THE MAKING OF A POST-PMTA PRODUCT

Jul 18, 2020

THE MAKING OF A POST-PMTA PRODUCT

For the public who do not know what a PMTA is here is an explanation:
A Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:
· Risks and benefits to the population, including people who would use the proposed new tobacco product as well as nonusers.
· Whether people who currently use any tobacco product would be likely to stop using such products if the proposed new tobacco product were available.
· Whether people who currently do not use any tobacco products would be likely to begin using tobacco products if the new product were available; and
· The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
On the market now are items like a Puff Bar that has been commerce via Chinese websites like Alibaba. The devices were usually sold with a liquid included and this is a one stop item for on the go users. The issue is finding out if these products are in fact useful to help you quit smoking or not. But what the FDA is doing is finding out just how effective these products are and making you the manufacturer pay to do so. So, anyone can make Puff Bars and sell them but getting rich doing it is a matter of successful distribution. It may be that the people who claim ownership of Puff Bar have been the most skilled at getting the product into stores and onto major vendor websites, and thereby have some claim to being kings of the Puff Bar empire. Or the concept really is theirs, and they have been copied and cloned by everyone else selling Puff Bars. Puff Bars—like all vaping products that were not on the market before Aug. 8, 2016—are illegal to sell, whether you are the bonafide owner of the brand or not. No product introduced after that date can be legally brought to market without first having an approved Premarket Tobacco Application (PMTA) from the FDA. Since no PMTAs for vape products have been approved yet, Puff Bar is de facto illegal.
Getting the PMTAs is Omari-o's main aim is to ensure we are safe to use under the public eye of the USA FDA. The Slyeek PMTA should be going into effect as soon the application is accepted.

For as long as Puff Bar has been around, Chinese commerce sites like Alibaba have featured Puff Bars being sold wholesale from multiple manufacturers. Essentially, anyone with a few thousand dollars and some time could turn a shipment of these products into a business. The devices were (and are) usually sold without liquid included. All an enterprising importer has to do is fill them up and push them out the door.
So anyone can make Puff Bars and sell them, but getting rich doing it is a matter of successful distribution. It may be that the people who claim ownership of Puff Bar have been the most skilled at getting the product into stores and onto major vendor websites, and thereby have some claim to being kings of the Puff Bar empire. Or maybe the concept really is theirs, and they’ve been copied and cloned by everyone else selling Puff Bars.
However, it seems likely that a large number of the devices being sold are coming from multiple importers. A quick Alibaba search shows dozens of Chinese factories producing and wholesaling the familiar rectangular devices (and several non-rectangular variations). There would be no need for multiple manufacturers to provide one supply chain—and certainly no need to advertise it. No, there’s clearly a large and diverse Puff Bar economy out there.
Puff Bars—like all vaping products that were not on the market before Aug. 8, 2016—are illegal to sell, whether you’re the bonafide owner of the brand or not. No product introduced after that date can be legally brought to market without first having an approved Premarket Tobacco Application (PMTA) from the FDA. Since no PMTAs for vape products have been approved yet, Puff Bar is de facto illegal.