Chris Allen, Broughton Nicotine Services’ vice president of scientific and regulatory affairs, told Tobacco Reporter: “Those working towards a PMTA have benefited most as this [the deadline change] has either provided the time to complete existing studies or generate more data. Also, those that are intending to exit the market have a slight reprieve in that they can continue selling their products for an extra 120 days.”
Nobody in the independent sector, priced out of business by the cost of the application process, will be celebrating those 120 days. Products will vanish from shelves, employees will lose jobs, and businesses will shut the door for the final time.
Allen’s statement also fails to reflect the impact COVID has had on business activity during the last few months. ECigIntelligence don’t think the impact of the deadline will be immediate, but it will eventually hit everybody. It predicts fewer companies and many of the well-known brands vanishing, but “we don’t expect the FDA to start enforcement immediately on brands that have not submitted a PMTA application”.
Avail Vapor, a company that received investment from Altria, voiced concern that this will inevitably see a shift from vaping back to smoking, it’s a view shared by investment website The Motley Fool (TMF): “Because the cost of complying with the regulations is staggeringly high, many manufacturers will not be able to make it over the hurdle, and the e-cig market will be left largely to the tobacco giants.”
The FDA is shouting that 650 PMTAs is a reflection of the success of the process, but it isn’t telling the whole truth. An example of this is that Philip Morris International placed four applications just for its IQOS product as separate ones are needed for the product and the flavours.
The Rocky Mountain Smoke-Free Association estimated that each PMTA would end up costing a business in excess of £6.5 million for each product and each juice flavour. As a result, the trade body reckons more than fourteen thousand businesses will go to the wall, resulting in layoffs running to well over 150,000.
“The e-cig market is about to become significantly smaller in just a few days, a change that is not necessarily better for trying to wean smokers away from traditional cigarettes,” concludes TMF.
Not even the giants are finding the going easy. Juul announced that it has cut a third of its staff during 2020 and now announces plans to scale back operations outside of the USA – creating further unemployment.