 This meeting is being recorded and or transcribed. In attendance we have Ingrid Jonas from the advisory committee. We have Julie Hulberg from the board. I'm from NACB. And Nellie is here and Nellie Marvel and two members of the public who they wish to speak. We can introduce them toward the end of the meeting. Sound good? Sounds great. Alright Tanika why don't you pick it up and introduce our invited guests and we'll get down to business. Thanks. Thank you so much Mark. This morning I'm Tanika Scott. I am an advisor with the National Association of Cannabis Businesses and Mark has called our meeting to order. I would like to note that we do not have any written public comments this week that were submitted to the CCB. But I would like to remind the public that if you would like to make a comment you may do so at ccb.vermont.gov as a public intake form. This morning we have an honored guest with us Omar Loryasebal. Did I do okay with that? Thank you very much. Excellent. He has a PhD in microbiology and food safety. So he has a very deep background in food, in the safety of food, in of course microbiology. He understands a lot of elements that are often foreign to us in the public health subcommittee except for maybe Dr. Levine. It's going to bring us a wealth of knowledge today as we go through this last half, which is to talk about the oversight of edibles, the consumables by the consumer. So with that being said, because we do have such a small group today, Omar this morning said that if there were questions in grid or Mark or Gina or even you, Julie, during the presentation, because there are not a lot of a peer, he is more than happy to entertain those. I don't want to speak on his behalf. He has a PhD of course from Auburn University, the War Eagles, and also was a professor for quite some time at the University of Vermont. He is now a consultant and has a great deal of knowledge of what is going on in cannabis, in hemp, and all of the different nuances I would say that we are hearing a little bit about. So with that being said, Omar, welcome and we're going to turn it over to you. Thank you so much, Danica, for the introduction. Thank you, Julie, for the invitation. It's always a pleasure to try to talk a little bit about, you know, manufacturing. And I'm going to start a little bit this presentation. And I guess I thought, Danica, I'm going to try to make it not too complicated. I'm going to try to see if I can actually share this screen. Can you see the screen there? I was doing great before. Yeah, see it. That's it, right? And now I'm going to go and just put the title of the manufacturing hemp product. And we will try to focus on that. And as I mentioned, I would be glad to answer some questions as we go. There are also some, if you see in the lower right corner, there are some numbers that hopefully it's going to appear in most of it. In case you have a question that you want to answer or we'll send it a little bit later. So the outline that I have is just trying to review some terms. Discuss a little bit the 2018 Farm Bill. Discuss also the current position of the Food and Drug Administration that oversees most of the, you know, manufacturing regulations related to safety at the federal level. Review a little bit of difference between food manufacturers and manufacturers of dietary supplement products. Mention the issues about claims. And questions as we go. I would like to acknowledge, you know, Green Queen Candies and Korea Botanical for kindly letting me have access to some of the pictures that I will be presenting. A disclaimer, you will hear something about food safety regulation because I work in the area of regulatory compliance, but I do not provide legal advice. Okay. There are also remembering interpretations about some regulations. Even happens after several years or decades after those, some of these regulations have been implemented. So you will see that implementation is not always a straightforward line as we may think. This topic is still evolving. It's in flux. We have issues still even coming with terms and how we define them and we reshape them a little bit. And the only thing I want to show about my background is that several years ago I started this. I got involved with a journal, a scientific journal that is still going on. It's called Microbial Risk Analysis, published by Elsevier. And we talk a little bit maybe sometimes about what is the concept of risk, which applies quite well for some of these, you know, discussions that we will talk about. When I am asked which one I work with, I always try to explain that I work with food manufacturers. And I use the word manufacturing because it's very easy to differentiate from what we have in our kitchen, right, that the food processing. And because, thanks to FISMA, the Food Safety and Modernization Act, we have a clear definition about manufacturing and processing, which actually are considered, you know, right. You can see in this slide some of those, it includes a lot of things, even going into labeling, packing, streaming, waxing, okay. So FISMA, separation and clearly defined farms and then manufacturing activities. However, if you actually read 21 CFR 117, it will be titled 21 of the Code of Federal Regulation, Part 117, you will find that sometimes they use manufacturing coma processing. I think they were different, but in other times they just put the backslides, meaning they are the same, okay. So there are things like this, all right. One thing that we wanted to cover is the 2018 Farm Bill, which is