North American Certification Introduction to U.S. Tobacco Product Premarket Application (PMTA)

Premarket tobacco application (PMTA1) refers to the application under Section 910(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on February 15, 2007. If a new tobacco product (New Tobacco Product) is to be sold legally in the United States, it must submit an application to the US Food and Drug Administration (US FDA2), review and obtain approval.
Note:
1. PMTA is one of the three ways to apply for marketing of new tobacco products. The other two are SE (Substantial Equivalence, proving substantial equivalence) and EX REQ (RequestExemption from Demonstrating Substantial Equivalence, requesting exemption to prove substantial equivalence). So far, all ENDS (Electronic Nicotine Delivery System, also called Vapes) approved for marketing have gone through the PMTA route.
2. According to the US federal "Family Smoking Prevention and Tobacco Control Act" (the Family Smoking Prevention and Tobacco Control Act), it grants the US Food and Drug Administration FDA the power to regulate tobacco products, allowing the FDA to agree or reject risk-modified tobacco products application and passed the final deeming rule (81FR 28973) to extend its tobacco product management authority to all products except accessories of deemed tobacco products (also including e-cigarette ENDS) . The rule also grants FDA discretion over the sale and distribution of unsubstantiated modified risk tobacco products (MRTPs).
To make a determination and authorize marketing, FDA considers, among other things, the following 4 points (under section 910(c)(4)):
1) the risks and benefits to the entire population, including people who use the proposed new tobacco product as well as non-users;
2) whether people who currently use any tobacco product would be more or less likely to stop using the product they are currently using if the proposed new tobacco product comes to market;
3) whether people who do not currently use any tobacco products will start using tobacco products to a greater or lesser extent if a new tobacco product becomes available;
4) Methods, equipment and controls used to manufacture, process and package new tobacco products.
the Final PMTA Rules
In 2021, FDA determines the final PMTA rules, namely: Premarket Tobacco Product Applications and Recordkeeping Requirements.
1) This rule specifies the content (Content), format (Format) and review (Review) format required for PMTA.
2) In order for FDA to complete a substantive review of the PMTA, the application must include the information mentioned in the final rule.
3) The rule also requires manufacturers to maintain records to prove that their tobacco products are legally sold.
4) The final PMTA rule also includes information on how to amend or withdraw an application, how FDA communicates with applicants, and FDA’s disclosure procedures.
Preparing and Submitting a PMTA
In October 2023, the FDA's Center for Tobacco Products (CTP) released the sixth edition of the "Electronic Submission File Formats And Specifications" document, which clarified the relevant requirements for electronic submissions. Detailed explanations, especially demonstrations of Heading of Contents and Hierarchic.
✓ For example, the electronic document should contain 7 templates:
1) Module 1: Administrative information (Module 1: Administrative)
2) Module 2: Summary (Module 2: Summary)
3) Module 3: Product Description and Manufacturing
4) Module 4: Nonclinical
5) Module 5: Clinical - Product Impact on Individual Health (Module 5: Clinical - Product Impact on Individual Health)
6) Module 6: Clinical – Product Impact on Population Health) 7) Module 7: Environmental Impact (Module 7: Environmental Impact)
✓ Electronic submission tool: eSubmitter Software
✓ Data submission platform: CTP Portal
FDA has also prepared a large amount of information and resources to support applicants in preparing and submitting PMTAs, such as:
1) Standard PMTA preparation process
2) Supplement and resubmit PMTA process
3) Revision preparation process
4) Process for submitting PMTAs and revisions
5) Additional resources to help prepare and submit a 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 1)
A formal Voluntary meeting conducted by the applicant and FDA (specifically Staff from CTP’s Office of Science) to discuss the PMTA of the tobacco product planned to be submitted.
The FDA has strict requirements on meeting content. Before the meeting, all types of materials should be prepared in accordance with FDA requirements (official guidance documents are available:
Guidance for Industry and Investigators). Meeting formats include conference calls, meetings at FDA offices, video conferences, or written responses. Meeting length is typically 1 hour.
