Tobacco Product Marketing Orders
On this page:
- Premarket Tobacco Product Applications
- Substantial Equivalence
- Exemption from Substantial Equivalence
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
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
FY 2020
PMTA Actions | Oct | Nov | Dec | Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep* | FY 2020 To-Date | Total To- Date |
Marketing Orders | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 14 |
No Marketing Orders | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
Refuse-to-Accept (RTA) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 6 | 141 | 150 | 518 |
Refuse-to-File (RTF) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 63 | 6 | 150 | 219 | 226 |
Withdrawn | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
Total Applications Received | 15 | 0 | 0 | 0 | 0 | 38 | 104 | 48 | 28 | 36 | 10184 | - | 10453 | 10870 |
*Due to the large volume of applications received in September, the exact number of applications is still being processed. This information will be updated in the above table when available.
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 | 1 | 368 |
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..
- Refuse To File Determinations
- Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing, and Promotion
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:
- It was commercially marketed in the United States after February 15, 2007 but before March 22, 2011; and
- 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 2020
SE Actions | Oct | Nov | Dec | Jan | Feb | Mar | Apr | May | June | July | Aug | Sep* | FY2020 Total-To-Date |
Total To-Date |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SE Orders | 10 | 20 | 20 | 3 | 3 | 25 | 34 | 35 | 25 | 4 | 27 | 7 | 213 | 1419 |
NSE Orders | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 17 | 409 |
Refuse-To-Accept (RTA) | 0 | 0 | 2 | 4 | 0 | 0 | 1 | 0 | 2 | 16 | 41 | 0 | 66 | 378 |
Withdrawn | 12 | 23 | 4 | 0 | 29 | 2 | 10 | 5 | 1 | 1 | 2 | 0 | 89 | 2184 |
Total Applications Received | 18 | 14 | 44 | 25 | 46 | 21 | 748 | 52 | 106 | 224 | 879 | - | 2177 | 8865 |
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 | 71 | 296 |
NSE Orders | 48 | 0 | 0 | 0 | 0 | 4 | 9 | 3 | 9 | 6 | 5 | 0 | 84 |
Refuse-To-Accept (RTA) | 0 | 0 | 0 | 8 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 10 |
Withdrawn | 10 | 8 | 5 | 6 | 36 | 21 | 34 | 3 | 24 | 29 | 21 | 39 | 236 |
Total Applications Received | 18 | 42 | 21 | 12 | 4 | 29 | 32 | 7 | 63 | 20 | 18 | 36 | 302 |
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 September 30, 2020. 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.
*Due to the large volume of applications received in September, the exact number of applications is still being processed. This information will be updated in the above table when available.
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.
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 2020
EX Actions | Oct | Nov | Dec | Jan | Feb | Mar | Apr | May | Jun | July | Aug | Sep* | FY 2020 To-Date | Total To-Date |
EX Orders | 11 | 30 | 35 | 40 | 16 | 8 | 40 | 5 | 6 | 13 | 15 | 0 | 219 | 546 |
NEX Orders | 20 | 3 | 3 | 0 | 24 | 0 | 6 | 6 | 1 | 0 | 7 | 0 | 70 | 92 |
Refusal-To-Accept (RTA) | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 0 | 0 | 0 | 18 | 0 | 23 | 99 |
Withdrawn | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 59 |
Total Applications Received | 34 | 54 | 44 | 14 | 20 | 20 | 39 | 47 | 50 | 55 | 12 | - | 389 | 958 |
*Due to the large volume of applications received in September, the exact number of applications is still being processed. This information will be updated in the above table when available.
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 | 20 | 244 |
NEX Orders | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 4 | 4 | 4 | 14 |
Refusal-To-Accept (RTA) | 0 | 0 | 0 | 2 | 0 | 1 | 4 | 5 | 0 | 9 | 0 | 0 | 21 |
Withdrawn | 0 | 2 | 0 | 0 | 17 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 20 |
Total Applications Received | 16 | 21 | 73 | 15 | 27 | 11 | 14 | 40 | 77 | 24 | 32 | 16 | 366 |
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
- 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