Document ID: FDA-2014-N-0189-42348
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-11T04:00Z

Comment Info: =================

General Comment:Dear recipient,

I am requesting a extension on the comment period to the proposed, seeing as the proposal becomes law 2 years after its initial publication a 1 year period would be justified for open commentary following each change to the proposal.

I would also like to comment that the proposal is very reminiscent of the former chicken tax fiasco. Regulation of electronic cigarette devices for all intents and purposes should not fall to the FDA as alone they are merely battery and heating elements. A battery powered hairdryer would thus be deemed a tobacco product as some have kanthal based heating elements and thus can be used to vaporize.

Stick to defining tobacco products as products that actually come from tobacco, and there will be little to no backlash from the proposal. A reduction of fees for the application process should also be admissible, as well as use of previous studies for the definition of the general health safety of e-liquids.

Seeing as these products are essentially inhalations I think that timestamped MBI-144 & endotoxin test would be sufficient for determining the relative beyond use and relative purity of e-liquids. This would actually lower the cost and prohibitive nature of providing e-liquids from entering the market.

Thinking more to the nature of USP<797> an ISO class 8 environment with a dedicated work area and proper washing and gowning procedures should be sufficient for the production of e-liquids for inhalation. This combined with the constant improvement manifest in the aforementioned guidelines would be sufficient to relatively guarantee a safe product. (there will always be outliers, i.e. meningitis in compounded IV admixtures)

Thank you for your time,
Alex Dybowski

Feel free to reply to alexdybowski@gmail.com