Process output file:
 Meeting granted letter
 Meeting denial letter
 Meeting minutes letter (if meeting is granted and held) (Meeting minutes letter (if meeting is granted and held))
Stage 1: Acceptance Review (Process 2)
Pass a preliminary review to ensure that the product falls within the jurisdiction of the CTP and comply with Section 910 of the FD&C Act: Application for Review of Certain Tobacco Products and 21 CFR §1114.27 Review Procedure Part (a): Acceptance review in the Review procedure) to confirm whether the requirements of the Act and the procedure have been met.
Process output file:
 Acceptance letter
 Refuse to accept (RTA) letter
Stage 2: Filing Review (Filing Review) (Process Three)
This stage is to confirm whether the application contains sufficient information and has reached the threshold of substantive review (samples are required at this stage). FDA may deny filing/filing if any of the conditions described in 21 CFR §1114.27 Part (b) of the Review Procedure: Filing Review in the Review procedure arise.
Process output file:
 Filing letter (Filing letter)
 Stage 3 of Refuse to file (RTF) letter: Application Review and Action
A． Application Review (Process 4)
FDA will evaluate the information and data in the application document and will also consult the Tobacco Product Scientific Advisory Committee
Advisory Committee (TPSAC)).
Process output file:
 Deficiency letter/Deficiency letter: FDA will issue supplementary requirements for the information submitted by the applicant to complete the scientific review. and this
The letter will specify the deadline within which the applicant must respond.
 Environmental information request letter (Environmental information request letter): If the submitted information is scientific and complete, the FDA will issue a marketing authorization order (marketing granted order) after scientific evaluation—but before this, the applicant needs to submit a report on environmental impact Report.
B． Action/Judgment (Action) (Process 5)
The FDA will rule on all information and processes as to where the product ends up.
Process output file:
 Marketing granted order letter (MGO)
 Marketing denial order letter (MDO)
Stage 4: Postmarket Requirements (Process 6)
FDA requires applicants to establish and maintain product data and submit reports upon FDA's request to determine or assist in determining whether FDA has grounds to withdraw or temporarily suspend a marketing authorization order. 21 CFR §1114.41 Reporting requirements (Reporting requirements) specify the specific requirements for reports to be submitted, such as: clear organization, clear handwriting, and writing in English, etc.
If the document is translated from another language, the source document must be submitted together with the translation, and a statement must be provided that the information in the English version is complete and accurate.
Also submitted together with the translator's qualification certificate.
There are two types of reports submitted:
 Periodic reports
 Serious and unexpected adverse experience reporting (Serious and unexpected adverse experience reporting)
Replenish:
Submission Tracking Number (STN) refers to the code assigned by the system after FDA receives the applicant's information, such as PMTA or supplementary PMTA, and undergoes preliminary review by the system. Primarily used to identify any previously submitted information about tobacco products that matches the applicant. This process occurs around Phase 0 (i.e. before or after the meeting). Getting an STN is just the beginning of a PMTA.
Harmful or Potentially Harmful Constituents (HPHCs) refers to any compound in tobacco products or tobacco smoke or emissions that: (1) is or may be inhaled, ingested or absorbed into the body, including as aerosols or any other releases, and (2) cause or are likely to cause direct or indirect harm to users or non-users of tobacco products.
In compliance with the requirements of the FD&C Act, the FDA has developed a list of HPHCs for tobacco products and tobacco smoke, which currently totals 93 items. For ENDS, in order to help the FDA assess potential health risks and facilitate the FDA's assessment of whether new tobacco products are suitable for protecting public health (APPH) (Appropriate for the Protection of the Public Health, APPH), the FDA recommends that applicants submit at least 38 copies of e-cigarette liquids and aerosols. Test data (36 substances plus the pH value of the smoke liquid and Total Particulate Matter (TPM) - that is, the content of particulate matter in the smoke. The same as the environmental monitoring quality indicator PM2.5 or PM10 content, TPM It is one of the main quality indicators for measuring smoke in electronic cigarette products).

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