Some big news?
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Hearing anything about rescheduling hemp up to III?
Idk why they want to reschedule it to schedule 3 other then to give it to big pharma
So dumb
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Hemp was already descheduled. CBD is already schedule V for the one approved FDA medicine.
There are no other approved FDA medicines at this time.
I didn’t see any news about the FDA moving to allow cannabis derived stuff in food or cosmetics. But they already allow cannabis in one drug product - so people will need to submit IND and NDA or ANDA to get this ball rolling if they want to make FDA approved drugs.
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I mean - rescheduling to be aligned with our allies in the European Union and Israel, after the change to schedule at the UN a couple years ago, doesn’t seem totally aligned with big pharma.
Pharma has been making pharma grade weed available in parts of Europe for a minute now - through your pharmacy anyway.
Same with some other countries around the world, with like Canada being a strange exception although originally a leader with Uruguay.
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I think Big Tobacco is the one who will throw their hat in when cannabis is rescheduled. I think Big Pharma will not be as interested as we think since they will be so late to the game. But, who knows.
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After working in an EU cGMP spot for the last few months and building out/developing some EU cGMP compliant processes (and real cGMP not the fake unregulated/unaudited USA hemp GMP bullshit) let me tell you… yall dont want cannabis to go GMP its instantly going to kill majority of the industry right then and there; and by the stroke of some asshole politicians pen.
it takes literally weeks and massive man power to get anything to move in a GMP environment; the documentation control and quality management systems are a nightmare to deal with if your trying to move quickly.
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The irony of medmen bankruptcy and reclassifying in the same month. The whole game plan of medmen was to eat losses and corner the market and flip a switch one day after legalization and be profitable and a huge marketshare percent holder.
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Correct
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Rescheduling not descheduling. Thanks for the update.
This exactly. Couldn’t agree more. Doing this will not solve for the demand in the market which ultimately we saw leads to people buying shit products if it’s all they can get. The way to raise general quality in the market is via competition not regulation.
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You’re correct. I’ve been preaching since 2016 that the FDA will be coming to the cannabis industry at some point soon…
It’s not a shocker than 99% of the facilities would not pass an FDA inspection. I am curious to what level of standards they will require.
If we want to be taken serious, this is the path. I feel like those of us with experience in food and pharma facilities know there will be a massive change from a facilities and equipment standard.
Say good bye to all the direct refrigeration everybody uses, better brush up on the NSF HT-1 certified thermal fluids.
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I’d rather not be taken seriously by the government 
totally agree though that this is where it’s heading. The fact that 99% will fail is not even most concerning, it’s about who will swoop it up for pennies on the dollar.
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Lots of weird stuff in there - I had like 15 pages of comments for them last time.
Anyone else take a real read over CAOA?
Haven’t had time to get through all 277 very dense pages
Only thing I’ve seen is federal decrim/descheduling + involving atf
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The “Cannabis Administration and Opportunity Act” is a legislative proposal aimed at decriminalizing cannabis at the federal level. Key components of the bill include:
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Decriminalization and Descheduling: The act proposes the removal of cannabis from the Schedule of Controlled Substances, effectively decriminalizing it.
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Restorative Justice: It includes provisions for expungement of previous cannabis offenses and resentencing for those currently serving sentences for cannabis-related crimes.
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Regulatory Framework: It proposes transferring cannabis regulation from the Drug Enforcement Administration to the Department of Health and Human Services and the Department of the Treasury.
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Research and Public Health: The bill encourages more extensive research on cannabis and its effects, including a study on the societal impacts of legalization.
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Protection and Opportunities: The act aims to establish funding and guidelines to protect consumers, prevent underage use, and ensure public safety. It also focuses on providing opportunities for communities disproportionately affected by past cannabis laws, including access to business opportunities and restorative justice measures.
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Federal and State Relations: It acknowledges state rights in determining their cannabis laws and seeks to regulate cannabis similarly to alcohol under federal oversight.
This bill represents a significant shift towards reforming federal cannabis policies, focusing on decriminalization, regulation, and correcting historical injustices related to cannabis enforcement.
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I think a lot of people have come to believe that all these people who are “GMP compliant” (the bullshit hemp GMP you speak of) are legitimate cGMP certified facilities. They’re not even close to the same thing.
I’d be hard pressed to believe there is a single THC facility in the US that is operating by actual cGMP standards right now.
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I mean… I definitely started two facilities based on pharma level cGMP principles. Which is a lot of extra work that most cannabis people don’t give a fuck about, to be quite honest.
Doesn’t mean they are not there.
And there are at least 2 in MA that are subsidiaries of biopharm companies which definitely meet this definition.
I just talked to both of the owners of the cGMP facilities and asked, shall we start the process for INDs and ANDAs now (assuming we can use the old Merck cannabis data from way way back in the day…) because we can start this paperwork and get the ball rolling in 18 months, when things settle out, we’ll be ready to GO GO GO.
But I cannot tell you how many facilities I have been to that say they are GMP and they aren’t even scratching the surface. Its like they haven’t ever heard of the 6 pillars of quality from the FDA perspective.
Its like they have never even considered what making a FUCKING DRUG in the US is like.
Such is life.
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