ASTM International has announced the approval of a new standard in development that could have potentially wide-reaching influence on the cannabis industry throughout the world. ASTM’s cannabis committee (D37) has approved the new standard (D8449) for development that aims to develop internationally aligned label specifications for all products containing cannabinoids.
According to the press release, The new labeling standard is the first of its kind, attempting to harmonize regulations throughout the cannabis industry with universally recognized labels that could be adopted by regulators anywhere in the world. ASTM member Darwin Millard has spearheaded the development of this new standard and believes it will have countless practical applications.
“Having the same information presented in the same manner across jurisdictions means consumers of products containing cannabinoids will have consistent information conveyed to them in a way they are familiar with,” says Millard. “This ensures consumers have the information they need to make an informed purchase decision, and will ultimately lead to increased consumer safety and confidence.”
ASTM International is a nonprofit, voluntary consensus-based standards development group. They are inviting feedback and input as they refine the standard and work on presenting it to the international cannabis community. “We welcome regulators, producers, and consumers from around the world to give us feedback,” says Millard. “This is intended to be a living document to remain relevant throughout this ever-changing landscape.”
Affinity Bio Partners on Working with Zelira Therapeutics to Complete Enrolment for Diabetic Nerve Pain Drug Trial
It’s an exciting time in the medical cannabis community as Zelira, a global leader in the research, development and commercialization of clinically validated cannabinoid medicines, and Affinity Bio Partners, a leading, global clinical research organization, have completed enrollment for a diabetic nerve pain drug trial. The Institutional Review Board (IRB)-approved head-to-head trial read out is expected in Q1 of 2023. Two years in the making, the study’s clinical management, clinical trial site monitoring, subject recruitment, regulatory submissions and review and query of data have brought us to a pivotal point that could pave the way for how future clinical studies are conducted in the medical cannabis community. As someone who comes from traditional pharma and biotechnology industries, heading up a clinical study in the medical cannabis realm has been a significantly different, eye-opening and informative experience that reinforces the dire need for mainstream, medical cannabis education.
Difficulties of Enrolling Subjects in a Cannabinoid-Based Clinical Study
There are a number of reasons that enrolling a cannabinoid study is very challenging. One of the biggest challenges to overcome is creating educational clinical study material that will be approved by the Institutional Review Board while educating potential subjects who are interested in enrolling. In other words, one must fully understand the regulatory landscape that they’re operating in, and we all know cannabis is a tricky one, while still educating potential subjects.
When screening subjects, it is important to be able to thoroughly share facts regarding cannabinoids, terpenes and other ingredients utilized in the study material. Also, sharing information on the endocannabinoid system is important, and a must for subjects to understand. In addition, it is integral to share and contrast between the traditional pharmaceutical products versus the cannabinoid study drug. Meaning, most subjects understand and are familiar with pills and other treatments approved in the traditional FDA regulated pharmaceutical space. Therefore, you must ensure that you create a bridge between a study’s educational materials and the lack of mainstream education about cannabinoid-based therapies.
The Impact This Will Have on Future Cannabinoid-Based Clinical Studies
There is a lot of hope that by working on a study of this magnitude, that we will pave the way for many more companies to bravely enter the clinical trial space as it pertains to medical cannabis. Everything that is being performed in this Zelira clinical study is in accordance with all applicable laws and regulations. The team is utilizing an electronic patient reported outcomes and electronic data capture system to receive data directly from the clinical trial sites as they are seeing the patients. As more patients, groups, communities and organizations learn about this, we hope that other large players in the cannabis industry invest their money wisely and perform clinical studies on their formulated products. Companies are unable to make claims of product safety and efficacy legally without these clinical studies. As we approach 2023, it is time for us as an industry to begin forecasting future clinical studies that will help power the therapeutic benefits this plant has to offer in responsible, controlled settings.
The success of reputable cannabis and CBD brands has inspired an influx of inexperienced and disreputable competitors in the market. These so-called “bad actors” in CBD advertise products that are not manufactured under current Good Manufacturing Practices (cGMP), which help to ensure that all products are consistently produced and controlled according to specified quality standards. cGMP helps guard against risks of adulteration, cross-contamination and mislabeling to guarantee product quality, safety and efficacy.
