FDA Extremely well done (and not yet available) FDA comment

[StefanDidak]

There was some talk going on about FDA regulations today and someone was kind enough to show the FDA comment that was written and submitted. Very impressive, especially given that it's been written by a non-smoker/non-vaper who is really passionate and an advocate for vaping (and who gave me permission to upload it to one of my dormant domains because it's not yet published). I figured folks here might want to see it also. I'm just sad that comments like these are rare. If even 10% of the comments could've been like this, wouldn't that have been something. Anyway, here's the link: http://designatedvapingarea.com/fda-vh-comments.pdf

 

[Kent C]

I did make it through the syrupy first paragraph but after: "The Vapor Hut... has long recognized the need for reasonable regulations." and "Because there is no regulatory oversight of vapor products consumers are not afforded those basic protections that are applied to all other consumable substances.", then the heading "II. The Need for Regulation of Vapor Products", I bailed....

 

[dragonpuff]

At the bottom of page 7:

I would like to urge FDA to reject portions of the proposed rule that are not appropriate for the protection of public health, and add new sections that would protect public health.

Yes, it is worth it to read further it does get better.

 

[Kent C]

Rogerian argument - Wikipedia, the free encyclopedia

I understand the tactic, but 'brown nosing' is still 'brown nosing' or better - propitiation is still propitiation. In the deeming document, whoever wrote it - likely much came from Zeller, when he states that the cost of application will likely cause many small vendors to exit the market, he's not really following the Rogerian model

The comment about how 'they' Zeller and FDA staff could be making more money elsewhere - iow, "their 'altruistic stand' is appreciated", etc. etc. While it is likely that they could make more money as lobbyists around the beltway, (which Zeller basically was before getting this appointment), I've found that while many politicians when under attack will make this claim as 'how they could be making more money in the private sector' is unfounded and an extreme overestimation of their own ability.

Most have never owned or run or even worked for, a private sector business. (There are exceptions to this in one particular party.) And if they ever attempted to run a real business like they run their agency or their council or mayor's job, school superintendent, etc., where they run deficits for as far as the eye can see and do nothing to reign in spending, where when you need money you can't just raise taxes - you have to produce something.... and sell it! .... they wouldn't last one week in the private sector, let alone make 'much more money' as they like to claim.

 

[Kent C]

At the bottom of page 7:

I would like to urge FDA to reject portions of the proposed rule that are not appropriate for the protection of public health, and add new sections that would protect public health.

Yes, it is worth it to read further it does get better.

Add new sections of regulation?!? Oh boy!!

 

[dragonpuff]

Add new sections of regulation?!? Oh boy!!

Ha ha The regulations they propose are simple manufacturing standards to ensure safety, nothing more, nothing less. They are actually quite mild in comparison to standards I've seen proposed in other comments.

I like this part:

Not only is this regulatory structure contrient to the Surgeon General’s findings
and an obvious breach of common sense, it does not fit with the intentions of Congress
when granting CTP authority. As discussed earlier, one stated purpose of the FSPTA is
“(4) to provide new and flexible enforcement authority to ensure that there is effective
oversight of the tobacco industry's efforts to develop, introduce, and promote less
harmful tobacco products.” (Ref. 4) While we acknowledge that FDA only has the
authority to create regulations within the framework provided by Congress, we believe
that the proposed rule represents a clear deviation from the spirit of the law.

I appreciate the repeated invoking of Congress's original intention when passing FSPTA. It's refreshing

 

[pamdis]

One of the best comments I've read so far. And I have read a lot of them.

I worked on my comment for weeks trying to make many of the same points, but in the end, I discarded mine entirely because it was so vitriolic I felt it would cause more harm than good. No matter how much I edited it, I could not seem to remove my anger from it, and the entire tone was {MODERATED}

I ended up submitting a one page comment highlighting one point and including my personal story, and a couple micro comments that were highly sarcastic (insulting).

I think she ended up with the perfect tone.

