# ELI5: What is really going on with the new FDA regulations?



## Alex (27/3/15)

_Will eliquid be illegal in 60 days? Will I be able to purchase coils? Will only shitty cig-a-likes be available?_


_Honestly, I'm confused to what all of this means._

purecigsdotcom 30 points 15 hours ago* 

EDITED FOR ADDED CLARITY:

Yes, and on the surface that looks "not bad" but here is why you keep hearing that it will destroy 99.9% of the industry:


Hardware is indeed included in the mix.


There is no predicate product, an SE application is not possible


The PTA application is close to $2,000,000 per sku. Any variation what-so-ever requires a new application (a change from 50/50 pg/vg to 60/40 is a new app, 12mg to 6mg is a new app, upgrading from 30w to 50w is a new application...)


The cost of the PTA application is not because its "fill out this form and pay $300,000". This is not the type of application you are familiar with in day to day life... The application is "pay for thousands of hours of laboratory research, clerical, administrative work, THEN submit your encyclopedia collection of work along with a fee. Then when we finally respond telling you what else we need, pay even more for all that. And in the end, we may reject you anyhow because we felt like it."


No 'e-vapor' company that any of us are familiar with can afford that. Period. Only big tobacco has pockets big enough for that, and maybe NJoy or Logic. Even then the FDA states in their own draft document that they expect THEM to have to slim down their product line.


Without diving further into bullet points, look no further than the table on page 53 of the actual draft linked below. They expect 25 applications, and expect 5000 manhours spent on the application, 200 hours making updates, 4800 hours of laboratory work.

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM394914.pdf

The simple explanation is that by that requirement alone they will be de-facto banning the entire industry except for big tobacco. Everyone will have up to two years from the date of the final rule to get their applications in before having to exit the market. Those that got the application in will be allowed to stay until the application is processed, which by current FDA standards can take years.

What options will we have left if the final rule looks much like the draft, which is highly possible?


Litigation: congress at the time that they passed the FSPTA was trying to "freeze" the market to prevent new tobacco products growing the industry. They could not in their wildest dreams have anticipated something like the electronic cigarette, many of them speaking out against us still clearly don't even understand what it actually is.


Legislation: getting congress to write new laws updating the law to carve out seperate regulation for electronic cigarettes that is reasonable and sensible, rather then trying to fit a square peg in a round hole.


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