Submit Tobacco Product Applications for Deemed Tobacco Products
Resources for Applicants Required to Submit by September 9, 2020
Applications for many e-cigarettes and other new deemed tobacco products that were on the market as of Aug. 8, 2016 were required to be submitted to FDA by Sept. 9, 2020. The deadline has now passed. If you have submitted an application and are looking for information on next steps, visit the “What Happens After I Submit the Application?” section on this page. If you are looking for information on FDA compliance and enforcement, visit the “Why Must I Comply?” section on this page.
On Sept. 9, 2021, CTP Director Mitch Zeller provided an update on FDA's progress on tobacco product application review and related enforcement.
This page was created as a compilation of information and resources for those who prepared and submitted tobacco product applications for deemed products – that were on the market as of August 8, 2016 – in accordance with the September 9, 2020 submission due date. Although this deadline has passed, any company who wishes to introduce a new tobacco product onto the market must submit a premarket application – and receive authorization from FDA – before doing so. Accordingly, those planning to submit a premarket application to FDA may find some of the general information and resources on this page helpful as they prepare their application(s).
On this page:
- When Do I Need to Submit an Application for a Tobacco Product?
- Determine the Appropriate Pathway to Legally Market a New Tobacco Product
- Tips and Resources for Tobacco Product Manufacturers
- How to Submit
- What Happens After I Submit the Application?
- Why Must I Comply?
- Questions?
- Additional Resources
When Do I Need to Submit an Application for a Tobacco Product?
All new (i.e. non-pre-existing) tobacco products are required to obtain premarket authorization. If you were marketing a deemed tobacco product that is new and that was on the market as of August 8, 2016, you were required to submit a marketing application by September 9, 2020 as required by the Court, and as set forth in CTP’s compliance policy (see exception for premium cigars). If you want to market a new tobacco product that was not on the market as of August 8, 2016, you will need to submit a marketing application and receive authorization before marketing the product.
Products on the market as of February 15, 2007 are considered pre-existing tobacco products. A pre-existing product is not a new tobacco product and does not require an application. Learn about your product’s potential pre-existing eligibility and submit a voluntary pre-existing determination request.
A new tobacco product is:
- Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
- Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
Determine the Appropriate Pathway to Legally Market a New Tobacco Product
In order to submit a tobacco product application, it is first necessary to determine which pathway to market and distribute a tobacco product is most appropriate.
There are three pathways to legally market a new tobacco product:
- Premarket Tobacco Product Application (PMTA)
- Substantial Equivalence (SE)
- Exemption from Substantial Equivalence (EX REQ)
Each pathway page linked above includes information on how to prepare the application, as well as resources on the review process, previously issued order letters, review summaries, and other relevant resources for that type of application. In addition, we’ve highlighted some of the most important application resources for each pathway on this page under Tips and Resources for Tobacco Product Manufacturers below.
One approach to streamline PMTA submissions–which may be especially helpful to ENDS manufacturers with many e-liquid variations–could be to group applications for products from the same manufacturer or domestic importer, and in the same product category and subcategory, into a single submission.
See Grouped Submissions Resources below.
Tips and Resources for Tobacco Manufacturers
1. Premarket Tobacco Product Applications (most likely pathway for Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes and e-liquids)
To date, no valid pre-existing ENDS product has been identified and all premarket applications for ENDS products received by the FDA have been through the PMTA pathway. Tips and resources to help prepare a PMTA are provided below.
- The presentation, “Overview of Electronic Submissions Preparation and Tools” discusses how to properly group multiple products or PMTAs into a single submission and provides examples of how it may be done.
- Please note FDA regulations require individual environmental assessments to be submitted for each individual tobacco product.
- The “Proposed Rule: Premarket Tobacco Product Applications and Recordkeeping Requirements” discusses FDA’s proposed thinking regarding how an applicant may also submit a single premarket submission for multiple products (i.e. grouped submissions). This is only a proposed rule that would not create any requirements until it is final and in effect. However, the agency envisions that when it receives a premarket submission that covers multiple new tobacco products, FDA intends to consider information on each product as a separate, individual PMTA, and it is important to identify the content that pertains to each product.