a very interesting regulation. And the one where we have the term HEM a little bit better defined. We're talking about plants from the cannabis that Eva, you know, species that includes part of the plants that have a PHC content, and this is the Delta 9 tetrahydrocannabinoid content of no more than 0.3% on a dry wave basis. This Farm Bill, really what it did is created the difference between those things that we can see in the left side of your screen that are HEM, that are product with very little content of THC, versus the rest. And the rest, there is the word, you know, marijuana for those. Some states are trying to get away from that word because of the, you know, social connotation. In any case, we're talking about a few cannabis plants that have a higher PHC content. By now, we know that there are specific varieties that will probably get you always to be on the left side. That is a low amount of THC. And that's what we are kind of going into it. It's not a random that I have a light in here and it kind of dark in this area, because I intentionally tried to talk about the left area that is where we have more potential for growth. That brings us to some terms. Cannabinoids are all those products that we substance these compounds that we can get out of the plant, including CBD, THC. THC is the cannabinoid responsible for psychotropic effect. As we said, the cannabis plant can be divided into two groups now, HEMP and marijuana. And again, that term marijuana may probably disappear, I don't know. We are still dealing with those specific terms. So basically, what the farm bill brought is a removal of those restrictions that we used to have through the Drug Enforcement Agency. And as long as you are growing and cultivating what is called inductor HEMP, that are plants that have less than 0.3% of THC, we are okay. And also, the farm bill kind of empowered the Secretary of Agriculture in each state to monitor for the growing and cultivation of HEMP plants, and provides more opportunity to create a farming business and a uniformity for trade. It's important to remember that this farm bill does not change at all the way FDA enforces this regulation, and remember, FDA is regulating food manufacturers. So in that way, with the farm bill, we get all of these organizations of industrial HEMP, the growing of the plant, cultivation, the drying, the creation of this biomass. But once we go into manufacturing, we are still a little bit in limbo, okay? Another term that we have been using, and kind of abusing also a lot, especially in the media, is the cannabidiol, that is the compost from the plant, the cannabis plant, that doesn't have a psychotropic effect. And that product, CDD, now has been associated, has been approved by FDA as a trap, okay? And that comes from a company from Europe that we will talk a little bit more in a few moments, all right? So with that, in 2018, when FDA approved this product, it's starting to go into the direction of approval for drugs. The Epidiolexis I, there are some others where you can see names that are dronobinal, different type of cannabinoids. Some of them are synthetic, some of them have a combination. So we see a lot of research that has been there fighting out for the last 10, 15 years, even with some specific human trials, where, you know, the agency is providing approval but as a drug. So what is the FDA position? Hemp and CDD are not the same. For them, a CDD is still a drug. No use of CDD as a food or dietary committee because it's with a drug, okay? They use, still the FDA is using what is called an enforcement description, the thing giving warning letters is still telling us about the safety of some other products that are appearing in the market and giving us warnings about some of those products. The states are taking a little bit of that role here. It happened a few years ago and the company has to recall a few jars of a product that, you know, was infused with CBD. So for the FDA, the position is still clear. For, based on the Food Drug and Cosmetic Act that prohibits the commerce of products that are dragged into food, that's enough for them to say we cannot approve it and the evidence that the FDA have concluded that those products are excluded. THC and CBDs are excluded from dietary supplement definition. Have the industry tried yet? They have tried several times to get a little bit of an approval of a new dietary ingredient using what is called the SHIA, the Dietary Supplement Health and Education Act of 1994. I briefly want to mention that that act, what it did, is created this opportunity for several old, what we consider old dietary ingredients to be accepted in the market without a pre-market approval by FDA. That's the ingredients that were in the market so for October 1994. New dietary ingredients can be marketed only after a pre-market notification and of course CBD cannot be grandfathered because it was not sold legally in the USA. And also we have GW Pharmaceuticals that brought these products to market as drugs. So back to this, this is where if we go to the right side, we have a still decision with marijuana, the Schedule 1 control staff, that's where states have taken a little bit of a lead over the last decade to start allowing for some medicinal and recreational use with quite a degree of digitalization or not. We're more interested in these other parts. And when we go there, we are under the FDA regulations and there are some products that are coming from him that have been given the grass status, which means generally recognized