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Information | Introduction to Pre Market Application (PMTA) for Tobacco Products in the United States
Author.
LCS
Source:
Post time:
2024-04-09
Pre market tobacco application (PMTA1) refers to the requirement under section 910 (a) (2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that new tobacco products (New Tobacco Products) that are intended to be legally sold in the United States after February 15, 2007 must submit an application to the US Food and Drug Administration (FDA) for review and approval.
Note:
1. PMTA is one of the three channels for applying for the listing of new tobacco products, the other two being SE (Substantial Equivalence) and EX REQ (Request Exemption from Demonstrating Substantial Equivalence). So far, all approved ENDS (Electronic Nicotine Delivery Systems, also known as Vapes) have been marketed through the PMTA pathway.
2. According to the Family Smoking Prevention and Tobacco Control Act of the United States, it grants the FDA the authority to manage tobacco products, allowing the FDA to approve or reject applications for risk improved tobacco products, and extends its tobacco product management authority to all products (including electronic cigarette ENDS) except those considered as accessories of tobacco products. This rule also authorizes the FDA to exercise discretion in the sale and distribution of tobacco products (MRTP) with unverified risk of improvement.
In order to make a decision and authorize listing, the FDA primarily considers the following four points (in accordance with Article 910 (c) (4)), among other things:
1) The risks and benefits for the entire population, including those who use the proposed new tobacco product and non users;
2) If the proposed new tobacco product is launched, will people currently using any tobacco product more or less stop using the products they are currently using;
3) If there are new tobacco products on the market, will people who currently do not use any tobacco products more or less start using tobacco products;
4) Methods, equipment, and control measures for manufacturing, processing, and packaging new tobacco products.
The Final PMTA Rules
In 2021, the FDA established the final PMTA rules, which are: Pre market Tobacco Product Applications and Recordkeeping Requirements.
1) This rule standardizes the content, format, and review formats required by PMTA.
2) In order for the FDA to complete the substantive review of PMTA, the application must include the information mentioned in the final rules.
3) The rule also requires manufacturers to maintain records to prove that their tobacco products are legally sold.
4) The final PMTA rules also include information on how to modify or withdraw applications, how the US Food and Drug Administration communicates with applicants, and the disclosure procedures of the US Food and Drug Administration.
Preparing and Submitting a PMTA
In October 2023, the Center for Tobacco Products (CTP) of the FDA released the 6th edition of the Electronic Submission File Formats and Specifications document, which provides detailed instructions on the requirements for electronic submissions, particularly demonstrating the heading of contents and hierarchy.
Electronic documents should include 7 templates:
1) Module 1: Administrative Information
2) Module 2: Summary
3) Module 3: Product Description and Manufacturing
4) Module 4: Non Clinical
5) Module 5: Clinical - Product Impact on Individual Health
6) Module 6: Clinical Product Impact on Population Health Module 7: Environmental Impact
Electronic submission tool: eSubmitter Software
Data submission platform: CTP Portal
The FDA has also prepared a wealth of information and resources to support applicants in preparing and submitting PMTA, such as:
1) Standard PMTA Preparation Process
2) Supplement and resubmit PMTA process
3) Preparation process for revision
4) Process for submitting PMTAs and revisions
5) Other resources to assist in preparing and submitting PMTA
PMTA Review Procedure
The PMTA review process can be roughly divided into 5 stages and 6 processes, as follows:
Stage 0: Pre submission Meetings (Process One)
A voluntary formal meeting between the applicant and the FDA (specifically staff from CTP's Office of Science) to discuss the PMTA of tobacco products to be submitted.
The FDA has strict requirements for meeting content. Before the meeting, all types of materials should be prepared in accordance with FDA requirements (official guidance documents:
Guidance for Industry and Investigators. The meeting format includes telephone conference, FDA office meeting, video conference or written reply. The duration of the meeting is usually one hour.
Process output file:
Meeting Granted Letter
Meeting denial letter
Meeting minutes letter (if meeting is granted and held)
Phase 1: Acceptance Review (Process 2)
To ensure that the product falls under the jurisdiction of CTP through initial review, and to confirm whether the requirements of the FD&C Act and the Review Procedure (a) of 21 CFR § 1114.27 have been met, in accordance with Article 910 of the FD&C Act: Application for Review of Certain Tobacco Products.
Process output file:
Acceptance letter
Refuse to accept (RTA) letter
Phase 2: Filing Review (Process 3)
This stage is to confirm whether the application contains sufficient information and has met the threshold for substantive review (samples are required at this stage). If any of the circumstances in Part (b) of the 21 CFR § 1114.27 review procedure, Filing Review in the Review procedure, occur, the FDA may refuse to file/file.
Process output file:
Filing letter
Refuse to file (RTF) letter Phase 3: Application Review and Action
A. Application Review (Process 4)
The FDA will evaluate the information and data in the application documents, and also refer to the Tobacco Product Scientific Advisory Committee
Opinion from Advisory Committee (TPSAC).
Process output file:
Deficiency letter: The FDA will issue supplementary requirements for the information submitted by the applicant to complete scientific review. And this
The letter will specify the deadline within which the applicant must respond.
Environmental information request letter: If the submitted information is scientific and complete, the FDA will issue a marketing granted order after scientific evaluation - however, the applicant needs to submit a report on environmental impacts before that.
B. Action/Decision (Process 5)
The FDA will make a ruling on the final direction of the product based on all information and processes.
Process output file:
Marketing Granted Order Letter (MGO)
Marketing denial order letter (MDO)
Stage 4: Postmarket Requirements (Process 6)
The FDA requires applicants to establish and maintain product data, and submit reports in accordance with FDA requirements to determine or assist in determining whether the FDA has reason to withdraw or temporarily suspend a marketing authorization order. The reporting requirements of 21 CFR § 1114.41 specify the specific requirements for the submitted report, such as clear organization, clear handwriting, and written in English.
If the file is translated from another language, the source file needs to be submitted together with the translated file, and a statement must be provided: the English version of the information is complete and accurate.
The submission also includes the qualification certificate of the translator.
The submitted reports are divided into two types:
Periodic reports
Serious and unexpected adverse experience reporting
Supplement:
The Submission Tracking Number (STN) refers to the code assigned by the system after the FDA receives information from the applicant, such as PMTA or supplementary PMTA, and is preliminarily reviewed by the system. Mainly used to identify any previously submitted information about tobacco products that matches the applicant. This process occurs around stage 0 (either before or after the meeting). Obtaining STN is just the beginning of PMTA.
Harmful or potentially harmful components (HPHCs) refer to any compound in tobacco products, tobacco smoke, or releases that: (1) is being or may be inhaled, ingested, or absorbed into the body, including as aerosols or any other release, and (2) causes or may cause direct or indirect harm to users or non users of tobacco products.
The FDA has developed a list of 93 HPHCs for tobacco products and tobacco smoke in accordance with the requirements of the FD&C Act. Regarding ENDS, in order to assist the FDA in assessing potential health risks and facilitate the FDA's assessment of whether new tobacco products are suitable for the Protection of Public Health (APPH), the FDA recommends that applicants submit at least 38 test data for electronic cigarette liquids and aerosols (36 substances plus the pH value of the cigarette liquid and Total Particle Matter (TPM) - the content of particulate matter in the smoke. Like the environmental monitoring quality indicators PM2.5 or PM10 content, TPM is one of the main quality indicators for measuring smoke in electronic smoke compounds.
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