What is the American PMTA certification of electronic cigarette? PMTA, its full name is PremiarketTobacco Product Application, which means "pre marketing application for tobacco products". The U.S. Food and Drug Administration (FDA) will implement the marketing certification system for tobacco products from September 9, 2020. To put it simply, in the future, tobacco products, especially the electronic cigarettes that people pay attention to, whether open electronic cigarettes, closed electronic cigarettes, electronic cigarette oils, or non burning by heating, as well as various types of tobacco products, will be the same as drugs and medical devices. FDA needs to conduct a series of evaluations on products and product manufacturers before they are officially marketed in the U.S. market, Through the "self certification and innocence" of the manufacturer and the "notarization" of a third-party testing institution or clinical institution, it is proved that the product applied for listing is reliable in quality and stable in performance. It is not only safe for the product itself, but also the harm to users or contacts must be within an acceptable limit.


1、 Which products must be applied for PMTA?

1. Smoke oil;

2. Electronic cigarette set;

3. Set and related accessories and parts.


2、 Compliance requirements for electronic cigarette manufacturers:

(1) Production site registration and product list

1. 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 production site registration and product list to FDA of the United States;

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

(2) Health document submission

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

2. It may include the analysis and test reports and research on products, but it does not include the 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 components can include single chemical substances and composite components;

4. The newly launched products must be submitted 90 days before the products are launched.

4、 Hazardous and potentially hazardous substances report (HPHCs)

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

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

3. Compounds specifically tested;

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

5. For atomizing appliances, the following conditions shall be met during the test:

(1) Select samples that are still within the shelf life;

(2) The sample shall include at least three different batches, each batch shall have at least seven parallel samples, and the sampling location and date shall be recorded;

(3) For the atomizing device that can be repeatedly injected with oil, the smoke oil with different nicotine concentration shall be provided for testing;

(4) For enclosed atomizing devices, the test shall be conducted with the tobacco oil used for packaging and intended for sale.

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

(1) Use the atomizing device with small atomization amount;

(2) Use the atomizing device that can provide higher concentration aerosol.


5、 List of Ingredients Submittal (PMTA) Application/Certification List

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


2. Submit scientific research and analysis related to products.

Product analysis:

Components, ingredients, additives;

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

Complete description of operation principle and consumer use mode;

Description of the whole production process.

Health Research:

Clinical research;

Consumer perception data;

Usage data;

Human factors;

Non clinical research on abuse of responsibility;