- On March 10, 2020, FDA reopened the comment period on only the agency information collection activity associated with the PMTA proposed rule to seek input on a new application submission form that may assist industry and FDA in identifying products that are the subject of a grouped submission. The FDA believes that the proposed form would assist applicants in organizing and providing information for each individual product in a grouped submission. Additionally, by having product information more clearly organized, FDA would be able to more efficiently process and review the applications contained in grouped submissions. View the proposed form. Note: Please view instructions on how to download the proposed form.
On October 2019, FDA held a public meeting to outline product review policies, procedures, helpful tips, and general scientific principles that specifically apply to the manufacturers submitting applications – including PMTA – by September 9, 2020. All materials from the meeting, including transcripts, video recordings, and presentation decks are available on the meeting page.
- Refuse to Accept Final Rule: In December 2016, FDA issued a “Refuse To Accept Procedures for Premarket Tobacco Product Submissions” final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. For example, FDA will refuse to accept a tobacco product submission that is not in English, does not pertain to a tobacco product, or does not identify the type of submission.
- PMTA ENDS Final Guidance: In June 2019, FDA finalized the “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)” guidance, which is intended to assist persons submitting PMTAs for ENDS products. The guidance reflects FDA’s current thinking on issues such as what products the guidance applies to, general procedures for review of an ENDS PMTA, what information FDA recommends you submit in an ENDS PMTA to show that permitting the new tobacco product to be marketed would be appropriate for the protection of public health.
- TPMF Final Guidance: A Tobacco Product Master File (TPMF) is a file voluntarily submitted to FDA that contains trade secrets and/or confidential commercial information about a tobacco product or component that the owner does not want to share publicly, but still wants to be of value to application submissions by others. TPMFs are a beneficial tool for manufacturers, component suppliers, ingredient suppliers, and researchers, and can assist the tobacco product submissions process. In May 2016, FDA published a “Tobacco Product Master Files” final guidance. The guidance document includes information on how to establish a master file, considerations for TPMF owners in maintaining TPMF submissions, how tobacco product applications can rely upon a TPMF and FDA’s role.
2. Substantial Equivalence (SE) and Exemption from Substantial Equivalence (EX REQ) (most likely pathways for Cigars, Pipe Tobacco, Hookah Tobacco)
Manufacturers of cigars, hookah tobacco, or pipe tobacco who wish to market a new tobacco product that may be similar to a tobacco product that is pre-existing, or to one previously found to be substantially equivalent, can consider the SE and EX REQ pathways. Tips and resources to help prepare an SE Report or EX REQ are provided below.
Note: FDA expects that many cigars, hookah tobacco, and pipe tobacco products may be eligible for pre-existing status. Pre-existing tobacco products do not need to submit premarket applications to be legally marketed. Although a premarket application is not required, FDA encourages firms to voluntarily submit a standalone pre-existing submission. Learn about your product’s potential pre-existing eligibility and submit a voluntary pre-existing determination request.
In October 2019, FDA held a public meeting to outline product review policies, procedures, helpful tips, and general scientific principles that specifically apply to the manufacturers submitting applications – including SE and EX REQ – by September 9, 2020. All materials from the meeting, including transcripts, video recordings, and presentation decks are available on the meeting page.
FDA reviewer guides and science policy memoranda provide information about FDA review processes and several regulatory science issues. These documents were developed to assist FDA reviewers with the evaluation of new tobacco product applications. Information contained in these documents is subject to change based on advances in policy, the regulatory framework, and regulatory science, and is not binding on FDA or the public; however, it sheds light for potential applicants on the types of information FDA considers during various review processes.
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SE FAQ Final Guidance: In December 2016, FDA finalized the “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” guidance, which provides information in response to frequently asked questions the center has received from manufacturers and other interested stakeholders on demonstrating the substantial equivalence of a new tobacco product. Among other things, this guidance includes information on FDA’s current thinking on whether a change to the product quantity in the package renders a product “new” and thus subject to premarket review.
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SE Report Final Guidance: In January 2011, FDA finalized the “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products” guidance, which provides information for those submitting reports concerning substantial equivalence under section 905(j) of the FD&C Act, including FDA’s interpretation of the statutory sections related to substantial equivalence and recommendations on the form and content of section 905(j) reports.
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EX REQ Final Rule: In July 2011, FDA issued a final rule, “Exemptions From Substantial Equivalence Requirements” which describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions.
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Refuse to Accept Final Rule: In December 2016, FDA issued a final rule, “Refuse To Accept Procedures for Premarket Tobacco Product Submissions” describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. For example, FDA will refuse to accept a tobacco product submission that is not in English, does not pertain to a tobacco product, or does not identify the type of submission.