 

[aikanae1]

100% of the deeming regulations reguarding ecigs is economical, thinly vieled for safety, so it's not like they are unfamiliar with "brown nose" arguments - and may expect them. No one with a public profile is going to make changes unless they can explain why they did it to others. Comments like this helps to provide the phrasing necessary to explain why they did, voted, etc. How something is said, framed is just as important as what is said.

 

[ClippinWings]

best i've read so far...

Though some (SmokeyJoe, Kent C, and others) are going to criticize it for pushing for GMP.

I think GMP is a MUST, so long as it's reasonable and specifically tailored to Vapor products, Just as Vapor Hut states it must be.

 

[Kent C]

You, all, make some very good points. I should read the whole thing, as I am certain that there are some truly valid views, communicated in such a way, that the FDA will seriously consider when making their final rule.

 

[dragonpuff]

best i've read so far...

Though some (SmokeyJoe, Kent C, and others) are going to criticize it for pushing for GMP.

I think GMP is a MUST, so long as it's reasonable and specifically tailored to Vapor products, Just as Vapor Hut states it must be.

Well that's exactly it - very few here would argue against basic safety standards. Unfortunately they need to be reasonable, i.e. actually promote safety, and not be prohibitive. Unfortunately I think this is fast approaching the territory of "when pigs fly" at this point.

 

[Kent C]

best i've read so far...

Though some (SmokeyJoe, Kent C, and others) are going to criticize it for pushing for GMP.

I think GMP is a MUST, so long as it's reasonable and specifically tailored to Vapor products, Just as Vapor Hut states it must be.

And as you note, include Bill G. :

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.

Page 28

• 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.35

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 truthfully 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.

As does Vapor Hut as you point out in that thread.

 

[ClippinWings]

And as you note, include Bill G. :

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.



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 truthfully 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.

As does Vapor Hut as you point out in that thread.

Bill's complaint is not GMP.

His is the Adulteration and Misbranding provisions.

 

[Kent C]

Bill's complaint is not GMP.

His is the Adulteration and Misbranding provisions.

His conclusions as to the affect are similar - but agreed, not the same. And you are right, I think our own self-regulation here have served us well and as a result, the industry as a whole and that without the 'help' of the FDA or any other gov't agency that doesn't have the information and immediacy that we do here, that would continue to be the case, without this 'intervention' into the private decisions of individuals. We have established our own GMP and it has worked rather well, imo. We put the pressure on vendors with non-violent suggestions of 'boycott' and with suggestions as to how they can maintain our business, rather than the coercion that is explicitly and implicitly part of gov't intervention - and, I might add, the people who would support it.

And we have no reason to believe that such intervention would make vaping any safer. As I mentioned in another thread all the ecoli breakouts were from foods 'approved' by the USDA. I hope I wouldn't have to list the trail of failures in regulations that result only in more cost and, as above, less control and as Bill and others point out - ends in propping up those companies who they say are their mortal enemies!

 

[Moonbogg]

Out standing "comment". More like the perfect paper that sums up every valid concern. I did notice one huge flaw. They repeatedly try to sell APVs as a way to save lives, but we don't know if that's the case yet. You want honesty? The truth is, for all we know people in the thousands can end up with lung cancer or anything else 15 years down the line from damage caused by flavorings. I wouldn't speak of honest regulations and then claim that e-cigs will save millions of lives. We don't know if they will or won't. It appears likely that they may save lives, but we don't, and can't know yet.

 

[dragonpuff]

Out standing "comment". More like the perfect paper that sums up every valid concern. I did notice one huge flaw. They repeatedly try to sell APVs as a way to save lives, but we don't know if that's the case yet. You want honesty? The truth is, for all we know people in the thousands can end up with lung cancer or anything else 15 years down the line from damage caused by flavorings. I wouldn't speak of honest regulations and then claim that e-cigs will save millions of lives. We don't know if they will or won't. It appears likely that they may save lives, but we don't, and can't know yet.

