The Patient’s Guide to Contaminants

Hi, and welcome to Aces 9th Annual Unity conference. This is a discussion with myself and Holly Johnson about our upcoming patient's guide to contaminants in cannabis and cannabis-derived Prada. Also, known as what's in your medicine. Natalia second to introduce yourself. Hey everyone. Thank you so much Heather for inviting me today. So pleased to be here to talk about this great forthcoming document for patient. Again, I'm Holly Johnson. I am the chief science officer for the American herbal products Association. And my

background is in pharmacognosy. He and I used to study indigenous, medicines and ethnobotany mostly in the South Pacific, and I've been researching and standard settings about 2014. Course, cannabis is one of our longest known as no mechanical used as food and fiber and medicine. So not be more pleased to be involved. And to be here today with Thanks, Holly. And I am Heather despres. I am the director of the PSE program. At Americans. For safe access.

We are recently ISO accredited program, that certifies products, processes and services. And we also do a lot of training and education courses to help educate the industry consumers and patients about the topics that are important to them. Isa has a lot of different resources available for patients, consumers Health Care practitioners and this guide is intended to follow along in those footsteps. Some of our previous Publications. Include our patients guide to medical cannabis patient's guide to CBD every year. We issue a state of the states report, which breaks down the

different regulations in all 50 states plus all the territories and identifies ways in which states can improve their access to cannabis, especially for patients who may have limited access to it. We also issue a congressional briefing book, which will be updated for this year's new Congress. Also, the guy on talking to your doctor about medical cannabis. Research guide to contaminants is intended to provide an overview of the different types of contaminants that can be found in cannabis as well as hemp products. And I think that one of the things that we

should really start off talking about is kind of the difference between cannabis and hemp and as a Botanical expert Holly. I love it. If you could explain to everyone kind of cannabis and hemp are difference how they are the same and kind of how we're going to be handling our discussion today. Sure. Absolutely. So, you know, obviously cannabis and hemp, it's all cannabis. It's all Cannabis sativa. And one of the more interesting academic disciplines is taxonomy, and there's always this infighting among the taxonomists. But one of them are recent interpretations, is

that the genus cannabis is really made up of just one species and they've done this a lot, because it's one of the most hybridized Human hands for so long. So there's been some ways quite difficult to make a difference in the world today in the way that he specifically is defined. And I can also be a u.s. Centric definition, but there's some more definitions in in in other nations in the United States is now defined as the plants in the in the species Cannabis sativa,

that have not more than 0.3% THC. So it's kind of interesting that there's there's not many other species or varietals are cultivars over. The other articles define solely on the basis of one single chemical constituents, not usually how we Define, you know, at this point, that is really what it is. They are essentially the exact same thing, and of course, there's different varieties and cultivars, their Spigen fiber types that grow quite call with their stocks. Thought it was kind of the traditional industrial can but these days hemp can also

be, you know, big Christmas tree like plants Laden with with inflorescence. And again, just the one defining factor for him, is that it isn't has two hands. Not more than 0.3% THC. I think that's really important to remember is it's that differentiation is really strictly for regulatory purposes. In terms of the actual plant itself. They are all the same. They just have different levels of chemical constituents. Particularly Delta 9-thc because it is this like a Tropic ingredient

really quickly. You just made that the best point there is that it's really the significance is really more regulatory than in scientific in many ways. And if so related to Eric's your patient's guide to canciones here because I will get into talking about later the different states, you know, where where hi Stacy cannabis is regulator on a state. Not a federal level has led to this kind of Patchwork of regulations and of different testing requirements. So it is largely a regulatory definition, but it has some invitations for for quality and for contaminants

testing. It does and we're going to talk about that in just a little bit. A person to talk about some of the contaminants that we can't find and that have been found in cannabis and cannabis drive and what exactly is a contaminant. A contaminant is something that's not supposed to be there. It can be anything from microbiological species such as Beast, phone cases that are not beneficial to the plant. It can be residual. Testifies, that may have been used to combat some of the microbiological issues. I can be residual solvents. That may remain. After an extraction has

