Cannabis is a Good Neighbor: Consumer Safety

We’ve round up key takeaways from our latest “Cannabis is a Good Neighbor” podcast episode featuring featuring Sarah Chase, Executive Director of the Council for Federal Cannabis Regulation, and David Vaillencourt, CEO and Founder of The GMP Collective, to discuss cannabis regulation and its vital role in human health and safety. Listen as these industry experts address how cannabis operations are a good neighbor here.

Key takeaways:

  • Currently, we have an illicit market moving to the licit space. Education must occur with those who have been operating on the fringe of this industry. There is currently no incentive for people to move from illicit to licit market as the standards and regulations are so complicated and chaotic to navigate. It is highly frustrating for the legal cannabis industry as the illegal, unregulated market is still working freely.  
  • There is a lot to consider regarding the cannabis industry, but it all comes back to the health and safety framework. We have the resources to provide our marketplace and set minimum requirements to ensure public health and safety. 

 “We have untested, unregulated, and sometimes extremely dangerous products that continue to proliferate throughout the country, creating a needless risk to public health. The lack of oversight, framework, and understanding of the process only creates more problems. The cannabis industry is full of potential and opportunity, and we do not want the lack of standardization to do a disservice to the industry’s reputation. We need to work towards implementing safeguards so everyone can have a trusted marketplace.” 

 

Federal Regulation Benefits: 

  • Currently, industry standards vary by state; there are no uniform standards. Federal regulations could alleviate some of these industry pains by setting standards across the board instead of the assortment of regulations and standards states are implementing.  
  • Facility design, dosage, product type, labeling, packaging, everything from seed to final consumer will be considered for regulatory standards. Standards and regulations set the bar to inform and ensure human health and safety across the board. 
  • Federal regulation would limit corporate liability because they can get outside investments, safe banking, and international trade. 
  • Something often overlooked is the burden of regulation in any industry, but it’s a burden that creates tremendous opportunities. It opens substantial trade markets, additional interstate markets, internet commerce. 
  • As the industry matures, it will be amazing to see how regulation protects the business by putting in the demanding work designing it and committing to patient and consumer safety.  

 

Federal Regulation Roadblocks: 

  • Our main point is that the Federal Regulatory Agency, specifically HHS and the FDA need to address a public health crisis that’s been unfolding across the country for several years. It’s a national crisis resulting from erratic state legalization and the increasing severity of low THC cannabis products, hemp, opened and created by the 2018 Farm Bill.  
  • The FDA’s reading of the exclusionary clauses, which were put into the Federal Food Drug and Cosmetic Act, prevents the regulation of CBD products and has hand-strung the agency. 
  • The FDA has been working under limited resources due to the COVID19 Pandemic.  
  • Each state has a varying tax rate on cannabis right now, and all approach it differently. Adding federal regulation or federal taxation will burden the system again. At the same time, we need to be cognitive about taxing people out of the market, both the producers and the buyers, as repercussions could lead to paying an astronomical amount to produce and buy products. That is one of those unintended consequences that could occur depending on how we tax these products. 

 

“There is a multibillion-dollar marketplace where consumers can go to 7-11, grocery stores, convenience stores everywhere and get product. And as a consumer to the untrained eye, it’s fairly reasonable to assume it’s on a store shelf? Must be safe! Must be overseen by somebody; it wouldn’t be sold in the supply chain and available at a publicly registered, legal company if it wasn’t safe, but that is patently false.” 

  • Depending on the state, a different office handles cannabis control, or a new office is established. The way various offices approach cannabis control can vary drastically. One way of regulation would be to establish an office of cannabis control that falls under the FDA. Still, a new office requires funding for resources, leading to the issue of where the funding is coming from? Funding this office is critical. There is a significant mandate to protect public safety; 25% of consumer goods purchased have FDA oversight. We have differing perspectives on how cannabis should be regulated at the state level, which informs what we can do at a federal level, but we should identify and adopt the best practices from each of these states. 

“I’m a very satisfied American knowing that the FDA, CDC, and NIH, and all these other agencies are looking after public health. We should be trying to assist as we are lucky to have an agency doing the due diligence.” 

Brian Anderson

Principal, Co-Founder

Anderson Porter Design

www.Andersonporter.com

Brian@andersonporter.com

617. 354. 2501

 

DV Headshot good manufacturing practicies cannabis ultivation human safety

David Vaillencourt

CEO & Founder

The GMP Collective

www.gmpcollective.com

David@gmpcollective.com

720. 588. 2458

Sarah Chase

Executive Director

Council for Federal Cannabis Regulation

www.uscfcr.org

sarah@uscfcr.org

402. 889. 5152

Cannabis is a Good Neighbor: Consumer Safety Transcript

Below is a transcript of the podcast episode, which you can listen to in full here, edited and trimmed for clarity and brevity. 

Brian: Alright! Welcome to Cannabis is a Good Neighbor, a podcast from Anderson Porter Design. This is our episode number 5, and I am super stoked to have Sarah Chase and David Vaillencourt joining me today. This is a Public Safety 501 course, a master’s course on where the cannabis industry is headed in health and public safety, because Cannabis is a Good Neighbor, is designed to talk about issues surrounding cannabis from the laypersons perspective or the legislator’s perspective. I have two experts here who can help fill in where we are today and where we are going in 2022 from a perspective of drug manufacturing, really embracing this industry as a drug manufacturing industry. So, Sarah Chase, could you please give us some highlights and backgrounds to help our listeners know who you are and where you are coming from. 