I want to point out here that there is no such thing as a "certainty" in science. When we state something is a "fact", there is always the possibility, however remote, that it could be wrong.

What we do know is the effects of nicotine on the human body, the effects of PG and VG on the lungs, and the effects of flavorings when ingested. We know that none of these are carcinogenic (reducing the probability of causing lung cancer at some later date to near zero), and that the amounts of PG and VG we use have no long-term damaging effects on the lungs. We're still a little shaky on the long-term effects of nicotine, but we're sorting that out fast, and we haven't found any major concerns yet. The great unknown is the effect of these flavorings - however, given that we can ingest them it is unlikely that these will pose very serious problems when inhaled.

Now to your point - how can we predict that these will save lives? What I've illustrated so far is that we expect no more than minor health concerns from long-term use, based on what we know for sure. Now there still remains the possibility that a few lives will be lost when millions use these long-term - that is an expected probability. However, we also know that smoking kills 480,000 people per year in this country alone, and when adjusted to expected population increases over time we expect to lose about a billion people within the next century.

The reason that they can make the claim that APV's will save millions of lives is that they have been proven to be an adequate replacement for smoking. When you compare the expected death rates from vaping with the expected death rates from smoking, it makes perfect sense to say that if even half of the smoking population switches to vaping, millions of lives will be saved.

Of course there is no absolute certainty, but that does not mean that we can't make a persuasive argument based on the knowledge we currently have.

 

[Moonbogg]

I want to point out here that there is no such thing as a "certainty" in science. When we state something is a "fact", there is always the possibility, however remote, that it could be wrong.

What we do know is the effects of nicotine on the human body, the effects of PG and VG on the lungs, and the effects of flavorings when ingested. We know that none of these are carcinogenic (reducing the probability of causing lung cancer at some later date to near zero), and that the amounts of PG and VG we use have no long-term damaging effects on the lungs. We're still a little shaky on the long-term effects of nicotine, but we're sorting that out fast, and we haven't found any major concerns yet. The great unknown is the effect of these flavorings - however, given that we can ingest them it is unlikely that these will pose very serious problems when inhaled.

Now to your point - how can we predict that these will save lives? What I've illustrated so far is that we expect no more than minor health concerns from long-term use, based on what we know for sure. Now there still remains the possibility that a few lives will be lost when millions use these long-term - that is an expected probability. However, we also know that smoking kills 480,000 people per year in this country alone, and when adjusted to expected population increases over time we expect to lose about a billion people within the next century.

The reason that they can make the claim that APV's will save millions of lives is that they have been proven to be an adequate replacement for smoking. When you compare the expected death rates from vaping with the expected death rates from smoking, it makes perfect sense to say that if even half of the smoking population switches to vaping, millions of lives will be saved.

Of course there is no absolute certainty, but that does not mean that we can't make a persuasive argument based on the knowledge we currently have.

I agree that it is likely that APVs may save lives, and that's what I said in my post. What I was trying to get at is that if we make the claim outright, and don't express caution in doing so, then they will use that as ammo against us, which they have wasted no time in doing already. Instead of saying "Vaping will save millions of lives" We can say something like "Vaping, so far, gives us good reasons to choose it over smoking, and here are those reasons". People have heard these promises before. They will not be receptive to the same language and claims of certainty, even if true.

 

[Jman8]

we also know that smoking kills 480,000 people per year in this country alone

And how do we know this, pray tell?

 

[Moonbogg]

And how do we know this, pray tell?

Statistics? Just saying. Probably statistics.

 

[SeniorBoy]

Thanks OP. Kudos and best wishes to Allison Taylor. A vendor submission!!!! We are on the same page and that's all that ever matters for me. HA! How many vendor's web sites have a prominent FDA blurb and just how many MORE comments would we have garnered if a significant number of vendors and that's MORE vendors would have helped our cause??? Go look at : https://www.thevaporhut.com/

Then go skulk around in the docket (kudos to DR/DOC MA) and ball park the number of vaper only submissions.

/sigh