What kind of certification does the American electronic cigarette need? According to the requirements issued by the US Food and Drug Administration Center in May 2016, electronic cigarette products are included in the scope of tobacco products and are subject to the supervision of the US Food and Drug Administration. Goods not certified by PMTA are not allowed to be sold in the US market. FDA requires all electronic cigarette products sold in the United States to submit an application for detailed ingredients.

Compliance requirements of electronic cigarette manufacturers:

1. Production site registration and manufacturing

1. Registered manufacturing is only applicable to manufacturers whose production and business activities take place in the United States;

2. Chinese manufacturers do not need to submit production site registration manufacturing to FDA of the United States;

3. Definition of manufacturer: any person, including any person who repackages or relabels, produces and processes, manufactures, installs, produces and processes, or packages tobacco commodities, or imports tobacco products for sale or distribution in the U.S. market.

2. Submit health documents

1. Health documents usually include documents related to current or future tobacco commodities and their ingredients (including smoke ingredients), raw materials, additives and their health, toxicology, behavior or physiological effects;


2. It may include analysis and test reports and their research on products, but it does not include research on designated commodities in published literature.

3. Submission requirements for ingredient list

1. Applicable to all commodities listed in the United States, not limited to products registered in the United States;

2. Each component must be identified separately;

3. The composition type can include single chemical substance and composite composition;

4. New products must be submitted 90 days before the launch.

5. Hazardous and hazard factor substance reporting (HPHCs)

1. Harmful and potentially harmful substances refer to all chemical substances in ENDS products or their smoke that will cause direct and indirect harm to customers;

2. The latest listed products shall be submitted 90 days before listing;

3. Delivery method: electronic submitter and CTP system;

4. Propose to designate chemical substances to be tested;

5. FDA proposes to improve PH value (tobacco oil) and total fine particle detection (TPM);