FDA So how would you categorize / summarize your FDA comments?

[Gato del Jugo]

Just curious of a sampling to what & how others wrote & submitted..


Mine were mainly logical arguments on topics which apparently publicly "concern" Mitch Zeller, the FDA & our opponents, with my final one a personal story (incorporating logical real-life points)..

At times some of them could be considered sounding a bit angry & accusatory -- but I prefer the terms "passionate" & "impartiality-seeking"..


Each comment tended to focus on one central topic per submittal, including but not limited to: attacking nic gum & lozenges the same way our opponents attack e-cigs (my personal favorite & most fun, since I got to act like an ANTZ ); zero-nic e-liquid & vape-gear argument, which I'm told by an advocacy "insider" is a strong legal point; how dual-use is simply a real-life transition for many vapers; non-tobacco flavors & their positive role; FDA regs creating a black market (I didn't have the time/energy to get as detailed & graphic as I wanted to, though I suppose I did a decent-enough job for shock value ); called for Mitch Zeller's resignation due to professional conflict of interest; a summarized overview of "connect-the-dots, follow-the-money" of e-cig opposition which has been discussed here individually, but never all in one post; the FDA's blurred definitons of nicotine & tobacco; and finally, my personal story, which touched on some of the above, and also how my health has improved & why e-cigs are not a gateway to analogs, as well as some other points (I loosely followed CASAA guidelines)...

Summarizing like this seems to sort of trivialize the comments & make them sound less impactful.. But I thought each & every one of them came out pretty good.. It's all in the delivery!


I had originally wanted to also dive deeper into the scientific aspect, but didn't for a few reasons.. One of which is that I know for a fact through conversation ahead of time that a fellow vaper did some extensive write-ups using pro- e-cig studies, attacking anti- e-cig studies & even using the FDA's own studies against the FDA! I read some of their work, and they did a bang-up job.. Aside from that, it's not exactly my field of expertise -- and while I probably could have done some pretty good ones, it would have taken up too much time & energy away from my other comments, while other life-stuff was popping up.. However, I felt very comfortable knowing that those bases were more than covered & came out better than I ever could have done...


Anyway, just curious of briefly what & how some of you wrote & submitted -- basically, your comment(s) categorized, summarized & condensed down to a paragraph or two...

 

[supertrunker]

I'm just an ex-smoker and i'd like to remain that way. No graphs, no links to prestigious studies, just a matter of fact appraisal of why the regulations as currently formulated are bad and do nothing to safeguard consumers.

My comment was 4 sentences long because that's all i needed.

T

 

[Alexander Mundy]

Except for my personal story I tried to stick with one subject they addressed at a time. I also noticed that when browsing the comments the first 1 & 1/2 or so lines showed in the preview window. Because of this I started each of the one item comments with a famous quote that summarized what I was getting at. My favorite was "Make the lie big, make it simple, keep saying it, and eventually they will believe it." Adolf Hitler. The lie: Flavoring is there to entice youth. This was more an to attempt to get the public that might be browsing the comments to read my comment and to think about what I said.

 

[aubergine]

Mine was long, an attachment. I began it with these bullet points; the rest was the personal story, in which I tried to show how those issues have personal and specific impact on consumers:

"I’m writing this comment as a concerned and informed consumer, a mother of three, a mental health professional who has spent some years working in public health, an ex-smoker who was able to quit smoking after decades with the help of electronic cigarettes, and a citizen who would like the FDA to honor its stated mission to serve the best interests of the people in its efforts to promote public health.

The portion of the proposed ruling concerning electronic cigarettes purports to improve the health and life expectancy of the millions of consumers who use this product for harm reduction and of the public at large, but as conceived and written it would significantly jeopardize it in a number of ways:

*by failing to acknowledge and disseminate the growing body of scientific evidence that strongly indicates the effectiveness of e-cigs in reducing/quitting cigarette smoking with greatly reduced harm
*by promulgating myth and misinformation that discourages smokers from seeking harm reduction via e-cigs, thus misleading the public, to their detriment
*by suppressing and effectively eliminating the vibrant, rapidly evolving and innovative existing market for e-cigarettes with costly, time-consuming requirements and delays that only very large businesses can afford
*by thus awarding big tobacco companies market dominance of the very product that most threatens their own cigarette sales (an absurdity), thus protecting them at the expense of consumers like me and insuring higher prices and highly restricted consumer choice
*by promoting only an outdated and relatively ineffective and unappealing product (“cigalikes”), mass-produced by tobacco companies and restricting product features most likely to encourage smokers to quit and maintain abstinence from cigarettes
*by preventing manufacturers from advertising the product’s potential to reduce harm, which misrepresents e-cigs as only “recreational”, falsely equates them with cigarettes, obscures their value in harm reduction and leaves vendors no recourse but to promote flavor, attractiveness, etc., which features the FDA purports to abhor
*by focusing on nicotine, the negative effects of which are, by all scientific consensus, dwarfed by the ravaging effects of combustable tobacco
*by leaving consumers like me who have quit cigarettes by replacing them with e-cigs with only the options of resuming smoking, quitting altogether, reverting to product models abandoned years ago for more appealing and effective ones, or (I think most likely for a very significant number of consumers) turning to the inevitable black market in order to continue cigarette free..."