Joseph Dowling, Author & CEO of CV Sciences
CBD products without cGMP regulations are often inaccurately labeled and deceiving to consumers. In fact, in a test of over 100 CBD products available online and at retail locations, Johns Hopkins Medicine found significant evidence of inaccurate, misleading labeling of CBD content. The prevalence of such brands not only reduces consumer confidence in CBD but also limits the growth of the sector as a whole. Fortunately, CBD consumers and retailers can easily discriminate between a well-tested, reputable brand and inferior bad actors with a few straightforward, minimum requirements to look out for when selecting a product.
Why are “bad actors” a problem for consumers and the industry?
Bad actors in CBD sell products that are not produced under cGMP conditions and are typically not tested by third-party laboratories to ensure identity, purity, quality, strength and composition. This means they are not verified for contaminants, impurities, label claims and product specifications. This frequently results in misleading advertising with inaccurate levels of cannabinoids or traces of compounds not found on the label, like THC. To combat this, the FDA issues warning letters to actors that market products allegedly containing CBD—many of which are found not to contain the claimed levels of CBD and are not approved for the treatment of any medical condition. Still, bad actors manage to slip through the cracks and deceive consumers.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Bad actors that put anything in a bottle and make unsubstantiated medical claims hurt the reputable operators that strive to create safe and high-quality products. It is easy for consumers to be drawn to CBD products with big medical claims and lower prices, only to be disappointed when the product does not produce the advertised results. Inaccurately labeled products may contain unexpected levels of cannabinoids, including ingredients that consumers may not intend to ingest, like Delta-9 or Delta-8 THC. Along with unexpected levels of THC, many CBD products available now are not as pure as advertised, with one in four products going untested for contaminants like microbial content, pesticides, or heavy metals.
Further, inaccurate labeling of products and their compounds also prevents consumers from establishing a baseline impact of CBD on their bodies, leaving them vulnerable to inconsistent future experiences. Such a poor experience can turn consumers off to the category as a whole, drawing their trust away from not only the bad actors but also the reliable, reputable brands on the market. The saturation of the market with these disreputable brands delegitimizes a category that has only just begun to break down the stigmas, creating stagnation rather than growth as consumers remain wary of low-quality products.
How can consumers identify bad actors in CBD?
There are several simple ways to identify a bad actor among CBD products and make certain that both consumers and retailers purchase quality, reliable and safe brands in legitimate sales channels. To start, consumers should avoid all CBD products that are marketed with unsubstantiated medical claims. This is a significant area of abuse, as brands that relate any form of CBD product to a disease state, like cancer, should not be trusted. The science to support such medical claims has not been completed, yet, product marketing is years ahead of the evidence to support such claims. Unsupported medical claims could also mislead consumers that may need more serious medical intervention.
Just some of the many CBD products on the market today.
Additionally, consumers must review the packaging, which should include nutrition information in the form of a supplement fact label. The label should include the serving size, number of servings per container, a list of all dietary ingredients in the product and the amount per serving of each ingredient. All labels should include a net quantity of contents, lot number or batch ID, the name and address of the manufacturer, and an expiration or manufacturing date. These signs of a reputable brand are easy to look for and can save consumers from the trouble of selecting the wrong CBD product.
What to look for when selecting a CBD product
With this in mind, products from reputable, tested brands can be identified by a few key factors. Reputable CBD companies are already compliant with the FDA regulations on nutritional supplements, including a nutritional or supplement fact panel on the packaging—just like vitamins. The information in this panel should include all the active cannabinoids in the product, both per serving and package. Clear potency labeling allows consumers to confidently select products that suit their needs and understand the baseline impact of CBD concentration on their bodies, thus helping them to tailor their experience with thoughtful product selection.
Reputable brands also include a convenient QR code on the packaging, linking the product to a certificate of analysis that details the testing results to demonstrate compliance with product standards and label claims. In terms of specific ingredients, consumers should be skeptical of high concentration levels of “flavor of the month” minor cannabinoids, which are often associated with unsubstantiated medical claims. Current scientific research has set its focus on major cannabinoids like CBD and Delta-9 THC, leaving additional research necessary for understanding minor cannabinoids. Minor cannabinoids are typically included in full spectrum products at concentrations found naturally in the cannabis plant, which is a safer approach to consuming CBD until more research is completed.
Consumers should not let the existence of unreliable, untrustworthy brands curtail their confidence in the CBD sector—there are many high-quality, safe and trusted brands on the market. With a knowledgeable and discerning eye, consumers and retailers can easily select top-quality CBD products that millions of consumers have found to improve many aspects of their health and well-being. Looking ahead, clear federal regulations for CBD products that require mandatory product registration, compliance with product labeling, packaging and cGMP will be crucial in weeding out bad actors and will allow compliant companies to gain consumer trust and responsibly grow the CBD category.
