Regulatory consulting
services
services
The nicotine industry is constantly evolving due to changes in consumer lifestyles, policies and regulations. we have been in close contact with EU and USA 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.
NIOO in US market
PMTA, short of Pre-market Tobacco Application. According to the regulations promulgated by the FDA, nicotine pouch products are included in the scope of tobacco products and are subject to FDA supervision.
In 2023 NIOO spent 2 million USD and successfully obtained FDA submission acceptance
PMTA registration process
Materials to be submitted
Basic Information
Descriptive information
Product sample
Product label
Scientific research results
Product attributes and production process
In vivo toxicology studies
Review process
Pre-commission meeting
Meeting rejection letter or meeting minutes letter (if approved and meeting held)
Acceptance review
Output Letter of Acceptance or Rejection of Acceptance (RTA) Letter
Application review
Output Submission Letter or Rejection File (RTF)
Substantive examination
Review results
Output volume marketing order letter or no marketing order letter
Post-market reporting
Want to know more about regulations
in other countries or regions?
in other countries or regions?