PMTA

What is PMTA?

Definition:

Pre-market Tobacco Applications

Requirement:

Any modified tobacco product that was commercially marketed after February 15, 2007 must approved by the U.S. Food and Drug Administration, which is determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products.

Window:

Any tobacco product that was commercially marketed in the United States on February 15, 2007 does not require an application.
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.
The submission due date is September 9, 2020.

Our Preparation

Consumer
Safety
  • Chemical/
    Biological Safety

  • HPHC
  • Toxicological Study
  • Clinical Study
  • Electric
    Safety

  • Device(UL8139)
  • Battery(UL1642)
  • Other Parts
Public
Health
  • APPH

  • Perception
    & Behavioral Study
  • Marketing Plan
  • Packaging/Instruction
High
Quality
Production
  • System

  • GMP Product
    R&D
    Manufacturing
  • Environmental Assessment (EA)

What can we do for your brand?

Firstunion has been engaged in Vape industry for many years, and the international professional compliance team provides customers with one-stop PMTAs service. Including project management, program design, testing and research, scientific writing, review and release of all-round services, a great deal of manpower and material resources are saved meanwhile can save application costs. To support customers achieve long-term development in the international market.

Our PMTAs One-Stop Service

PMTAs coordination, communication, evaluation, submission
  • CRO &
    Client Interface

  • Business Communication
  • Contract Negotiation
  • Information Collection
  • Consultation
  • Product
    Improvement

  • Gap Analysis
  • Product Re-design
  • Product Validation
  • Supplier Management
  • Strategy
    Planning

  • HPHC Test
  • UL Test
  • Perception & Behavioral
    Study
  • Test

  • UL
  • HPHC Screening
  • Parameters Study
  • Document
    Drafting

  • EA
  • Marketing Plan
  • Product Info
  • R&D Info
  • GMP
    & TPMF

  • Prep of GMP
    Documents/Records;
  • Prep of Other TMPF Files

Commitment to Social Responsibility

Firstunion Group always puts product safety in the first place and is committed to being responsible to the industry, users and society. After more than a year of work, we have completed more than 100,000 pages of application material evidence to support our claims, and multi-faceted testing data and reports prove that our products are suitable for protecting public health.

We believe that under the new regulatorys, a fair and honest PMTAs process will be adopted to establish a higher standards for the industry to meet the needs of development for industry. By assisting customers to apply with PMTAs services, protect the health and safety of global consumer users, and promote the orderly and sound development of the industry.

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