California is the fastest-growing cannabis beverage market, according to a recent Headset report. The count of beverage product offerings in California has grown quickly, nearly doubling from 2020 to 2021. As of December 2021, there were approximately 530 distinct cannabis beverage offerings.
Mocktails have been a growing product category within the cannabis beverage segment. Klaus, headed up by Warren Bobrow, the “Cocktail Whisperer,” recently entered the California market with their ready-to-drink THC cocktail, Mezzrole, a unique terpene-forward beverage with three simple culinary-grade ingredients.
We caught up with Warren to learn more about his path to the cannabis industry and his inspiration for Mezzrole. Warren is a multi-published author of six books including “Cannabis Cocktails, Mocktails, and Tonics” and has contributed to publications such as Forbes and Skunk Magazine. After the loss of his fresh pasta business in Hurricane Hugo, he worked in banking for 20 years before reinventing himself and following his passions—becoming a bar back to bartender and master mixologist and penning his six cocktail-focused books. Warren crafted Klaus with knowledge gained from years of experience in the mixology and culinary worlds and with his strong enthusiasm for cannabis.
Aaron Green: How did you get involved in the cannabis industry?
Warren Bobrow: It was a happenstance, and it was something that I never considered before. I was working in the traditional liquor industry, and because liquor is inherently a poisonous substance, I was slowly poisoning myself and my mind with the alcohol. I made a conscious decision back in July of 2018 – I was down to Tales of the Cocktail in New Orleans – and I said, “this is my last drink.” I was halfway through a Hemingway, which is absolutely my favorite cocktail to have and that’s what I was known for. That’s the drink that paved the way to a wonderful career on-premises and off-premises doing brand ambassadorship and being a named person within the liquor industry. As with all great careers, this one had to come to an end, or I was going to die because liquor was poisoning me. I was probably about 75 pounds heavier than I am right now. I just didn’t feel myself and I was going to be sick.
So, I decided to take my knowledge of cannabis, which was something that I’ve enjoyed since I was 12 years old – I am 61 now – and put it to use for me in this book, Cannabis Cocktails, Mocktails and Tonics. My first book, Apothecary Cocktails, really did pave the way. I wanted to include cannabis in my early books, but my publisher wouldn’t let me. It just wasn’t time until 2015 when I wrote Cannabis Cocktails, which is all based on the early apothecary. The inspiration for writing the book certainly was from being down in New Orleans and going to the Pharmacy Museum. They had an exhibition of cannabis in the early apothecary, and I knew immediately what I was going to do with the rest of my life. There you have it!
Green: It seems like it was a sharp cut off with the alcohol industry
Bobrow: Yes, like one day to the next, literally. It was absolute. I made the decision; I came back to New Jersey, and I never drank again. I drink a little beer and wine, but I haven’t had a distilled drink in years.
Green: How did the concept for Klaus come about? Was it something that you always had in the back of your mind?
Bobrow: The idea for creating a cannabis infused beverage came from being incarcerated in New York City for smoking cannabis in the street and being taken out of commission for 48 hours, I knew that if I was drinking a cannabis infused beverage like Klaus, which is the one that I created in California, no one would know my business. Of course, when this happened, it was in the early 2000s, so the technology and the pretense just weren’t available yet. But it did put something in my mind. If I was to create a cannabis-infused beverage using my knowledge and experience as a master mixologist, the fear of consuming cannabis would be diminished.
If you look at the book, Cannabis Cocktails, and you see the recipes, they’re not for the meek. They’re really meant for a medical community – someone who needs to really eliminate pain, if you will. Cocktails in the book started at about 250 milligrams of THC, whereas with Klaus they’re 10 milligrams, Two different stories completely!
Warren Bobrow, CEO & Co-Founder of Klaus
My inspiration for creating Klaus certainly was from the gnome [Warren displays Klaus, The Gnome]. He’s a star and he’s been all over the world with me. I don’t know why I first started traveling with him. Maybe it’s because he was sitting up there up on my mantle and he told me that he wanted to go out on the road with me. I was traveling all over the world as a rum judge for the Ministry of Rum and for Rum XP. We just show up at food events. I’m a trained chef, I love going to the Fancy Food Show in New York City, and I’d meet people and they invite me out to see their places. Then I started writing for Forbes and I don’t know, my career has been up and down. I’ve tried to follow my dreams ever since I left the corporate world in May of 2009.
