PMTA of Freemax
Premarket Tobacco Application
PMTA of Freemax
A PMTA must provide scientific data that demonstrates a product is appropriate for
the protection of public health. In order to reach such a decision and to authorize
marketing, FDA considers, among other things:
· Risks and benefits to the population as a whole, including people who would use t
he proposed new tobacco product as well as nonusers;
· Whether people who currently use any tobacco product would be more or less likely
to stop using such products if the proposed new tobacco product were available;
· Whether people who currently do not use any tobacco products would be more or
less likely to begin using tobacco products if the new product were available;
· The methods, facilities, and controls used to manufacture, process, and pack the
new tobacco product.
PMTA Review Process
Freemax PMTA Submission
It takes about two years for Freemax to complete the whole preparations and Freemax has submitted a PMTA to the FDA before September 9, 2020.
| Module | Description |
|---|---|
| Module 1: Administrative | Forms, cover letter, Master File Authorization, etc. |
| Module 2: Summary | Index of studies, integrated summary, and product,nonclinical, clinical and environmental impact overviews |
| Modules 3: Product Description and Manufacturing | Detailed tobacco product information |
| Module 4: Nonclinical | Detailed nonclinical information |
| Module 5: Clinical | Detailed clinical information |
| Module 6: Product Impact on Population Health | Detailed population health information |
| Module 7: Environmental Impact | Detailed environmental impact information |
Our Preparations for PMTA
Strict Safety Evaluation
Extractables and leachables are substances within the device (in this case
vaping) that are required for the device to function, but are not intended to
come into contact with the final inhaled product. Leachables or extractables
are an important consideration within inhalables given the potential harm
they can cause when coming into contact with the lungs. PMTA requires a
full extractables and leachables isk evaluation and quality control process
for any closed vaping system. Therefore, we conduct strict safety evaluation
of extractables and leachables for our products. We can ensure that the
product components are harmless to users.
vaping) that are required for the device to function, but are not intended to
come into contact with the final inhaled product. Leachables or extractables
are an important consideration within inhalables given the potential harm
they can cause when coming into contact with the lungs. PMTA requires a
full extractables and leachables isk evaluation and quality control process
for any closed vaping system. Therefore, we conduct strict safety evaluation
of extractables and leachables for our products. We can ensure that the
product components are harmless to users.
Comprehensive Production Control
GMP refers to the Good Manufacturing Practice regulations promulgated by the
US Food and Drug Administration under the authority of the Federal Food, Drug,
and Cosmetic Act. These regulations, which have the force of law, require that
manufacturers, processors, and packagers of e-cigarettes take proactive steps to
ensure that the products are safe, pure, and effective. Therefore, we conform to
GMP regulations, minimize or eliminate instances of contamination, mixups, and
errors. We are committed to protecting the consumer from purchasing a product
which is not effective or even dangerous.
US Food and Drug Administration under the authority of the Federal Food, Drug,
and Cosmetic Act. These regulations, which have the force of law, require that
manufacturers, processors, and packagers of e-cigarettes take proactive steps to
ensure that the products are safe, pure, and effective. Therefore, we conform to
GMP regulations, minimize or eliminate instances of contamination, mixups, and
errors. We are committed to protecting the consumer from purchasing a product
which is not effective or even dangerous.
Special Group for PMTA
We have set up a special group to follow up the whole process of PMTA and there
is a person in charge for every department. Strict quality supervision and control is
required for the manufacturing of the products, including design and development,
product raw materials, production and manufacturing, product testing, quality
control and other processes. We strive to guarantee standardized and intelligent
management and take a more procedural approach in every detail of the
manufacturing. Regular check will be conducted to ensure the operation is done
according to the system and the standards.
is a person in charge for every department. Strict quality supervision and control is
required for the manufacturing of the products, including design and development,
product raw materials, production and manufacturing, product testing, quality
control and other processes. We strive to guarantee standardized and intelligent
management and take a more procedural approach in every detail of the
manufacturing. Regular check will be conducted to ensure the operation is done
according to the system and the standards.
Our Commitment to PMTA
PMTA has a long-term advantage in spite of the though preparations. On the one hand, it will reduce the exposure of minors to e-cigarettes
and provide an alternative to traditional smokers. On the other hand, it rectifies and standardizes the market order for the benign
development of all e-cigarette companies.
Freemax has always been focusing on product safety and protecting the minors from contacting e-cigarettes. We have spent millions of dollars on preparing for PMTA and facilitate the operation of standardization. We are committed to becoming the industry benchmark and promoting orderly development of e-cigarettes.
Freemax has always been focusing on product safety and protecting the minors from contacting e-cigarettes. We have spent millions of dollars on preparing for PMTA and facilitate the operation of standardization. We are committed to becoming the industry benchmark and promoting orderly development of e-cigarettes.
PMTA of Freemax
Premarket Tobacco Application
PMTA of Freemax
A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:
· Risks and benefits to the population as a whole, including people who would use t he proposed new tobacco product as well as nonusers;
· Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
· Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available;
· The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
PMTA Review Process
Freemax PMTA Submission
It takes about two years for Freemax to complete the whole preparations and Freemax has submitted a PMTA to the FDA before September 9, 2020.
| Module | Description |
|---|---|
| Module 1: Administrative | Forms, cover letter, Master File Authorization, etc. |
| Module 2: Summary | Index of studies, integrated summary, and product,nonclinical, clinical and environmental impact overviews |
| Modules 3: Product Description and Manufacturing | Detailed tobacco product information |
| Module 4: Nonclinical | Detailed nonclinical information |
| Module 5: Clinical | Detailed clinical information |
| Module 6: Product Impact on Population Health | Detailed population health information |
| Module 7: Environmental Impact | Detailed environmental impact information |
Strict Safety Evaluation
We have set up a special group to follow up the whole process of PMTA and there is a person in charge for every department. Strict quality supervision and control is required for the manufacturing of the products, including design and development, product raw materials, production and manufacturing, product testing, quality control and other processes. We strive to guarantee standardized and intelligent management and take a more procedural approach in every detail of the manufacturing. Regular check will be conducted to ensure the operation is done according to the system and the standards.
Comprehensive Production Control
GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of e-cigarettes take proactive steps to ensure that the products are safe, pure, and effective. Therefore, we conform to GMP regulations, minimize or eliminate instances of contamination, mixups, and errors. We are committed to protecting the consumer from purchasing a product which is not effective or even dangerous.
Special Group for PMTA
We have set up a special group to follow up the whole process of PMTA and there is a person in charge for every department. Strict quality supervision and control is required for the manufacturing of the products, including design and development, product raw materials, production and manufacturing, product testing, quality control and other processes. We strive to guarantee standardized and intelligent management and take a more procedural approach in every detail of the manufacturing. Regular check will be conducted to ensure the operation is done according to the system and the standards.
Our Commitment to PMTA
PMTA has a long-term advantage in spite of the though preparations. On the one hand, it will reduce the exposure of minors to e-cigarettes and provide an alternative to traditional smokers. On the other hand, it rectifies and standardizes the market order for the benign development of all e-cigarette companies.
Freemax has always been focusing on product safety and protecting the minors from contacting e-cigarettes. We have spent millions of dollars on preparing for PMTA and facilitate the operation of standardization. We are committed to becoming the industry benchmark and promoting orderly development of e-cigarettes.
Taste the Clouds, Feel the Flavors with Freemax
Taste the Clouds, Feel the Flavors with Freemax
Tanks
Coils
Tanks
FIRELUKE 2
M PRO
Coils
M PRO MESH
X MESH
