Two years after first proposing to regulate vapour products as tobacco, the Food and Drug Administration has finally followed through on its threat.

The new rule will take effect on 8 August this year and effectively freeze the category after that date. While all products on the market by that point will have two years to submit a Premarket Tobacco Application (of which more later) in order to remain legal, every product invented after 8/8/16 will need that authorization to be approved prior to marketing.

Getting FDA authorization will be impossible for almost all vape businesses. Companies will have to prove that their products are “appropriate for the protection of public health”, an almost impossible standard to meet and one that is not clearly defined. In order to meet it, FDA states that companies will need to spend millions of dollars per individual product just to get a hearing. Most companies won’t bother trying and will exit the market in two years’ time, or look to sell in other territories where the rules are not as burdensome.

Additionally, the FDA states in the rule that the process for “open system” components will be significantly more difficult given the almost endless range of potential product combinations. They stop short of suggesting that open system products have no chance of being granted an authorization.

Worryingly, reports that surfaced after the rule was published suggest that the FDA wanted to go even further and ban all flavoured products immediately. While the White House deleted this provision, it does not look likely that FDA would grant marketing authorizations to product lines that they wanted to ban. It would seem, therefore, that flavours have a very limited life expectancy under the rule.

Consumers and industry are outraged. “By simply dumping vapour technology products into an already antiquated federal regulatory scheme, the FDA will, in one stroke, kill almost a decade of innovation in the vapour technology industry and, at the same time, kill the many thousands of small and mid-size businesses in communities across this country who have invested in establishing retail stores and developing new technologies that sit outside of the influence of Big Tobacco” said Tony Abboud, National Legislative Director for the Vapour Technology Association”.

“If enforced, the unreasonable and excessive regulations proposed by the FDA will only serve to put these innovators out of business, their employees out of work, and hand deliver a monopoly on vapour products to Big Tobacco,” he added.

Unsurprisingly, the rule was followed by legal action, with Florida-based manufacturer Nicopure Labs filing the first suit in the US District Court for the District of Colombia.

“Nicopure Labs has taken a stand to ensure the voices of all vapers are heard and that vapers are treated fairly and not with a single stroke of a broad brush by the FDA,” said Jeff Stamler, CEO and co-founder of Nicopure Labs.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness”, added Nicopure Labs General Counsel and Chief Compliance Officer, Patricia Kovacevic. “The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”

The public health establishment took a different view. The Centre for Tobacco Free Kids expressed outrage that the White House blocked FDA action on flavours.

"FDA made an overwhelming scientific case to OMB," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in an interview. "For reasons that are not articulated, those people substituted their own judgment."