Sarah: Sure Brian, thanks for having me on the show with you guys, and congratulations on your 5th episode, you are hitting milestones here! I’m Sarah Chase. I’m the Executive Director of the Council for Federal Cannabis Regulation, we are a non-profit based in DC. Our main mission is to help bring evidence-based, well-informed science to the federal regulatory agencies. To be conducive to information that flows freely between the people within the industry, with government, with business, and to really work with everybody involved to normalize the use of cannabis as both a sustainable product, a health product, a medicinal product, and with normalization, to help legitimize it, and really with everyone in the industry to destigmatize it. That includes expunging records, working with people on diversity and inclusion initiatives. It runs across the board. I will state that we are a unique group that we are very objective, and we are sort of a neutral third party so that we can work more effectively and efficiently with some of the federal agencies in order to bring this information forward and to really be working with all of you as a unified voice for the industry where the health and safety of the American people are first and foremost in our minds.

Brian: Awesome, and I will want to get into that, some of the things that you have been coming out with and publishing, but let’s introduce David Vaillencourt. David and I have a long history together, both on the facility design committee, but David, tell us about your background.

David: Awesome! Yeah, thanks to Brian, it’s great to be here, and Sarah, so great to see you again. Really excited about this, thank you for putting this together, guys. So, I am David Vaillencourt, I am the CEO and Founder of a company called the cGMP Collective, we are working with our team of consultants and experts to bring credibility to the marketplace, the cannabis and hemp marketplace that is, through quality management. One component of quality management is current good manufacturing practices which I know we will get into. In addition to this, I serve as incoming Vice Chair, probably Vice Chair by the time this episode drops for ASTM Committee D37 on Cannabis. That’s ASTM International, a 120-year-old standards development organization that help launched and support member-driven, volunteer-based standards development group, Committee D37 on Cannabis, to really bring credibility to the industry where the scope is to develop and maintain standards, and guidance materials for cannabis and its products. This work is coordinated with other ASTM committees and other organizations having mutual interests. So we currently have over a thousand members across 30 countries workings on the consensus standards process which can be utilized by industry, all stakeholders really, in the industry, from how do you actually follow best practices, what are those best practices, regulators can adopt them and incorporate them by references. Over 200 ASTM standards are currently referenced in the code of federal regulations in the United States, let alone globally and beyond that protect consumer health, which everything that we are here to talk about. Without these best practices, without the work we’re doing, without the FDA showing up, we are doing a disadvantage to the consumers today, and their health and safety is first and foremost. So it’s really fun and awesome to be here and through all the work that Brian, you, and I do at NCIA and elsewhere. It’s a labor of love and really rewarding.

Brian: Yeah, so listeners know – David and I have known each other a few years now. David is from Massachusetts lives in Colorado now. We met way back through mutual friends, and David now consults on projects that we work with, so it’s great to have that. David has introduced me to Sarah, and Sarah I’m just absolutely fascinated to hear more about what you mentioned earlier about a news announcement. So you’re working at your organization to influence policy at the federal level. What I want to bring forth here is to the folks that don’t know that cannabis is a drug manufacturing or drug production industry, it’s not in the basement anymore. People involved in facility design, and every aspect, is a drug delivery system, all the way from growing the plant to extracting and manufacturing the plant and delivering the plant to people.

Sarah: Yeah, and we are dealing with a long history too. Basically, you have an illicit market that is moving to the licit space. So, a lot of education has to occur with people who have been operating on the fringe of various areas throughout this whole time. And I think what you do with standards and eventually with regulation is that you start to set bars that inform and ensure human health and safety across the board. So, you know it’s vital the work that GMP does with David, the work that you do in facility design, even from just making sure you’re OSHA Compliant, and you know you want to make sure you got the sinks before you pour the foundations and you don’t have to strip everything out and redo it based upon code and regulation for various areas. My father was an architect and in constructing, and it’s the same thing its design think, to make sure your installing the best practices, building the best foundations, and working towards various standards. Now the difficulty we are dealing with right now is there are no uniform standards across the board which is why federal regulation begins to make a lot of sense, because then you can sort of say ‘here are main targets’, the places you really have to go to in terms of standards, and not just in terms of facility design but also in what the dosage is, what the product is, what the labeling is, what the packaging is, everything from seed to the final consumer you have to be in consideration of what those regulatory standards are. And right now, it’s sort of just a hodgepodge of all the states coming up with their own variations and rules. That causes a lot of chaos at the end of the day and doesn’t incentivize people to move from an illicit to a licit market. And ultimately, talking about federal regulation, that’s also something that limits corporate liability, because they can get outside investment, you can do things like safe banking, you can do international trade. All the doors really start to open up. And to sort of help with that is CFCR – we are kind of the nerds of the groups because we are focused on the ways you can start to create pathways and start to open initial doors. So yesterday, Brian, you had talked about the bit of news we had. We sent a letter to Secretary Xavier Becerra, the head of Health and Human Services with a CC to Jannet Woodcock, who is the current commissioner at the FDA. Our main point is that the Federal Regulatory Agency, specifically HHS and the FDA need to address a public health crisis that’s been basically unfolding across the country for a number of years. It’s a national crisis that’s been the result of erratic state legalization and the increasing severity of low THC cannabis products, basically hemp, that was opened and created by the 2018 Farm Bill. The view of CFCR is that it is critical that we work to overcome the choke point that has been repeatedly pointed out by the FDA, which constrains it from regulating a lot of cannabinoids. So, the current legislative attempts, including the CBD Product and Safety Act that I think was introduced last week. They’re stagnant. These legislative processes right now aren’t really going to go anywhere, whether it’s the CAO Bill or Mace’s bill, there not going to see the light of day for a while.   

