We recently had a chance to catch up with Brett Puffenbarger to talk about his work at FOCUS. Founded in 2014 as The Cannabis Health and Safety Organization, FOCUS addresses the many shortcomings in quality, safety, and consistency that became evident with the explosive growth of the global legal cannabis industry.
FOCUS is an international, nonprofit cannabis standards development & third-party certification organization dedicated to protecting public health, consumer safety, and safeguarding the environment.
FOCUS is not an advocacy organization nor an industry trade association. Accordingly, FOCUS does not accept membership dues or fees for standards development. This autonomy fosters a principled, objective environment that serves end-users, providing an impartial bridge between industry and regulatory.
FOCUS Standards provide current good manufacturing practice (cGMP) guidelines for all critical areas of the cannabis industry, including Cultivation, Retail, Extraction, Infused Products, Laboratory, Security, Sustainability, and Packaging & Labeling. The FOCUS certification process is designed around proven processes for quality and safety. FOCUS certification is a partnership designed to help cannabis businesses achieve their goals and vision, improve efficiency, remain compliant, and minimize risks.
Learn more at https://www.focusstandards.org/
(edited for publication)
Good afternoon and welcome to Cannabis Conversation. My name is M. Patrick Doherty. On I am your host. We are here with Brett from Berg, who is the Director of Sales and Marketing at FOCUS. So what is FOCUS?
FOCUS is the Foundation of Cannabis Unified Standards. And the short answer is we’re a 501-C3 nonprofit certifying body to upregulated standards.
And why do we need this? Why do we need this nonprofit?
The short answer is, is that cannabis isn’t like any other industry. We’re similar to a lot. We have similarities to consumer packaged goods; we have similarities to alcohol and tobacco; we have similarities to pharmaceuticals. But none of the current standards or standardized bodies encompass everything that cannabis needs.
So our founder, Leslie, took it upon herself to think about what I would want as an operator because she’s an x operator herself, just like me. And it came down to we don’t need to reinvent the wheel. But we do need to take the best pieces of all of the wheels that are similar and put them into one thing. So she decided to go about this using the CARF Model and come up without the existing standards for the mainstream industry, which pieces are most relevant and which pieces are most applicable to the cannabis industry and then put them in a particular format that hits the four main pillars currently of cannabis operations. So cultivation, retail lab testing, and manufacturing are a little broader terms than some people might think. So hence, manufacturing is extraction, processing, packaging, and fusion, all of the things that happen after you harvest the plant before you start to sell the plant.
And honestly, the big thing is, standards are crucial for the long-term development of an industry. And at the end of the day, FOCUS strives to be a health and safety organization. That’s it. That’s all FOCUS cares about. That’s FOCUS, his main primary mission; it’s the whole thing that keeps us all up at night. So how do we ensure a safe, healthy industry for consumers for patients, and employees? How do we help cannabis businesses do better in those realms?
And are you creating the standards? Or are you just simply looking to enforce them and moderate them?
So we created the standards, and we’re going through the final stages of Anssi accreditation now to be a fully accredited, standardized body.
And does this include products such as CBD and things like that?
Of course, it does. Yeah, so we are nondenominational between which side of the cannabis plant we’re talking about. Truth be told, the differentiation is arbitrary and legal. It’s not scientific. So whether it’s the hemp side of the house or the high THC cannabis or marijuana side of the house, at the end of the day, it’s the same plant, and it should be looked at the same way. So it doesn’t matter if it’s a CBD gummy producer or a high THC multistate operator or anything in between. We believe at the end of the day that standards are crucial for their long-term development. They’re crucial for the health and safety of patients and consumers. And just in general, they make for a better business.
I brought up CBD because that was a clear example of not knowing what you were getting when you bought a pack or bought a product. That was either not labeled or mislabeled or representations of what was contained. It was just basically a crapshoot. What you were getting product wise
This is still happening to a large degree with Delta-8 or THC synthetics, semi synthetics, or minor cannabinoids; we’re still very much in that boat.
Do the products like Delta-8 undermine the credibility of the cannabis industry in general?
That’s kind of a loaded question.
That’s why I asked.
