FDA Accepts Vaporesso's First Round PMTA Application

The first round of Vaporesso’s Premarket Tobacco Product Application or PMTA has been accepted by the U.S. Food and Drug Administration or FDA. In just 3 days after the submission, the leading vaping brand said the FDA gave positive comments on its application’s overall preparation.

The acceptance of its application is a boost to its parent company Smoore' efforts to keep investing and bringing more vaping products into PMTA in the future. With the first of the applications accomplished, Smoore promised more products to come.

“Our commitment to vapers in the U.S.A. remains the same: we will make vaping as easy as possible and we will consistently provide high-quality vaping experiences for vapers all over the world,” the company said in a statement.

Established in 2015 by Smoore, Vaporesso has been fully focused in bringing its vaping product to the regulatory framework created by the FDA through a premarket tobacco application, whose deeming rule was first released in 2016. Smoore said it has hired professional service providers that worked closely with their in-house team and supported by its research and development team to secure a successful acceptance at the PMTA. The company attributes Vaporesso’s readiness in the application from its many years of ODM/OEM experience with international customers.

Smoore, who recently had a successful IPO at the Hong Kong Stock Exchange with a total market value of $21.8 billion last month, is also the vaping industry’s market leader in terms of revenue last year.

The Premarket Tobacco Product Application or PMTA is a requirement that e-cigarette manufacturers have to submit to the FDA if they want to continue marketing and selling their vaping products in the United States. The aim of the PMTA is to ensure the company provides scientific data that demonstrates the vaping product abides by the health standards and that it has appropriate public health protection measures.

Before approving the application, the FDA considers risks and benefits of the vaping product as a whole to users and nonusers; the probability that users would switch to new tobacco product if the new one is approved; the probability that non-tobacco users would be more or less likely to begin using tobacco products if new products are available; and finally, the methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.

Products that must undergo the PMTA are vape devices, e-liquids and separately sold components like drip tips and atomizers.

Vaporesso noted that 99% of all vaping products will have to go through the whole review process, which include pre-meetings, acceptance, filling, review, action, and post-market reporting before the Sept. 9, 2020 deadline. It noted that the entire application would be very long, but the FDA does not leave much time for the preparation of application materials. During the course of the entire process, the FDA may request for more information during the review.

As such, the PMTA is important to establish a long-term business locally because of its extremely high standards and complicated process. The company said going through Premarket Tobacco Application entails considerable manpower, capital and time investment.

One of Smoore’s sub-brands, Vaporesso has 800 million users across 60 countries with a massive brand reach across Europe, America, and the emerging markets. Vaporesso counts VECO, ZERO, LUXE and GEN in its product lineup, which covers an entire range of vape systems to satisfy each vaper’s preference.