Brian: Break that down for us. There’s a lot of 3 letter acronyms, so maybe people don’t understand the jargon here. So, your organization CFCR has written a letter to Health and Human Services. How do you see that stagnation? What is that stagnation again, where the low THC coming out of the Farm Bill impedes development or growth?  Sarah: Well, it’s a little more specific than that. So, we believe that the FDAs reading of the exclusionary clauses, which were actually put into the Federal Food Drug and Cosmetic Act, is preventing the regulation of products containing CBD and have sort of hand-strung the agency. While at the same time, you have untested, unregulated, and sometimes very dangerous products that continue to proliferate throughout the country. That is creating a needless risk to public health. So, our point with FDA is; alright, lets wave the drug exclusion rule and start to work on regulating these products right away, which we know can be regulated right now because they are in the market, and they are legal under the Farm Bill.   

David: If I can add to that, and you guys are the experts over there, I’m so grateful for that level of nerd work going on, you’ve got the engineers, the standard developers. I call ASTM D37 the nerd group as well for sure, for complimentary reasons, and without knowing, you can maybe speak on how the drug exclusionary act can work, but back to the point, ASTM. I just helped them develop a white paper on Delta-8 THC, and it was done in conjunction of the US Pharmacopeia, which is a 200-year-old nonprofit scientific organization that essentially has monographs and Pharmacopeia chapters, general chapters that ensure that our worlds medicine is safe literally the world, in addition to the United States where they started in the 1820. And the takeaway from our research and what we publish through ASTM and the US Pharmacopeia is back to its not just Delta-8 that is unsafe, that’s not the issue – it’s the lack of oversight, it’s the framework it’s the lack of understanding the process. And because of the Farm Bill of 2019 we have opened up pandora’s box! Forget whether it’s legal or not, forget what the FDA says, forget what the Feds say. There is a multibillion-dollar marketplace where consumers can go to 7-11, grocery stores, convenience stores everywhere and get product. And as a consumer to the untrained eye, it’s fairly reasonable to assume it’s on a store shelf? Must be safe. Must be overseen by somebody, it wouldn’t be sold in the supply chain and available at a publicly registered, legal company if it wasn’t safe, but that is patently false. There is no oversight, and it’s through this void. If we don’t correct that, we will be in big trouble, it’s going to be just a matter of time until we see other problems crop up. We’ve already seen recalls, heavy metals being in regulated products. What’s in the unregulated products? Who’s going to oversee and ensure that? Where are the standards to assess the toxicological data or etcetera? We need that. We have so much opportunity within the cannabis industry, and we don’t want to do a disservice to the reputation of our industry. Back to the whole point of this podcast, right? Cannabis is a good neighbor. Let’s ensure we have the safeguards in place so the products are safe and everyone can have a trusted marketplace. 

Brian: So, I’m speaking now as a practitioner, so joining this conversation to say that as an architect working in the cannabis industry, I am finding that different laws in different states lead to a lack of standardization. So therefore, you are saying – how is a consumer going to know when they go into a gas station to buy a CBD product versus going into a dispensary, maybe medical or adult use, is the product safe, is it controlled, is it the same? And I know trying to follow regulations as a designer of facilities is difficult. So, we are looking for those standards, and then we are looking for them to be adopted federally. Quick snapshot here, the industry is nauseant, the industry is still growing, and we don’t have complete consistency amongst states. The big news coming out of New York was all the folks looking to develop a business in New York State will be required to follow the Code of Federal Regulation, 21 CFR Part 111, more specifically part 117, which is GMP for food. We know that Connecticut also follows that standard. I think both of you have some experience in Connecticut that could be relevant to our listeners, how these new states, looking at New York, New Jersey, Pennsylvania, Ohio, and the New England states that’s a massive amount of people. How do those people know, in these various states, that there is consistency across products coming out of those states? So what are some takeaways about cGMP and its implementation that you could add Sarah or David? 

Sarah: I have a question for both of you. Varying by state, I believe but could be wrong, that in Connecticut cannabis, it’s kind of funny that in each of the states, it goes to sort of a different office or establish a new office. Each one comes at it from a different perspective, so you can automatically think that the philosophy or ethos of, let’s say, consumer affairs is going to be dramatically different from a state where maybe it goes to their version of health and human services. 

Brian: Ohio is the Board of Pharmacy, Massachusetts created an entity. Some states do it through the Department of Agriculture. 

Sarah: So, you have all of these differing perspectives on how cannabis should be regulated at the state level, which does inform what we can do at a federal level. But it’s going back and saying, what’s the best practice from each of these states? I did a pretty cool webinar a few weeks back with two women who I appreciate immensely, one is Gillian Schauer of the Cannabis Regulators Association and Toi Hutchinson, who put this all together for the state of Illinois. They talked about some best practices from Illinois, what Gillian had seen across the board in all 50 states, and how that can inform federal regulation. That all to say is one of the concepts that was brought up in the Cannabis Administrative and Opportunity Act, the CAO that I referenced earlier as one of our many acronyms. That was put forward by Schumer, Booker, and Wyden, and one of the ways they thought this could be regulated was to create an office of cannabis that would fall under the FDA. Now CFCR does support that idea, but with the recognition that when you call on the FDA to create an office out of thin air, you have to fund that too. So, what we are suggesting is that it’s a great idea to create this office of cannabis products under the FDA, but you have to put in some funding mechanism behind that to staff it and give it the resources it needs to do its job. So, we would call on Congress and say, let’s earmark a certain percentage of the appropriations or put towards an appropriation to fund this office and give the FDA the authority and the power it needs to do its job effectively.  

