The FDA (United States Food and Drug Administration) issued the final regulation, Deeming Regulation, which came into effect on August 8, 2016, and included all electronic atomization products into the scope of tobacco products. Through this regulation, FDA can legally supervise new tobacco products, including ENDS (Electronic Nicotine Delivery Systems), and the regulation regulates the production, import, packaging, labeling, advertising, promotion A series of regulations are made on sales. Products containing nicotine or products that may be used with nicotine are subject to the supervision of FDA. The supervision objects include not only the finished products of ENDS, but also the parts and components, but also the accessories. Therefore, all electronic atomization products, including electronic cigarettes, must comply with the requirements of the FDA Tobacco Control Act and the compliance requirements that manufacturers need to comply with. The FDA of the United States requires all electronic cigarette products sold in the United States market to submit an application for ingredient list.

PMTA application content:

1. General information

Provide the applicant's basic information and specific products.

2. Contents

A comprehensive index containing each item and page number specified by the PMTA.

3. Product information description

The main information required by FD&C 910 (b) to describe electronic cigarette products.

4. Product sample

FD&C 910 (b) (1) (e) stipulates that samples of products and components of electronic cigarettes must be provided according to the requirements of FDA.

5. Label/identification

FD&C 910 (b) (1) (f) stipulates that all label samples of electronic cigarette products must be provided, including labels, inserts, instructions and other auxiliary information or materials.

6. Environmental assessment

According to the requirements of 21 CFR 25.15, the applicant must prepare an environmental assessment report according to 21 CFR 25.40, which mainly includes atmospheric, terrestrial and water environmental assessments.

7. Summary of all research information

FD&C 910 (b) (1) (a) stipulates that PMTA shall include a complete report of the applied product with published and known information, which involves the applicant's investigation of the health risks of electronic cigarette products; And whether the product has lower risk than other tobacco products.

8. Scientific research and analysis

FD&C 901 (b) (1) (a), (b) and (c) stipulate that the PMTA must contain a complete report of all data.

PMTA data preparation:

1. Consumer safety

HPHC test

Pay attention to the type and concentration of toxic and harmful substances in the smoke, and ensure that the substances in the electronic smoke should not migrate into the smoke liquid, thus causing health risks.

Toxicological studies

Cytotoxicity, genetic toxicity, carcinogenicity, respiratory, cardiac, reproductive and developmental toxicity, etc.

clinical research

It mainly studies the pharmacokinetics and efficacy of nicotine, as well as the user's acceptance of the product, abuse tendency and use behavior.

UL 8139

Product safety test certifies the corrosion resistance and fire resistance of raw materials, electrical safety of finished products, structural safety and use safety.

2. Public safety

Cognition and Behavior

Describe the channels through which products are promoted and sold. How to supervise these channels to prevent products from effectively identifying the use methods.

Market plan

Describe the channels through which products are promoted and sold. How to regulate these channels to prevent product abuse.

packing design

Review and assessment of reasonably foreseeable risks related to the product and its packaging design.

3. Quality system

GMP system

The enterprise is required to implement a complete set of control system from product demand, product research and development to product production.

Environmental assessment

It mainly includes atmospheric/terrestrial and water environment assessment.


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.