FDA FDA Deeming Comments - I'm starting to be worried

[DrMA]

There are now 39,252 comments posted on the FDA deeming docket website, but a search for the terms electronic cigarette, e-cigarette, e-cig, and ecig returns only 2503 results total. And many of those appear to be either ignorant endorsements, or ANTZ junk.

I understand CASAA's position for waiting may have served the purpose of securing an extension of the comment period. And we've gotten 30 days. I also know CASAA has requested an additional extension, but I don't see that happening. In the mean time, ANTZ have reorganized and have started to submit massive amounts of comments spewing their slurry in support of the regs. They're going for the win by overwhelming the docket with the sheer number of comments in support of the regs. In the mean time, it looks like most of the current comments are about cigars.

In light of these developments, I've decided to submit single-issue micro-comments (1 page or less) to the FDA docket on a daily basis, from now until the comment period is closed. Of course I will also continue to participate in the CASAA commenting efforts, in addition to my own micro-comments. Some of these are posted on my blog for anyone to use should they choose to do so.

I might be completely wrong on this, but wouldn't it be a positive impact if the majority of comments about e-cigs were against the deeming, rather than the other way around?

BTW, in spite of the initial fears on this, anyone can submit as many comments as they wish. So, my fellow vapers, start submitting, even if it's just one-liners like this:

"Electronic cigarettes are not tobacco products and should not be treated as such. Deeming them as tobacco is a grave error with deadly consequences for more than 40 million American smokers who will be denied access to an alternative that is more than 1,000 times safer than combustible tobacco."

 

[coldgin96]

DrMA, I appreciate your passion and thank you for it. I hope they don't screw us, but unfortunately, what our government does is usually in favor of the entities with the most money. I have until now resisted the temptation of looking at the glass half empty. I believe what we do probably won't matter, but we have to try. I have wrote and/or called every elected official that represents me and the campaigns of the ones running. I joined CASAA and made a donation. I also joined the Vaping Militia.

 

[Cullin Kin]

Welp, I'm sold. Can you please provide a link to the website?

 

[DrMA]

Direct link to comment page:
http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0189-20870

 

[DC2]

I tend to agree with your assessment of the situation and your plan of action.

Having said that, would you mind posting something about this in the CASAA forum to get some feedback from them?
I think they would possibly agree, but I'd like to hear their thoughts.

I'd make such a post myself, but I would start by deferring to you in case you'd rather do it yourself.

 

[DrMA]

Thanks, DC2. I'm not looking for deference, credit, or ownership of anything. What I would like is a few hundred thousand anti-deeming comments submitted to the FDA. If you have any ideas on how to make that happen, please, by all means, start doing it.

I posted a link to this discussion in the CASAA forum: http://www.e-cigarette-forum.com/fo...ers-re-fda-deeming-comments.html#post13671191

Please, let's use this thread here for discussion, not the one in the CASAA forum.

 

[Elizabeth Baldwin]

I actually read a lot of the comments. Have you noticed there's one comment on cigars that is just copied and pasted hundreds and hundreds of times. Every day this one comment is posted hundreds of times. It's identical. It's crazy!

I've been posting a comment here and there. I noticed very few comments about ecigs/vaping and quite a few about premium cigars. I figured adding a comment every now and then wouldn't hurt.

I really have to wonder if commenting will do us any good. Obviously it can't hurt but I think their minds are dead set on eliminating the majority of the vaping industry. They have said they know it will cause most of the smaller businesses to close. They also could care less that vaping has the potential to save millions of lives. It's sad!

I'm also a little disappointed in the number of vaping comments submitted thus far. You would think of all the people who use ecigs or vaping there'd be quite a few, but there's actually very few. Premium cigars seem to be the majority of comments.

I am writing my huge comment that has studies and such and I'm going to submit it near the end of the commenting period but I'm also commenting here and there just because I think we need quantity as well as quality.

 

[DrMA]

Thank you, Elizabeth.

I'm actually almost convinced we cannot successfully oppose the deeming based on science, fact, or evidence. They have their own junk and summarily dismiss the real science on funding/COI grounds. It's easy for them, as they have years of experience doing the exact same thing to BT (successfully I might add).

However, we may yet have a chance to win by showing overwhelming popular opposition to these regs. IMHO, we can only win if our show of opposition is so massive that it will convince the FDA that they will have to face us and be held accountable in court for their actions. Anything short of that, they'll know that they can get away with anything by hiding behind the lies, propaganda, and "the children."

 

[DrMA]

Update: Glantz himself has submitted more than 20 comments (that have been posted so far; I'm sure more are coming).
Link to search results: Regulations.gov

And an outstanding comment by Joel Nitzkin: http://www.regulations.gov/contentS...74917d&disposition=attachment&contentType=pdf

 

[Elizabeth Baldwin]

Looks like he's doing all he can. We need to do the same! His comments are probably biased research. It makes me sick.

I posted 2 comments today just because I feel we need more!

 

[Painter_]

I have started copying and pasting your one page comments every day. Today I posted #3.

 

[Jman8]

I might be completely wrong on this, but wouldn't it be a positive impact if the majority of comments about e-cigs were against the deeming, rather than the other way around?

I'm not sure how we would ever know this, would be my first response to such a question. My second one would be based on what FDA has said that comments don't equal votes and that one well written comment is worth more than 1000 comments that treat a comment as if this is actually up for some sort of vote.

