PMTA APPLICATION FOR VAPE PRODUCTS

Jul 03, 2020

PMTA APPLICATION FOR VAPE PRODUCTS

PREMARKET TOBACCO APPLICATIONS FOR CLOSED SYSTEMS

Many people have heard about the FTA wanting vape companies to produce a pre-market tobacco application for closed paving system products. All the big tobacco companies are able to submit their applications for the PMTA's. The issue is only one company a small one called EAS has been able to submit there PMTA and not be owned by a major tobacco company. The devices that are being submitted are what we call closed systems which mean they have flavor and battery in one. These products are often sold at popular convenience stores and are a complete package. Since the FDA’s 2020 guidance prohibiting the sales of prefilled pods in flavors other than tobacco and menthol, all the sales of fruit and candy flavored pods has been discontinued by major vape companies. The new deadline to submit your currently marketed products is September 2020 where the FDA will review your application. The issue is developing the data to support PMTA’s will cost millions per application and will be impossible for the small companies that make up the ENDS industry to complete before the September deadline. Here at OMARI-O we are working on our ENDS PMTA’s approval and hope to have things submitted on time for our products. We encourage all us vape enthusiast to contact your local government and advocate for the vaping cause. PMTA applications include more than 100k thousand pages of tests results and analysis, including toxicology, behavioral studies, and an extensive review of existing literature of vapor product science.
“From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith,” Howard added. “Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”