When the FDA discloses the PMTA review application process, it means that the US e-cigarette industry will usher in a more standardized and institutionalized regulatory environment.
Although the development of the industry towards standardization is a good thing, it indicates that e-cigarette products can be sold in the market as “accepted” products, but such regulatory policies seem to make the e-cigarette industry an emerging market in which only consortium and a few capital companies can survive.
In addition, more than 90% of the world’s electronic cigarettes are manufactured in China. Except for brands such as JUUL, which have the ability to bear the cost of review, but most brands are not able to bear the review cost of PMTA, so the regulatory policy ultimately affects the Chinese Electronic cigarette manufacturer.
To put it simply, starting in May next year, any e-cigarette products to be sold in the US must be applied for and reviewed by PMTA, and each product must be independently applied.
If you apply for a vape oil flavor of $1 million, the ten-flavored cartridge is $10 million, which does not include review cost of devices.
This mechanism basically cuts off any innovation or development in the e-cigarette industry, and no small manufacturer dares to risk millions of dollars on a product.
When PMTA is the only legal way to sell vape products, vape oil manufactures and other small vape device manufacturers will have only three options: 1. Sell illegally. 2. Sale beyond the US borders. 3. Close the business.
The first option may become one of the difficult problems for the FDA and the federal government after the future law comes into force.