taken place particularly with hydrocarbons, and it can be foreign matter. Such as trellising, netting animal, droppings rodent droppings bird. Droppings, many of which are outdoor cultivation areas and ask the toxins and so Holly. Can you tell us a little bit about Larger Public Health implications for what it would mean, if contaminated products were to get into a patient's hands. Yeah, absolutely. You don't just send it to follow a little bit on what you just said. This is even though

cannabis is in the state system, many of them at least, considered a medicine. We know that on a federal level is sold as a dietary supplement to Stow courthouse. On that street already ate any disease and so it's another distinction is to think about pharmaceutical drugs as opposed to this thing called cannabis that grows out in the wild, like all of our other herbal products write these things are while they're in nature. They do have birds in the past and things around them as they grow for the most part. I'm so we wouldn't expect them to be cleaner free from some environmental

contaminants as we would have a pharmaceutical product that was made in a, in a laboratory or manufactured in a plant. Right. Good. Good. Remember that. These are wild things but cannabis in itself and way it works in the dietary supplements Federal Regulations. Is that for each or her brakes component, or that you're going to use? And they're certains, texting me to said, and including for the risk that you might have for each of particular, cereal component or finished product in, for cannabis. There's some very specific risk because of some of the ways especially that high THC. Cannabis is

cultivated variety of you know, very specific microorganism that are specific to. It is interesting that in some of the State Medical system that or just the state system Weatherby medical or recreational use contaminant testing, is really mandated mandated at different levels across the supply chain. That's really quite more specific and intensive than the, or more prescriptive than federal regulations for Botanical products in So, in some ways, if you're buying, you know, canvas products through your speaker systems, you can expect that. They've been quite well tested for

for contaminants such as you know, especially the ones that are required among states heavy metals, residual Solomon's testifies in that kind of thing, so that there is quite regressed and specific prescriptive contaminant testing but again, differing first date, so it is true Heather what you just alluded to that, if you're in, you know, Maryland that the products in and things that are available to you. There may have undergone a different level of of rigor, in terms of what different types of sage has

to be either, or either allowed or are required to be tested for. So I'm not sure. Exactly answered your question, but I think the point being is that patients buying things in that in the state-regulated systems have quite a good chance of Coming across the products that have been subjected to some pretty rigorous evaluation. Two ways that the Stace enforce quality control is through laboratory, sampling and testing. And so labs are tasked with identifying how the products to be tested. What is the

best method of testing? And, as you guys know, my background is in Laboratory Testing, so this is kind of my big area. So the Laboratories initially before they were even any Cannabis Testing regulations, were kind of tossing figuring out what are the most important things to even test for what are people interested in and realistically? Most everybody was very interested in just how is he testing? And it's only very recently that Laboratories has started to become more required to test for contaminants. And this has been an evolution as the state to

figure it out. What is the problems? What are any Adverse Events that may have been reported? What are the issues that patients and consumers? May be one of the big ones and if you look to our guide we talked about some of the recalls in the different things that have happened is the testing now, has it started to change in the landscape is getting a bit more rigorous in that more states are getting on board with more rigorous testing. Requirements versus just simply requiring potency testing, which For a lot of CBD products. That's all that's being done for them.

There are certainly producers who are going to lengths to get their products tested and provide accurate labeling. But what are some of the things that you think consumers and patients should be aware of if they're looking for products that how do I, how do they identify products that may have gone through a level of quality test and how do patients become more informed about product safety? That's a great question, Heather. And I think, you know, he's the guy that were talking about here. Today is a great step forward to that, too. It's a

kind of put, some of this technical Nuance into a, into a way. That's that's easier for you to understand. I think one of the big things, you know, when you talk about a sampling and testing the sampling in particular, I think even you know, many of the patients also wrote a recognized as materials are kind of oily right there with the cilic and so oil and water separator. And so when you try to put on put cannabis extracts and things into foods and beverages, you can have some issues with modernity and the the the stove I want to call Holmes may not be Distributed equally

throughout the product. And I think that's one of the biggest issue is not only with you, no inconsistencies that that patients might experience from buying the same given product is due to this incomplete Manufacturing in attention to sampling in when you're doing texting. So I think that's one of the few things and I'm not sure how well I think he's a truncation perspective, being able to ask the manufacturer. And I know that's not always possible in the context of dispensaries that you can come to look on the manufacturer's website.

