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PMTA TPD
What is PMTA?
The Premarket Tobacco Product Application (PMTA) is a mandatory FDA review process for new tobacco products (e.g., e-cigarettes, vapes, heated tobacco) under the Family Smoking Prevention and Tobacco Control Act. Without PMTA approval, products cannot be sold in the U.S.
Our PMTA Services
We offer end-to-end PMTA solutions, from pre-submission to FDA approval:
Pre-Application Consulting
Ingredient screening & compliance review
Product classification (PMTA requirement assessment)
Customized application strategy
Scientific Evidence Preparation
Toxicology studies (e.g., cytotoxicity, inhalation toxicity)
Behavioral & usage research (consumer use patterns)
Youth appeal assessment (flavor & packaging review)
Application Drafting & Submission
Compile FDA’s 5 required modules:
Product description & ingredients
Manufacturing & quality control
Health risk studies
Public health impact analysis
Submit via FDA’s CTP Portal & track progress
FDA Communication & Resubmission Support
Address RTA (Refuse to Accept) and RTF (Refuse to File) issues
Assist with additional data requests