I am only speaking to the means of deriving the numbers, and differences between. If the FDA is saying only 1676 exist, we have to use that number, when attempting to understand what their 80 PMTA (or 25) means.
I used the numbers from that doc to make the case. The 1675 number is only 'products' and there's a UPC number 1717 as well as 'accessories'. I know there's more and so do they in the note
22 regarding myvaporstore. I also use the argument I put forth in the Economic Impact Analysis thread as a 'solution' to reduce paperwork and as a 'preview' of one of my arguments coming up on the deeming doc, which will include a charge on Zeller for 'lying to Congress' IF his comments to Sen. Alexander about how the regulatory alternatives are still open, were actually closed by the deeming doc that preceded his comments. Here's my comment:
Re: The Food and Drug Administration Deems
tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking
Prevention and Tobacco Control Act; Regulations Restricting the Sale and
Distribution of Tobacco Products and Required Warnings for Tobacco Product
Packages and Advertisements.
I am writing to comment as an individual consumer on the Paperwork Reduction Act
aspects of the proposed regulation. I expect to file a separate comment on
other aspects of the proposed regulation later.
The FDA has estimated that there will be only 25 applications for premarket
review of new tobacco products filed in connection with e-cigarette products.
Yet in their own document, which actually address the impact: Preliminary
Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded
Mandates Reform Act Analysis
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
... they contradict by multiples, their estimate of how many products will be
involved. From page 25 of that doc:
"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" (my emphasis in asterisks).
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.
However, there is a solution available upon which I will be making further
comment but it is operative here as well. IF you truly want to reduce paperwork,
I offer this solution:
In the same 'impact analysis' doc on pg. 67:
'C. Additional Flexibility'
'4.Change New Product “Grandfather Date” to the Date of Issuance of a Final
Deeming Regulation [Regulatory Alternative 3]' is pg 69
"The table shows the reduced burden for cigar manufacturers but ******this
alternative would provide even greater relief for small businesses producing
electronic cigarettes.***** (my emphasis)
And on pg. 69:
"4. Change New Product “Grandfather Date” to the Date of Issuance of a Final
Deeming Regulation [Regulatory Alternative 3]
This alternative would change the grandfather date for determining which
products are new from February 15, 2007, to the date this rule is finalized.
Therefore, new product submissions would not be required for products introduced
between February 15, 2007, and the date of a final rule. As shown in Table 56,
upfront costs would fall. "
So this is one way to reduce paperwork. And according to Mr. Zeller, in his
Senate HELP committee testimony, those alternatives are still open:
Zeller to Sen. Alexander: "We've proposed regulatory options on cigars, and
****one of the options is to exempt premium cigars. *****Another one is to
include them. And we are in a rule making period now and we need to wait for all
the comments to come in and we will then consider our regulatory options in
large part informed by the information (he gets interrupted) that comes in
(assuming 'from those comments'). " (my fill in in parentheses, and emphasis in
asterisks - showing alternatives are still in play since the committee hearing
was after (May 15, 2014) the deeming doc Apr. 24 2014)
While this was addressing cigars, the options for those are the same options as
applied to ecigarettes, as stated in the above by how each different product
would be affected.
That said, the intent of this comment is to make the point that the FDA's own
documents belie the "25 products" that they estimate will need applications, and
everything that affects my vendors, affects me as well.
