Avail vapor, a Virginia based e-cigarette retailer and e-cigarette maker, announced today that the FDA has accepted the PMTA for flavoring electronic liquids submitted by avil for substantive review.
For all products intended to be sold on the legal market after this date, all manufacturers must submit a PMTA (pre-sale tobacco application) by September 9.
Avail said the application is the first of many applications that avail plans to submit, which will allow avail to provide customers with a wide range of flavor products.
The company did not release the names of all the submitted products, but confirmed that they included mixed berry flavors.
Avail’s announcement today marks the first fact that flavored bottled electronic liquids (or any form of open electronic cigarette products) have been subject to further research by federal regulators. Entering the substantive review stage means that the submitted product may remain on the market for up to a year, or until the agency makes a final decision on whether it can be legally sold.
In two ways, it is important to accept the avail submission for further review.
First, it means that at least some bottled e-liquids can be used legally after the September 9 PMTA deadline. Second, it indicates that the FDA will at least review open system products and bottled e-cigarettes for flavors other than tobacco.
James Xu, chairman of avil, said: ‘we started planning our regulatory framework and PMTA from 2015, and then included nicotine aerosol products in the FDA’s tobacco mandate. We are very happy that our years of hard work, investment and dedication have brought us to this point. Our ultimate goal is to seek FDA sales orders, which will enable us to continue to retain our products for adult smokers seeking alternatives to traditional tobacco products.
Avail, headquartered in Richmond, Va., is a senior retailer offering a wide range of online products in 97 stores in 12 states.
So far, the only independent e-cigarette manufacturer considered to be subject to substantive review has produced e-alternative solutions’ leap and leap go devices and pre installed sealed leap cartridges.
EAS announced on July 8 that their leap PMTA submission has been accepted for substantive review.
Juul labs announced its PMTA filing in July, and all tobacco companies selling e-cigarettes have submitted their applications, the latest of which is myblu of imperial brands / fontem ventures. All of these companies, except Juul, can pay for the PMTA submission through cigarette sales.
But this is not the case for small, independent atomizing enterprises.
As avail celebrated the successful completion of the first step of approval to the PMTA, ejuice monkeys, an Arkansas E-liquid manufacturer, made its own announcement, which many small e-cigarette companies may repeat in the coming weeks.
The company announced that although we are fully compliant at every step of the process, we will not submit the PMTA (pre sales Tobacco applications) required to maintain compliance. Preparing enough PMTA is not only expensive for 98% of steam product enterprises, but also an extremely complex and time-consuming work. Almost all companies except large companies can not succeed. Large tobacco manufacturers have enough resources to prepare and submit six pmtas for use in a limited number of tobacco products they want to provide, and we have no resources at all to do this and survive. But we are not alone. Most e-cigarette businesses are in the same position. In the past ten years, enterprises and organizations have established an industry from scratch, changed their lives, carried out a good struggle, persisted to the end, and is now ready to turn the page. We think we are a very good company.