Then the quit story, long as I tried to expand on specific points as it went, as in this paragraph, after one describing the success of family members who also vape:

"Notably, my other two adult daughters never smoked and, like most non-smokers of all ages, are completely disinterested in e-cigs except to the extent that they’re relieved for their Mom and sister. Claims that this is a “gateway” product are as poorly unsubstantiated as claims that flavors are designed to attract children, that e-cigs will ‘normalize’ smoking (actually, they have the potential to all but eliminate combustible tobacco products) and all of the other misleading, erroneous and ultimately cruel claims that work against a relatively harmless product that in fact significantly reduces harm and is assuredly beneficial to public health."

Then a bit about the inevitable black market, and a paragraph on this:

"There’s a growing consensus that we are being “gamed” by big money players who have no vested interest at all in our health and wellbeing; to the extent that that’s the case, I am addressing corruption and not concern..."

and close.

Unfortunately, I was interrupted and didn't edit as tightly as I'd have liked to, which is my fault for waiting until the last minute to actually assemble all of the stuff that I wanted to say. But it's not bad, I think.

I only sent one. Spoke my peace fully, and that's enough.

Oops, I'm sorry, that's a long 'summary'. But that's basically what I did.

 

[dragonpuff]

One of my posts was my personal story, along with a summary of my feelings on major issues like flavoring and product access.

After that I made about 35 comments (I don't know the exact count offhand). The majority of my comments were simply attachments to scientific studies that I feel speak for themselves. The rest were arguments based on science emphasizing the FDA's job to protect public health; I covered many points in those comments, including flavorings, harm reduction, the FDA's conflicts of interest in TPSAC, the fact that the deeming regulations are not based in any kind of scientific fact, etc.

It is very hard to "summarize" my comments overall, as OP put it, but I am a very scientific person, and so I can say with confidence that my comments were largely evidence-based. I focused on science because I felt that, based on my personal and professional experience, that is where I can make the most profound contribution.

 

[Worzel]

In a nutshell, I questioned the FDA's motives, their track record, then asked them for THEIR sources of misinformation.

 

[AndriaD]

Mine was long, "verbose" as most of my communications are. But I just told my own story, and informed them that they had no right to regulate something into non-existence which is saving my life and the lives of millions of others, and that I didn't give a flying flip what regulations they attempt to foist on the american people, I will continue on my own vaping path using my own choice of APVs, mechanical mods, rebuildable atomizers, and stockpile of nicotine, and that they ought to get back to their MANDATED job of protecting americans from dangerous drugs, not relatively-harmless ones like nicotine. I also made it a blog post here, for anyone who cares to read it.

They can like it or lump it.

Andria

 

[Kent C]

I started out by saying that our gov't was created to protect the rights of individuals, rather than the utilitarian rule of the 'greatest good for the greatest number'. And I acknowledged that most people don't know that or don't care, but that as a government agency, the FDA should care about the reason why our gov't was created. I indicated that there is no reason to believe they do, since Zeller used the 'greatest good' to justify his position on curtailing ecigarettes. Showed his 'quote' at the HELP hearing. And basically copy and pasted the 'silly syllogism' - his reasoning why he thinks that stopping ecigs are for the greatest good. And giving links showing that it wasn't.

Also gave links on 'second hand vapor' that flies in the face of the junk science that the ANTZ have provided. (didn't use those words :- )

I also invoked Jefferson's 'it neither breaks my leg nor picks my pocket' in regards to what people do (vape) for themselves that doesn't involve others and the Hippocratic Oath - 'first, do no harm'. On this, if something does no harm to others then it shouldn't be any part of regulation and that the regulation of a product which doesn't harm can and would promote a product that does - cigarettes. So the regulation 'oath' is just the opposite that the medical oath. And that by doing so shows bias toward junk science that says otherwise. Then I brought up the bias that Judge Leon recently cited.

I put forth the 'unintended consequences' of the deeming and how it may very well prop up the tobacco companies they've been fighting and brought into doubt, by the mere obvious consequences of heavy regulation on ecigs, how perhaps those 'unintended consquences' were not so 'unintended' and that even if not it will appear to be, showing even more bias.

