Three big talking points to kick off your week
US federal judge orders FDA to implement 10-month deadline for e-cig applications
A US Federal Judge has ordered the FDA to impose a 10-month deadline for submission of PMTAs on all e-cigarette products sold on the US market.
The judge stipulated that the FDA should finalise approvals for submitted products within one year.
At the time of writing, just one electronic device, PMI’s IQOS, has received a PMTA and official guidance was only given by the FDA in recent weeks.
The FDA now has 60 days to submit an appeal to the court if it wishes to propose any changes to this timeline.
With the very high costs involved with PMTA submission and the still-unclear processes involved, the news has many in the industry worried.
Acting FDA Commissioner, Ned Sharpless, said:
“Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth.”
Vaporized: America’s E-cigarette Addiction
CNBC’s documentary about the rise in e-cigarette use, titles “Vaporized: America’s E-cigarette Addiction” is set to premiere tonight.
The documentary has already received press coverage due to its interview with JUUL CEO Kevin Burns, who reportedly said:
“First of all, I’d tell them that I’m sorry that their child’s using the product. It’s not intended for them. I hope there was nothing that we did that made it appealing to them.
“As a parent of a 16-year-old, I’m sorry for them, and I have empathy for them, in terms of what the challenges they’re going through.”
The documentary will feature interviews with other prominent figures in the debate, including former FDA Commissioner Scott Gottlieb, who is now an executive at pharmaceutical giant Pfizer.
The film stirred up further controversy online when it was revealed that CNBC representatives had reached out to vaping influencers, encouraging them to promote the documentary to their audiences.
PC MLA asks government to increase vaping age or ban products
PC MLA Cory Deagle raised concerns about the rise of teenage vaping in Canada on Friday.
“Being around the rink and the soccer fields all the time, I’ve seen youth first-hand that have started vaping, and it really has become an epidemic, I believe”.
This coincides with the Canadian Cancer Society’s recent lobbying of the P.E.I. government to raise the legal purchasing age for tobacco and vaping products from 19 to 21.
P.E.I health minister James Aylward voiced concerns about the growing trend of teen vaping but said his department is not currently considering changing any legislation regarding vapour products.
We’ll be bringing you all the latest news from Canada in the next issue of Vapouround Magazine.