FDA Premarket Tobacco Product Application

Telling your product’s story through science

For FDA to authorize the marketing of a new tobacco product, you must fully tell your product’s story with scientific justification at each step. This roadmap starts with product design and its manufacturing, then continues to evaluation of the chemicals and aerosols that users inhale. With consideration to these factors, your product distribution and advertising, alongside an understanding of the critical areas of study that impact product addiction and perceptions, we create a scientifically supported pathway to PMTA authorization. The diagram below provides a simplified outline of the pathway to proving your product is appropriate for the protection of public health (APPH). Your product’s story needs to be told in a language that FDA can understand. Let us help you tell that story.