David: If I can jump in or address your question there, Sarah, you have my head spinning with some things. Like the states how you mentioned – is it under the department of health or revenue? Where I live currently in Colorado, it’s a completely different mindset on who is trained to go out there and enforce, make sure programs are followed and enforced according to the regulations that have been implemented, and that is different from state to state. They are all abiding by some version of the COLE Memorandum. States were mandated with making sure you’re not selling to minors, keeping it within state boundaries. Those basic frameworks allow the state programs to run. I listened to the Attorney Generals Alliance, which is a great group. They have a cannabis group within that, and that’s something like 46 or 42 states attorney generals out of the 50 states that are active members a part of it. One thing I learned, well, not learned but remembered from pulling back my US history and Civic lessons, the states voted to form the federal government, and how is that playing out with state rights? And the Cannabis Administration Opportunity Act asked a lot of questions about how that interplay will be? Because you can’t really disrupt and disentangle or dismantle these state marketplaces but do eventually need to make federal frameworks and interstate commerce. We live in 2022; it’s a global marketplace. So, there is a lot to consider, and it comes back to the health and safety framework. I think your point about how we fund the FDA, or an office is so key because another thing I’m reminded of is the level of funding for the FDA is something like 9 dollars per person I think is the number per capita for funding. When you think about 25% of consumer goods, products we spend our paychecks on have FDA oversight, including microwaves because of radiology. That’s a big mandate to protect public health and safety. Dietary supplements are already a major challenge for them to oversee. It’s really on a risk-based approach. So, are we going to ensure that they have the right resources and set the industry up for success at a federal level? I think those are really key points. 

Sarah: And I think you have to be empathic towards FDA right now because COVID has slammed them. They’ve been working under limited resources, as most agencies do right now, and you have the added burden of covid on top of that at this stage. No wonder it is taking a long time for things to happen. It has taken a long time for us to get back in the swing of things. So I have a great deal of empathy for the job they are doing, and personally, I’m a very satisfied American knowing that the FDA, CDC, and NIH, and all these other agencies are out there looking after public health, and we are lucky to have them do it, and I think we should be spending more to help them do it. The other point we may overlook is that regulation is a burden in any industry, but it’s a burden that creates many great opportunities. It opens up substantial trade markets, opens additional interstate markets, internet commerce. From our perspective, even working with our DEI inner access to capital committee opens up the small business administration, grants, additional funding, and overall business support that wouldn’t be possible until the legalization and legitimation of the cannabis industry. I wanted to touch on a point too that you were talking about, David, with the various issues of states’ rights and things, is the competing bill to the CIO that’s out there, which is Nancy Maces Bill which she put forward early December. Interestingly, it is getting some bipartisan support the bill regulates more of the industry under TTB. It is essentially the bureau that wine, alcohol, and spirits fall under. It understands the way they have put forward this part of the bill because it allows the FDA to handle the health and human safety aspects. Still, its more on the taxation side that it falls under TTB, which is solving a little bit of the issue since each state has a varying tax rate on cannabis right now. They all approach it differently, and you will burden the system again by adding federal regulation or federal taxation. You don’t want to tax people out of the market, that is, both the producers and the buyers, because you could face double intended and pay an astronomical amount to produce and buy the products. That’s one of those unintended consequences that we have to think about is how we tax these products. I will quickly go back to what I was talking about with the drug exclusion rule. Right now, the DER precludes CBD from being sold to consumers other than by prescription, so like Epidiolex. And as I mentioned earlier, CFCR sent a letter to HHS, and more broadly, the Biden administration, to address this in the public health crisis that is being created by unregulated psychoactive products being sold on the internet and across state lines without any restriction.     

Brian: Wow, that is major. When we have incredible restrictions on a productive market of cannabinoids, knowing there is an illegal or unregulated market that can act and work freely is very frustrating.    

David: It comes back to the podcast’s theme, Cannabis is a Good Neighbor, one of my favorite titles. I’ve been watching like ‘Brian, you’re brilliant!’ I love that you came up with it. It makes so much sense! You have all the data, you regularly speak at town boards, commissions, and offices and whatnot about its value, and that is just today with a nascent industry with states doing the best they can. It’s going to be amazing to see, as we mature, how it’s going to protect the business by putting in the hard work that is designing it and committed to patient and consumer safety. If we figure out the interplay at a federal level with TTB of taxation, let’s not forget back to the FDA, and as you mentioned, Sarah, you support that. The Federal Food Drug and Cosmetic Act, I think the one thing is that if anybody recognizes, the first paragraph is very clear that the FDA is a scientific organization mandated to oversee these types of products PERIOD. Whether you like it or not, it may not be perfect, but it is literally the best we have in the world. It is the gold standard. And we have those resources we can provide to our marketplace and set a minimum level of requirements to ensure public health and safety.     

Brian: What’s our path through that? So, I know Sarah you mentioned Cannara, an organization of states that have regulating bodies and I know that from speaking to them, I’ve made it a point through my work at the NCIA to reach out and talk to them Cannara member states. How do we get these standards adopted state by state? Because right now, they are radically different, what one state adopts is not necessarily what another state adopts.   