Increasingly are pretty open about the products. They are selling even within their state, this type of thing, and displaying their certificates of indicators as quality on their website. And so that's one good indication that I made a specific brand or manufacturer is really paying attention to their their quality weather in sampling or the types of contaminants. That they're putting up and you can imagine nobody's going to post a B of A on their website that says, who are product field

for lead, right? So the fact that they're, they're able to display those. You don't even as a patient. You wouldn't need to be able to interpret the results necessarily and really dig in at a sea of a level. But the fact that they're putting cives there is and can be somewhat of a relief, you know, without having to go past one of a layperson's understanding of interpreting the results. So I think that's a really good sign. It seems very strange to me at first that companies were doing this because you don't have your, you don't put up your analytical results of your experiments, are your

turmeric products, but obviously, there's some very specific and special things about cannabis in some special quality concerns. So kind of transparency if they're willing to tell you what kind of things they tested for even. Even if the results are says conforms or class. It's a really good indication that they're doing their due diligence. In quality control in, in Tennessee way. Protocols overall. You and I think the information disclosure is really important are patient's guide to Steve Ade. He actually goes

into a very great lengths and detail to explain how to kind of look at a certificate of analysis and understand it. And you know that takes us to kind of like some of the different requirements. Some states do require disclosure on their packaging and labeling to say what one into the cultivation process. What was used in the manufacturing process? What ingredients have gone in Tuesday, food products, so that people have full transparency and information. And other manufacturers where they're not necessarily required to our meeting that information

available on their website. And I think one of the best ways that patients can protect themselves that you really look at all of the information, emailed, the manufacturer, what's the worst? They do tell, you know, we're not going to give you that information. Maybe you move on to another manufacturer who is willing to provide that information to you. Have a level of transparency that says we're committed to the quality of this product and we're willing to show you what we've done to make this product. But voluntary is all well and good. People used to

voluntarily get their cannabis product testing in. Now, as we move into more mandatory testing, we're starting to Grapple with the differences between not only state and federal regulations. But also the differences among the states themselves. And so are dyed, really goes into death about the different testing requirements that are at but I want to spend a couple of minutes talking about kind of what are those differences mean? For people who are purchasing a product in California vs, Illinois versus Maryland where they all have different testing requirements. They have

different labeling requirements and it's still different from what any sort of Federal Regulation would require as they determine their Pathways receive. Products on the market place. Yeah, Heather, I think of this is, this is one of the coolest parts of this of this Jason guy that that is just coming out. There's going to be a big table display it right on the final version that will go through each different state. And it's not even just as complicated. As you know, some of these require, this testing different

kind of thing. It really is even the level of at different places in the supply chain. So, you know, of course, you're going to be required to test for THC, at least, at a plant level and other products level as well. And then there's a certain States. Like, California has has three categories and a different requirements for each of those categories. So the flowers and then there's other inhalable products and concentrates, and then just other products. How much is a lot, right? That other category could be anything from your gummies.

