FDA issues final PMTA guidance
The US Food and Drug Administration (FDA) has issued its final guidance for vape companies seeking authorisation to market their products in the US.
The Premarket Tobacco Product Application (PMTA) will require manufacturers to prove that their products are ‘appropriate for the protection of public health’.
Products manufactured before 2016 will not require a PMTA.
Acting FDA Commissioner Dr Ned Sharpless said in a statement:
“There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications.
“At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”
Before issuing a PMTA, the FDA will assess the impact of a product on people’s behaviour, most crucially whether non-smokers are likely to use it.
The agency will assess a product’s individual components, ingredients, packaging and labelling as well as its potential health risk.
Many in the industry have criticised the process for being too expensive for non- Big Tobacco companies to compete and survive.
Former FDA commissioner Scott Gottlieb said that the vaping industry had ‘missed [an] important opportunity’ to confront the supposed spike in youth e-cigarette-use.
I think it’s fair statement that the vaping and e-cig industry doesn’t have a single association, company, or other entity that’s engaged consistently and constructively with the regulatory process. The entire apparatus seems focused on fighting FDA. That hurts progress long term https://t.co/QfvuR27WvB
— Scott Gottlieb, MD (@ScottGottliebMD) June 11, 2019
If open system retailers had took to the streets with BAN JUUL signs, would that have changed a single thing in this final guidance? Nope. You wanted the industry to get behind you while simultaneously doing nothing to give independent companies a hope of survival.
— Gregory Conley (@GregTHR) June 11, 2019
The finalised guidance is just the latest controversy in an ongoing conflict between the FDA and the vaping industry.
In April, the department alerted the public of a potential link between e-cigarettes and seizures before an investigation had been completed.
We address the FDA’s motives for issuing the warning in the latest issue of Vapouround Magazine. Click here to read the story