Where art thou Christmas Cheer?
- Thread starter jmatt
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I think actually physically being sold and "on the market" are 2 different concepts, as SToP beat the deadline with Warhorse, but it's not readily available today.
I'll be entertained to see how all the blends that have been announced in the last 5 days, but not yet actually available for sale, will fare under the new FDA rules. I'm going to predict here today, some bankruptcy-causing fines based on the "rollouts" in the last week. Write it down, you heard it here first.
Maybe, maybe not. What I'm being told is that all that is needed to meet the deadline is a record of sale prior to the predicate date. If buyers have ordered, whether at the retail, or wholesale level, prior to the gong, the basic requirement has been met. This is the logic that allows for some Dunhill resurrections to come to market in October.
First, let me say that I know nothing about what the FDA regs say on this point, but as a legal matter, a sale of a product hasn't occured until ownership of the product has passed from the seller to the purchaser. I don't know how you could have a record of a sale, when this hasn't happened. What you have is a record of a pre-order - ie executory documentation relating to a sale that has yet to have occured.
With what Peck said, my order of the War Horse Green, Dunhill's and some other stuff has already been packed and awaits shipment and this was done within hours of my purchase. I would guess that while I don't have the product in hand the shipping transfer to UPS would be good to show transfer of product from seller to customer.
But not Christmas Cheer, right? If you read deep enough, the FDA says test-marketing isn't enough. And test-marketing implies some limited retail sales. I'm suggesting if the FDA has said limited retail sale isn't enough, that orders (without even shipping) at the wholesale level won't count either.
I would bet that Mc, for example, has at least a few tins of the 2016/17 CC and at a minimum they sold some tins to a friendly party, which they carefully recorded. Or at least that's what I would try to do if I couldn't roll the product out completely by August 8th. Just speculation on my part.
They didn't even have the gold 2017 labels at IPCPR for Christmas Cheer yet, so I suspect it'll be a week or two but they already sold to retailers even if they haven't delivered.
Bottom line: It's not my risk, right? Manufacturers will all determine where on the risk curve they're comfortable sitting. I'm saying it looks like a number of these "releases," many of which haven't actually been distributed for normal retail sale, are sitting way on the risky side of the curve. So far to the risky end that the risk/reward profile doesn't make sense to me. But I'm not the boss of those decisions. I'd just like to buy some more Christmas Cheer.
I think the question being raised is whether that is truly a sale for FDA purposes. They have an order, and maybe even have received payment, but have they sold the product? Again, this is all above my paygrade since I don't know what the FDA regs actually require, but if they require a legal sale of the product to have occured by August 8th, then I don't know why what you describe would qualify. Maybe orders are enough. No idea.
By the way, I just took a stroll through the rule and I see nothing that requires that an actual sale take place. All it seems to say is that the product has to be "on the market" on August 8th. I would expect there is some uncertainty as to what that means, but the same language is used for the February/2007 cut-off as well, and in that context they have indicated that the product only needs to have been "commercially marketed". They list a number of documents that would help support that and one category listed is purchase orders. I could not find anything actually requiring a legal sale of the product by the particular date.
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Well shoot! I was about to go run to the local store to pick one up for $26.99 but I'm gonna hold off and try my luck on-line. I hope they do a limit so we don't have people buying 100 tins and re-selling them for a much higher price later on.
I'm just hoping that the FDA will be too swamped with the massive vaping industry to pick on us pipe people too much.
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