O’er the land of the free and the home of the brave, e-cigarettes face near annihilation.
In tandem with the implementation of the Tobacco Products Directive throughout Europe, the USA’s FDA has produced its own regulations for e-cigarettes. These regulations will, if left unchanged, close down 99% of the industry.
It is somewhat ironic then that words in the title of this article are repeated four times in the American national anthem.
The FDA have decided that any e-cigarette currently on the market that is equivalent to e-cigarettes sold back in February 2007, i.e. very basic quality and design and essentially prototypes, will remain on sale and will not be subject to regulations. Anything that has come onto the market after 2007 will now have to go through what is called a Pre Market Tobacco Authorisation process, or PMTA. A PMTA is an FDA ‘permission slip’ to sell tobacco products to the American public.
To obtain a PMTA, it is estimated to cost anywhere between $300,000 to $1,000,000 per product, and takes (according to FDA estimations) anywhere between 500 to 1,700 hours of paperwork. 500 hours works out at roughly 62 working days.
A PMTA will be required for each vape product and each e-liquid strength and flavour, and there is an element of near insanity in the FDA’s regulations where batteries, if used in e-cigarettes, will be classed as tobacco products. One assumes, as such, that they too may require a PMTA?
Yet surprisingly it is not all doom and gloom.
The FDA has granted a two-year period of grace before products without PMTA’s are removed from the market, and this has given a glimmer of hope to many. This will allow time for lobbying and at time of writing, two law suits have been filed against the FDA’s e-cigarettes regulations.
Perhaps the land of the ‘not so free to vape’ will win the right to vape as they please, using the products they desire, but it is going to be an interesting time for vaping in the USA over the next two years as this story unfolds.