I think you missed most of what they stated. I'm not going to go into specifics on that. But I will say I am a carpenter, not a lawyer, and I found it very easy to understand.
FDA Lorillard comments to the FDA deeming regs
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I think you missed most of what they stated. I'm not going to go into specifics on that. But I will say I am a carpenter, not a lawyer, and I found it very easy to understand.
And any 'FDA approved' tag will wrongly assure vapers, where they themselves should know what's going on. Much of the ecoli and botulism comes from FDA or USDA approved foods. They should be able to be sued for that as well. Kinda like the 'You had one job' meme.
During my conversation with Senator Isakson's LA for the HELP committee, he made the same point. The Senator believes the FDA is NOT meeting their foundational responsibilities currently. Adding more work/regulations is dangerous to the "public's health".
Food and pharmaceuticals. If they can meet the guidelines for food and pharmaceuticals, then I am sure they will meet those for e-liquid. There isn't much difference between the guidelines for food and pharmaceuticals, so there won't be for e-liquid.
i read and understood it. my point is not against the parts by themselves which are very good for us.
its the sum of the whole. the impression i get over all and its just an impression.
for clarity my impression is on the one hand they are asking for every thing we would want.
on the other hand considering the form and style in which it was written i get the impression
they are also saying "whatever happens we have our ducks in a row"
remember their products meet the 2007 cut off date.
when compared to Innokins response the difference in presentation and style is quite evident.
their both good comments. i liked Innokins comments better as they seemed a lot more direct and straightforward.
when taken in their entirety didn't leave much to read between the lines.
neither of these approaches are bad. i am just speculating here anyway.
regards
mike
That's entirely plausible and consistent with protecting the bottom line.
Absolutely.
Any Company has to consider the Financial Ramifications of Defending themselves against a Lawsuit or Multiple Lawsuits. And there are Times when the Risk / Reward ratio Isn't Large Enough to warrant engaging in a Sales Practice.
If e-Liquids were Fully FDA Regulated and if e-Liquid Packaging contained Warning Labels, I believe that Dow would/will take a Different View of Supplying PG and VG to FDA Compliant e-Liquid Manufactures.
The company and their products didn't exist until several years later.
BTW - How does Lorillard's Comment play out with regards to e-Cigarettes?
Seeing that Lorillard currently owns Blu, but if they are Acquired by Reynolds (which Most People believe will happen) Blu will be Spun Off to Imperial Tobacco. And this will Most Likely happen Before the FDA Rules have been Finalized.
Seems like Lorillard will be a Company who Does Not have a Stake in a Regulated e-Cigarette Market. But RJ Reynolds will. And of course, Imperial Tobacco will since they are going to get Blu.
So when Lorillard makes a Comment regarding e-Cigarettes, are they Speaking for their Soon-to-be Parent Company Reynolds? Or for Blu's Soon-to-be Parent Company Imperial?
Or a Little of Both?
Seeing that Lorillard currently owns Blu, but if they are Acquired by Reynolds (which Most People believe will happen) Blu will be Spun Off to Imperial Tobacco. And this will Most Likely happen Before the FDA Rules have been Finalized.
Seems like Lorillard will be a Company who Does Not have a Stake in a Regulated e-Cigarette Market. But RJ Reynolds will. And of course, Imperial Tobacco will since they are going to get Blu.
So when Lorillard makes a Comment regarding e-Cigarettes, are they Speaking for their Soon-to-be Parent Company Reynolds? Or for Blu's Soon-to-be Parent Company Imperial?
Or a Little of Both?
Apart from some concerns about certain e-liquid ingredients such as flavorings, I can see two primary safety concerns with e-cigarettes: battery overheating and liquid overheating. A simple timer should take care of the former. As for the latter, Innokin's Cool Fire 1, for example, automatically adjusts voltage to account for resistance in order to yield a steady 8.5 watts. Theoretically, you can use it with any tank or coil and still get 8.5 W. Any VV mod could have a similar built in limitation and I believe some do. However, I don't have the technical knowledge to say whether that would necessarily prevent overheating the liquid.
- Apr 2, 2009
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Please note that Lorillard's comments repeatedly (but stealthily) endorsed provisions in FDA's proposed deeming regulation (and in the TCA) that would ban all e-cig products unless the FDA approves either an SE report or New Tobacco Product application.
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Please note that all regulated tobacco products that are not approved by the FDA are legally defined as "adulterated"
Also note that any e-cig product whose marketing thruthfully claims it is less hazardous alternative to cigarettes would be defined as "misbranded".
