DEA to move to Reschedule Cannabis Associated Press Reports

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Wow. This is so incredibly wrong. Implying that somehow cGMP only applies to companies regulated by the FDA - is wrong. Good Manufacturing Practices apply whether or not you are selling products in the US. They apply in lots of other jurisdictions as well, all over the world. And implying that only the FDA can say you are cGMP is both false (they don’t ever actually say this…) and implies that accreditation which is both approved by the FDA (they have accepted the ICH requirements for this and the ISO requirements for this into the federal register) because they say no to cannabinoids is also false. There are plenty of hemp manufacturing facilities out there that have been approved by the FDA - they make food that doesn’t have cannabinoids in it (although it is tested for cannabinoids).

I’m not sure where you are getting your information from but the origins of GMP go back to before the FD&C that gave the FDA its teeth. And they certainly go back further in places like the UK (and the rest of the British empire). But I digress. Implying that somehow companies get an accreditation from the FDA is just plain misinformation the FDA does not provide this service at all. Never has.

This is also not true - what are you talking about? The FDA doesn’t ask for these things or look for these things when they come for an inspection. I’ve had to do dozens of these in my career and never once has an FDA inspector been like - can you show me your accreditation. They don’t ask for them, because they are not required. They ask for your list of SOPs, they ask for evidence of your QA/QC program, they ask to see evidence of your equipment validation and facilities commissioning documents.

ISO is after - its for a higher standard. Always has been because its not required.

It feels like you have never worked in an organization that was regulated by the EMA or the MHRA or the FDA… because what you are saying is so far from the truth.

Why are you saying this stuff?

Also - there are more than just the companies you have listed doing this work, that are in FDA and DEA registered facilities. Why are you acting like they don’t exist.

Fuck man - I was doing this work on Sativex back in 2009, which isn’t a legal product in the US yet but was under clinical trials via an IND. Why are you implying that it is legal in the US? Did you mean Marinol or Syndros or Cesamet? And why are you saying there is a drug shortage for these? There isn’t a shortage for these in the US - and that is public record which anyone can about here read here. And none of them are currently on that list and are still readily available in the US with a prescription.

I don’t usually get on top of people about saying things that are just not true - this is a cannabis forum after all and there’s lots of really weird information out there.

But this was my thread. And you are talking some serious nonsense. I don’t know why you would want to do that.

There are at least three other companies that you fail to list that are cannabis companies first that have jumped through the hoops for the DEA and FDA to do IND studies for cannabis products. One in California that is doing amazing work and one that was in Massachusetts but has now moved to Minnesota, where I have had the pleasure of visiting and seeing the hard works. Both are doing amazing preclinical work - and will probably be people pushing those clinical materials out faster once things are rescheduled than anyone can expect.

Just because all you see are people derping around not knowing anything. Doesn’t mean those businesses don’t exist. And perpetuating misinformation isn’t going to help them get there any faster. And those people that are doing it as the government makes them - are using the worst weed in the world, working with intense security and scrutiny, and spending millions on products which many in our industry are already making money off hand over fist without following any rules at all.

There are cannabis specific voluntary consensus standards from ASTM - a 125 year old international standards organization that facilitates the writing and maintenance of standards for most industries, including ours.

You can check out the standards here - there are more than just quality standards, but since that is what we are talking about… I figured we could start there. There are dozens at this point, covering all kinds of things - and from those we’re starting to see regulators pick them up and use them like they do for all kinds of other things like say…building codes.

So that’s nice. There is a path - should we choose to walk it.

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The last 15 posts on this thread made my head hurt and to me prove how convoluted and unnecessary most of this is. I’d be far more supportive of voluntary standards that leave room for innovation, and mostly that are not convoluted and inconsistent based on your inspector or interpretation of the law. Hemp producers are small stores with under 5 employees, we spend thousands a month testing products as is, and now we are wanted to have these standards hoisted on us as if we are a ten million dollar operation that can take a month off to adjust.

The whole legalization push was based on that cannabis isn’t dangerous. If black market edibles never killed anyone why are we so concerned about legitimate business with insurance and SOPs like there is going to be a massive recall that kills people. Oh wait, pharma does have that happen but they get to keep existing. I don’t know how you can objectively look at our economy and say we aren’t being stifled on purpose, that those in power play by different rules.

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I appreciate you detailed response; with all do respect i dont have the time to type out novels on my phone so my responses are typically short and to the point its easy to skip important details; especially when talking about something as intricate as stuff like this.

my point to all this is joe-schmo vape brand is not going to get cGMP status for their shortpath and trap lab.

im currently in europe working on various cannabinoid API’s and we know through our sales channels/teams that there is not enough pharmaceutical material stateside to meet the demand. the US is a massive target for us because of this. the lack of material isnt enough to register as shortage but oh man is the market massive and unsupported.

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Exactly what I’ve been saying about demand and Joe schmo vape shop. They are not going to be able to enforce this, just as the industry already told the FDA to fuck off. I can buy THC edibles every mile of the road, none of them are FDA approved. This is just creating sketchy situations, lawsuites, as well as loss of tax Rev, jobs, and supply.

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i think its fucked its just going to push everything underground and perpetuate the black market.

i really hope stuff gets sorted such that legacy facilities wont have to undergo the horrors that is pharma.

lots of good people in the industry just trying to make a decent living; feels the gooberment is just pulling the rug from under them and giving it to big pharma. which is ridiculous because for some of these pharma companies; adding cannabinoids to there skus will only; add a few hundred mil a year to the billions they are already making. shits a drop in the bucket for the likes of pfizer and whatnot.