And going to the 'science' of the 'harm' - I linked the Burstyn study as a meta study that showed all the outpoints and bias and lies in the ANTZ studies and held that up over any other study that will be linked by anyone, as it addresses almost all the other studies one by one and shows where the 'science' in them suffers. And I quoted some good passages showing the obvious errors.

Then I attacked the stuff on formaldehyde in the manner mentioned on my posts here - the 'co-carcinogenic' that isn't itself carcinogenic and the abundance of the stuff in other things.... And I took up the 'flavor factor' - how getting away from some cig flavors is a behavioural adjustment to stay away from cigs, etc.

I basically said that all studies are going to have some 'interest' behind them from both sides but it is expected that gov't should be objective, but from the deeming and the studies that the FDA has ordered that, that obviously isn't the case.

I went into all the benefits of nicotine citing several studies from NIH and others that should have some weight with them.

I closed with "Your 'deeming' is a lie. It is a not true that e-cigarettes are 'tobacco products'. " and added my 'cat analogy' lol...

I offered some solutions in asking congress to move the grandfather date to final rule but also added Azim Chowdhury pdf that included the alternative to a grandfather date - "Establishing a “baseline” predicate product"

http://www.khlaw.com/webfiles/What_To_Expect.pdf

...and pointed out the benefits of that even from a regulatory point of view - they get to establish the model, in accordance with the wealth of information that is now out on 2nd and 3rd generation hardware and the improvements that we've made at ECF on all of those, and how they could work with CASAA and AEMSA to establish some sound and safe practices for making and using ecigs....

And something I've included in all the comments - that they don't want to be on the wrong side of an issue that may mean more in saving lives that other discoveries, etc. And that they will be judged in history by the decisions that they make. And that ecigs will live on in the black market if they resort to only allowing cigalikes....

 

[kristin]

CASAA is doing an FDA Comment Survey. It's short and very easy. We would greatly appreciate people completing the survey and sharing their comment with us "for the record."

More information here: CASAA: Call to Action: FDA Comments Survey

 

[Kent C]

CASAA is doing an FDA Comment Survey. It's short and very easy. We would greatly appreciate people completing the survey and sharing their comment with us "for the record."

More information here: CASAA: Call to Action: FDA Comments Survey

Done! Thanks for posting....

 

[Rickajho]

CASAA is doing an FDA Comment Survey. It's short and very easy. We would greatly appreciate people completing the survey and sharing their comment with us "for the record."

More information here: CASAA: Call to Action: FDA Comments Survey

Yay!

Mornin' Kristin

I was wondering if you at CASAA were wondering:

We know the total number of comments now. (Or at least the most recent figure.) Is there any way to parse out of that, roughly, how many were e-cig/THR related? As opposed to all the pro-cigar form letter comments. I was surprised at how many of those cigar letters are showing up.

It would be good to know if there was any way to get that info out of the stream.

 

[kristin]

I don't know the anwser to that, Rick. Because a lot of people attached their comment and just wrote "see comments" in the comment box, they may not show up on any searches. Also, depending on how they submitted, some of their comments may be private and it could take months for the FDA to get them all approved for the web site (there was a notice on the regulations.gov site that said that comments would be posted "once they are reviewed." Which are the main reasons we are doing this survey.

 

[Rickajho]

Got it. It's just so danged frustrating to try and find "us" in there amidst all the "As an adult who enjoys premium cigars..." form letter submissions.

 

[Jman8]

I would summarize my 5 submitted comments (or around 7000 total words) by saying:

Dear FDA,

Please allow actual science to guide reasonable regulations or you will be directly responsible for creating a black market.

P.S. My suggestion for grandfathering products will be shared with Congress and SBA.

Yours truly,
a vaping enthusiast.

 

[aikanae1]

I submitted 6 comments; 3 were short versions < 5,000 words and 3 were long versions with supporting links and only one actual document submitted. I told short/long versions of my story in 4 of them and all of those questioned regulations, turning an entire industry over to corporations that had little to do with development of the industry and that NRT's are not successful, nor likely ever to be since that would limit a company's market. I pointed out the benefits of having smaller business' and health competition / then intentional lying, misleading comments made by the FDA and how I felt that made them liabel and a party to tobacco companies causing harm to millions of people.

The next two were a bit saterical in that I called for a ban on flavors, in everything and went on to point out how many serious illness it would solve (I had seen some data reflecting that smoking may not be public enemy #1 but obesity and diabetes are when it comes to lifestyle illness). I worded it to be a little more humorous, but it's clear I was serious about the point I was making - oh and I asked for regulations banning all flavors to be published by April next year.

Currently I'm not impressed that the FDA isn't more accountable for the comments they recieve.