FDA Lorillard comments to the FDA deeming regs

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dragonpuff

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If that is the case, Vapor Hut's comments may actually be the worst yet.

They really didn't expand much on that point, they simply included it in a bullet list of recommended regulations. The entire rest of the document stands on it's own merit.

Plus you have to keep in mind that the definition/endorsement of adulteration/misbranding will depend entirely on whether the deeming is passed as is, whether it's modified, or whether it's rewritten entirely. We're assuming that it will be defined as a product not being approved under SE/PMTA, but we have yet to be certain whether that will be the requirement a product has to meet (we don't even know yet what their PMTA requirements will specifically be for vapor products). I still see a lot in the deeming that could potentially be overturned in a court of law (I have posed that question in other threads and never got an answer), so no matter how much the FDA and special interests want this to be the final rule, it may not be. Thus, the requirements as stated in the deeming are likely to change.
 

pamdis

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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.

Especially since later in the document they talk about how unnecessary and inappropriate any pre-approval process is for vapor products.

I think the same thing when I see a vapor company ask for GMP standards. Have they looked up any on FDA's website for other product categories? Or are they just assuming, based on common sense definition, "well, of course we think the place should be clean"

Vapor Hut is not the only ones who have done this - making a short list of things they think would be OK for FDA to do - but it seems they all just list these phrases without understanding them. Because, they just 'sound' reasonable.

This still does not take away from the other outstanding sentiments in their (Vapor Hut's) submission. IMO.
 
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Kent C

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Vapor Hut is not the only ones who have done this - making a short list of things they think would be OK for FDA to do - but it seems they all just list these phrases without understanding them. Because, they just 'sound' reasonable.

Wait..... So, here, 'How something is said, or framed, isn't just as important as what is said.'
 

pamdis

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Wait..... So, here, 'How something is said, or framed, isn't just as important as what is said.'

They are both equally important. But I try to keep in mind that most of the comments submitted were probably done with no legal input. I think some did more harm than good with their comments, because they didn't understand 'what' they were saying.

Or maybe they understood perfectly well what they were saying, and I just can't believe they would say it.

Of course, like I stated above, I think Lorillard understood perfectly.
 

Jman8

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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.

So much untruth. "Lorillard repeatedly endorsed FDA's proposed regulations" with one cited example to back up the alleged repetition.

On p. 2 of Lorillard's document, they write:

Aspects of the existing regulatory system for conventional tobacco products are not well-suited for electronic cigarettes. FDA should reconsider the current regulatory system and the manner in which the Agency should apply certain elements of that system to electronic cigarettes specifically. Moreover, before certain aspects of the FDCA can be implemented, there needs to be further development of key scientific and regulatory tools.

So, here they are saying existing regulatory system is NOT well suited for eCigs. FDA should reconsider.... needs to be further development.

Why did you subjectively quote only part of what the Lorillard document said about adulteration. It says:

Application of the adulteration and misbranding provisions: Lorillard fully supports FDA’s enforcement of the adulteration and misbranding provisions of the FDCA against electronic cigarettes.For example, Lorillard fully supports enforcement of the FDCA against unlawful labeling and promotion claims regarding cessation and health claims, including against claims that include modified-use descriptors without appropriate regulatory clearance.

You left off the example they provided and instead chose to go with own bias on what this means. You don't cite the FSPTCA where it brings this point up and again just choose to have your understanding be seen as only possibly correct way to understand what Lorillard is 'really up to.'

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.

Again, there are millions of products currently on the market, not 100K. You see this as legit criticism when the alternative that you seem to imply as zero chance of occurring (that the FDA will not regulate at all). Lorillard, like anyone sane looking at the deeming regulations, is saying if you are going to regulate, at least allow all existing products a fair chance to be allowed on the market. Thus countering your ongoing schtick of 99+% will be banned (unless they do what makes sense to do in a regulatory system).

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.

Correct, FDA would clearly prefer this. Lorillard, seeing the great potential for this industry given the current market, is advocating against FDA stated preference by suggesting the grandfather date be moved.

Lorillard's comments presented an accurate analysis of the scientific evidence on e-cigs.

Which appears central to what they are going for.

Lorillard is in favor of reasonable, science-based regulation of electronic cigarettes and supports marketing restrictions that mirror the continuum of risk among nicotine-containing products. In the absence of current regulations, blu has voluntarily implemented and follows responsible practices, including the prohibition of sales and marketing of electronic cigarettes to youth.

p. 82
 

Jman8

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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.

I think anyone advocating for this knows what FSPTCA says about it and is where they are coming from in their advocacy. IMO, putting things concisely, it is an attempt to make sure everyone is playing on the same field. If regulation is going to exist, then players in that system ought to be playing by same rules. I think it sucks that those with most resources automatically get to benefit more, but where is that not true in life?
 

ClippinWings

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I am now quite sure that many people are reading Lorilard in the header and then proceeding to read the document with Blu colored glasses on.

Lorilard's documented stance on FDA's proposed regulations is no worse than Vapor Hut and dramatically better than Innokin.

Based SOLELY on the content of this document, I have to say without a doubt Lorilard is on the side of vaping, vapers and the larger vapor products industry.

Now, taking into account everything else... It's a shocking document... I almost question it's authenticity.
 
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zoiDman

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I'm particularly proud of that.

You Should be. It was a Classic!

ozzy-sunglasses-2.jpg


Blu Colored Glasses is a Registered Trademark of ClippinWings Inc. 2014
 
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