Monday, May 20, 2024

SMOORE’s Vaporesso submitted PMTA, which has been accepted by FDA


According to foreign reports, the company’s own e-cigarette brand, vaporesso, has received the first round of application for PMTA from FDA.

According to its U.S. agent, the application received positive comments from FDA on its overall preparation.

What is PMTA?

PMTA is a pre-sale tobacco product application that all e-cigarette manufacturers must submit to FDA in order to continue marketing and selling their electronic atomization products. The PMTA requires applicants to provide scientific data to demonstrate that the product is suitable for the protection of public health.

On May 10, 2016, the US FDA finally determined its rules to review other products in accordance with the federal food, drug, and Cosmetic Act (as amended by the family smoking prevention and tobacco control act). Although the whole application process is very long, the FDA does not spend much time preparing application materials. After several time modifications, the deadline of September 9, 2020 is finally determined.

Due to its high standards and complex processes, PMTA has become the basis for establishing long-term business in the local area. In addition to the requirements that the product must meet, PMTA also requires a lot of manpower, capital and time.

The company was founded in 2015 by its parent company, smore (established in 2006 and publicly listed on the stock exchange of Hong Kong on 10 July 2020).

Since the promulgation of the accreditation rules in May 2016, vaporesso has been fully prepared to bring its innovative e-cigarette products into the FDA’s PMTA regulatory framework. The company has engaged us professional service providers to work closely with their own in-house teams with different backgrounds and expertise, and is further supported by a strong R & D team from leading smore laboratories and basic research institutions.

Since smore has many years of ODM / OEM experience in international customers, from the first day on, vaporesso is known for its outstanding manufacturing, which is the key and basic element of PMTA application.

On August 20, the first round of the application was accepted by FDA. This is a challenging time, and there is still uncertainty in the regulation itself. However, the successful acceptance has increased smore’s confidence and enabled them to continue to invest in introducing more e-cigarette products into PMTA in the future.

As the world’s largest e-cigarette equipment provider, smore is also the first company to conduct an IPO in the e-cigarette industry. Smore has 14 years of experience in this field, has the most advanced e-cigarette technology, and plays an important role in the whole industry, with a global market share of more than 16.5%.

Founded in 2015, vaporesso is one of the sub brands of smore. It inherits the spirit of smore and integrates it into its mission. Its products cover all open e-cigarette systems and meet the needs of e-cigarette users.

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