Yes - and not only FDA approval and certification, that's just to be approved for import - which is federal jurisdiction.
Then another application and approval process for each and every state - because the individual state still decides what can and can't be sold in its jurisdiction.
Simple Simon thinks all you need is a GMP facility and you're good to go - after all he says medical cannabis is legal in 44 states (which is not correct), he doesn't understand inter- country and inter-state regulation.
The 44 (?) legal states do not override federal law as far as imports. If what he says is logical - why isn't Tilray already selling in those states?
Clown.
Comment by
okgonowon May 02, 2024 3:07pm 
5 Views
Post# 36020116
RE:RE:RE:We're prepared to export cannabis to the U.S. medical market
okgonow wrote: Oldweed wrote:This interview was very eye opening! As the reporter pushed Irwin to respond to how the change in schedule in the US will change anything for Tilray, Irwin finally stated we will enter the market through the medical lane. He then went on and stated "if we can't, then we will find a way". That in itself is very telling, the only strategy is medical and he is not sure if that will be permissable. This is from the horses mouth. Under schedule 3 there is no other pathway into the US ccannabis market for Tilray. When pushed on how will Tilray break into the medical market against the well established US MSOs he explained they will be able to ship into the US with there expertise and know how using existing ditribution. Ok, great thats how you will ship, but how do you differentiate and take customers away from their current provider? Florida alone is bigger than Canada and is a medical market only with several big players now battling it out. TRUL for example still has about 70% of the market cornered in Florida and the other MSOs are slowly chipping away at that segmenrt, but it takes years and money. In reality, the real prize is recreational opening up in the state. Again, Tilray admitidly, will not be permitted to sell rec if/when Florida moves in that direction. Looking at Canada we know the medical market represents only 25% of the sales, so with incredibly fierce US competition and with the removal of 280e, the MSOs are making massive amounts of money selling rec in half the states wich represents 75% of the sales opportunity. How on earth could Tilray possibly be successful? Tilray has no tax break at home in Canada and are losing money rapidly at a time they need to make massive investments, so they are really behind the eight ball. Considering all this, and considering the stated back up plan into the USA is "we fillfigure out a way in" instills little confidence there is or will be a viable plan, and indicitive of the value in the guidance of a 30m/yr CEO. To ittle to late sitting on the wrong side of the fence for in my books. GLTA
It dosent matter what any of these Canadian companys put on their lables or say about their product in tearms of it being a Medical product or branded as a health product.
unless A company is not aproved by the FDA as a licenced producer and by DEA as a licenced importer federaly you cant sell your product as Pharma/medical grade nation wide.
Without FDA you are no where exept that you can sell it in the states where it was legal to do so already!
PS:FYI
Also the site where you produce your medical canabis product has to be inspected by the FDA and get the green light as beeing acredited