as safe. And we're trying to find out where these products are going to fit, are they going to go into food ingredients, dietary supplements, cosmetic drugs. And that's where these companies that are getting into the business are a little bit complex and not traditional food companies. They concentrate products, they do extractions, they use words like tinctures or an infusion that are more within, you know, a dietary substance. There are, of course, edibles, of course, but those edibles all come out of extracting something, especially in the areas of the flower where these products concentrate, okay? It can become a little bit more complex because I've seen and I'm trying to filter companies that created products that are considered infused by state regulators before we have some issue with the potential for prostrate and botulinum to grow. I've seen some that have been trying to create, like, an acidified food based on the additional components. So here is where, you know, the general manufacturing state that we are seeing are the traditional extraction, further purification, concentration, mixing, using the term infusion, sometimes the term infusion creates a little bit of, you know, a great flag for some state regulators. The word infusion is used in different ways sometimes. And, of course, packing and labeling. Remember, we are trying, we see that companies are trying to get into the market and they try to use some claims to try to sell this product, okay? So are there any products or by-products from the hemp plant that can be used, really? Yes, those are under what are called the grass notices. Generally recognized as safe. And these are products that can, all of them come from really the seed, whether it is a seed protein, a powder, an oil, because it's known that this part of the plant doesn't accumulate too much of DHT, okay? Or other, you know. So we've come now to this regulatory framework for food manufacturers, right? So I'm just mentioning the basic regulations that are covering a product. Basically, you want to have the environmental conditions to manufacture wholesome food that carry good manufacturing practices. We need to use ingredients that have been approved, that are safe, especially when it comes to additive colors. There are many different types of ingredients that we can add. We can add, you know, a large number of products that have been known to be safe. Then we need to pack the food in a food approved container. We have to use honest labeling, basically when it comes to the nutrition fact panel, the certain sizes, because we want to avoid, you know, misbranding. And of course, be consistent with those claims. All of that, when it comes to carry good manufacturing practices, the moment the FISMA Act was signed in 2011, created this movement of the CGMPs to a new regulation. They used to be regulated. They used to be codified under 21 CFR 110. Now they all move to 117 subpart B, okay? This is what we have currently for people that are trying to manufacture food for human consumption. It's become a little bit more complex because this regulation also got subpart C that is where we have risk-based preventive controls. That is where I work the most within the industry, how to create those and implement those controls. Those manufacturing dietary supplements fall in a little bit of a different area, different regulation. Dietary supplements are those taken by mouth that contain dietary ingredients, as we were mentioned. There are several examples of those dietary ingredients. You have labels that have to be useful, honest. It allows for some type of functional claims. That's different from food. But the CGMPs for dietary supplements are a little bit more complex. And I just highlighted in there some of the things that are different from the rest of the CGMPs that are applicable to food. You have to have a process control system, quality control, production. There is a lot of, you know, these products are made by batches and they want to have very strict control of the batch records. Here the laboratories play an important role. As you can imagine with this product like CGMP, laboratories are very important and they're going through a lot of different methodologies for testing the potency of the product. We know that those methodologies have quite a large variation still. These are methods that are being developed as we speak. So they have some specific things that are more unique to them. So with that background, where is the industry going? We are all guessing. This is also my guess, right? From what I see, companies are trying to go more into a dietary supplement type of manufacturing because they can make a structural function claim. Why do you want to sell a product as a food ingredient when you cannot make any claim? It doesn't give you an edge. That's what I see with some companies. That brings us to the testing for potency that, as I mentioned, has quite a bit of a variation in the methodologies. But there are also companies going and pursuing drugs. And those are companies with deep pockets that are extracting natural products. Remember, we talk about many different bi-products that can be extracted from the plant, but also going into synthetic drugs. So it's going to be a matter of time to see which is the industry that claims the most out of these bi-products and kind of take it in a way. Remember something. If the agency, and I'm saying the Food and Drug Administration, approve a product as a drug, it cannot be used in a food. It cannot be used as an