Green: Let’s talk about the product.
Bobrow: I just have one SKU right now, which is the Mezzrole named for Mezz Mezzrow, Louis Armstrong’s weed dealer. You can’t make this stuff up. It’s all real.
Green: First, how did you land on the flavor profile?
Bobrow: For someone who’s a rum head like myself, we used to drink rum for breakfast. That’s how you become a rum head. The Mezzrole is based on a Ti’ Punch, which is the national drink of Martinique. Ti’ Punch is usually made in Martinique with rum Agricole, which is a sugar cane-based rum rather than a molasses-based rum. It’s the freshly pressed sugar cane rum before it ferments so it has a lovely floral quality and it’s 100 proof. There’s nothing weak about it!
A Ti’ Punch is freshly squeezed lime quarters, the 100 proof Agricole – one or two ounces – and cane sugar syrup stirred usually with your finger like my old friend Gaz Regan, who’s no longer with us, used to do it. He was known for his finger stirred negronis. I would do it preferably in a clean glass and there’s no ice involved because if you’re on a sailboat, you probably don’t have ice anyway. So, it’s potent. It’s a very potent drink. That’s the basis of the Mezzrole.
The Mezzrole contains a single strain of cannabis. We used a craft, land-raised strain called Hippie Crasher. It’s an indica leaning hybrid that is terpene forward. The Mezzrole utilizes the terpene aromatics of the cannabis strain. So, we have this gorgeous French lime puree that I get made from limes that are sourced down in Martinique. They have a certain oily quality to them and they’re very pungent. They’re very citrus forward and very flavorful.
Then, I’m using a ginger syrup that’s made in what I would say is a Great Britain or Jamaican style called Picketts. It’s from Denver, Colorado. My old friend Matt Pickett, and his late brother Jim created it. Jim was the bartender for Malcolm Forbes on his yacht, the Highlander, when they had it in the waters between me and Palm Beach, or wherever they happened to be on the island. Jim crafted this incredible ginger syrup, which is really authentic. And in later years, it became the Pickett’s ginger syrup that I would use in this beverage because I’m paying homage to Matt’s brother by using his extra hot and spicy ginger syrup in here along with the French lime purée.
The final element – there are only three flavor elements [besides the cannabis] – is rice vinegar. Rice vinegar in this case is something called mirin. There are two different types of mirin. There’s the sweet mirin and then there’s the dry mirin, and Mezzrole utilizes the dry mirin. I didn’t want to add any sugar. Mezzrole is six tenths of a gram of sugar for the entire can, which is eight ounces, 16 calories.
So, to recap, each can of Mezzrole is eight fluid ounces, six tenths of a gram of sugar, ginger, lime and rice vinegar with THC infusion. And it’s not a seltzer!
Green: What was special to you about the Ti’ Punch?
Bobrow: My family had a yacht, and we would go places in the Caribbean. One of the places we would go in the Caribbean was Down Island and they would have drinks like the Ti’ Punch. I remember that it was emblazoned in my brain. It was a drink that got me drunk. It was what sailors did; they got drunk. And you would get drunk on drinks that go back to the days of the pirates, because they probably didn’t have ice on the sailing vessels. So, why should a couple million-dollar yacht make any difference? We had icemakers, but you drink the drink without ice. You drink it like it was drunk in the age of sailing.
I wanted to reinterpret the Ti’ Punch and bring credence and life to that drink by bringing it to life in the Mezzrole. But the Mezzrole has another story behind it entirely. That’s because Mezz Mezzrow, who was a jazz head during the jazz era, brought between two and 4,000 pounds of cannabis up from Mexico, and sold it in Detroit, Chicago and Harlem during the early days of jazz. He made quite a name for himself. At the time, cannabis was not illegal on a national level yet. If you were to ask for a joint or reefer, you might become detained by the police, especially if you were Black. Not only were the police at that time incredibly anti-jazz and anti-Black and anti-cannabis, but they were just anti people having fun! So there had to be code names and a well-rolled cannabis cigarette was known as a “Mezzrole” and that’s what I named the cocktail after.
