Last week, the FDA announced a major change in its e-cigarette policy, including reducing nicotine in cigarettes and extending PMTA submission deadlines. So what do the experts who have been following this closely actually think?
On Friday, July 28, the FDA released a new plan for tobacco and nicotine regulation, which includes extending the PMTA filing deadline to 2022.
However, this first step is not perfect. The extension only applies to existing products; new products will still have to submit a PMTA before they can be sold. In addition, there have been no changes to the law since February 2007, one of the most burdensome aspects of the entire regulatory framework.
The extended time period allows more time for development
“This is really good news for the US market—the only question is how much,” said Barnaby Page, editorial director of ECig Intelligence. Page added that many were hopeful that the FDA would simplify the PTMA process and that the vaping industry would “avoid the most damaging effects of the regulation.” However, he said that while the process would not be streamlined, at least now the industry would have more time to get used to it and figure out how to influence the regulation.
“We believe the FDA’s approach to e-cigarettes has softened, and the PMTA submission process should be a little easier, but approval is still not a given – companies still have to work hard to convince the FDA that their new product is acceptable from a public health perspective,” said Page.
He also pointed out that the FDA's decision does not have much impact on the European market, however, he said, “Even with the FDA's new attitude, it is still much easier to comply with the TPD than with the FDA's regulatory laws.”
How will this plan affect e-cigarette development?
As for product development, Page points out that since new products don’t receive any PMTA benefits, it’s up to the FDA to come up with specific guidelines. Not Blowing Smoke founder and president Stefan Didak agrees with Page.
Didak also said the FDA announcement came as a surprise, although the PMTA delay was not. “The four-year extension to the PMTA is actually good news, although the downside is that states will have more work to do to regulate tobacco and the number of health care organizations will increase,” he said.
A positive step forward
Both Stefan Didak and Barnaby Page agree that, overall, this is a positive first step in the right direction for vapers and the US vaping market. Four years gives vapers more time to change and refine the current regulations “into something that is easier to understand and implement.”
Source: Vapingpost
Translated by: The Vape Club