According to the proposed Deeming Reg and the FSPTCA, all "adultered" or "misbranded" e-cigs would be banned.
Lorillard did, however, urge the FDA to move the February 15, 2007 grandfather date (for e-cigs) up to the date FDA issues the Final Rule for the Deeming Regulation. While doing so would allow manufacturers of the 100,000 e-cig products currently on the market (and those introduced to the market prior to the Final Rule) to keep their products on the market by submitting Substantial Equivalence Reports, it would basically halt the development of new e-cig products after the Final Rule is issued.
While it would be very helpful to the e-cig industry if FDA changes the 2007 grandfather date to 2016, 2015, 2014 or even 2013, I'd be shocked if the FDA does so simply because they'd be deluged with several thousand SE reports by different e-cig comanies (and tens of thousand of SE Reports filed by all newly deemed tobacco products including e-cigs, cigars, pipe, hookah, etc).
Since FDA still has a backlog of about 4,000 SE Reports that were filed in 2011 by cigarette, RYO and smokeless tobacco companies, I doubt the FDA would decide to repeat that fiasco by trying to deal with an even greater number of SE Reports for newly deemed products. Realistically, FDA strongly prefers regulating a dozen e-cig products manufactured by a half dozen large tobacco companies (and perhpas NJOY) than responding to and processing several thousand SE applications filed by several hundred vape shop owners and other small e-cig manufacturers and/or importers.
Lorillard's comments presented an accurate analysis of the scientific evidence on e-cigs.
Page 28
Please note that all regulated tobacco products that are not approved by the FDA are legally defined as "adulterated"
Also note that any e-cig product whose marketing thruthfully claims it is less hazardous alternative to cigarettes would be defined as "misbranded".
According to the proposed Deeming Reg and the FSPTCA, all "adultered" or "misbranded" e-cigs would be banned.
Lorillard did, however, urge the FDA to move the February 15, 2007 grandfather date (for e-cigs) up to the date FDA issues the Final Rule for the Deeming Regulation. While doing so would allow manufacturers of the 100,000 e-cig products currently on the market (and those introduced to the market prior to the Final Rule) to keep their products on the market by submitting Substantial Equivalence Reports, it would basically halt the development of new e-cig products after the Final Rule is issued.
While it would be very helpful to the e-cig industry if FDA changes the 2007 grandfather date to 2016, 2015, 2014 or even 2013, I'd be shocked if the FDA does so simply because they'd be deluged with several thousand SE reports by different e-cig comanies (and tens of thousand of SE Reports filed by all newly deemed tobacco products including e-cigs, cigars, pipe, hookah, etc).
Since FDA still has a backlog of about 4,000 SE Reports that were filed in 2011 by cigarette, RYO and smokeless tobacco companies, I doubt the FDA would decide to repeat that fiasco by trying to deal with an even greater number of SE Reports for newly deemed products. Realistically, FDA strongly prefers regulating a dozen e-cig products manufactured by a half dozen large tobacco companies (and perhpas NJOY) than responding to and processing several thousand SE applications filed by several hundred vape shop owners and other small e-cig manufacturers and/or importers.
Lorillard's comments presented an accurate analysis of the scientific evidence on e-cigs.
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Just an FYI:
Vapor Hut also fully supports the adulteration and misbranding provisions.
http://designatedvapingarea.com/fda-vh-comments.pdf
I think it's important to note that both seem to support that provision AFTER registration standards for vapor products have been established.
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Correct me if I'm wrong, but isn't this just advocating for measures against counterfeitting?
yes, and "truth in labeling"
what Bill appears to be suggesting is that Lorilard, Vapor Hut, and likely other companies, would like this provision enforced as a way to ban most products because anything not FDA approved/registered would be considered "adulterated".
I think many assume the common sense definition of misbranded or adulterated.
But the definitions of each term are precisely laid out in excruciating detail in the FSPTCA.
I think Lorillard knows precisely what they are advocating for on this one. I suspect many small vapor shops do not.
But the definitions of each term are precisely laid out in excruciating detail in the FSPTCA.
I think Lorillard knows precisely what they are advocating for on this one. I suspect many small vapor shops do not.
If that is the case, Vapor Hut's comments may actually be the worst yet.
Thank you for the clarification. So that means in the future they can claim that they're fighting counterfeitting when in reality they are fighting anyone who didn't get their SE/PMTA approved. How nice.
I think you're absolutely right on this one. I don't think the Vapor Hut would've asked for that if they knew what the legal definition had turned out to be.
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