FDA SE long-shots: The Premier & the Eclipse from RJ Reynolds?

[Gato del Jugo]

Only mentioning them since I haven't yet seen anybody else doing so...


The Premier & the Eclipse from RJ Reynolds were cigarette-like devices which used a heating element to generate an aerosol from a non-combusted substance which originated from a tobacco plant..

Technically & legally speaking, that is arguably the same definition of today's nicotine-containing e-cig...


Potential for substantial equivalence..?


[Note: Wikipedia links aren't working.. Have to click-thru at the landing pages]


Premier:

http://en.wikipedia.org/wiki/Premier_(cigarette)

Premier Lights - Tobacco Products


Eclipse:

http://en.wikipedia.org/wiki/Eclipse_(cigarette)

Eclipse - Tobacco Products

 

[Gato del Jugo]

Another one..


Philip Morris came out with an apparent precursor to Innokin's MVP in a kit form back in 1998..

Accord - Tobacco Products




[Above photo from NOVA | "Safer" Cigarettes: A History ]

 

[tombaker]

Interesting stuff. Both were not on the market on February 15, 2007, which they would need to be.
In the case of the Ruyan, they were definitely marketing on February 15, 2007, whether or not enough to be considered for SE for USA is open question (some say shut, but I think there remains argument for why it would be acceptable for the FDA as predicate.)

What will be helpful with these finds, is any paperwork and studies done to bring them to market, that were publicly filed with the FDA or otherwise available. Perhaps on PubMed. Those documents may be helpful in any new filings, much like Nicotrol demonstrations on Nicotine inhalation.

 

[Gato del Jugo]

Interesting stuff. Both were not on the market on February 15, 2007, which they would need to be.

Only the proposal doesn't state "on" February 15, 2007 -- but "as of" February 15, 2007..

If the FDA meant "on" that date, then why didn't they say "on" that date, instead of "as of"?


Their phrasing can be read as a couple different ways.. 1.) That it was being sold "on" that date, as you suggest; 2.) That it was sold, at one point, prior to that cut-off date, regardless of whether it was still being sold on that date.. and the late '80s through the mid '00s certainly fulfill that requirement..


Of course, in typical -- and arguably, intentional -- FDA fashion, this phrasing is vague, undefined & open to public interpretation...


In terms of the Accord from Philip Morris, which was the most-recent of the products, it was pulled off the shelves in 2006, and if going by the 1st definition, then it would not qualify, as it was not being sold "on" that 2/15/07 date.. (Unless there's an isolated instance out there that escaped through the cracks?)

However, if going by the 2nd definition, & looking at the technical aspects of the product, again, this appears to be a precursor to Innokin's MVP, which as a kit includes a charger & pre-filled cartridges..

Owner's guide..

http://tobaccodocuments.org/pm/2060500060-0077.pdf


If GMOs can fall under the SE rule, then this leap should be no problem, as well..

Then again, we don't have Innokin executives hopping back & forth between the vaping industry & the FDA, helping to shape these regulations, now do we...