I’m paying homage to Louis, and I’m friendly with Louis’ daughter, Sharon. She’s the daughter that no one ever knew about. It’s a very interesting story. We’re hopefully going to do something together. I find great inspiration in jazz, and we wanted to pay homage to the role of characters in jazz by creating a beverage that hopefully wouldn’t get us arrested.
Green: Can you walk me through your choice of strain for the beverage?
Bobrow: I work with a company named Vertosa. They are the magicians in the world of nanotechnology emulsions. They’re scientists like yourself, who are upper intellects who dream in color. And the colors that they’ve chosen are the colors of the plant. So, they’ve enlivened the plant chemically through their process. I’m not privy to that process, but I’ll tell you it works. Their emulsion is gorgeous stuff. I just chose the emulsion for my next two SKUs and it’s exactly what I was looking for. It’s slightly bitter, it has depth and character, and we haven’t even added the terpenes in yet. So, it’s well balanced, and it will work exceptionally well with the craft ingredients that I’m working with. I don’t use industrialized ingredients, these are all bartending ingredients, if you will. We do 5,000 can production runs with bartending ingredients. It’s incredible food science. I love it.
Green: What was behind your decision in adding the terpene flavors?
Bobrow: What makes that interesting is no one else is doing it. So, we’re the first again! Not only did I write the first book on cannabis, and cocktails, and tonics, and all that stuff, but I created the first beverage that actually smells like cannabis. So, when you’re drinking one of my beverages, and you drink down maybe a quarter inch, and you put your nose right over the top and smell it, it smells just like the plant along with that ginger and the lime and that tangy quality of the mirin. And it’s spicy. It has an herbaceous quality to it. It’s really uncanny.
Green: Were there any challenges in working with terpenes in a beverage?
Bobrow: Yes, there’s always challenges. First off, I’m here in New Jersey, and the company that I’m working with is in California, so they can’t send me anything. So, I work very closely with a food scientist named Chris Anderson who did my scalability, and he’s absolutely brilliant. His palate mimics my own. I don’t want a sweet beverage. I want a tangy beverage. I want something that has balanced quality and fun and it makes you want to dance. I’m not looking for something to put me to sleep. That’s not my goal in life. Life is very short, and you want to have a beverage that is talkative and doesn’t get you totally destroyed. There are beverages out on the market that have 500 milligrams of THC called syrups. They’re absolutely delicious, but they’re so destructive because they want you to put them in a sugary beverage and drink the whole thing down.
I’m not a kid anymore and I don’t drink like a kid. I drink with sophisticated flavors and make beverages that are memorable. People come to me – and have since the early part of 2009 – and they say things like, “That’s the best cocktail I’ve ever had in my life. How do you do that?” My aim in life is to ruin people for their bartender because I expose all the things that our bartenders are doing to rip them off.
I started as a bar back and I worked my way up. I went to this guy named Chris James, who was working at The Ryland Inn running their beverage program. I needed a job, and he hired me as this bar back for a year and they kicked my butt. After that I could write about this stuff with knowledge and not just with something I read in a book. There’s a lot to be said for education and going to bartending school. There’s also a lot to be said for cutting your own ice and squeezing your own juice and taking out the trash.
Green: What are some of the challenges you are facing at Klaus?
Bobrow: We’re hoping to do a Series A round of financing. I wonder who would be interested in lending to us or giving us money or investing in us. I always wonder why anyone would be interested in any of this! But I have a talent and a passion, and I know that it will take me to the next step in life. I’ve waited and been very patient. I have massive shoes to fill, and I’m so committed to being ambitious.
I was an executive assistant in a Trust Bank for 20 years. I put my life on hold for others because they wanted to make an example out of me. I never became the person that my parents wanted me to become. They wanted me to become a lawyer and I didn’t have the aptitude for that. I had the aptitude for being a creative soul and a creative mind. It just took me 20 years longer to be able to achieve that.
I consider myself the luckiest man in the world because I did work for the C-suite and for the top of the house and I sold wine to them when I worked on the nights and weekends in a wine store. My customers were the presidents and “kingmakers of the world.” Here in Northern New Jersey, if nothing else, it’s pretty affluent. So, I’ve long been accustomed to coming from that environment. I know what that environment means and the importance of that environment. I had to figure out how to make it myself because I was, in polite parley, “disowned.” So, I am self-made, and I have a great product that I’ve created out of nowhere. It’s hopefully going to allow me to figure out what the next step will be in my life. I want to make this a national name.
Green: What trends are you following in the cannabis beverage space?