ingredient, as a dietary ingredient. You can have some of those kind of unique companies that have a specific function. And remember, the way the regulatory process is established in this country, the company has to bring the information to the agency for review for either approval of a new drug or a new dietary ingredient. I think Julie asked me to talk a little bit briefly about the state. This is where also it's very dicey. It all depends. To me, it's how important the business is for the state. Some states are making quite a bit of business out of that. How organized is that? There's a game program out of the 2018 Farm Bill and how much it has been fostered. And of course that goes to the resources. Not all the states have the same resources, right? And that brings us also to financial incentives that are still under development. A few states where I have worked a little bit are here is the state of Vermont. It tells you a little bit about what is there, what can be taxed. Remember in some of these cases there is a taxing by the state that is important. Colorado has developed a little bit of a better website in a way because they have quite a bit of a business in here. And they have a specificity for those that are manufacturing, packing, taxing, and distributing industrial hemp products within the state. And they cover food, diet, supplements, and cosmetics. I'm not going to even mention too much about cosmetics, but that's also an area where we can see more. So what do the manufacturers have to do? Well, they have to be in compliance with the state regulations, get an approval. They use the term standard of identity that is a very interesting one. I haven't seen that term used a lot, but that's a term that refers to a case when we can really have a very good identification of the product that we are selling, whether it's the food or an ingredient. And really the FDA has presented a standard of identity over the year, providing the maybe 250, 270 products that have standard of identities, but other foods don't. So that, you see, we're talking about the development of terms. Maybe in a few years, maybe sooner than later, we may have that standard of identity for hemp products. Clearly they will include these statements, not tested by FDA for efficacy and safety. So although they have provisions to allow for stay within the state, they're also saying watch out, don't go outside the boundaries of our state because you're going into a federal trade, interstate commerce. And of course, don't include health claims. I forgot. Very interesting slide. The Department of Health and Environment is what appears. Great. So they have a nice website. There is a rulemaking. Oh, we are already in the state of California. Oh, yeah. Well, California just recently also passed another regulation trying to promote more. They have a very large website with rulemaking regulations. This is the assembly bill number 45, as I think the governor signed it recently a few days ago. So just as a gist of what is going on there, it's a long one. Now they also have to register with the State Department of Public Health. They must demonstrate that the parts of the plan that they are using are within the 0.3 or less of THC. So they are really not doing something completely new. They are just more promoting the sale of hemp. OK. One thing that is unique in this rule is that they consider the amount of THC in the final product not in between. So you can have parts of portion of the plan that may be above that, which will be considered hemp. I mean, we would consider marijuana, right? Class 1, stuff. And so this is the area where they have a little bit more leeway or more relaxed regulation. They are only concerned about the end product, which makes sense. You have to have testing, again, the labeling. In this case, they say efficacy because, remember, people are telling this product because of some type of claims. All right. It's also interesting because it leaves open to the Department of Health in California to impose maximum serving sizes, which is very interesting. At least I haven't seen it before in other cases. So they are trying to say, as we get to know more about these cannabinoids, we can also try to put them in packets and say, this can be allowed to certain size or concentration or not. So quite a bit of an interesting regulation. Again, they say that in that hemp does not include grafts because for them, of course, it's already accepted as an ingredient by FDA, so it can be used anywhere. Also, it doesn't include hemp that contains derivatives or compounds from the seed, which we know it doesn't have too much of a concentration of these cannabinoids. Interesting terms, manufacturing and processing, preparing, holding or storing hemp products. Very interesting. And it clearly says in the manufacturer that it does not include planting, growing, harvesting, drying, curing, grading or trimming. As you can see, at the state level, they are redefining some terms that again we know have a definition from the agency, from FDA. So basically, let me see if I can go back to here wherever I am. So that's basically what I have as a short presentation. I hope it wasn't too long or complicated. I don't think I'm bringing anything new just a perspective of what I see with the industry going on. Dr. Levine has joined us as well. Welcome, Dr. Levine. He is part of the subcommittee. So in pieces of the discussion this morning, we were discussing that it's coming down to the state of Vermont to determine who would have oversight over