FDA Tobacco Application Tips Email Series

Applications for premarket review for deemed new tobacco products on the market as of Aug. 8, 2016—including e-cigarettes—must be filed by Sept. 9, 2020.

In order to assist applicants, FDA created the “FDA Tobacco Application Tips” email series—a limited CTP News email series highlighting application tips that will be helpful to companies preparing to submit their premarket review applications. This page will be regularly updated to include all of application tips emails sent by FDA.

Click on the buttons below to read the full emails:

How and When to Apply Electronic Submissions Resources to Apply Efficiently

Key Definitions PMTA for ENDS Observations About Submissions

To receive these emails directly to your inbox, sign up for CTP News email updates. For more information and tips, you can also follow @FDATobacco on Twitter and visit FDA’s new webpage on preparing and submitting deemed tobacco product applications.

July 24, 2020

Below are some tips on how and when to apply to help manufacturers and importers prepare and submit applications.

There are three steps for submitting a tobacco product application online:

Package an application using FDA’s e-Submitter: FDA’s e-Submitter tool is used to package files and information for tobacco product applications.
Request an Industry Account Manager account to use the CTP Portal: To submit applications using the CTP Portal, you will need to first submit a request that designates an individual to be the primary Industry Account Manager (IAM). Designating an IAM for your organization is the only way to create & access a CTP Portal account for your organization. Once the CTP Portal account & IAM user account are created, the IAM will manage all the CTP Portal user accounts for your organization.
Submit online via the CTP Portal: CTP Portal is a convenient, secure online system for electronically submitting documents and receiving messages from CTP. Users must log in to the CTP Portal every 60 days to keep their account active.

Although it is not always required, FDA recommends electronic submissions in order to more efficiently transmit and receive applications.

FDA encourages manufacturers and importers to submit their tobacco product marketing applications for new deemed tobacco products promptly. Those that plan on submitting applications for a large number of products are encouraged to contact FDA as soon as possible to discuss their plans and method of submission.

July 31, 2020

For most electronic submissions—including premarket review applications, meeting requests, and tobacco product master files—companies may use the FDA e-Submitter tool to package files and information and then transmit those files via the CTP Portal.

Below are some resources for manufacturers and importers about the electronic submission process, including information on recommended file formats and submission methods:

Overview of Electronic Submissions Preparation and Tools: This presentation discusses various topics related to electronic submissions, including grouping products in submissions, organizing submissions, and preparation tools.
Electronic Submission File Formats and Specifications: This document provides in greater detail the orientation and best practices, including file types and electronic submission standards, for data formats and tobacco product submissions.
FAQs and Common Errors and Questions that Delay Submission Processing: This document contains more information about electronic submissions to CTP, including confidentiality and trade secret policies, and common errors that may delay submission processing, as well as links to additional relevant FDA guidance documents.

Aug. 7, 2020

Below are some tips and resources available to help manufacturers and importers complete premarket review applications efficiently:

Grouped Submissions: FDA recently sought comment on a proposed product grouping form that may be used to include any number of tobacco products within a single premarket tobacco product application submission. Previous FDA guidance and presentations have identified certain types of ENDS as candidates for a single grouped submission, such as e-liquids that are the same other than flavor variant or nicotine strength, e-liquid variations in the same product category and subcategory, cartridge-based e-cigarettes devices and e-liquids packaged together, and other e-cigarette devices and e-liquids packaged together and where studies have been conducted using them together.
Tobacco Product Master Files (TPMFs): TPMFs are files about a tobacco product or component voluntarily submitted to FDA that typically contain trade secrets and/or confidential commercial information that the owner does not want to make public. TPMFs can be a beneficial tool for manufacturers, component suppliers, ingredient suppliers, and researchers, and can help with the tobacco product submissions process.
Deemed Tobacco Product Application Meeting Resources: Last October, FDA held a public meeting to outline product review policies, procedures, and helpful tips for manufacturers and importers submitting deemed new tobacco product applications. All materials from the meeting, including transcripts, video recordings, and presentation decks are available on the meeting page.

