From what I’ve heard, it sounds like the FDA will probably regulate the overall mg threshold for over the counter products with CBD, then have an unlimited amount allowable for pharmaceuticals. Question is, if that’s the case, what is the OTC threshold going to be?
Here’s some related reading: https://www.cnbc.com/2019/02/27/fda-plans-first-public-hearings-on-legalizing-cbd-foods-in-april.html
When Phizer starts dropping oxy/cbd or norco/thc. the vision will be complete. These companies are coming for all of our work. Soon assimilate or die. this may be just my paranoid perspective. Yet if a commercial OP can to me with a bag of cash id prob grow for them. Not sure if i could stomach working for certain groups though.
Lets not act surprised by this. Even more will be coming our way. I was never in support of full legalization. I wouldnt be surprized if they take away private citizen rights to grow thier own. Too much money not going to big whatevet they are called. Capitalists want ALL the money, not just some of it. Im sure this will seem like nothing. compared to what is coming. Grow your own. KEEP IT TO YOURSELF. the enemy is the person who grows at home. Again i might be paranoid. But if you know me. you know why.
I’m not sure where you are hearing things like that from. The groups that handle these two things (food and drugs) are separate. The people that regulate the mg quantities are actually at the DEA not the FDA - and so we shouldn’t be expecting that we will have “drug need” quantity limits put in place, but should instead continue looking towards a higher level of descheduling and therefore no limits.
What we should be expecting is that the warning letters that have gone out before will become inspections of facilities, seizures of materials (where warranted), and potential consent decrees at larger facilities. We should also be expecting that just like every other potential “active” supplement out there - that they will have specific tests that need to be performed, and will publish “safe” limits for adults and children (this is based on “poison control” - not efficacy, so we can consider that there will really be no limit, I mean…are there CBD deaths yet?).
Above and beyond that - for foods, we should expect much broader food testing requirements including stability testing, broader contaminate testing, and in general more regulatory oversight. These things are actually all required right now, but like the article says, the players are small and not everyone even knows there are “rules” let alone follows them.
And then for nutraceuticals (since it is all about marketing after all…) we should be looking to expect the same kind of general crackdown that the industry has been having for about 10 years. Where it will be specific to mislabeling (aka making non-clinical claims) and contaminate screening.
I’m not sure about this Pfizer mixing of things that have similar or the same binding locations…it seems like that would make the drug super ineffective while also more expensive. Lucky for us the FDA doesn’t like opiates just now AND lucky for us, they require more proven efficacy these days - so if it is the case that “designer” drugs are really no better, then why would we expect them to be approved. Also - that timeline is dozens of years away, and billions of dollars. So don’t think it will happen just because the FDA has a hearing.
The FDA is an amazing bureaucratic machine, it moves slowly and with a not insignificant amount of time given for public and corporate comments. So don’t forget to comment, provide briefs, fund your lobbyists, and write letters. Seems like a bit of scaremongering to me…you know how many pharmaceutical grade nutraceuticals are out there - that are available both by prescription and OTC? Hundreds and hundreds. Just because once - a designer nutraceutical was pulled from the market (with some pretty significant safety and efficay concerns on top of it…) doesn’t mean this is their normal type of activity.
And finally - I know that GW Pharma seems scary but they are a European company, which means they have EU rules (unless Brexit…) and that means they can’t hold complete market share, they have much more stringent monopoly rules, and if/when they get to holding upwards of I think its 30% of the market, then they actually have to start helping the competition (aka us). I’m happy they spent all the time and money to do these two things - it means we have solid data on efficacy, and we have better info on side effects and poison issues, which the FDA actually cares about.
I’m freaking out about local states and municipalities changing utility rules to make it so you can’t grow because you won’t have power or water. I’m freaking out about local states and municipalities creating “dry areas” where no plants are allowed at all and trying to enforce that. I’m freaking out about continued disparities with the federal justice system, people who are still imprisoned in states for things that are no longer illegal, and the amount of time and mismatched methods for expunging (or not) records for people involved with the plant.
I’m not freaking out about the FDA.
That all sounds good and all. however we all know the FDA is a corrupt group. they take payoffs to push things through faster. and in some cases never at all. The DEA and FDA both are dinosaur groups that arent capable of rational thought. Money is king, money calls the shots. Who ever pays them the most gets what they want. This is America where cash is the only thing that matters. We potentially have cures for cancer and aids. but we know the money isnt in the cure. its in the treatment. CBD in my opinion is pretty amazing. in what it does. Do we all believe that a miracle product like this will be allowed to flow freely without their control? Im mpre then confident we will see THC and CBD being used in Pharma. It makes a lot of sense. It would make even more money. We can speculate all day long. Sadly only time will tell. by then its too late. as history has shown WE will be the losers in Legalization. Legalization isnt for us the people, rather its for the big boys to make more cash. Its Capitalizism at its finest. Lets take a hypothetical situation. Trump fully legalizes Canna. Why? because omce he leave office he invests in it. He has seen the projected numbers. It blows away anything he has ever imvested in. We dont ever have a count of how much money is actually being generated yet. On the same foot the black market is stronger then ever. Think the Feds arent working on how to end that? Answer is clear. Federal Weed grown by them and sold to us. At amazing prices. lets just say $1-200 a pound. Also making laws stating WE can only own thier product. This will cause every dispensary to close. And make ever home grower or small farm a federal criminal. The war on drugs isnt over. Its just reforming in favor of who pays the most to controll the seed. this goes back to the Monsanto thread. I could go on and on. If it doesnt make money it doesnt make sense. econ 101
Also lets not forget why hemp was banned to begin with.
Meanwhile, 90% of beers tested have Glyphosate. Just lovely.
DEA is NO longer involved with CBD as it is now classified as a medicine and on the FDA’s watch. It could result in the withdrawal of GW’s patent. The chief of the FDA reiterated that today.
Not sure which gw patent you’re referring to, but their patent for CBD as an antiepileptic was denied!
Vote Hemp’s proposal for FDA regulation of CBD products focuses on the imperatives to 1) Require that U.S. manufactured CBD products be produced in accordance with FDA standards for dietary supplements; and 2) Assert the importance of FDA acceptance of only plant-derived CBD products within existing framework for dietary supplement manufacturing and labeling; and 3) Have FDA promptly issue an Interim Final Rule with an accelerated effective date authorizing the sale of hemp-derived dietary supplements and foods containing CBD. @DispensaryOwners @DispensaryEmployees @mastergrowers