summary SE0006260
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

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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

FY 2019

Exemption from SE Final Actions	Oct	Nov	Dec	Jan	Feb	Mar	Apr	May	June	July	Aug	Sept	FY2019 Total-To-Date
Exemption from SE Orders	1	8	10	7	68	14	6	-	-	-	-	-	114
Not Exempt from SE Orders	0	0	0	1	0	1	0	-	-	-	-	-	2
Refusal-To-Accept (RTA) Letters for Exemption Requests	0	0	0	2	0	1	4	-	-	-	-	-	7
Withdrawals	0	2	0	0	17	0	0	-	-	-	-	-	19

FY 2018

Exemption from SE Final Actions	Oct	Nov	Dec	Jan	Feb	Mar	Apr	May	June	July	Aug	Sept	FY2018 Total-To-Date
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

FY 2017

Exemption from SE Final Actions	Oct	Nov	Dec	Jan	Feb	Mar	Apr	May	June	July	Aug	Sep	2017 Total-To-Date
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

2016

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

2015

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

2014

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

Pre-June 2013 to December 2013

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.

• Exemption from Substantial Equivalence Marketing Orders

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Additional Resources

• Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems
• MRTP Application Actions (Orders, Denials, and Responses) 
• QandA: Substantial Equivalence Tobacco Products  
• Substantial Equivalence Webinars 
• Not Substantially Equivalent Determination Summary
• Applications for Premarket Review of New Tobacco Products: Draft Guidance - Sept 2011 
• Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products: Guidance - Jan 2011