Reality is they are going to regulate eCigs as tobacco products because thus far they fully believe they are empowered to do so. And so, a comment saying, "don't regulate this for these are better than smoking" is IMO a waste of a comment. How harsh or tame those regulations are, over the long haul, remains to be seen. Thus far, I see what has been proposed as tame. And haven't yet seen a comment go into detail that shows good reason for why harsh regulations make sense. Yet, I do think harsh regs over the long haul are something that could occur.

I still think moving the grandfather date, to whenever regs become finalized, is the thing for us consumers to be pushing for. A comment to FDA on this sort of item is likely not to have the desired effect. A campaign from likes of CASAA whereby hundreds, if not thousands (hopefully even millions) of us are writing to congress to move that grandfather date, with reasoning provided, might lead to that desired effect as Congress does get to weigh in before the rules become final.

But lately, I'm now thinking best way to address what FDA is asking for in its proposal is to say that regs ought not to occur until the scientific studies are concluded AND reviewed by independent scientists AND that data is extrapolated into sensible policies by elected officials. I think making policy/regs before the science is completed works against basic mission of FDA and what they keep saying in hearings when asked what is role of TCP. Furthermore, it would bring into question their credibility if they were to invoke harsh regulations wrt where the data currently stands, and would mean litigation galore would ensue (under best case scenario) or just open door for an underground market that the rational people amongst us could support, knowing they are dealing with a deceptive government.

And I kinda think FDA is going to wait for the studies to conclude, though not sure if they will allow for independent scientific review and for elected officials to weigh in before they try to invoke certain regulations. IOW, I think FDA is a good 2 years away from Final Rule, but of course, don't quote me on that, as the old adage of "we just don't know" is applicable to FDA response to eCigs, more than it is to actual harm from an eCig.

 

[DrMA]

Very interesting points, Jman. Would you consider rephrasing a little bit and submitting something along those lines as a comment to the FDA?

Also, I'd encourage you to read Nitzkin's comment posted above. He also presents a different and compelling perspective.

 

[Jman8]

Very interesting points, Jman. Would you consider rephrasing a little bit and submitting something along those lines as a comment to the FDA?

Fully intend to do so.

 

[catlady60]

My comment:

The only way I was able to quit smoking conventional tobacco cigarettes was by means of vaping. I have been smoke-free for 8 consecutive months, thanks to e-cigs and the flavors such as cotton candy, creamsicle, and coffee, that keep me, a 53-year-old woman, vaping.

I had tried just about every other quit method--gum, cold turkey, and even Wellbutrin/buproprion (sp?) -- in the past, all with no long-term success. The only reason I haven't tried Chantix was that I have a medical condition that contraindicates its use.

E-cigs contain no tobacco and should not be regulated as if they were combustible tobacco products. The vapor from e-liquid contains no smoke, and thus, no significant amounts of the toxic chemicals and cancer-causing agents from smoked tobacco. Even my family doctor notices a vast improvement in my lung functioning.

Please hold off on imposing e-cig regulations that would be burdensome, cost-prohibitive, and even inappropriate until all the scientifc evidence concerning e-cigs have been conducted. It would be unfair and unjust to consumers and small businesses that make e-cigs to presume harm with insufficient evidence. It would also be unjust to impose burdensome rules based more on moral panic, rash judgment, and ideology that science

 

[JustJulie]

My apologies for not responding sooner to this thread. Life has been . . . busy.

Today, we issued our First Call to Prepare: CASAA: First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment

We expect to issue the Second Call to Prepare early next week, which will provide guidance on further refining draft comments. The Fourth Call to Action (requesting consumers assemble their prepared thoughts and submit the comment to FDA) is expected to be issued towards the end of next week.

Our belief is that individualized, responsive, and intelligent comments by consumers will be far more persuasive than multiple comments that are simply copied and pasted. This isn't a vote or a popularity contest . . . it's a process designed to inform the FDA on the topic.

We appreciate that for many, the thought of reading the proposed regulations and all accompanying documents and then preparing a well thought-out comment in response is daunting (and that's a bit of an understatement). The whole basis for CASAA's Action Plan is to help people prepare thoughtful and responsive comments by giving them a road map (but not a form) and providing guidance on what information is likely to be most helpful and effective.

Yes, it'd be nice to see hundreds of thousands of comments from vapers . . . but given a choice between quantity and quality, I'd pick quality. Having said that, the guidance we're issuing is just that . . . guidance. People are, obviously, free to do as they wish. But we're hopeful that those who believe that the number of comments is of primary importance will still take the time to read CASAA's guidance and formulate a responsive, personalized comment that won't be dismissed out of hand by the FDA.

(This is a post copied from the CASAA subforum.)

 

[DC2]

I like the idea of doing both.

 

[DrMA]

I like the idea of doing both.

That's been my plan from the beginning.

Thank you, Julie, for sharing your thoughts.

 

[DrMA]

New micro-comment posted

 

[dragonpuff]

Here is what I posted for my first comment:

Any regulation regarding e-cigarettes will best serve the public interest if they are protected. E-cigarettes serve as a viable alternative to smoking which is far less hazardous and has already served to help thousands of lifelong smokers abstain from cigarettes. It is crucial to keep this technology user-friendly so people continue to use it instead of going back to cigarettes. Eliminating flavors, severely restricting nicotine amounts, and prohibiting newer, more effective forms of electronic cigarettes all serve to discourage their use; contrary to popular opinion, this will likely lead to people going back to smoking instead of quitting altogether, as many users of this technology were unable to quit previously. Preserving e-cigarette use for adults in its current form is crucial to protecting public health.