How do I apply for e-cigarettes from the FDA? FDA can legally regulate new types of tobacco products, including Electronic Nicotine Delivery Systems (ENDS). The regulations provide a series of regulations on the production, import, packaging, labeling, advertising, promotion, and sales of new types of tobacco products. Products containing nicotine or products that may be used with nicotine are subject to FDA supervision, and the regulatory objects include not only the finished products of ENDS, but also components and components, But does not include accessories.

All electronic atomization products, including electronic cigarettes, must comply with the requirements of the FDA Tobacco Control Act and the compliance requirements that manufacturers are required to comply with. The FDA of the United States requires all electronic cigarette products sold in the United States market to submit an ingredient list application.

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 occur in the United States;

2. Chinese manufacturers are not required to submit production site registration and product list to the FDA of the United States;

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 the health, toxicological, behavioral, or physiological effects of current or future tobacco products and their components (including smoke components), raw materials, components, and additives;

2. It may include analytical test reports, studies, etc. conducted on products, but does not include studies not conducted on specific products in published literature.


3、 Composition List Submission Requirements

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 components can include single chemical substances and composite components;

4. Newly launched products must be submitted 90 days before their launch.


4、 Hazardous and potentially hazardous substance reports (HPHCs)

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

2. Newly launched products must be submitted 90 days before their launch;

3. Submission method: eSubmitter and CTP system;

4. Specific tested compounds;

5. FDA recommends increasing the pH value (for tobacco oil) and total particulate matter testing (TPM);

6. For atomizing appliances, the following conditions need to be met during testing:

6.1 Select samples that are still within the shelf life.

6.2 The sample shall consist of at least three different batches, with a minimum of seven parallel samples per batch, and the location and date of sampling shall be recorded.

6.3 For atomizing devices that can be refilled with oil, smoke oil with different nicotine concentrations should be provided for testing.

6.4 For closed atomization devices, the test should be conducted using tobacco oil used for packaging and intended for sale.

7. For tobacco oil, it should be tested under two different conditions to facilitate FDA's understanding of the product's emission range:

7.1 Use an atomizing device with a small amount of atomization.

7.2 Use an atomization device that provides higher concentrations of aerosols.

5、 Component List Submission (PMTA) Application/Certification List

1. The product must be proven to be suitable for protecting public health.

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

2.1 Product Analysis

2.1.1 Components, ingredients, additives.

2.1.2 Product performance, such as dimensions, overall structural description, design features, etc.

2.1.3 Complete description of operating principles and consumer usage.

2.1.4 Description of the entire production process.

2.2 Health Studies.

2.2.1 Clinical Studies.

2.2.2 Consumer Perceived 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.

The key information to be submitted for applying for 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, phone, etc.)

● Compile all information into a volume and provide 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: Provide at least one sample to FDA, which may also require a reasonable number of samples for testing and analysis.

● Product label: reflects the most authentic state of the sample (such as size, color), including warnings, etc.

● Scientific research results:

1. The health risks of this product to users and non users compared to other tobacco products on the market. As electronic cigarettes are a new type of tobacco, they are not of the same type as heated non burning electronic cigarettes, so they only need to be compared with traditional tobacco.

2. It is necessary to submit the chemical and physical characteristics and quantitative levels of aerosol emissions under normal use conditions. That is, manufacturers should pay attention to the amount of gas released by electrons and the substances contained therein, and pay attention to collecting data and submitting them.

● Product attributes and production process:

1. Product attribute descriptions need to be submitted: dimensions, structure, design, performance parameters, and description of oil storage tanks. And whether the battery is safe and prone to explosion. The chemical substances contained in tobacco oil and whether the released substances are harmful to human health.

The FDA not only focuses on the product itself, but also attaches great importance to enterprise management. Therefore, it needs to submit employee training, management supervision, design process and control, supply management, product testing and testing standards, complaint handling, non-conforming products and processes, and corrective and preventive measures.

● In vivo toxicology research: The FDA does not recommend conducting manufacturer clinical studies. It hopes that all research and experiments can be completed within six months. However, if the relevant experimental research information is insufficient to support the safety of the product, appropriate in vivo toxicology research should also be conducted.

HPHCS (Hazardous and Potentially Hazardous Ingredients) Testing Requirements Product analysis testing requirements Attention: Select samples within the shelf life. The testing should include three different batches, with a minimum of 10 samples per batch, and record the sampling time and location. Include a generator plan and complete description for analyzing and testing aerosols. In the case of a repeatable oil injection atomization device, smoke oil with different nicotine concentrations should be provided for testing. In other words, to complete the analysis and testing of a product, a total of 60 experiments are required. The FDA estimates that the cost for submitting a PMTA is $330000, and the preliminary calculation time requires 1700 hours.