services
The nicotine industry is constantly changing and developing to adapt to changes in consumer lifestyles, policies and regulations. we have been in close contact with EU governments to improve and maintain the implementation of new regulations. The professional compliance team at Nioo can escort your product to comply with local regulations and smoothly facilitate your business operations.
In US market
PMTA, the full name is Premarket Tobacco Application. According to the regulations promulgated by the FDA, e-cigarette products are included in the scope of tobacco products and are subject to FDA supervision. Products that have not passed PMTA certification are not allowed to be marketed in the United States.
TPMF (Tobacco Product Master File), the working principle of TPMFs is that once the master file is submitted, if relevant parties want to refer to the master file, they can request authorization from the TPMF owner. If the request is granted, FDA reviewers will be able to access and review the nonpublic information in the TPMF based on the authorization granted during the review submission, even if such confidential information is not provided to the authorized party.
Nioo already gets FDA submission tracking number in 2022
PMTA registration process
in other countries or regions?