What supervision does FDA have on electronic cigarette manufacturers? Manufacturers in the United States need to register every tobacco production site in the factory with FDA and report any harmful substances and potential harmful substances. (Companies outside the United States do not need to register temporarily, but they must also register in the near future)

American manufacturers are required to submit a list of tobacco products to FDA

ENDS manufacturers are required to submit the ingredient list of each product to FDA (applicable to Chinese manufacturers)

Hazard modifiers, such as light, low, and mill, cannot be used to describe tobacco products

Free samples considered as tobacco products (such as electronic cigarettes) are not allowed to be sold (except B2B)

For electronic cigarettes and other new tobacco products, if they are launched after February 15, 2007, the product manufacturer must submit a PMTA (pre-market tobacco application) or SE report to the FDA within the specified time. If no reply from FDA is received during the submission of PMTA, the manufacturer can continue to sell products in the market. The PMAT procedure allows FDA to recommend products to protect public health and prevent the sale of products harmful to public health to the market.


FDA's latest requirements for electronic cigarettes:

• Establishment Registration&Product Listing

• Health Document Submission

• Ingredient Listing

• Hazardous and potentially hazardous substances report (HPHC)

• Pre-market Authorization (PMTA)

Electronic cigarette FDA certification data:

1. Copy of business license of the applicant or manufacturer;

2. Copy or scanned copy of product test report (English version);

3. Product manual in English;

4. List of models and specifications;

5. List of product ingredients;

6. Process flow diagram;

7. Product formula proportion table.


Electronic cigarette FDA certification process:

Step 1: Confirm whether the product is within the scope of FDA food control

Step 2: Select a US agent

Step 3: Prepare enterprise English information and product English information

Step 4: Register successfully

(Note: FDA registration does not have a certificate. If the product is registered with FDA, the registration number will be obtained. FDA will give the applicant a reply letter (signed by the FDA chief executive), but there is no FDA certificate.)