You notice that kind of stuff all the way to know, topicals, and that kind of category or he's in Wednesday, either still some pretty broad categories with different types in there. So it's kind of infinitely when you start looking at this Matrix of all the different states. I think this is one of the key is immunocompromised or have, you know, some other types of this type of testing required. And I think that's going to be really useful in these types of systems and kind of develop their own. Regulations and requirements. And I

think that's one of the biggest things is that, you know, as we just been talking about it is so complex when the different states have totally different different requirements. So that's one. Great thing to come out of this particular piece inside and texting is really how I mentioned different places in a rush to develop these methods that are specific to cannabis and hemp cereals. And so obviously you're going to use when you have a brownie. Peanut butter cup, vs. Soda, water, or you don't concentrate or or gummy bear that for that matter. So

I'd especially with the contaminant. So that's been one of the biggest Some kind of some of the standard-setting bodies, like a owaisi that are trying to get really specific and validated accurate, and precise method that works on a gummy bear and just as well as it works on a on a brownie or on a. So we'll continue to develop those really fit for purpose message, but it is complicated enough and we both know people that have been, you know, charging through this end and you and I

need something to keep in mind for patients, that different states, have different requirements and in the patient's guide, you'll be able to come take a look at that what the different levels of testing especially for contaminants that are required for specific. Thank you, and I will see the ad that one other thing. That just patient guide will do is kind of give give all of your patience and people out there who are wondering. How is this going to affect me? It's going to give you some information about how to talk to

your regulator and how to go and get these changes made. If your state doesn't have the testing requirements that you need to do. Then, you know, you want to get that put into action so that you have a mandatory testing and that Jason's are going to be safe. And so, I think that's our time. We've been joined by a sleepy. Guest. Thank you guys for joining us. And if you have any questions, please feel free to reach out. Put them in the chat, ask questions and if we can't get them. All right. Now, we will definitely answer them at some point. Thank you very much.

Thanks. Aloha, everyone. If you have any questions, feel free to put them in the chat for Holly and died. We're happy to answer questions about our upcoming died. And we're looking forward to really giving everyone the information that they need to be an informed patients and informed consumer and have the the tools needed to help get the changes made to get these states are on track to start harmonizing the various regulations. Looks like we're not getting a whole lot of questions right now. So I don't know what color you want to add anything or give anybody some more

information and details to see a cartoon here in the in the chat about asking. When will the patient's guide be available on the ASA website and I know it's Force coming, but I wonder if maybe you could talk a little bit more about not only this patient sky, but kind of where it fits in the context in series of your other patient guides and how people can access those. Sure, so I had mentioned earlier in the discussion about some of the guys and information that is currently has available the Acer resources and we have a number of

resources out there that include our patients had two contaminants that we just put out a couple of years or patient's guide to cvd sorry that we just put out a couple of years ago, that goes into length to discuss various CBD applications that people are looking at, and it also refused how to read a certificate of analysis to identify the products that have been made safely and in manufacturing facilities that are trying to adhere to the highest quality standards. We also have a patient's guide to medical cannabis, our state of the state report and our Congressional

briefing book. That will be going out to this year's new Congress in a little bit are patient's guide to contaminants. We are putting the final touches on it and should have that. In a few weeks. That's great. So many good resources, Heather. Thanks for sharing that with everyone. I do see a couple other questions hear that, maybe we could, we could chat about one of them says, please share your ideas on acceptable levels of mold or mycotoxins in cannabis products. And you know how they feel

like you're almost more of the expert is when you want to come here that through on a pan States. Maybe you can discuss a little bit molding mycotoxins. And is it is it a required testing in all the states? And, and if so are the levels, the same? Mold mycotoxin testing are very tricky. There's a number of different ways that Laboratories can test for his product. And this is not the first commodity that requires this type of testing, especially for products that you're going to be in airing the United

