Our vendors should read this
Page 22...
"Although we do not have an estimate of the number of electronic cigarette manufacturers
and importers affected by this proposed rule, we similarly expect that rather than bear the cost of compliance, some would cease to offer their products in the U.S. The total costs of complying with the proposed rule would create the potential for exit;"
And contrary to some comments about substantial equivalency - how if one carto is allowed then all follow... here's the FDA's estimate for the number of ecigarettes and UPC's (basically accessories... see note 22 on myvaporstore, pg25):
Table 16 summarizes the number of products affected by this proposed rule, while Table 17 provides cigar product detail by foreign and domestic origin.
Table 16: Number of Products Affected by this Proposed Rule
Electronic Cigarettes2 1,675(Products)_ 1,717(UPC's)
2 If there is no valid predicate tobacco product for e-cigarettes, the number of products or UPCs on the market under the proposed rule would depend on the number of marketing authorizations obtained through premarket tobacco applications.
Depending on the evaluation of 'predicates' to ecigs, those numbers might change but earlier this is what the FDA says about predicates for ecigarettes: (page 20):
"If electronic cigarettes are deemed to be subject to chapter IX of the FD&C Act, the cost of premarket applications would increase the cost of entering and remaining in the market. (It is uncertain whether there are any valid predicates for the electronic cigarette products currently on the market. If no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market."
From reading some other posts, where some think components will be exempt, I think this may need some clarifications:
UPC = The Universal Product Code (UPC) is a barcode symbology (i.e., a specific type of barcode) that is widely used in the United States, Canada, the United Kingdom, Australia, New Zealand and in other countries for tracking
trade items in stores.
Trade items = The term trade item refers to any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced or ordered or invoiced at any point in any supply chain. It is a term used primarily by people in supply chain management and logistic engineering. In colloquial usage, it refers to
any item that is the subject of trade.
From FDA deeming doc:
"Number of Affected Products
a. Number of Products
Many costs of this proposed rule depend on the total number of affected products, measured as the number of unique product formulations or universal product codes (UPCs), depending on the provision. (The number of UPCs exceeds the number of product formulations because the same product can be packaged in multiple ways, with each packaging configuration receiving its own UPC.)"
Here, they're differentiating between "product formulations", for example a cigalike or an ego or mod kit) vs. the "UPC's" - each component of a product or kit, where "each packaging configuration receiving it's own UPC" - so the battery could have it's own UPC, the atomizer/clearo/carto, the drip tip, the replacement coil.
Now from the above: (they estimate the number of full products and the components that may be sold...)
Electronic Cigarettes2 1,675(Products)_ 1,717(UPC's)
2 If there is no valid predicate tobacco product for e-cigarettes, the number of products or UPCs on the market under the proposed rule would depend on the number of marketing authorizations obtained through premarket tobacco applications
Valid predicate tobacco product - this would be a tobacco product that already has FDA approval, such as most regular cigarettes, some cigars and.... no electronic cigarettes. Hence:
"ii. Premarket Tobacco Applications
Among traditional product categories such as cigars and pipe tobacco, the proportion of proposed deemed products that would not be found substantially equivalent to a valid predicate product is uncertain. Therefore, the number of new products requiring premarket tobacco applications within those categories would also be uncertain, though our best forecast is that it would be small. (As of November 2012, no premarket tobacco applications had been submitted to FDA for currently-regulated products.) By contrast, it is uncertain whether there exists a valid predicate for the electronic cigarette products currently on the market. Because all electronic cigarettes are expected to qualify as new products, if no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market."
So, they are saying that since some cigars may have a valid predicate, they may not require premarket applications, but "by contrast" ecigarettes probably don't have a valid predicate..... So....
all products AND UPC components "would require premarket applications in order to remain on the market".
(just as an aside, most people know this, but they have stated in the 'Definitions' of the deeming doc, that a 'tobacco product' doesn't have to contain any tobacco to be defined as a 'tobacco product'. They cite accessories, etc. as examples).
It is the premarket applications that would be the concern of small and medium size vendors, since the FDA's own estimated costs would be prohibitive. They point this out in a 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.
Therefore, the significance of the statement in their above quote:
"If electronic cigarettes are deemed to be subject to chapter IX of the FD&C Act, the cost of premarket applications would increase the cost of entering and remaining in the market. It is uncertain whether there are any valid predicates for the electronic cigarette products currently on the market. If no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market."
and...
"Although we do not have an estimate of the number of electronic cigarette manufacturers
and importers affected by this proposed rule, we similarly expect that rather than bear the cost of compliance, some would cease to offer their products in the U.S. The total costs of complying with the proposed rule would create the potential for exit;" (ie. a potential for going out of business).