I don’t normally shy away from answering a question directly, so I’ll do my best. I believe it is the position of FOCUS that all minor cannabinoids could have a place, and they deserve to have a place because we just don’t know there needs to be more research into them t; there needs to be more efficacy or understanding of the efficacy there needs to be more put into it to know so by no means should any of the minor cannabinoids not be considered in the pantheon of therapeutic medicine that is cannabis. But they’re also made in a potentially very dangerous way. A lot of the time, they’re made in a very scary way.
A simple question I’ve seen thrown around there that have gotten into the habit of using too is do you want to vape acid, because at this point, the creation of those is made with that, or, even worse, it’s acids and palladium and additives, and they’re very much. They’re very much substances that aren’t necessarily made simply, like growing some cannabis and extracting it from the machine. They’re created through a lot of fancy lab work. And we just don’t know if they’re healthy if they’re safe. And if we are going to create them, as an industry, we should be doing that with the utmost care.
So that’s kind of where we land on that one. It’s, are they a bad cannabinoid in and of themselves? No, is the current way they’re being marketed and created and sold on the market detrimental to the industry as a whole? Probably. And that’s a problem, right? We’re just now coming out of this era of stigmatization. And the last thing we need is to be asking for a black eye while we’re still kind of in the toddler stage of the industry.
Yeah, I mean, this was produced to circumvent some of the regulations around other cannabis products. So the fact that it was created to circumvent and sort of bypass what any other cannabis product would have to undergo suggests that it’s questionable in nature.
I mean, so the particularly with Delta-8 is a naturally occurring cannabinoid. It’s not a naturally produced cannabinoid. And what I mean by that is, the plant doesn’t produce it during its growth. So you’re never going to get a healthy growing plant that’s got any measurable amount of Delta-8 in it. Delta-8 traditionally exists in a dynamic state during the degradation of CBD. So basically, while the plants rotting, it shows up and in the process with which to get it in a commercially viable state or to produce it even is basically to take CBD and acid wash it and degrade that CBD down into this molecule, which is quite similar chemically to Delta-9 THC, the THC, we all know from regular everyday cannabis. And right now, we can test for Delta-8. So we know it’s in there. We can test for a lot of the interesting things that we normally test for heavy metals, pesticides, all of that.
But depending on the lab, we might not be able to test for the acids used as the solvent to get there; we might not even be able to test for the Delta-8 accurately. I saw a recent study, I can’t remember who conducted it, but somebody went out and purchased a large chunk of Delta-8 products. And most of them weren’t even registering with the amount of Delta-8 0n the label. And that becomes a kind of sketchy. And then you get even further down the line. You get into something like Hexahydrocannabinol (HHC), where, up until a few weeks ago, there wasn’t even a lab standard to tell us if that’s what was in the products, yet, they were immediately being flipped and oversold the market, you could goy them in a gas station. And that’s kind of a sketchy proposal for anybody, whether you’re like US Health and Safety Organization (USOR) you’re just the average everyday consumer, I at least want to know – and I think most people do – is that what’s on the label is what’s in the package.
I mean, that has been one of the primary selling points of legalization. Understanding what you’re buying and sort of the risk of the black market. With the black market, you don’t always know where it came from, what’s on it, that type of thing. With legalization, one of the talking points was to ensure that, through legalization, you would know what you were getting. This Delta-8 product sort of reverts back to a black market sort of deal where it’s questionable what we’re getting at what it contains. And in the early days of CBD, people clearly jumped on the CBD bandwagon and put CBD on the label, regardless of what was in the product, because it sold as a result, and it just feels like Delta-8 is trying to do the same thing.
Oh, it most definitely is, if not even bigger, right? It’s this whole phenomenon of minor cannabinoid chasing where, particularly in the United States, we as a country are producing more hemp products than we’re consuming. So then it inevitably leads to this kind of tiered effect or this domino effect. Were, oh, well, if this one doesn’t sell, let’s go ahead and use some fancy chemical maneuvering and try to sell this one, or this one, or this one. And at the end of the day, particularly the psychotropic or the minor psychoactive cannabinoids produced under the hemp banner are proof in the pudding that the demand for high THC products is there.