the edible pieces. And so if you have perspective on that based on everything that you have seen, we certainly would welcome that perspective. So basically, the farm bill kind of gives the opportunity for the secretary of state in each state to handle the industrial hemp programs. This is here under the secretary of state food and markets, right? Now, everything boils down to what I said a few moments ago. We have this biome. So there are a lot of farms making that. But that's the bottleneck who is going to process that. In this state, any processing of food goes under the food and lodged division of the Department of Health. It's very similar actually to what happened in many other states that have these farm manufacturing, farm growing, harvesting under one state agency and then the manufacturing under another. The same example as I mentioned with Colorado, with California. So really the Department of Health will be dealing with it. In my experience and from what I've seen in the last few years, the Department of Health in different states are really quiet because it's something that falls in their lap without probably knowing too much about it or being too interested about it. The farm bill revolutionized the idea of the farm but we haven't taken good care of the manufacturing. And all the state agencies that are in charge of manufacturing, whether it comes from meat and poultry that will be coming from FSIS, USDA, put safety inspection service of the U.S. Department of Agriculture. I'm sorry, I have to say that. Or the Food and Drug Administration through Steve's and so those two, so all the agencies at the state level follow regulations from federal mandates. They said we will do equivalencies. We will try to be similar to, right, one state that has everything in one group under the Department of Health in New Hampshire right here next door. They don't get money to import the food codes from the federal mandate but they do follow the food codes in a way. It's very interesting because all states still use the guidance from federal mandates. And because there is none, states are kind of quiet. I hope you made sense what I just said. And that's the reason why I see the states, the manufacturers are kind of quiet. They don't respond sometimes. They don't want to engage because they don't have guidance. Are there any questions? Dr. Levine or Ingrid? And Dr. Levine, I realize you didn't see all of the discussion but wanted to open the floor. Unfortunately, I saw only the very last couple of slides. I assume I'll be able to access those slides though. Yeah, and I don't mind sending also like a PDF form for all views to share. Yeah, that would be great. It's a lot to take in but I think for the Department of Health that may put some things and for the CTB into a little more perspective in terms of what is there. Any questions, Mark? Yeah, I'm just, you know, this is a complicated business and I'm assuming that some of the, some aspects of this commerce falls under FDA. Some of it might fall under, I don't know, Treasury Department or other agencies. And it's not, it wasn't all straight out by the congressional farm bill. And I'm just wondering if you think there's more legislative guidance that's needed either at the federal or maybe both the federal and the state level or whether we're going to be able to make our way through this with despite regulatory decisions? So basically I don't think there is a need for more regulations more than just everybody's holding waiting for FDA to make a decision to help. But the problem again comes from the fact that we are still misunderstanding terms. We keep using the term CBD which is a specific one product but that has been kind of hijacked by the drug company. And again, it's against the Food and Drug and Cosmetic Act to go against that. Once we have a drug you cannot put a drug into a food product or a dietary supplement product. So it's not going to change, it has to not change quickly. And the issue is again all of the other drug, all of the other companies that can be extracted, that can use different names, all of a sudden from what is under the regulation of FDA I think the drug company is being very active. That may take a role and may go further and start getting more approval. And that kind of explains why some of the companies are lobbying for this CBD to be a supplement, right? They want as much of this to be a supplement, to find a supplement rather than drugs. And just the FDA recently denied again two applications as a new ingredient, as a new ingredient, dietary ingredient. So they have tried because India has tried many times, many times. I don't know where they can go. I think again the search for new products, new compounds that can have a little bit of a different name. I'm not a chemist, but you see the formula for this product. They're all very similar. So creatives in 31 she's also very attractive for some companies, especially drug companies. Omar, I do have a general question for you as a food safety expert. Have you seen with the use of edible issues as it relates to the manufacturing of the food product, understanding the THC component and what that is, but you know, allergens, anything that could... Right, right, right. So basically no allergen. It hasn't been associated to any allergen, despite products so far. Once you have an ingredient, what we do in food, we use ingredients. And once you consider this product an ingredient, it would follow the tradition that we have in food of understanding what are the potential hazards