What are the new FDA regulations imposed on e-cigarettes?

My answer to What are the new FDA regulations imposed on e-cigarettes?

Answer by Miles Dolphin:

Q: What are the new FDA regulations imposed on e-cigarettes?


That is a very difficult question to answer in a simple way. I will start by posting a link to the FDA's own website : Vaporizers, E-Cigs, and other Electronic Nicotine Delivery Systems (ENDS) , and their impression of what they have done – FDA Tobacco on Twitter. Now I will add my own comments on this, and finish with some links to other peoples commentary.

  • All vaping products must go through the pre-market authorisation process (unless grandfathered in – products from before 2007). The estimated cost of this varies enormously depending on who you are reading, from a low of $300,000 and 1000 man-hours of work, to a high of $1,200,000 and 1700 man-hours, per product! This includes batteries, mods, atomisers, coils, cores as well as every different liquid (For a company producing or importing 30 different flavours in 3 different strengths it may cost more than $27 Million). This costing is out of the range for many businesses, as their annual turnover is considerably less than they are asked to pay. The Tobacco and Vaping analyst at Wells Fargo has estimated that this will take 99% of the models and flavours off the market.
    The only companies producing vapes and liquids in two years time, assuming this POS regulation is final, will be Big Tobacco, as they are almost the only people who can afford to go through the regulation procedure.
    The other problem with the pre-market authorisations is that the permissions can be arbitrarily withheld, with no reasons given, and your money is gone.
    See also – The Compliance Fallacy  and "The Cigarette Smoking Promotion Regulations of 2016."
  • The second problem with these regulations is that they don't protect the health of the US citizens at all. The regulations contain no restrictions, controls, or recommendations as to quality or contents, the only item of any importance is the complete ban on minors buying the products, which almost all vape shops (on-line or otherwise) have done for a while anyway.
  • I expect a full-fledged black market to emerge over the next few years, unless this mess of regulation is withdrawn or at least heavily modified. (see The MEH-Cigs are coming! ).

Commentary on FDA Deeming Regulations:

FDA went way too far on e-cigarettes: Opposing view

FDA deeming regulation on e-cigarettes: an effective ban on most (and on most effective) products

Bluffer’s guide to FDA regulation of tobacco and nicotine products – A month before final publication, but accurate enough.

FDA Imposes a Slow-Motion Ban on E-Cigarettes

A Billion Lives on Twitter

Predicting the black market in e-cigarettes

What are the new FDA regulations imposed on e-cigarettes?

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About mdolphins

Hotelier, Vaper, husband.

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