And I think a lot of this is a symptom of continued quasi-legal or somewhat prohibition status. We’re still federally illegal in the United States; we end up having a workaround or a loophole, if you will. And that’s a problem in and of itself. Like the people want the real stuff, and they’re settling for the less real stuff. And at the end of the day, we’ve kind of taken a position at FOCUS that these cannabinoids shouldn’t be banned. They shouldn’t be outright forbidden. But they probably should belong in the regulated market along with their other psychoactive cousins, rather than sold in a gas station or a head shop, or your local big lots are online.
eCommerce? You have a credit card, you can buy it? Absolutely. I mean, this is about understanding what you’re getting; this is about understanding whether or not it’s safe. And the other sort of pushback that we’ve heard relates to legalization and stuff like that was, and standards were, well, they won’t let you get the good stuff that they’ll cap how potent it can be. And that’s why people don’t want standards, because we want the highest possible buzz that we can get. And we’re afraid that that will be infringed upon. So if you are subjected to standards, what do you think about that?
I think that’s a little bit of a slanted argument; straight to standards, from our perspective, has nothing to do with what you put out as a final product. It has everything to do with the process you go through to get that final product. You should follow good agricultural or manufacturing practices throughout your facility that didn’t edit the end product. That doesn’t lower the amount of THC or CBD or whatever thing you’re looking for in your product. That just ensures that the product you are putting out is what you say it is. It ensures that it’s clean and safe and that your employees are safely creating it. So a lot of these concentrated products are made with hydrocarbon extraction, ethanol extraction, or supercritical co2 extraction.
And I don’t think it’s a stretch to say that those are arguably dangerous methods. Suppose done wrong, right there. They’re volatile solvents that could explode, or they’re under extreme pressure. And standards don’t talk about what you’re getting out of the machine. They talk about what you’re putting into the machine, they talk about how you’re operating the machine, they’re talking about how you construct your facility, they’re talking about how you handle a situation if there is a catastrophic or minor failure.
And an example that was used in the recent FOCUS and after joint webinars surrounding the cannabis administration and Opportunity Act was a facility without standards that had a catastrophic failure of a hydrocarbon extraction machine. And it resulted in an employee going to the hospital that resulted in multiple days of downtime while they cleaned up the facility. And on the other side, highly regulated GMP facilities had a very similar catastrophic failure; they only had 27 minutes of downtime. And that number was something that gets thrown around the FOCUS, water cooler, or conference table is often a misconception that standards are an expense, and they aren’t. They’re an investment. They’re an investment in future time saved. They’re an investment in future employees’ lives saved; they’re an investment in continuing to have better products out there.
So something I heard said a long time ago is that as a product producing company, or a service producing company, but in this case, a product producing company, your goal should be one thing to delight your customer. And how do you delight your customer by delivering consistent, guaranteed products at a very consistent clip when they demand it in a format that they’re looking for. And you live up to your promises? And too to do all of those things. You can’t just throw a machine in a shed somewhere, turn it on and hope for the best. You follow the same process every time right your source Your product is from a very reputable place that’s following standards that guarantee that you’re getting the right products, you’re putting it through the same process done the same way, you’re packaging it the same way. And you’re double-checking those things. And it all kind of comes back to standards or like that adage of Measure twice, cut once. Well, we’re not cutting anything, we’re producing things, but the idea still stands.
And that’s, that’s a big issue, I think, within the cannabis industry, because, like I, the whole idea of consistency can walk into a McDonald’. II can order something anywhere in the world and expect I will get what I expect to receive. The French fries taste like McDonald’s french fries, regardless of what country I’m in. My experience in the cannabis industry I that I will find a product I like, and the next time I go to buy it, I’ll have a different experience because it’s not the same product. It’s not the same, I mean, so that lack of consistency is a big problem, and then typically, if we have products, such as we talked about with it earlier, CBD products, where they weren’t even, we don’t know what was in them half the time. So, of course, we didn’t have any consistency. Let me like your question about standards; how did the standards impact what results on the labeling? So, by looking at the label, we know what we want and what we expect?
So I think the simplest way to answer that is, his standards start with a quality management system and the ability to track what you’re doing. And to get an accurate label on something, you have to have honesty. So, like, we can’t teach that we can’t, we can’t regulate honesty. But what we can do is provide a framework for honest people to do what they will do. So we can provide that framework where we can test for honesty. We can, though, the cannabis industry does have a good bit of interesting pieces in the lab testing thing. So not very many places in cannabis require true third-party sampling of the test, which is kind of a sketchy endeavor.