Bobrow: I’ve had some good ones. I’ve had some okay ones. And I’ve had some that are just, I don’t know. I’m a cook. I’m a saucier. I love flavors. I’m trained in France. I cook. It’s a lifelong thing. I started as a dishwasher, and I worked my way up. I’ve traveled the world eating.
I’ll tell you, if you don’t know flavors, you can’t put anything together. And if you don’t know what goes into making a beverage that’s different than what anyone else is doing in the world, then you don’t deserve to be in this business because it’s highly competitive and people play for keeps. If I only get one chance to capture people’s imagination, it comes with this beverage right here [Warren holds up a can of Mezzrole].
Green: What’s next for Klaus?
Bobrow: I hope to be doing Klaus Nein. It’s a terpene forward, non-cannabis infused craft beverage. It doesn’t have any THC, so I can sell it everywhere. I caught the travel bug years ago, when I was traveling all over the world for the rum business. And I got it back again. I hate that the world became such a small place during COVID. Because it really is a big place. And it’s a place that I need to explore more of. Stay tuned!
Green: What are you most interested in learning about?
Bobrow: You know, it’s funny. I think everyone that I come across I can learn something from. My teachers at Emerson and later at MIT, where I spent a fitful year, taught me that I wasn’t the smartest person in the room, but I certainly was the most inquisitive. So, I want to be known as someone who has pretty good listening skills. I also have great skills in the way of trying to draw out answers from people. So, I have a lot to learn and I’m excited about the opportunity of learning. If I can share a little bit of my knowledge with other people within the industry and they respect me for what I’ve achieved, then I’ll be a much happier person. I’m already happy. I’m very lucky. I am the luckiest guy in the room.
Green: Thank you Warren. That concludes the interview!
The Center for Scientific Cannabinoid Information (CSCI) announced their launch on June 14. In a press release announcing their launch, the non-profit organization says they want to serve as a resource for healthcare professionals, psychologists, doctors, athletic trainers and others looking for information on the safety and efficacy of cannabinoids. The organization is focused on providing current, research-based information on cannabis.
The advisory board for the CSCI includes: Margaret Roche, a dietitian; Dr. Steven Salzman, a surgeon; Dr. George Gavrilos, a pharmacist; Joseph Cachey, an attorney and former hemp executive; Dr. David Kushner, a hospitalist; Dr. Bonni Goldstein, a physician; Dr. Kylie O’Brien, an integrative medicine specialist; and Dr. Jason Canner, an oncologist.
According to Dr. Steven Salzman, who is named as CSCI Chief Medical Officer, their organization will help fill the knowledge void in the healthcare space. “As a physician and practitioner working with cannabinoids, I’ve heard from many other practitioners who have been searching for reliable, evidence-based information on cannabinoids, and realized there was a void,” Says Dr. Salzman. “The CSCI fills this void by serving as a valuable resource where practitioners can access accurate, up-to-date information on CBD and other cannabinoids to help them gain a better understanding of this emerging field.”
The press release says that the organization will compile the latest research and clinical best practices for cannabinoid treatments and share the information with their community. The CSCI invites folks interested in medical cannabinoid research to check out their website and join their community to receive up-to-date scientific information.
Regulators in New York are continuing their push forward in launching the adult use cannabis market. They have approved 58 conditional licenses for hemp growers to begin cultivating cannabis for the adult use market. In just the past few months, the state has already awarded 146 conditional licenses for cultivation.
The Office of Cannabis Management (OCM) in New York also announced their “Get Ready, Get Set” virtual workshop series, designed to help social equity applicants prepare for license applications and better understand the conditional licensing program.
Earlier this year, following an amendment to state law, the OCM launched the conditional licensing program to ensure that hemp farmers in the state with a desire to grow adult use cannabis could get started in the 2022 season.
Applications can be filed with the OCM for conditional licenses through June 30, 2022, with a $2,000 non-refundable application and licensing fee. The licenses are only for farms that have already grown hemp in New York State.
“New York is building the most inclusive cannabis industry in the country and including small farmers with an expertise is an essential component in accomplishing that goal,” says Chris Alexander, executive director at the OCM. “The growing season isn’t waiting for anyone and I’m grateful for the hard work of the CCB and my colleagues at OCM to ensure these licenses are being reviewed as quickly as possible so New York’s farmers can take full advantage of the growing season and cultivate the products that our equity entrepreneurs will be the first to sell when they open their dispensaries this year.”