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I’m sure this will go to the Supreme Court. Hemp is a $7b a year industry and growing rapidly, much less the legal dispensaries. You can’t take away tens of billions of people’s livelihood and expect no push back.

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FS Oil is a hemp processing facility here in Oregon and is completely cGMP complaint

Einstein 6100 fs oil pic cold trap
Einstein 6100 fs oil pic cold trap1440×1920 318 KB

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Einstein 6100 fs oil pic 1
Einstein 6100 fs oil pic 11440×1920 261 KB

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That is very impressive and something to strive for definitely, but I’d wager unnecessary and I think a very similar quality product in terms of safety and usability could be achieved much easier and less expensively. How many thousands of dollars are in those pictures? This directly affects the price of cannabis and is going to put undue burden on small businesses.

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Doesn’t look like exceptionally more than normal operations. Looks like a FFE in a booth, you know?

And it looks like the Einstein models are similarly priced to other FFEs on the market. So unless you were building your own, from like spools - probably not a huge equipment price difference.

Normal clothes. Normal PPE. And I say normal - meaning, you should be wearing a lab coat and a head covering if you are even trying for food grade cGMP…

But I guess you could have no PPE… and no head coverings. Not sure how much cheaper things would get because of that though…

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You mean a c1d1 booth? What would you approximate everything in that photo costs?

I’m genuinely curious, I have no idea about these things or honestly what that is used for. I’m more marketing and brand building, I dabble in all the tech here and think it’s interesting but I’m a moron compared to most of you in that realm. What am I looking at, what would that cost, is it something smaller hemp companies are going to have to account for? Even in a booming market running a small business is difficult and I’d like to understand what the industry is facing because some people in this thread are making it sound like no big deal, others are saying it’s a huge deal. When I see that facility, which I presume is a c1d1 I can’t possibly imagine why I’d need this in most of the hemp operations I’m familiar with… Making gummies, tincture, cream, bagging flower. Genuinely trying to understand why hemp processors need to invest more beyond what a certified kitchen should have, ppe, etc which you mentioned is cheap. Even hiring two full time person to head up compliance would be an astronomical cost for most small hemp producers, many of which probably have less than 5 employees.

I guess my crux is that a distillation lab should be treated differently from a small hemp processor doing business over the last 5 years. I’m all for more regulation , especially on things like Delta 8 distillation which is causing shit products in the marketplace. But there should be delineation. And I’m sure others would argue those labs don’t even need gmp but I will leave that argument to smarter folks.

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The thing is, this regulatory stuff exists already for manufacturing industries specifically because manufacturing itself can be dangerous, and that when profit is concerned, corporations generally can’t be trusted to hold consumer safety higher than their desire for increased profit. Actual big boy regulations are serious, and seriously necessary. Big Pharma plays by those rules and STILL manages to hurt people. The only reason why it’s not seemingly happening in the cannabis industry is because there isn’t a fine enough scope on things to define the hurt, know the hurt. Think about the vitamin E acetate thing as an example.

To go into further detail - I came to cannabis from microbiology, specifically food safety. I worked in one of the longest running food safety labs in the country. I may not be familiar with cGMP/ISO stuff from a management perspective, but I’m intimately familiar with its impact on the lab floor. I can speak with certainty, having worked in cannabis testing as well, that cannabis testing is a joke, and treated as a joke by most testing labs. Phrases like “fuck it, it’s the wild west” are common. If you think that current cannabis lab standards for micro food safety are sufficient, you simply don’t know what you don’t know, and that’s perfectly understandable, but doesn’t validate your perspective.

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I mean, an apron would be sufficient, technically speaking. but yeah. (god do I hate lab coats)

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I really refuse to believe this when you say it in the same breath as all those pharma has killed. One is not quantifiable because it rarely, if ever, has occurred in a legal market, and on the other hand, pharma has lobbied for specific protections because it happens so often that it is nearly unquantifiable.

No, big boy regulations are not needed to put a gummy in a jar or to grow a plant. You really think the vitamin e man would have made it to market with his products legally? No one died from vitamin e, they died because of a finished vape in the BM.

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You are, of course, more than welcome to your opinion.

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If anyone can show me vast evidence that current industry practices are causing significant harm to the public please do so. Under 10 cases in the last 15 years is honestly a great batting average, and I’d wager most of those instances were not due to poor manufacturing.

Otherwise let’s call it what it is, a money grab. Laws passed should be for public benefit. What is exactly wrong with the current situation other than people are mad about money?

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I’ve personally worked in a cannabis testing lab that was allegedly cGMP, that used actual factual Salmonella Typhoid (as opposed to a surrogate non pathogenic like abetuba) as their control organism, did their controls in the daily hood out on the shared floor with the chemistry lab, and the controls were not proving anything other than that the culture was viable, AND kept these cultures in an unlocked fridge accessible to all.

I hope this is illuminating.

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Who did this hurt? Also a cannabis testing lab is much different from a small hemp company bagging gummies and flower. C’mon.

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Ok so you just don’t grok what you’re on about, I understand now, thank you.

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Not sure what you mean by that. You didn’t answer the question. What negative impact, moreover harm, are current industry standards causing the public?

I’m open to all information so I can improve. Cannabis testing labs should be DEA certified anyways? This is different from the situation that will impact millions of small businesses.

I don’t know how protecting local artisanal farmers from this is controversial. If this were tomatoes people would be up in arms and saying that farmers are being prayed on.

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