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NEPA Cat Ex Final Rule: In September 2015, FDA issued a the “National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions” final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to SE Reports, EX REQ, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Tobacco Control Act.
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TPMF Final Guidance: A Tobacco Product Master File (TPMF) is a file voluntarily submitted to FDA that contains trade secrets and/or confidential commercial information about a tobacco product or component that the owner does not want to share publicly, but still wants to be of value to application submissions by others. TPMFs are a beneficial tool for manufacturers, component suppliers, ingredient suppliers, and researchers, and can assist the tobacco product submissions process. In May 2016, FDA published a “Tobacco Product Master Files” final guidance. The guidance document includes how to establish a master file, considerations for TPMF owners in maintaining TPMF submissions, how tobacco product applications can rely upon a TPMF and FDA’s role.
How to Submit
To be timely submitted, applications for deemed new products on the market as of August 8, 2016 must have been received by CTP by September 9, 2020. Although it is not always required*, FDA recommends electronic submissions in order to more efficiently transmit and receive applications. Given the file size of many applications, as well as the possibility of the system slowing due to many simultaneous users, FDA strongly encouraged manufacturers to submit their applications ahead of the September 9, 2020 deadline. The Agency also encourages applicants who plan on submitting applications for a large number of products to contact the Agency to discuss their plans and method of submission.
- Use FDA’s e-Submitter tool to package files and information for product applications by choosing the “CTP Transmittal Form” template.
- Submit online via the CTP Portal. Prior to using the CTP Portal, you will need to request and obtain an Industry Account Manager (IAM) account.
- Learn more about Electronic Submissions for Tobacco Products
- Read specific information and recommendations on electronic submissions file types and specifications.
- If you are unable to submit online, please mail or deliver submissions to be received by CTP's Document Control Center no later than 4:00 pm (EDT) September 9, 2020. We recommend you use a carrier who will provide tracking and delivery receipt. FDA does not accept applications via email.
*Requests for Exemption from Substantial Equivalence must be submitted electronically. If an applicant is unable to submit an application in electronic format, they may submit a written request to CTP explaining in detail why the applicant cannot submit the application in an electronic format and request an alternative format. The request must include an explanation of why an alternative format is necessary. All submissions, including requests to submit the information in an alternative format, application, and all supporting information must be legible and in the English language.
What Happens After I Submit the Application?
Once the application is submitted, the FDA review process consists of three phases:
FDA may contact the applicant at several points during the review process, such as at the end of the acceptance review, the end of the notification (SE and EX REQ) or filing (PMTA), during substantive review, or to inform the applicant of a positive or negative marketing decision.
*In addition to the above phases, the PMTA review process includes a Phase 4 (postmarket reporting) that requires applicants to establish and maintain records and make reports, as necessary, to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order.
Details for each application review process and relevant outputs are available on the individual pathway pages: SE, EX REQ, and PMTA.
On February 16, 2021, CTP Director Mitch Zeller provided an update on FDA's progress on review of the timely submitted applications.
Why Must I Comply?
On August 8, 2016, all deemed tobacco products (except for accessories of deemed tobacco products), including ENDS, cigars, hookah (waterpipe) tobacco, pipe tobacco, nicotine gels, and certain dissolvables became subject to the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
All deemed new tobacco products need to have authorization from the FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements for certain deemed new products on the market as of August 8, 2016.
On February 6, 2020, FDA began prioritizing enforcement against certain illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.
After September 9, 2020, FDA will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application. Additionally, based on several factors – including the likelihood of youth use or initiation – the FDA will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization. New data, such as that from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable ENDS will now be an enforcement priority for the agency. However, as the result of court decision, the FDA will not be enforcing this requirement for “premium” cigars.
Companies that continue to manufacture, distribute, and sell unauthorized tobacco products risk FDA compliance and enforcement actions ranging from warning letters to injunction, seizure, and/or civil money penalty actions where warranted. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
There are several requirements that a tobacco product manufacturer must fulfill in order to comply with the FDA’s tobacco regulations, including the premarket requirements. Learn more about manufacturer requirements, including other key submission dates.
Questions?
Additional Resources
- Perspective: FDA's Progress on Tobacco Product Application Review and Related Enforcement
- Perspective: FDA’s Preparations for the September 9 Submission Deadline
- Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline