Premarket Tobacco Application

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


Presubmission Meeting











Vaproma PMTA Submission



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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

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.

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.

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.

Vaproma 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.