States. Pharmacopoeia has chapters dedicated to our products, dietary supplements, such as oral sublingual. And so one of the ways that Regulators can really start to evaluate their state regulations and whether or not they're up to Snuff with what could happen in future potential Federal Regulations. It's mean, are they lined up with what's currently out there? And, you know, one of the challenges that researchers haven't had the opportunity to research how these may affect people. The same way that other researchers were pharmaceutical products

and dietary supplement have been able to research the, the health consequences of potentially consuming a contaminated product. And so we definitely want to make sure that we're pushing for greater boundaries for researchers to be able to study exactly what is going to happen to people. Potentially as far as Adverse Events, go and encourage people to report Adverse Events because some patience, especially that live in restricted, areas where maybe their access is limited or they're getting their medicines through alternative

channels. They may be hesitant to report Adverse Events because there would be consequences for patients that are reporting Adverse Events. If they have consumed, something that is going to be the templates for that. You know, Heather. I'll just add on to that too. I I love what you said at the beginning that, you know, this isn't the only commodity, or, or medicine that's over, you know, who had to deal with with Easton moles and we like to stay over at off of the American Products Association that. You know, what cannabis is just another herb as we

know. It's not just another herb for many, many reasons, but we do have it off of a guidance document and it's free to the public and open on our arpaia. Apa.org. Where we go over a total, like, we've got recommendations. It's a guidance document. So that, if you do decide to set limits on on, Multi, some multi mycotoxins, we have some recommended limits that can be said, is your specifications when you're choosing your methods of analysis. And so we have a whole column for, you know, dried unprocessed herbs. That might be all the Cannabis flowers and

then I'll suffer for powdered extracts off, text Jackson and that kind of thing. More processed materials. Have different limits. Obviously these standards organizations, especially like in their various standards will be adopted by the states. And hopefully uniformly, and the uniform this because, as a patient who may get their medicine, when they're traveling to visit family from somewhere else, that they're not sure there may not meet the same quality standards

that it would in their home state. If they're used to having product to be tested and understanding that if they're you know, some states that are allowing the dispensaries to provide the certificate of analysis to patients ahead of time. Some of them because they can't put it on a label there, putting QR codes on their packages. Nation. We want to make sure that information is available to every patient and consumer regardless of where they're located. And I think we are about a minute left to the question. So if anyone has any more questions go ahead

and put them in the chat. And if we don't have time to get to all of the questions, we will definitely reach out afterwards and be available either in the chat or via email to get any remaining questions. Answer. Yeah, I see. I see one of their additional, here. We might have time to just mention quickly at Heather, is on someone asking about remediation. So, if a, if a lot or a batch bails for a companion that might be different than it feeling for, you know, some other specification right. And I think for

mediation again, I'm not that familiar actually, another maybe you are in terms of certain, you know that certain states allow certain remediation stops for certain contaminants, but I think there's there's certain ones or are they allowed them to go in a certain direction? But in many states you just Must Destroy. I'm not sure that's a strange place. And although we have been talking about contaminants. But Heather maybe you have a parting comment on vacation and kind of the differences again throughout the states. Is that something we have to be aware of? What is some states? Do not

allow me to the remediation for those who are aware or reprocessing or reworking. Is, when a product fails a test and a state allows you to reprocess it for work and transform it into something that will pass it. And one of the big issues that you can't remediate pesticides and having there's just no way around it. Once it's in there. Even if you're making how to treat your just concentrating, those heavy metals. And at this point, there's not technology to get those removed and sell those products have to be destroyed for things like microbial contamination or residual. There are some ways

that you can repeat those prisons, residual solvents. You can just continue to process it and try and Purge any of those, all this out and get it to a level, where it's safe for consumption for microbials. I think the Sciences is really trying to help show that there are processing. Ways such as like CO2, extraction, where you're pushing, these are Robux. Rubio's into an anaerobic environment and ideally hoping, that during the concentration making process, they die off. And so there are some states that will allow reprocessing. The field flower has to be made into concentrate and some states.

That just force you to dispose of your entire product in your entire batch if it fails that. And so you should be aware of what their requirements are in your state, or testing and missed, or that your products, are meeting a requirement, that you feel safe and comfortable with. Awesome. I see there's some other questions in the chat, but I think sadly, we're out of time. And so, it's been so great to talk with you all. And I'm going to be at the event, the rest of the day. So if anyone wants to send an email, or we can admit that, it's been a pleasure.