Aug. 14, 2020

Below are key definitions that will help companies determine when, and if, they need to submit an application:

New Tobacco Product: Any tobacco product (including those in test markets) that was not commercially marketed in the United States as of Feb. 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after Feb. 15, 2007.
- All new tobacco products are required to obtain premarket authorization. If a company is marketing a deemed tobacco product that is new and that was on the market as of Aug. 8, 2016, they will need to submit a marketing application by Sept. 9, 2020.
- If a company wants to market a new tobacco product that was not on the market as of Aug. 8, 2016, they will need to submit a marketing application and receive authorization before marketing the product.
- There are three pathways to legally market a new tobacco product: Premarket Tobacco Product Application (PMTA); Substantial Equivalence (SE); and Exemption from Substantial Equivalence (EX REQ).
Grandfathered Tobacco Product: A tobacco product commercially marketed (other than exclusively in test markets) in the U.S. as of Feb. 15, 2007
- Grandfathered tobacco products do not need to submit applications by Sept. 9, 2020.
- FDA expects that many cigars, hookah tobacco and pipe tobacco products may be eligible for grandfathered status. Learn about a product’s potential grandfathered eligibility and how to submit a voluntary grandfathered status determination request.

Aug. 21, 2020

Among many other new deemed tobacco products, applications for the premarket review of e-cigarettes and other electronic nicotine delivery systems (ENDS) on the market as of Aug. 8, 2016 must be submitted to FDA by Sept. 9, 2020. To date, all premarket applications for ENDS products received by FDA have been through the premarket tobacco product applications (PMTA) pathway, and we expect most applications for ENDS products submitted on or before Sept. 9 to be submitted through the PMTA pathway.

In June 2019, FDA published a guidance on Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS). This guidance helps clarify the PMTA process for manufacturers and reflects FDA’s current thinking about information that may be helpful to include in a PMTA submission, as well as recommendations to address public health issues such as accidental nicotine exposure and battery failures. The guidance explains, among other things:

Products to which the guidance applies
When a PMTA is required under the statute and regulations
General procedures for review of an ENDS PMTA
How to submit a PMTA
What information the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires you to submit in a PMTA
What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH)
Additional considerations for scientific studies and analyses, including bridging information from similar products to the new product, using existing scientific literature or analyses, and referencing tobacco product master files to reduce research burdens on manufacturers and increase efficiency of PMTA preparation and submissions

To view information on products that have already received marketing orders through the PMTA pathway, visit the PMTA marketing orders webpage.

Sept. 3, 2020

As the result of a court order, a premarket submission must be made to FDA’s Center for Tobacco Products (CTP) by Sept. 9 for all deemed new tobacco products currently on the market (See statement on separate court decision regarding premium cigars). For many months, FDA has been strongly encouraging manufacturers to submit their materials before the deadline. FDA is beginning to receive many of these applications; to date, the agency has received submissions for thousands of different products, many of which were submitted in just the last two weeks.

As FDA begins the work of processing these submissions, staff have identified items that have slowed down the processing time. Many of the PDF files do not have “text recognition” enabled, making it harder for staff to search the submissions for specific information, such as:

The date the product entered the U.S. market (i.e., was the product on the market as of Aug. 8, 2016?)
If the product is currently on the market
The nicotine strength of the product
The characterizing flavor of the product

Additionally, FDA has received more paper submissions to-date than the agency would have expected; these take longer to process and move to scientific review. Although it is not always required, FDA recommends electronic submissions in order to more efficiently transmit and receive applications. For most submissions—including premarket review applications—companies may use the FDA e-Submitter tool to package files and information and then transmit those files via the CTP Portal, which will indicate the transmission to FDA was successful.

If you are unable to submit online, please mail or deliver submissions to be received by CTP's Document Control Center (DCC) 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. All applications must be received by 4:00 PM EDT on Sept. 9, 2020. The DCC accepts multiple forms of mixed media such as thumb drives, CDs, DVDs, and external hard drives.