So, if you’re in corn or alcohol or another industry, the testing body will send a person to get a random sample, a lot of the time in cannabis, you’re going to get to test your sample. So you’re going to pick the very best part so that it reflects so you can self-report. And then we get into the whole concept of lab shopping. So a lot of the time, the cannabis testing labs, particularly in the United States, are their own business. So it behooves them to return value to the customers if they want to continue getting a customer,s the cannabis operator who’s producing a product. I’m not saying they all do it. I’m not putting the onus on testing labs at all. But there is a very legitimate set of circumstances where we have the whole phenomenon of lab shopping. A cannabis producer will send out the same batch to four or five different labs, and they’ll go with the certificate of analysis, the CLA that matches what they’re looking for.
So is this a result of just still being a young industry?
Probably, yeah, I, a lot of the times, we’re emerging. Like we’re just now coming out of the black market legacy market prohibition mindset. And we’re very quickly becoming big business. And it’s probably safe to say that a lot of the time, the size of the cannabis industry and total volume and total numbers make the industry seem a lot more mature than it is. But the truth of the matter is, we’re still very much in our infantile stage. And another kind of interesting point along those lines is there isn’t a cannabis industry, not in the United States.
We have 37 different ones, or 38; many states are legal this morning because it seems to change regularly. But each one has its requirements, its structure for licensure, its requirements for testing, and its requirements for distribution for tracking and tracing of products for verifying any information. And the interesting part, at least from the FOCUS perspective,e is none of that matters if you’re following a rigid adherence to quality control. Suppose you’re doing all the right things if you’re following standards, whether there are standards or somebody else’s. If you’re following standards, it doesn’t matter what the framework is; it only matters what you’re doing and your adherence to those things.
And have you seen greater adherence when it comes to Medicinal Products? Maybe
It depends. There are a lot of places and a lot of companies that are incredibly cognizant that their target market is very sick people who need a very specific set of things. And then, of course, others just got the medical license to piggyback to an adult-use market. So the answer at the end of the day is maybe it depends. And I, at the end of the day, again, hate to reuse that. But at the end of the day, the only thing that we can guarantee is, do your research. Like, guarantee yourself that you know what you’re getting. My friend has at-shirt that says, skip the sales pitch and show me the lab results.
And I think that’s a safe way to shop as a cannabis consumer right now because there is no way to know until you know, and that’s the only real source of true data that one can find to know anything because if you apply the medical standard. Typically the medical standard is evidence-based. It needs to be tested; it needs to be put through trials. It doesn’t immediately go to market, which is the frustration and why we see the workaround. Because this is an expensive process, this is a timely process. So you can’t just drop things on the market. But one would hope that if you’ve gone through this evidence-based approach, we have a really good understanding of what is contained in the product and whether or not the efficacy is there or not, or the efficacy meets the claims that they’re making.
So something we did at FOCUS was we participated in the draft bill responses to the cannabis administration and Opportunity Act. Lots of cannabis organizations, companies individuals did. But something we did above and beyond in our partnership with after the Association of Food and Drug officials is we proposed a four, four-lane, or framework for federal legalization, right? So adult uses adult use, we know what that one is the device industry 21 And up and industrial hemp, that’s one of the four that one’s pretty, pretty simple. We found it unique or novel because we separated what we currently call medical from true medical. So we believed, myself in particular, that what we currently have doesn’t fit the medical criteria; it’s medicinal or, more accurately, probably therapeutic. It’s an illness, right?
It’s the rejection of westernized medicines, the rejection of standardized ingredients, and all of those things. And it’s a more homeopathic approach. So whereas medical, in our minds, would be advanced pharmaceutical ingredients, its isolated cannabinoids put into a very specific format and pill form or, Epidiolex, or one of these things, those fit more of the medical case. So when we put together our cannabis administration opportunity response, we cut it into those four.
So therapeutic being what we currently call medical, adult-seeing what we all know, industrial being kind of what we have under the Farm Bill. And then we have the actual medical pathway. The standardized API and ingredient-based pharmaceutical Processing. And that makes kind of the most sense in our world. And we’re going through a series of webinars now where we’re collecting feedback on our feedback, as met as that sound. So we conducted a webinar a couple we weeks ago, where we kind of went over this is our response. This is everything we put in there. This is our thinking behind it.
