FDA CASAA FDA Call to Action #2!

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Ryedan

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Never mind. I found it in the Deeming Regs--2. Applications for Premarket Review of New tobacco Products:

Therefore, the total annual burden for submitting PMTA applications is estimated to be 135,000 hours (27 respondents × 5,000 hours).

Good god ... 5,000 hours involved in one application! That's 2 1/2 person years of work :facepalm:
 

Janusxvii

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Yes, that's what I am referring to salemgold. I just went back through the deeming reg and the financial impact study and I'm not seeing it in either place. I hear what you're saying about having taken in so much data that it's difficult to keep it all straight. It doesn't help that the language in these FDA documents is incredibly convoluted. I deal with aerospace industry technical specifications on a daily basis and they aren't even this bad. It's the general mindset of my occupation (quality assurance) to personally verify everything. I'll keep looking and post if I find it for anyone else who might be interested. Likewise, if anyone else happens to find it please do the same (page number would be appreciated). Also, no worries aubergine. I didn't construe your response that way.
 

Janusxvii

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Never mind. I found it in the Deeming Regs--2. Applications for Premarket Review of New tobacco Products:

I saw that too Katya and though that was what they were referring to. However it doesn't fit with the language in the call to action.
"In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products."
 

Kent C

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I saw that too Katya and though that was what they were referring to. However it doesn't fit with the language in the call to action.
"In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products."

From the impact doc:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

Pg. 25

"This proposed rule would also extend the FD&C Act tobacco authorities to tobacco products that do not fit into traditional product categories, such as electronic cigarettes or nicotine gels. Current estimates in the press indicate that sales of electronic cigarettes are expected to be between $1.0 billion and $1.7 billion in 2013. Cigar sales are forecast to be about $8.1 billion in 2013 (Ref. 49, [Euromonitor, 2012]). Therefore, forecasted sales for electronic cigarettes are 12 to 21 percent of forecasted cigar sales. Using 15 percent as our best estimate of the size of the electronic cigarette market relative to the cigar market, and assuming the number of products and UPCs is proportional to dollar sales, we estimate there currently are 1,675 e-cigarette formulations and 1,717 electronic cigarette UPCs.22"

22A 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.
 

Katya

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I saw that too Katya and though that was what they were referring to. However it doesn't fit with the language in the call to action.
"In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products."

Hmmm... I'm not sure how to answer that. Maybe Julie will help us tomorrow.
 

Janusxvii

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Hmmm... I'm not sure how to answer that. Maybe Julie will help us tomorrow.

That would definitely be appreciated if she did. At any rate the FDA is absolutely underestimating their numbers with respect to ecigs. Assuming that their estimate of 1,675 products currently on the market is correct (I feel safe saying it isn't but for the sake of argument let's say it is), 25 products seeking premarket review represents just under 1.5% of what is currently available. In reality it is probably well under 1% of what would fall under their jurisdiction if deeming is approved as-is.
 

Katya

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That would definitely be appreciated if she did. At any rate the FDA is absolutely underestimating their numbers with respect to ecigs. Assuming that their estimate of 1,675 products currently on the market is correct (I feel safe saying it isn't but for the sake of argument let's say it is), 25 products seeking premarket review represents just under 1.5% of what is currently available. In reality it is probably well under 1% of what would fall under their jurisdiction if deeming is approved as-is.

It ain't aerospace industry, dear.

This is our government at work. :D
 

Ryedan

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As I'm Canadian and reside in Canada, can I do this call to action #2?

Talyon, I'm in the same situation as you. I did it. I have a Yahoo mail account and used that instead of my Rogers account for the email. They can still tell where it came form but they have to look a bit harder.

If anyone has a better idea, please let us know :)
 

sonicdsl

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From the impact doc:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

Pg. 25

"This proposed rule would also extend the FD&C Act tobacco authorities to tobacco products that do not fit into traditional product categories, such as electronic cigarettes or nicotine gels. Current estimates in the press indicate that sales of electronic cigarettes are expected to be between $1.0 billion and $1.7 billion in 2013. Cigar sales are forecast to be about $8.1 billion in 2013 (Ref. 49, [Euromonitor, 2012]). Therefore, forecasted sales for electronic cigarettes are 12 to 21 percent of forecasted cigar sales. Using 15 percent as our best estimate of the size of the electronic cigarette market relative to the cigar market, and assuming the number of products and UPCs is proportional to dollar sales, we estimate there currently are 1,675 e-cigarette formulations and 1,717 electronic cigarette UPCs.22"

22A 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.

My e-liquid vendor has over 500 different flavors posted (and custom mixes beyond that if requested). Each one, with different flavor concoctions, would be a different product, right? If so, that's just one vendor with one product line, out of hundreds, if not thousands, of vendors.
 

Kent C

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My e-liquid vendor has over 500 different flavors posted (and custom mixes beyond that if requested). Each one, with different flavor concoctions, would be a different product, right? If so, that's just one vendor with one product line, out of hundreds, if not thousands, of vendors.

Right, according to what they've said in the docs, yes. "Formulations" likely include(but not only count) eliquid flavorings and UPC's are individual product codes - for accessories... they're defined in the 'economic impact analysis' thread - early pages.
 

Jman8

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My e-liquid vendor has over 500 different flavors posted (and custom mixes beyond that if requested). Each one, with different flavor concoctions, would be a different product, right? If so, that's just one vendor with one product line, out of hundreds, if not thousands, of vendors.

500? That's it.

I cited the number 14,000,000 in my comment because that's what my vendors states on their site, and which I believe to be accurate given the various combinations possible.

If a vendor sells menthol, and cinnamon, and has ability to mix those two together then a new flavor is made. So, if it is 500 base flavors, and all those can be combined and thus new flavors created, then we really really are talking about millions and not hundreds or thousands.

And 14,000,000 x 5000 hours equals (according to my computer's calculator) 7e + 10. So probably about 7000 lifetimes just to catch up with current products available. Somewhere in the year 8367, the FDA will be caught up with review of all products that were available in May 2014.

Totally doable.
 
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