of that ingredient. I don't think there are potential hazards as long as you treat it... It's according to the food. It's according to how you prepare food. It's in manufacturing itself. Remember, food safety relies on manufacturing practice. In one instance, I worked with a company that tried to do an actual infusion and was trying to use very little temperature because they didn't want to decarboxylate and to eat the product. The Department of Health in that state, whoops, hold on a second. We had chances of crusty and botulinum because you're not destroying the sport. You may have the spales. The vegetative spales, when they have an opportunity, they grow and the toxin is produced in no time, right? And I said, yes, you're right. So that product was chill. That would be one of the worst case scenarios. The others would be just a regular production based on what is the intended use as an ingredient. But remember, I don't see... I particularly don't see an incentive for a food company to use an ingredient like this for which they cannot have any claims because food are very limiting. If there is anything where claims are going to be very, very, very remote, they're going to be food, so you have to be very careful. And these companies are trying to position themselves about claims and that's where, you know, I see the dietize supplements may allow them for that. And of course, drugs. Did any of the discussions this morning center around potency issues? I mentioned briefly that this is an area where we go into dietize supplements and they're trying to do a claim. They're going to have to support that claim with some, you know, testing. And what I see with the testing with potency is quite a bit of variation. It's the methodologies they're developing, the large variability in how they measure it. And so you may have some good protocols for identifying the analyte, the target, but quantification is illogical. And since you are going to go into potency, you need to have a quantification system that have a proficient variation that is small and I think the industry is still struggling with that. But I'm not an expert about that. I mean, that's what I see and some value that I have access to. Oh, when you're saying a quantification system, are you... I mean, does that have anything to do with how much is a standard serving? That's an issue. The standard serving hasn't been calculated, right? Because we are, again, talking about only less than 0.3% of ESC, but then if you want to do a claim about any effect, you're going to have to show that you have a drug and what is the product or the substance that you have in there, the compound. It's not for a small... I mean, testing for this type of compound is not inexpensive. You know, people use HVLT. There are systems that are complex, but the main issue with that is that... And the front-wheel is very strict on that. They want to have testing done in labs that have certifications and dealing with the food industry for more than 20 years. Not many labs have that. They are all over the map sometimes. So it's very important to have standards and to create protocols that have been validated before you can use them. We are still going through that. Do you have any considerations or have you gotten involved in warning language or warnings on the food products? Do you have any perspective on that you'd like to share? That's right. That's more of a legal advice. My take from speaking to the agency how they behave with others is that they have been kind of just using warning letters but not going to harden the compound. In other things, CBD is prohibitive. You go into the warning letters, you start seeing a lot of association with good manufacturing practices, violations of that. Which, by the way, is probably still 80, 90% of the warning letters are associated to violations of 21 CFR, 117 sub-parties. Are there any additional questions from the subcommittee or from the CCB? I don't have any questions. Thank you, Omar. This actually answered quite a few of my questions. Thanks for that. Dr. Levine and Ingrid will be able to share a PDF version of what Omar presented today. And we thank you so much for your knowledge and your time. And so now, Julie, we are right at Tentill. If we have any comments from the public, we certainly are open to those at this time. Public comments? Just a feedback point. You're welcome to stay. You're welcome to stay. I don't think we have any public comment today. Okay. All right. Dr. Levine and Ingrid, before we were to adjourn the meeting, are there any additional thoughts or anything more you'd like to see on this subject? I will say, Dr. Levine, he did spell out very well many of the CFRs in the presentation as it relates to this subject. Excellent. Mark, I think we can take it away. We appreciate you so much coming in here today and speaking with the subcommittee and the Cannabis Control Board and members of the public from Vermont. To remind everyone who may be watching this, if you would like to make a public comment, you may do so at ccb.vermont.gov with the public intake form. All comments received that way are submitted to the subcommittee members for their review. I'll summarize and bring those up during our subcommittee meeting. Mark, if you'd like to close this act. Well, thanks, Omar. If there are no further comments or questions, then do I hear a motion to adjourn from one of the members? Make that motion. Thanks, Ingrid. In a second. Do we hear a second? Thank you, Mark. We use adjourn. Thank you, everyone. Bye.