And now we’re in the process of collecting survey results from relevant stakeholders. So industry members, regulators, government officials, on where they think we’re not feasible, where they think it is feasible, where we nailed it, where we went off, a. So we’re to continue through a series of things because, at the end of the day, we’ve got kind of these competing pieces right now. And there isn’t a cohesive industry regulator, relevant stakeholder for mainstream industry voice to talk to the federal government as they’re trying to kind of unlock the puzzle that is federal legalization.
We are hoping with our partnership with the Association of Food and Drug Officials (AFDO) and continuing to kind of drive down that path that we can hopefully provide that right so that we can bring in the relevant stakeholders and have a roundtable and a brainstorming session and come up with the best possible way that at the end that keeps Health and Safety First of mine, for consumers, for patients for employees, but also results in a healthy, vibrant industry that allows people to kind of live the American dream, we want people to be able to participate in the industry, in every possible facet. And into that, it’s going to start with the framework, and it’s going to proliferate out from there.
And so, what are the goals of FOCUS? Are you looking to establish these standards? Are you looking to increase adherence to these standards? What is, sort of the short term and long term goals of your efforts,
Both. In the end, we are the cannabis health and safety organization that is first and foremost on our plate. And then kind of pass, we want to provide a format with which every cannabis company can keep that at the front of mind. So short-term goal is to continue to drive forward and provide more standards with which cannabis companies can adhere to continue toward that international accreditation level where it’s becoming an industry standard.
And then the long term goal is exactly as you suggested, helping people adhere to those standards, because standards are the thing that will separate us from any other industry standards are the thing that will allow us as an industry to grow up and be part of the consumer packaged goods, alcohol, tobacco world of things because all of those industries have them. So that’s right, we need to we need a novel code for cannabis production, we need strict standards for every conceivable niche of the industry. And we need a framework that will allow that, and we’re trying to do all of those things at once. And not only in the United States, where we’re also working with foreign countries, foreign entities, whether it be private industry or government, to develop this on a global scale. Because eventually, cannabis will become a global commodity.
And we will have to start looking at GMP; we’re getting there now where countries will start importing and exporting and doing all of these very big things. And to get there, how else are we going to know that what’s produced in Morocco or Portugal or Spain meets the standards of Thailand or Australia or Lisu, and vice versa. And the only way to do that is if we have standards.
And once you know – not that the standards ever end – but once you have a set of standards? Well, you also then move into education. And trends
that are definitely on the docket of things. We are not unaware that eventually, we will run out of bandwidth. And you kind of have to take the larger model of how do you train third-party consultants and auditors to these standards? How do you allow other people to participate in that? That’s very much in the wheelhouse of things.
We break things down into three parts, we have the standards, and that is it. And then we also have our regulatory and Government Affairs portion, which is specifically designed to help governments, regulators, authorities, legislators, whatever you want to call it, understand the process of cannabis and then decide on adopting some standards. And then we also have the consulting arm because many cannabis operators aren’t the right now. They’re not at the level of being certified to the standard. So we’ve also tried to provide that helping hand on how we can help you learn the process work through the process? How can we be the guiding light to get you to a place where you’re ready for these standards?
And do you find that most of these entrepreneurs aren’t seeking out support? Or are they looking to pull it off as long as possible?
That’s dependent. It’s becoming apparent that quality is a selling point and is becoming a huge differentiator for operators. They want to differentiate,e and a lot of them look toward ISO certification or Code of Federal Regulations, Title 21 and insert a number here 111 211 Something.
We see that in all other industries, as you said, we’re used to that,t and we can get comfortable with that.
What we’re seeing right now is, is there’s a lot of people if they’re there, not the entire industry, but they still is this contingent of if it’s not required, we’re not going to pay for it but The ones who are interested right now the big hurdle is they hear these mainstream terms. And they and they go for that. And they want to retrofit a standard from another industry into cannabis. And the big hurdle for us right now I, how do we convince them that there is a native to the cannabis industry standard that meets or exceeds all of those but is also keeping the unique needs of cannabis operations in mind.
And if people want to learn more, where should they go?
Okay, we will make a point to put that website and your social channels in the text below. We very much appreciate your time today and sharing this information. We wholeheartedly support what you’re doing; we believe in standards and think it’s tremendously important. So please keep fighting the good fight. And again, thank you for your time today.
Thanks. Have a great day.