In a press release published this week, AOAC International announced it has partnered with Signature Science, LLC as the test material provider for the new AOAC Cannabis/Hemp Proficiency Testing program. What makes this proficiency testing (PT) program so unique is that AOAC will be the only PT provider to offer actual cannabis flower as the matrix.
This month, the pilot round with twenty cannabis testing labs begins with hemp-only samples being shipped in early May. The first live round of the PT program is scheduled for November of this year and will offer participating labs the choice of cannabis flower samples or hemp samples.
The program will include one sample for cannabinoid and terpene profiles, moisture and heavy metals, as well as a second sample for pesticide residue testing. According to the press release, mycotoxins will be added to the mix soon.
The new PT program was developed by stakeholders involved with the AOAC Cannabis Analytical Science Program (CASP), including state regulatory labs, industry labs, state and federal agencies and accreditation bodies. Shane Flynn, senior director of AOAC’s PT program, says the program is a result of scientists coming to them with concerns about testing in the cannabis space. “AOAC has a long history of bringing scientists together to address emerging topics, so when stakeholders came to AOAC with their concerns and need for quality proficiency testing in the cannabis industry, AOAC acted,” says Flynn. “Stakeholders noted the analytical differences in testing cannabis versus hemp and had specific concerns around it and asked for a program that would provide actual cannabis samples in addition to hemp. This is truly a program that was created by the stakeholders, for the stakeholders.”
AOAC says they plan on introducing microbiology to the PT program, with microbial contamination tests in both cannabis and hemp samples. They are also considering adding additional matrices, like chocolate and gummies.
Signature Science is an ISO 17043 accredited proficiency test provider that also has a DEA-licensed controlled substances lab, making them an ideal candidate to partner with AOAC for the PT Program. They entered into a 3-year MoU with AOAC for the program. Their team developed and validated methods used to create the samples for the PT program at their DEA-licensed lab in Austin, Texas.
A new ASTM International standard seeks to create an internationally recognized symbol that indicates a product contains intoxicating cannabinoids. The cannabis technical committee at ASTM, D37, developed the standard for the International Intoxicating Cannabinoid Product Symbol (IICPS).
The International Intoxicating Cannabinoid Product Symbol (IICPS)
The standard is labeled D8441/D8441M and is supposed to be used with all finished consumer use products, including topical use, ingestion and inhalation. ASTM International members David L. Nathan, M.D. and Eli Nathan designed the symbol with a group of volunteers from the D37 led by Martha Bajec, PhD of HCD Research. The symbol was concurrently developed by Doctors for Cannabis Regulation (DFCR) and Subcommittee D37.04 on Cannabis Processing and Handling. The symbol is designed “to create a truly universal cannabinoid product symbol, mindful of its importance as a means to communicating to adults and children the need for caution with products containing cannabinoids,” says Dr. Nathan. “The symbol has the potential to facilitate a spirit of collaboration among experts, regulators, and all other stakeholders in the cannabis industry.”
Darwin Millard, subcommittee vicechair for ASTM D37.04 and subcommittee co-chair for ASTM D37.07, says this is perhaps one of the most important standards to come out of the committee. “It serves to establish a harmonized warning symbol that is truly international,” says Millard. “It is not intended to replace symbols that have already been established, rather it is intended to be used by marketplaces that have yet to establish a symbol.” As more and more marketplaces adopt the symbol, the hope is that markets with their own symbol will harmonize with the ASTM symbol over time.
Millard says the symbol uses the ISO standard warning triangle, the ANSI standard warning orange/yellow and defines a standardized icon for cannabinoids, the leaf. “There are a number of cannabinoids that are intoxicating, not just delta-9-THC, therefore the symbol is designed to be used to identify any cannabinoid that can be classified as intoxicating,” says Millard. “The symbol doesn’t care if the cannabinoid is naturally derived, isolated and purified, synthesized by yeast or created in a lab; if it is ‘intoxicating’ and a ‘cannabinoid’ the symbol can be used to identify a consumer product containing it. ‘Intoxicating’ was used over ‘inebriating’ or ‘psychoactive’ since neither term is correct. Impairing was recently used by Washington State and might be worth considering down the road.”
The IICPS became the official symbol for the state of Montana as of January 1st. New Jersey and Vermont have also incorporated the IICPS design into their state symbols, already making it the most widely adopted cannabis product symbol in fully legalized states. Alaska and other states are currently discussing use of the symbol as well.
