That’s very clear and the major problem facing the industry. The warning letters are worrisome but they’ve been sent previously To major companies like Charlottes Web with zero enforcement.
You think they would bust the Stanley’s? It’s highly doubtful
Well diamond CBD is a corrupt company that was put DXM in their products. So they need to go.
I personally saw about 20 pounds of DXM in their white label facility. Enough to dose the whole population of Houston.
Dabatronicus - clarification:
Farming, processing: Legal
Selling under state regulations in-state: Legal
interstate sales: by this FDA guidance totally illegal
How to Remove FDA From Process:
Stick to state sales unless selling from licensed lab to licensed lab across state lines. State law is your saving grace. Set up distributor in-state for states where you want to sell retail.
This would be my plan for CBD; for D8 sales, same except favor sales in states where your state law supports your D8 loophole position. Take the FDA out of the equation
Didnt you use to work for infinite cbn out of Denver?
What did they get their letter for?
Any idea
id be far more concerned over the synthetic cannabinoids than the dxm, but both are alarming as hell
Reading some of these letters, most were making claims which any dipshit knows you absolutely shouldn’t do. They also throw in all of their cut/paste arguments (not grandfathered, not allowed as food additive, not a supplement, not approved drug);
Supporting the conclusion - stick to state laws that safe harbor your operation. Let the FDA shit-show sort itself out and hope your state doesn’t amend your current safe harbor to model the FDA.
Medical claims on products
Told them many times it would lead to exactly this
Never worked for them but my company partnered with them closely
One major conflict is Infinite is licensed by Colorado’s CDPHE allowing it to sell to medical dispensaries here in state
I agree , it just would take an act of Congress for that to happen
How did they manage to get that?
If theres one thing I know about the medical and rec market in CO is they’re kept seperate
I tried to get some of @murphymurri aqua tech and it was only at medical dispensaries so I couldnt even get any
That’s how our state hemp program is set up . Pretty sure it’s due to the fact dispensaries can sell non marijuana products . Hemp being a non marijuana product like you’ve stated I think allows for sale in dispensaries
So heres my question
If you dont make ANY medical claims
Can they come after you?
Like if infinite removed those claims would they be able to sell those products?
This is how most companies are staying under the radar but no, once formulated into a product intended for human consumption, it is illegal to sell per the fda
It is legal to sell and market CBD if your state law allows it - and you sell in state. State law is controlling for transactions within state borders. FDA regulations govern cross state transactions, or marketing to others out of state (across the state border).
Our state for example, has very specific safe harbors authorizing manufacture and sale of 8 medicinal forms of CBD within the state.
The FDA is stating interstate commerce of CBD is not lawful when the following conditions exist: (1) CBD is added to food; (2) CBD is sold as a supplement; (3) CBD is sold as GRAS (generally recognized as safe).
Further, the FDA is saying you can’t use the grandfathered argument (CDB was sold as a supplement prior to GW Pharma drug application and thus is grandfathered as a product that can be sold as a supplement now).
FDA probably gets pushback on the grandfathered argument as CBD was clearly sold before the GW Pharma application and the GW pharma product is a standardized synthetic, not full spectrum. So it should be grandfathered and the products are apples and oranges.
That said, FDA seem to be sticking their fingers in every loophole. What form is not excluded by that FDA guidance?
That’s got to be chilling to farming, processing & retail at the exact time everyone is looking to get paid for the fall harvest…