What are the requirements for electronic cigarette manufacturers to export to the United States? The FDA of the United States requires all electronic cigarette products sold in the United States market to submit an application for ingredient list.

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 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.