If you are interested in contributing to the development of this and other D37 standards, you are encouraged to join the committee. In addition, they will be hosting a free webinar on June 1 to discuss the development of the international symbol, how to use it and how the marketplace and consumers will benefit from it.
Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.
This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.
In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.
Oral Cannabinoid Delivery
Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.
Some of the many infused products on the market today.
Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.
Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.
Cannabinoid capsules
Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.
To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.
Fast-Acting Absorption
Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.
A drink additive, made by Splash Nano, that uses nano emulsion technology
Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.
As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.
Microencapsulation to boost cannabinoid absorption
Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.
Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.
Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.
This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.
Metered Dose Inhalers
So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.
A metered dose inhaler by MÜV
Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.
Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.
Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.
Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.
Automated extraction equipment and technologies are rapidly becoming the standard in the extraction sector of the cannabis industry. Like most evolving industries, manual and operator driven processes are what starts an industry, but with explosive growth, demand for increased safety, efficiency and repeatability grows. Specifically within the cannabis industry, we’re noticing a rising demand for higher quality extracts and a safer, more repeatable environment for cannabinoid extraction. These are all reasons for the industry making a shift towards automated extraction equipment and technologies.
What Automation Looks Like in Cannabis Extraction
Automation in the cannabis industry doesn’t necessarily mean implementing robotics and creating operator-less facilities; It typically refers to automated process control. Traditional, older technologies are manual and operator-driven. This means the equipment operator is in control of all parameters of the process, which leads to inconsistencies throughout the process caused by human error. As the extraction process has many steps: ethanol holding, chilling, extraction agitation, extraction discharge, extraction solvent removal, particle filtration, semi saturated solution storage, and so much more that involves valves, pumps and controls between each piece of the process, it becomes difficult to control such a tedious process manually. When all of these processes are controlled and monitored using proper automation technology, facilities can safely ensure that each batch is run following the same process and parameters accordingly. This is critical for product consistency, a concern for manufacturers and many end-consumers. As the cannabis industry grows, matures and makes its way closer to federal legalization, product safety and consistency become a top-priority for everyone involved.
Greater Quality Control of End-Products
Automated extraction processes ensures that the same solvent ratios are used batch-to-batch
Consistency and repeatability are just as important for cannabis processors as they are for standard food or pharmaceutical processors. Deploying a manual process of equipment operating and monitoring leaves far too much room for human error, and doesn’t provide the level of control needed for the industry as it continues to progress toward stricter product regulations and requirements. On the other hand, an automated extraction process ensures that the same solvent ratios are used batch-to-batch, the same extraction temperatures and recipe parameters are implemented, the same pump and process flow rates are deployed, and all processes are repeatable, predictable and scalable while producing a safe, consistent product.
Fewer Bottlenecks
The benefits of automated extraction are directly tied to establishing greater efficiency in processes. Efficiency can be experienced via less scrap product from unmanaged batches and/or less labor to operate and control the process. Automation means allowing a recipe-driven control system monitor and control the process, eliminating process bottlenecks that have been notorious for destroying productivity in manual extraction operations.
As Cannabis Extraction Processes Become Automated, They Become Safer.
automated extraction process ensures that the same solvent ratios are used batch-to-batch
A team is what drives any business forward. The safety of that team needs to be a top priority for any business leader. As cannabis extraction processes become automated, they become safer. With less equipment interaction, the likelihood for human error that could lead to safety hazards significantly decreases. Properly programmed automation can establish advanced system interlocks that check multiple points throughout the process for irregularities, and can halt a machine based on these irregularities it detects. That level of process monitoring and control is only available when automation and PLC logic controls equipment.
Data Collection and Validation
When we tie all the benefits of extraction automation together, it makes for a far more attractive system than traditional,manual processes that we’re used to seeing in the cannabis industry. In addition to the major benefits listed above, automation gives a superior level of data collection for process improvements and process validation which is key in cGMP or EU-GPM facilities. This is the future for every processing facility in the arena of cannabis. As the industry matures, it will continue to become more competitive. Facilities with automation will have the capacity to maximize their process efficiencies, produce a far superior and more consistent end–product and will have a competitive advantage in the extraction sector.
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According to the press release, The new labeling standard is the first of its kind, attempting to harmonize regulations throughout the cannabis industry with universally recognized labels that could be adopted by regulators anywhere in the world. ASTM member Darwin Millard has spearheaded the development of this new standard and believes it will have countless practical applications.
