At present, as an emerging substitute for traditional tobacco, e-cigarettes are sensitive to supervision policies, and the export of this product needs to be carried out according to national policies. PMTA, the full name of Premarket Tobacco Application, refers to the pre-market application of tobacco. According to the regulations issued by FDA, electronic cigarette products are included in the scope of tobacco products and subject to FDA supervision. Products that have not passed PMTA certification are not allowed to be listed in the United States. From September 9, 2020, the US Food and Drug Administration requires all electronic cigarette products sold in the US market to submit an application for ingredient list.

Which products must be applied for PMTA?

1. Tobacco oil;

2. Electronic cigarette set;

3. Set and relevant accessories and parts.

Compliance requirements for electronic cigarette manufacturers:

1、 Production site registration and product list

1. The registration and product list are only applicable to manufacturers whose production activities take place in the United States;

2. Chinese manufacturers do not need to submit the production site registration and product list to FDA;

3. Definition of manufacturer: any person, including any repackaging or relabeling person, produces, manufactures, assembles, processes or packages tobacco products, or imports finished tobacco products in the United States for sale or distribution.

2、 Health document submission

1. Health documents generally include documents related to current or future tobacco products and their components (including smoke components), raw materials, components and additives and their health, toxicology, behavior or physiological effects;

2. It may include analysis and test reports, research, etc. on products, but does not include the research on specific products in the published literature.

3、 Requirements for submission of ingredient list

1. Applicable to all products listed in the United States, not limited to products registered in the United States;

2. Each component must be individually identifiable;

3. The types of ingredients can include single chemical substance and compound ingredients;

4. Newly launched products must be submitted 90 days before the product is launched.

4、 Hazardous and potentially hazardous substances report (HPHCs)

1. Hazardous and potentially hazardous substances refer to any compound that may cause direct or indirect harm to consumers in or in its smoke;

2. Newly launched products shall be submitted 90 days before the launch;

3. Specific tested compounds;

4. FDA proposes to increase PH value (for tobacco oil) and total particulate matter test (TPM);

5. For atomization apparatus, the following conditions shall be met during the test:

A. Select samples that are still within the shelf life;

B. The sample shall contain at least three different batches, with at least seven parallel samples for each batch, and the sampling location and date shall be recorded;

C. For the atomization device that can be refilled with oil, smoke oil with different nicotine concentrations shall be provided for testing;

D. For closed atomization device, the test shall be conducted with the cigarette oil used for packaging and intended for sale.

6. For the smoke oil, it should be tested under two different conditions, so that FDA can grasp the emission range of the product:

A. Use atomization device with small atomization amount;

B. Use atomization device that can provide higher concentration of aerosol.

5、 Application/certification list of ingredient list submission (PMTA)

1. It must be proved that the product is suitable for protecting public health.

2. Submit scientific research and analysis related to the product.

Key information to be submitted when applying for PMTA:

1. The enterprise successfully applied for FDA

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

2. Basic information

Company name and address, basic information of the agent in the United States (name, address, telephone, etc.).

3. Information Collection

All information is collected into a volume and provided with a table of contents for easy indexing and reading.

4. 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.

5. Product sample

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

6. Product label

Reflect the most real state of the sample (such as size, color), including warnings, etc.

7. Scientific research results

A. Compared with other tobacco products on the market, the health risks of this product 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.

B. It is required 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.

8. Product attributes and production process

A. 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.

B. 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.

9. Toxicological study in vivo

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 and scientific research information is not sufficient to support the safety of the product, then appropriate in vivo toxicological research should also be carried out.

10. HPHCS test requirements Product analysis test requirements

Select samples within the shelf life. The test should include three different batches, with a minimum of 10 samples per batch, 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.