Sarah: I would say that one of the challenges is we don’t really know what the bar is for each state in terms of highest or best practices. And I know Cannara, and I don’t want to speak for them or overstate this, but I am pretty sure they’ve begun looking at some of the best practices so they can establish some of the standards. Then when you do have a new state, you can provide them with some very specific guidelines. That, really to me, ultimately is what will happen with federal regulation is that you will have the highest level of standards. So many things have left FDA and HHS a bit hamstrung because right now, you have a lot of untested, unregulated, and sometimes hazardous products that can proliferate around the country. It is creating a needless risk to public health right now. from our perspective, it impedes sound scientific discovery and the ability to rapidly grow a very promising domestic industry. One of the things CFCR has done is that we have various partner organizations that we work with, and we do work with one out of Europe, EHA, which is the European industrial hemp association. They are doing a series of safety studies that we believe the FDA will be able to use. Part of what we brought to attention to the agency in our letter is that we can bring the results of these safety studies and toxicology studies to the FDA under NDA. That is something that the agency has recognized themselves that they would like to see in a gap analysis that they put out. They want to see toxicology reports, what happens to your liver when using THC or CBD products? What are the effects on a pregnant woman? What are the impacts on the male reproductive system? It’s funny that they don’t mention the female reproductive system until you’re pregnant, but that’s a whole other argument. But what we would like to do, is say to the FDA when we can bring them the results of these studies is say ‘are these sufficient for you?’ can we get some feedback, is this the bar, or does it need to be higher?’ It is okay if it needs to be higher, it is also okay if that’s the bar, and that’s something they’ll accept because that will advance the industry forward light-years in a matter of months without the FDA or industry spending a lot of money on external or additional studies. I think, though this is me personally thinking this through, we will see a situation where the FDA says ‘Well we are still going to need x, y, z’ and have more boxes to check, which is fine; it’s just them doing the due diligence. And in that case, it will fall on the industry to come up with the funds necessary to conduct additional safety studies that are evidence-based and include a lot of biometric data and toxicology data that the FDA will require. Speaking as a consumer, good! Because the more that you can know about the products, the more informed and educated you are, the better! And better for the industry! That’s how you build trust in companies. It’s the difference between trying a new product for the first time that you’ve never been exposed to before and then going back to your name brand product that you’ve had around for a long time that you know is safe, know is regulated. You can say ‘yeah, I trust this product I’m always going to buy it’. For example, I will always buy Dawn dish soap because I like what they do to bring oil off of penguins, just throwing out a few names. That’s the kind of feeling you want to get. You want to know where the product is coming from and trust that it will do what is promised. 

Brian: That is an awesome segway because what brings it back home for me, as an architect and a consumer, is that regulations are in place so that the customer gets the same product every time. You know dawn soap doesn’t work differently on Tuesday than it did on Sunday, it is the same product. I know there is frustration amongst cannabis consumers that when you buy a product twice and you’re taking it for, let us say, narcolepsy or general sleep disorders, you want to know that it’s going to be the same product. You want to know A. that it is in stock and not sold out, possibly due to supply change issues, and then B consistency issues, which is at the heart of what we are talking about. Facilities that produce them, the organizations that produce them, must have consistency.     

Sarah: I think it’s called ‘Food Factory.’ It’s a National Geographic program that I love to watch because it takes you through the production facility of all these different food products. I had no idea there is a chief chocolate scientist at Mars – talk about missing ones calling.     

Brian: We all wanted to be Willy Wonka!   

Sarah: But it is fascinating to watch how the production lines are set up, Brian and David, speaking to sort of design think and human health and safety, such as the fact that the packaging goes through a metal detector to make sure there is no metals or piece of materials that are going to cause you harm when you open it. The point about Dawn Soaps, yes, the formulation is really important because you want to make sure there is consistency across the board. I loved your statement that it’s not dawn soap on Tuesday and something different on Thursday. And the same is true, mostly true, there are some nefarious characters, but in the wine and spirits industry. Merlot is always merlot; pinot is always pinot. There is some consistency, and that’s through centuries of coming up with all these standards and regulations. It is probably a little more standardized here in the United States within the wine industry. For example, in Germany with beer standards, very high standards and quality, formulation, and even dosing.    

Brian: So that is fascinating. This is an agricultural product, a horticultural product, and a natural plant. We can talk about the entourage effects and all these things, but when you talk about wine and consistency, there is a reason the Sommelier has a job, and there’s a reason that you send a wine bottle back from your table. You should not be embarrassed to send a bottle back if it does not meet, but you must have a nose for it and a palette for it to be a real conscious consumer. To what degree then are we eradicating that? And I do not think we’re talking about this. These things coexist as an industry, producing cannabis as a product for people to consume. There is raw flower, in many states, not in Georgia, that might be something that could be considered temperamental in the way that a wine bottle is temperamental, but when we shift to gummies and chocolates, that is 100% consistent. If it’s already gone through a kill system, safe practices, people wearing gloves, those are the things the buying public needs to know.   

Sarah: I remember going out to Saint Louis to see the Anheuser-Busch facility, where they make Budweiser. In the tanks, where they store fermented beer, the cleaning process is very regimented. There is a whole system of controls to check this box, you have to go in there scrub the container. That is the kind of safety procedure we want to see within the industry. And that is the sort of safety guidelines you want to ensure in the manufacturing process, also in the growing process. I’ll throw this out as an idea, and this is not the statement of CFCR, this is my own personal thoughts. It might solve a few problems if you had a grading system for cannabis, where you have ‘A’ grade plants that are for medical products, I’d actually put medical and recreational in the same category because it’s still for human consumption. ‘A’ grade for human consumption, ‘B’ grade for animal consumption, ‘C’ grade for industry or clothing, any sorts of material goods. And that’s not different from what you see in current agriculture situations with corn and soy and other major commodities, so they do have a grading system for it. In my opinion, it may save a lot of problems for the farms who would like to say, ok, here are the standards I need for this grade cannabis, and I’ll grow that this way, and then it’s sort of like track and trace. From there on, it leaves the farm, and this grade goes to these buyers, labs, and extraction places, and this one goes to these manufacturers for horse bedding and coder.   

Brian: Oh, yeah hempcrete, or fiber for jute in the automobile industry. 

Sarah: I met Geoff Whaling, I do not know if you know who he is, he is the head of the national hemp association. David and I saw him at CWCB Expo not too long ago, and he has a car where the whole interior made out of hemp. It’s amazing, it’s a great sustainable product. I think there are other car manufacturers interested in this, and there is much more that can be done with hemp. Google and Microsoft are looking to build textiles and facilities out of hemp. A great example is the US military, during World War II, a lot of the clothing was made out of hemp. In China, they still make clothing out of hemp, so it’s a huge sustainable, wonderful product that we overlook, and I don’t think we should be in the future.   

