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FDA takes aim at vapers

FDA takes aim at vapers

Two years after first proposing to regulate vapor 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 flavored 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 flavors have a very limited life expectancy under the rule.

Consumers and industry are outraged. “By simply dumping vapor technology products into an already antiquated federal regulatory scheme, the FDA will, in one stroke, kill almost a decade of innovation in the vapor 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 Vapor 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 vapor 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 flavors.

"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."

  • Kurt Heinlein

    The surgeon general & all the bureaucrats have it azz-backwards. I smoked for over 40 years, at times over 2 packs a day, I tried everything to stop, in just one day vaping gave me the help & strength to stop cigarettes & I never looked back. With the exception of nicotine, vaping has nothing in with common cigarettes, I can go hours without vaping & not freak out looking for a chance to vape, in fact the only reason I still vape is because I enjoy it so much & it does help deflect eating as a fill in habit. I also personally know 6 other people whose ages range from early 20's to mid 30's have quit cigarettes completely, within weeks of taking up vaping.
    So here is the bottom line the government knows vaping helps people break the tobacco habit, & that is why they want to destroy vaping, just follow the tax money the govt. is no longer receiving when people quit smoking, also the huge amount of money tobacco lobbyists are using to pressure the politicians to destroy vaping & don't forget the big pharmaceutical companies who have a lot of money invested it quit smoking drugs like, Chantix, gum & patches, etc
    So just follow the big money folks, it's nothing more complicated than that, most of you are to young to remember when cigarettes could be bought really cheap, that was before the federal & state govts. figured out that the smoking habit was a huge taxable money making gold mine. I think the vaping industry needs it's own lobbyists, like right now!

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