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FDA FDA Deeming Comments - I'm starting to be worried
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I finally got a chance to inform FDA of the new Hajek et al. (2014) review study (posted on my ECF Blog).
Also, a brief review of the comments posted on 8/1 to the docket website reveals many ecig-positive comments and user testimonials (likely related to the CASAA CTA4). Finally some positive developments; but no that does not mean I'm not still worried... Fact is there are still less than 6500 comments exclusively about ecigs out of 56,149 posted, the vast majority being about cigars.
Also, a brief review of the comments posted on 8/1 to the docket website reveals many ecig-positive comments and user testimonials (likely related to the CASAA CTA4). Finally some positive developments; but no that does not mean I'm not still worried... Fact is there are still less than 6500 comments exclusively about ecigs out of 56,149 posted, the vast majority being about cigars.
They had some idea even as early as the impact doc:
Note 22: "A single online retailer, myvaporstore.com, claims to sell over 1,000
unique products <http://www.myvaporstore.com/aboutus.asp>. FDA analysts counted
over 150 unique products among just the top 5 brands.
I'd guess they know a bit more now, but perhaps not the scope you mention. And I agree, they don't care.... other than perhaps how to avoid court cases.
I really think they're biting off more than they can chew here. Claiming that all e-cig products will just have to come off the market pending application review is a lot to ask of such a huge, diverse industry. I don't think the deeming regulations are enforceable as they currently are, and I think that once the FDA realizes this, they will likely zoom in and target e-liquid specifically for enforcement of regulations and leave the rest for another day.
Taking inventory of a SINGLE retailer in a field of thousands is just as ridiculous as using cigar sales to estimate the percentage of electronic cigarette sales or the expectation of eliminating hundreds and thousands of products to about 25 is possible, "significant consumer choice reduction won't necessarly mean a reduction in total volume of sales" BS without significant backlash.
Yeah I know I'm preaching to the choir here. The reason I mentioned it was for estimation purposes. I've made some wild guesses as to the size of the market and one thing FT does offer is nearly every brand of clone made. Now it's a matter of estimating the genuine products and that would be a half-... reasonable estimation of the variety of components currently available - eliquids.
I've already counted 5 vendors that have shuttered claiming that current and impending regulations had something to do with it. At least one retailer didn't open their doors. I hope someone else is keeping track of this stuff. One of the biggest problems the vaping industry has had is being counted and the lack of numbers at this stage will only do harm. That is how the FDA gets away with ignoring the economic impact - "we" aren't being counted.
I don't care if they care - but we should at least care.
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I read the note differently. I thought it more as just an indication of how many products were out there - iow, 'just one single retailer had 1000 products' - meaning there could be lots more. But the '150 items of the top 5' (whoever that is) tends to dampen that. I think it just says they don't know
That said, their estimations on costs were greatly understated.
Here's my latest (anynomous) comment to the FDA, and my first blog post.
Title: Why are e-cigs bad when all the ingredients are FDA approved?
Title: Why are e-cigs bad when all the ingredients are FDA approved?
I might submit one more comment before the deadline is up. It will be about the Farsalinos&Polosa letter to the editor of JAMA re: glANTZ&Dutra garbage.
Do it. I really enjoy reading your blog posts and I hope they have been read by many.
Thanks. Well, I did it (and posted it on my blog).
Also I did a quick search of the deeming docket and I was able to find almost all my previous comments posted
. At least they're part of the public record...I'm also happy to see a lot of new pro-vaping comments showing up in the most recent postings. By my most recent estimate there are now (as of 8/7 midnight PDT) 7,451 ecig-related comments (pro + anti) posted to the FDA docket (and a little over 50,000 about cigars). But there are also some 14,000 unposted comments, so I'm hoping we'll make it to the 10,000 mark by the time the deadline rolls in.
And don't forget the 38k FTV comments. Although who knows how they'll be counted
I've been on a days long crusade in my local fb group. Getting some traction!! Comments being made as well as interest in joining Casaa and Vaping Militia! WOOT!
They sent out an email today saying they have 39,000 comments so far
here is an excerpt from the email:We sent the Printer the first 39,000 submissions last night at 3:00am EST. They are letting us send them any additional we receive, up to 7:00AM EST tomorrow August 8th. They just called, and the first 10,000 are already printed and ready to go.
The FDA documents look GREAT! They did a really good job formatting them in the end! We will put up a copy of one soon, so you all can see what they look like. They are formatted correctly to make sure they are legal, accepted, and recorded.
We are picking them up at the Printer in the morning at approximately 10:00.
We will be dropping them off at the FDA at 2:30pm EST. We just got off of the phone with the FDA to confirm the time, and that we would like a receipt for them. They groaned... about having to stamp all of them in LOL
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