Brian: I’ll go back to, and I am quoting here from David Paleschuck’s book called ‘Branding the Bud’ but 1619 Jamestown colony Virginia, America’s cannabis law was enacted, and instead of making the plant illegal, it mandated farmers to grow hempseed. In 1619 in the United States Colonys, it was a mandate! There were times when hemp was used as currency; you could pay your taxes in hemp. Think about the shipping and whaling industry; the sailcloth, the uniforms, the ropes were made out of hemp, the oil burned in the lamps was hemp oil.   

Sarah: Have you read Martin Booth’s book called “Cannabis: A History” ? I highly recommend it to everybody. And Martin Booth is sort of one of those British authors that goes down the rabbit hole. It is great to read. And I believe, Brian, that it is from his book that states in Connecticut and Massachusetts, you had to legally plant a tablespoon of hemp seeds in your backyard. 

Brian: Yes! Because if people didn’t, they couldn’t make sailcloth or uniforms. They didn’t have enough production 

Sarah: And if you go to Mystic Seaport in Connecticut on the Mystic, they still have one of those big rope-making facilities, and it dates back to like 1830 or so, do not quote me on that, but that is all hemp rope. I will throw out one other little nugget. This is my jeopardy night, the UK, well Great Britain at the time, because they were the military sea power. They were competing against Russia for hemp manufacturing during the height of their navy period. They had to import a lot of their sailing materials, sailing cloth, hemp material from Russia, which was the largest manufacturer of hemp in the world.    

Brian: This is the fascinating side of cannabis and hemp industry, it is unbelievable as its resurfacing. And I did meet Geoff Whaling and he is an absolute vociferous advocate for the hemp industry, and I got to see the car BMW made.  

David: What I think is interesting is that you mentioned the different grades and classifications. We are seeing this finally start to evolve, and that, back to the standards, where we can discern or delineate what the FDA needs to oversee? The FDA doesn’t need to be involved in the industrial fibers that are going into your cars, those are a different set of standards and oversight. But if we are talking about the US Pharmacopeia paper where they didn’t publish a monograph because of the federal ban. But they developed considerations for medical cannabis and florescent, putting the quality attributes. They are saying there is a limit for patients, there is no zero just to dive into that nerdy rabbit hole, but there are levels of detection and limits of detection, and so what is the amount of microbial and yeast? What are the pesticides? What are the limitations that we can put around so immune-compromised patients are safe? And that might be a different level if it is consumed, flower combusted. And you mentioned kill step, right Brian? If it is going into production and submerged in ethanol in negative 20 Celsius well, micro toxins can make it through that potentially, but the actual living cells and cultures are not going to make it; that’s a kill step. If you can validate that, just like at Anheuser-Busch during the cleaning of their tanks, you’re not just scrubbing it, saying put in some of this and that it should be good! You are verifying using Teflon, ATP, verifying that it is actually a kill step. We can adopt all those same principles. Hey, if you have moldy weed out in the field, doesn’t look pretty, not the greatest, think about what goes into our smoothie, I could go on. Back to the point, there are different grades, just because it is not aesthetically pleasing doesn’t mean it doesn’t have value and the extraction for refined products. We can delineate that and make sure there is a marketplace that recognizes the different tiers for valid reasons. 

Brian: That is important right now. I think at the top end of that scale, the class A or the things designed for human consumption, there are many inconsistencies today within that level. I know that groups who use the extraction process as the cure for the ills in the grow process. If the plant has levels of mold, well you can extract that with a bath of ethanol. Or there are levels within that such as saying we are going to reserve this area for our prized bud because we are selling flower for 3.5g for $45 at retail, at least in MA, but nobody sees the bud if it gets extracted so [it doesn’t have to look good] but it should from a health and safety standpoint’. That’s where we are coalescing. These are all for human consumption, so all of these need to pass a heavy metals test, no level of led is acceptable, no level of arsenic and mercury is acceptable. 

Sarah: For both of you on that, that comes down to the safety questions we are dealing with right now in an unregulated market, where many of these products are being sold in or out of state lines, ‘legally’ and illegally. I put legally in-hand quotes here because some are not legal. In most cases, they are not. What you are not seeing is some of the additives that are being added to these products. So you have varying levels of psychoactive materials and molecules, but also additives like flavors that may or may not interact and may or may not be listed on the packaging and that may have dubious origins. For example, the state of Pennsylvania just cracked down on vapes. I think across the board, but I was reading specifically for the cannabis market, but they are saying you need to list all the additives in there and the additives had to be FDA approved. 

Brian: We had a huge scare here in Massachusetts about 2 years ago. We had at least 1 death, if not more, because of some sort of vitamin e additive added to vape cartridges, shutting production down. I know a lot of our customers got slammed by this. All the legal industries got shut down because of this even though it was the illegal produces adding these incorrect additives and selling them. 

Sarah: And you have a lot of these small buyers, like gas stations, that are getting duped into buying these products for resale market. They think that because it is legal in the state, they can sell them, but they actually can’t. For the most part, they are selling illegal products, and we need to crackdown. I was taken back at some conferences that we were at, where you would have a lot of little event booths that would have products and at the bottom would say “FDA CERTIFIED.” That does not exist. There is no FDA certification for any of these products at the moment. I saw them on cosmetic products, edibles, some drinks, and some vape products, and that to me was sort of like, woah okay, we have a crisis in this industry that we have got to address very soon. Again, I think that comes down to the federal regulators taking notice and stepping in because it will only worsen.   

