How much does it cost to apply for PMTA certification in the United States? The estimated cost for submitting PMTA by the FDA is $330000, with a preliminary calculation time of 1700 hours. The cost of PMTA certification is generally determined based on the application situation, and there are generally three types of fees. In addition to training fees, registration fees, and renewal fees are all unified standards.

According to regulations issued by the FDA in May 2016, electronic atomization device products are included in the scope of tobacco products and are subject to FDA regulation. Products that have not passed PMTA certification are not allowed to be listed in the United States. The US FDA requires all electronic atomization device products sold in the US market to submit an ingredient list application, abbreviated as PMTA.

Compliance requirements that electronic atomization device manufacturers need to comply with:

1、 Production site registration and product list

1. The registration and product list are only applicable to manufacturers whose production activities occur within the United States;

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

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


2、 Health File 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, as well as their health, toxicology, behavioral, or physiological effects;

2. This may include analysis and testing reports, research, etc. conducted on the product, but does not include research that has not been conducted on specific products in published literature.

3、 Composition List Submission Requirements

1. For 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 substances and composite ingredients;

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

4、 Hazardous and Potential Hazardous Substances Report (HPHCs)

1. Harmful and potentially harmful 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 instruments, the following conditions need to be met during testing:

6.1 Select samples that are still within their shelf life.

6.2 The sample should consist of at least three different batches, with a minimum of 7 parallel samples per batch, and the sampling location and date should be recorded.

6.3 For atomization devices with repeatable oil injection, different nicotine concentrations of tobacco oil should be provided for testing.

6.4 For enclosed atomization devices, testing 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 a smaller atomization device.

7.2 Use an atomization device that can provide higher concentrations of aerosols.

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

1. It must be proven 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, additives.

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

2.1.3 Complete description of the operating principle and consumer usage.

2.1.4 Description of the entire production process of the product.

2.2 Health research.

2.2.1 Clinical research.

2.2.2 Consumer Perception Data.

2.2.3 Use data.

2.2.4 Human factors.

2.2.5 Non clinical studies on abuse of responsibility.

2.2.6 Scientific literature review.