PMTA has become a certification threshold for e-cigarette manufacturers to enter the U.S. market, but few have crossed this threshold at present. Many e-cigarette manufacturers are still applying or preparing to apply. In the process of applying for certification, a lot of materials need to be prepared, and a lot of time, manpower and expenses need to be spent to pass the PMTA certification.

PMTA application process of American electronic cigarette

Materials to be submitted

Basic information: company name and address, basic information of agents in the United States (name, address, telephone number, etc.), all information collected into a volume, providing a directory 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, and 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 warnings, etc.

The chemical and physical characteristics and quantitative level of aerosol emissions under normal use conditions need to be submitted. 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 attribute and production process: 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.

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 it does not include research on specific products in 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. Harmful and potentially harmful substances refer to any compound in ENDS products or their smoke that may cause direct or indirect harm to consumers;

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

3. Submission method: eSubmitter and CTP system;

4. Specific tested compounds;

5. FDA recommends adding PH value (for tobacco oil) and total particulate matter test (TPM);

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

6.1 Select samples that are still within the shelf life.

6.2 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.

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

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

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

7.1 Use atomization device with small atomization amount.

7.2 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.

2.1 Product analysis

2.1.1 Components, ingredients and additives.

2.1.2 Product performance, such as size, overall structure description, design features, etc.

2.1.3 The complete description of the operation principle and the way consumers use it.

2.1.4 Description of the whole production process.

2.2 Health studies.

2.2.1 Clinical study.

2.2.2 Consumer perception data.

2.2.3 Use data.

2.2.4 Human factors.

2.2.5 Non-clinical research on abuse of responsibility.

2.2.6 Scientific literature review.