David: Brian, you and I, I think we were in Boston at the event when Shalin Title made the announcement that day that Massachusetts banned all vape pens across the industry because the vitamin E acetate was kind of the culprit. But to my knowledge, there was no evidence that it was related to any regulated products, which held true through time. So it came back to the whole importance of the regulated marketplace, it is the one showing up putting their best foot forward. We need to provide the framework and safeguards and establish those minimum standards nationally. Back to the illicit market, it’s what you mentioned there Sarah, that we are seeing at MJBiz where it’s really easy for unscrupulous folks to come in under the guise of this federal marketplace and say ‘oh yeah, it’s FDA approved, it’s FDA registered, its GMP proved.’ There’s Delta-10, Delta-8′ all these products that can sneak under the radar without having an overlord to ensure that it’s not getting into consumers’ hands. It’s a really tricky situation. We don’t want to ruin the reputation we have with the regulated cannabis industry because of a few bad actors. It will never stop in terms of creativity of what they’ll come up with.   

Sarah: And I think, David, you bring up a good point between federal and state rights too. This will be an ongoing battle to the end of time, and this is what American democracy is built on. We are probably better for it because it makes you think more strategically about some of the issues, it makes you think through the unintended consequences, and it gives you a chance to study what was done really well. That to me should always be what is informing the federal regulatory agencies as here are the states that are doing it really well, these are the problems they’ve already thought through and helped to solve, what can we learn from that, we don’t need to reinvent the wheel, and take it from there.  If there is a takeaway for the agencies at the federal level to be looking at, they should be examining what states are doing this really well, having these conversations, reaching out to the people who have been doing this from the start, and then also looking partners like AHA in Europe who are taking the next step, going through a lot of the research because there hands aren’t as tied as ours and taking a lot of that feedback from them and implementing it at a federal level.   

David: Even looking internationally for a second, let’s not forget about Canada just north of us. And wow. Since October 17th of 2018, they’ve had a fully legalized program. They’ve got cannabis 2.0 now, they’ve got edibles, they’ve brought on slow and steady, very strict, very very strict marketing and labeling requirements. But they have a marketplace there! It’s working. It’s incredible! What can we learn from there? Health Canada oversees that through good production practices, what can we learn? Back to let’s not reinvent the wheel, we can really come together and there’s a framework to, again, protect consumer health and safety, because right now, we are not doing that when products are going across straight lines and going unchecked 

Sarah: I personally got into this industry because I feel that there is a lot of scientific research that is going to come out in the next few years about what the endocannabinoid system can do and how this can be a benefit for people dealing with neurodegenerative disease, anxiety, depression, pain, and inflammation. So there is soo much that we still don’t know about the human body and all the good that this plant can do. So that was one of the first reasons I got into it. The other was just the sustainability of hemp itself and being able to have good products, clothing, bedding for animals, food, and fodder. So much can be done with hemp that will help us fight climate change and create a more conducive place to live and be human. So for me, that was the two main reasons to get into this industry, and then add on top of that, there’s a lot you can do for health equity and social equity. What could be a better industry to be in right now! 

Brian: We were all at the CWCBE in New York at the Javits Center and that to me was one of the biggest takeaways- the hemp industry. Geoff lined up the Black Buffalo 3D printing, the ability to now 3D print buildings, and they soon will be able to use hemp fiber for strengthening agent in the concrete. It will be true hempcrete. 3D printed hempcrete was just a jaw-dropper at that show as an architect. I was absolutely blown away by that. I am now looking for any opportunity with my customers who hear that in the narrative for their business, to 3D print their building as an alternative to steal and traditional concrete would be phenomenal, absolutely phenomenal.   

Sarah: I am a recovering horse person. This is to say I no longer have a horse, but I did for many, many years, and I’m excited about it for bedding, footing, and all sorts of things that are currently used. Hemp would be great for this. The conversation I know Geoff and many people in the hemp industry want to have with particularly the equestrian industry. This has to do with the DEA and all sorts of other things and this long history with drug classification. Right now, if a horse eats hemp-related bedding or food, it tests positive for drugs. Sport horses will test positive for drugs and will not be able to compete. So that is something that the industry needs to bring up with US track and field and swimming, gymnastics, and athletic committees to make sure that marijuana use is not counting against you. I don’t think it’s a performance-enhancing drug – I will state that as a personal statement.   

Brian: Maybe we can get Michael Phelps to come in and talk on the podcast about his position. There was a young woman in gymnastics who was disqualified for cannabis use. I don’t have the backstory all straight, but she was dealing with family issues and grandparents’ passing, and there was complete insensitivity to that in understanding that the consumption of cannabis is not incompatible with high-level physical performance.   

Sarah: That opens the door for the other side of this conversation that we need to have, which is the history of cannabis and illegal drug use, I don’t think I need to overstate how important it is to have that conversation and to make sure that that is absolutely a massive point in the dialogue we have going forward.

David: The book ‘Grass Roots: The Rise and Fall and Rise of Marijuana’ by Emily Dufton I read that about a month ago, and it is everything you just mentioned, it paints the picture really well, diving into the shafer report in the 60s, Aslinger prior to that in the 30s, and just the history of cannabis and its criminalization. Back to your point, we have so much opportunity to learn from that as a society. I’ll speak personally growing up I wasn’t a fan of history, my friends and teachers wherever they are can laugh at me remembering the things I did to ignore history class, but holy crap, we have so much power and understanding that we can learn from, we don’t have to make the same mistakes. There is a great narrative here, and we really need to right those wrongs and there is an opportunity to do it in front of us today. 

Sarah: Thank you for the recommendation I literally am just ordering it now while you’re talking.  

David: I love it. Oh, another thing back to the performance-enhancing, it just came in the Denver press maybe a week ago, I was trying to look for it because I had it handy, but UC Boulder is doing an observational study with ultra-runners, ultra-athletes, that are coming in that have admitted to consuming cannabis. They are now studying their performance, putting them on treadmills, and comparing before, during, and after cannabis use to understand. A lot of folks will talk that it’ll help them focus, helps them push through those 50ks, which I’ve done a couple of, it is going to be really cool to see the data that comes out of it to understand.  

