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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
FeelmixX offers end-to-end PMTA solutions, from pre-submission to FDA approval:
Pre-Application Consulting
Product profiling,
manufacturing processes,
compliance review,
product classification,
customized strategy
Scientific Evidence Preparation
Product safety testing,
clinical/non-clinical studies,
toxicology, behavioral
research, youth appeal and
environmental assessments
Application Drafting & Submission
Compile all 5 FDA-required
modules; submit via  FDA's CTP Portal
FDA Communication & Resubmission Support
Address RTA (Refuse to Accept) & RTF (Refuse  to File) issues;
support responses to additional data requests