What information does the electronic cigarette PMTA need to submit? The key information to be submitted by PMTA is as follows:

● Only enterprises that have successfully applied for FDA can apply for PMTA

● Basic information: company name and address, basic information of the agent in the United States (name, address, telephone, etc.)

● All information shall be collected into a volume and provided with a table of contents for easy indexing and reading

● Descriptive information: product brand, name and model, applicable standards, ingredients and product design description, taste, nicotine concentration, instructions for use, sales and distribution control, etc.

● Product samples: at least one sample shall be provided to FDA. FDA may also require a reasonable number of samples for testing and analysis.

● Product label: reflect the most real state of the sample (such as size, color), including warning, etc.

● Scientific research results: 1 Compared with other tobacco products on the market, this product poses health risks to users and non-users. As e-cigarettes are a new type of tobacco, they are not the same type as heated non-burning e-cigarettes, so they only need to be compared with traditional tobacco. 2. It is necessary to submit the chemical and physical characteristics and quantitative level of aerosol emissions under normal use conditions. That is to say, manufacturers should pay attention to the amount of gases released by electrons and the substances contained, and pay attention to collecting data and submitting them.

● Product attributes and production process: 1 The product attribute description shall be submitted: size, structure, design, performance parameters and oil storage tank description. And whether the battery is safe and easy to explode. Whether the chemical substances contained in the tobacco oil and the released substances are harmful to human body. 2. FDA not only pays attention to the product itself, but also attaches great importance to the management of the enterprise. Therefore, it needs to submit staff training, management supervision, design process and control, supply management, product testing and test standards, complaint handling, nonconforming products and processes, and corrective and preventive measures.

● In vivo toxicology research: FDA does not recommend clinical research of manufacturers. It hopes that all research and experiments can be completed within six months. However, if the relevant experimental research information is not sufficient to support the safety of the product, then appropriate in vivo toxicology research should also be carried out.

HPHCS (harmful ingredients and potentially harmful ingredients) test requirements Product analysis test requirements should be noted: select samples within the shelf life, the test should include three different batches, each batch of at least 10 samples, and record the sampling time and place. The generator scheme and complete description for analyzing and testing aerosol shall be included. In the case of the atomizing device with repeatable oil injection, the smoke oil with different nicotine concentrations shall be provided for testing. That is to say, to complete the analysis and test of a product, a total of 60 experiments are required. The estimated cost of FDA for submitting PMTA is 330000 dollars, and the preliminary calculation time needs 1700 hours.