Brian: We will get Trevor Morones next on our podcast, who is battling epilepsy and doing ultra-marathons around canyons in Nevada and not having any seizures. Just completely rocking it out in the lands of Nevada.  

Sarah: He is amazing. I talked to him the other day, and Dave and I both run ultras, so it was a pleasure to talk to him. I’m very new to the cannabis space, both as part of the industry and as a new user, but my general perception on it, and I’ll throw this out here for a further conversation point down the road, in exercise there is what is perceived exertion. It’s basically how somedays exercising seems really, really easy and other days it is a massive hard slog. It’s not that your body is any more tired or having difficulties, but sometimes you know you had a tough workday before, and all these things sort of compound on you, and that stays in your memory bank, and it leads to perceived exertion. Perceived exertion is just when things seem harder than they are. And that’s true of work, and in particular exercise science, it plays out. My recent query into cannabis products seems to indicate there is some way in which it affects perceived exertion. I am curious to know, and this could be a long-term scientific study. I am not a scientist is just me saying, ‘oh, this is what happens to my body’ it is almost like, excuse me for forgetting the chemical in the brain, can someone remind me?   

David: anandamide 

Sarah: Which affects memory. And I am curious to know whether it’s because it (cannabis consumption) sort of slows or blocks it a bit and cuts down on the perceived excursion. So I will state that that is the only thing that I’ve noticed in that capacity, it doesn’t make you run faster, but it does cut down on the fact that it feels like a slog. It makes it a little more bearable. I wonder if that has to do with memory and how those chemicals interact. If a scientist is listening, I will throw that out there for you to examine.   

Brian: My wife is a neuroscientist, she is a neurologist, and our professional lives have intersected these past 7 years because of the rise of cannabis. Her subspecialty is movement disorder, and a large group of folks in the movement disorder world have Parkinson’s disease, so Parkinson’s is what her mainstay practice is about. She says somewhere around 50 percent of her patients are asking about the efficacy of cannabis in dealing with a movement disorder. 

Sarah: A gentlemen who just joined our board of directors is Ted Thomspon, who is the SVP of Public Policy for the Michael J Fox Foundation, and we are extremely excited to have him joining the board because of the work that they are doing in Parkinson’s research, he comes from the multiple sclerosis society too, many years back. They’re primarily interested in this because of the medical use of cannabis for returning veterans. I think I’ve talked to you both, mentioning that between 10 and 12 percent of returning US Veterans develop Parkinson’s overtime, largely they think because of chemical exposure from burn pits. And to whatever extent that cannabis use can help them deal with the disease or mitigate some of the symptoms, I think that’s fantastic. Because again, it seems to slow or block the effects of neurodegenerative disease, and again I am not a scientist, so I don’t know how it works. The research is coming. I used to work for Alan Alda, who announced his Parkinson’s a few years ago, I do not believe Alan uses marijuana at all, but he is someone who is very interested in science, and I think that any kind of research that you can do into something that will alleviate or mitigate some of these symptoms. Why not do it? Why not look at this? And see if there is a better alternative that is naturally plant-based and plant-derived.     

Brian: This is where we are slipping. David brought up Canada, if it is federally legal, you can do that kind of research. And we are slipping here as a nation in not allowing this research to happen over very, very well understood, minor hang-ups. It is pure stigma and not fundamental for science. We are losing ground the longer we wait to allow this type of research to happen.   

Sarah: Yeah, imagine if we said, ‘oh, aspirin is so bad for you,’ and we put that as a schedule 1 drug. Why not take a look at this and see if it works? It is still plant-derived originally, why not study it?  

Brian: Wow, this is awesome. Maybe we need to interview some scientists doing the frontline of research. Perhaps someone from Israel or various places where this is happening and get some of that down. Those are all things I’m looking forward to.   

Sarah: I volunteer Dr. Reggie Gaudino too, on our science and regulatory affairs committee. He is at Front Range Biosciences he’s a great guy to talk to, anytime. Also, on our science committee is Vicki Seyfert-Margolis a former FDA leader and Advisor, she is fantastic about all of this. I have had masterclass conversations with them about the difference between synthetics, biosynthetic, natural plant-derived, so anytime you have questions come to CFCR. We have so many people we can introduce you to and are happy to open the door for the conversations.  

 David: I am so excited about all of this. Reggie is awesome, I’ve gotten to meet him. Again, maybe I sound like a broken record plugging this title, whether Canada is a good neighbor with their legal marketplace or Dr.Reggie, Vicki, the gentlemen you mentioned who came from the Michael J Fox Foundation, and Sarah, your team, and Brian, you didn’t come out of nowhere. So many people with amazing talent, integrity, and passion are all helping and believing in the cannabis industry and recognizing the data and the writing on the wall. And holy crap, if that’s a good neighbor today, what will tomorrow bring. It is just amazing to see the passion, the folks, the science that are starting to emerge that supports harm reduction basic best practices which we are all focused on.   

Sarah: I think we are all committed to being good citizens here. That underlines a lot of it, being both a good neighbor and a good American citizen. You want to ensure the health and safety of your fellow Americans, of your friends, families, neighbors. So that’s one of the reasons I’m here, and hoping that this industry thrives for a long, long time and can do some good for a lot of people, and I thoroughly believe it well, especially because it has good people like you two, it’s a good fight.   

Brian: Awesome, this has been a terrific conversation. Sarah Chase, Executive director of the CFCR, and David Vaillencourt CEO and founder of The GMP Collective, professionals providing GMP validation and certification throughout the US and Canada, and I suspect globally. This has been an excellent conversation.   

Sarah: and thank you to your listeners for supporting this!  

David: Yeah, thanks for having us and thanks to your listeners for getting something out of this and enjoying it.