On August 25, 2020，Firstunion Group has completed the first round
review of the PMTA application and received an acceptance letter from the US
Food and Drug Administration (FDA). This notification moves the Firstunion
submission to the substantive review phase of the PMTA procedure.
Firstunion has
always put the safety as priority during the ID design, manufacturing, and quality testing. When applying for PMTA,
in order to achieve overall health improvement, we need to prepare three
aspects. The first is consumer safety, which is for E-cigarette users. The
second part is public safety, which is for all people. The third part is
high-quality manufacturing, which is necessary to prove to the FDA that it can
continue to produce products with the same quality. The entire application process
requires a huge investment of capital, manpower, and material resources, not
just based on the consideration of entering the US market. More importantly, we
hope our global consumers to experience more safety products.
What has Firstunion done for the PMTA?
Receiving the acceptance letter from FDA represents an important
step for Firstunion in the PMTA process, because our vapor products, as an
alternative to combustible cigarettes, will be initially supported by the FDA
under high-quality requirements.
Before entering the substantive review stage, after more than
one year of hard work, we completed more than 100,000 pages of application
material evidence to support our claims. Multi-faceted testing data and reports
proved that our products are suitable for protecting public health. We look
forward to continuing to work with the FDA in the coming weeks and months and
remain optimistic that the PMTA process will bring orders.
Firstunion has 16 years of ODM/OEM experience with international
customers, excellent manufacturing capabilities and R&D advantages are the
fundamental elements to the PMTA application. Firstunion SRA team
is currently undertaking 7 projects of PMTA application for our ODM/OEM
customers around the world.
Firstunion Laboratory has been certified by UL and NEMKO WTDP
and other authoritative organizations, the test results are mutually recognized
by these organizations. The time and cycle of customer certification
requirements can be extremely shortened, which have a huge competitive advantage
than other company. During document submissions, which steps of preparing
documents should be formulated by the chief scientific compliance officer of
Firstunion and assigned tasks by a strict project management process. We strive
to ensure that our customers' products continue to be in the market and
continue to be sold.
What can we do for your vaping brands?
Scientific & Regulatory Affair ( SRA) of
Firstunion
Firstunion has been engaged in Vape industry for many
years, and the international professional compliance team provides customers
with one-stop PMTA 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.
We believe that under the new regulations, a fair and honest
PMTA procedure will be adopted to establish a higher standard for the
Vape industry, meanwhile which is the needs of development for Vape
industry. By assisting customers with PMTA application services, it
helps Firstunion maintain close communication with customers.