There are numerous plastic bottle and closure manufacturers in the cannabis industry today. And, there is a significant quantity of common bottle and closure styles as well. Many companies manufacture the same or similar products as their competition. But what if you’re searching for something different? Something unique that no one else has? A plastic bottle that will make your cannabis product stand out from your competition. Where can you find that package that is truly “something special?” Something that will elevate your brand?
It doesn’t matter if your cannabis business is a start-up in its infancy or a mature company with an established loyal customer following, creating attention-grabbing packaging is essential to your success. The packaging is the all-important and critical first impression. While the primary function of any packaging is to contain, protect and market your cannabis products, your packaging is a reflection of your company in the eyes of the consumer. In many ways, the package is the product. Using creative plastic packaging is a great way to differentiate your cannabis products from those of your competitors.
Finding the right manufacturing partner is the first step. Look for a company that has custom design capabilities and understands your vision for the perfect cannabis packaging.
When is Custom Bottle Design the Right Choice?
Sometimes, an off-the-shelf stock bottle and closure will work just fine. But if you are introducing a brand-new product that is unique to the industry, or if you are using a new product to introduce the fresh new look of your brand, it makes sense to develop plastic packaging that is distinct and eye-catching. You want your brand and products to look special and stand out on the shelf. There could also be filling equipment, regulatory, labelling, light sensitivity or other packaging requirements you must address as well.
Start every custom cannabis bottle project with a trusted manufacturer who thoroughly understands how you want the plastic packaging to look and the specifications it must meet. Ensuring that these qualitative and quantitative details are discussed will lead to on-time, on-budget and on-target custom cannabis packaging solution.
Achieving the Look You Want
Depending on your requirements, there could be several solutions to achieving the special look and specifications of your custom packaging. Discuss all of the design options that meet the needs of your product with your manufacturing partner; they should help you decide on the best direction for your packaging.
Selecting the right materials for your custom plastic bottle and closure is a big part of the process. Select materials that will provide the necessary aesthetics, chemical resistance, light transmission, bottle capacity and weight requirement that will protect your product.
Your manufacturer should also be able to guide you through the production process: should the bottle be blow molded or injection molded? Should it be made on IBM (Injection Blow Molding) equipment or EBM (Extruded Blow Molding) equipment? Answering these questions will ensure that the plastic bottle will be made efficiently and to the correct specifications.
Designing the bottle is important, but you must also consider what type of closure will work best. Both items must be engineered to work seamlessly with each other. If the closure doesn’t work properly with the bottle, it can compromise the product it contains. Closures must always seal perfectly to ensure the integrity of the product inside. They must also be designed to function efficiently and meet the requirements of your filling operation.
A detailed CAD drawing should be provided, outlining every critical dimension of your HDPE or PET bottle and plastic closure. The CAD drawing provides the direction needed to create the manufacturing mold for your custom design. It also serves as a reference check to ensure that the product is produced according to your specs.
Ensure Quality through the Manufacturing Process
Ensure that your packaging partner has quality checks in place throughout the manufacturing process. Error detection systems, random sampling and testing will safeguard 100% conformity. It’s also important that manufacturers adhere to cGMP best practices and certifications under a globally recognized accredited program. This represents their commitment to continuously improving manufacturing processes and quality systems. It also helps minimize waste and manufacturing errors while increasing productivity. Risk of product contamination and other errors will be alleviated, and product efficacy and shelf life expectancy will be met.
Many packaging manufacturers claim to provide exceptional customer service, but few actually rise up to that level. This is an important aspect of your project and you need to know that your questions will be answered and that your producer will keep you informed of any changes. Knowing that you can trust your supplier allows you to concentrate on other aspects of your business, like growth and profitability.
Reinforce Your Brand with Customized Packaging
In today’s competitive cannabis market, it’s more important than ever to have your product stand out from the competition. Your brand should help build awareness and develop consumer loyalty. When you deliver a consistently reinforced message, consumers will instantly recognize your brand. This consistency is a key factor in encouraging consumers to purchase your product over the competition — even when they want to try something new. Consistency makes your brand feel more dependable and people gravitate towards things they trust.
Your brand consists of more than just your logo and company name. Your brand identifies who you are, what your company stands for and the integrity of your product. Customized cannabis packaging will reinforce your brand and attract consumers to your products. Take time to find the right cannabis packaging partner who can help differentiate your brand and products from your competitors with special, eye-catching plastic packaging.
The journal Frontiers in Plant Science recently shared an important article from researchers at Simon Fraser University in British Columbia, highlighting the “Pathogens and Molds Affecting Production and Quality of Cannabis Sativa.”
As a chemist focused on the science of preventing and mitigating mold in greenhouse and indoor cannabis grow facilities, this piece was fascinating to me. Like many others, it details and explains prevalent mold like Penicillium, Cladosporium and Aspergillus – things I see in grows every day.
But wait, there’s more fungi
The research and resulting article also brought up another type of fungi – endophytic mold. Endophytic mold usually lives symbiotically with plants, or is at least beneficial for both plant and fungi.
But not always.
In the past, the industry has believed that damaging mold spores were found on the outside of the flower. When moved, that flower would release the spores and send them flying – often creating massive cross-contamination issues for indoor grows.
“While cannabis is an incredibly powerful plant in terms of its medicinal properties, it is unfortunately highly susceptible to many pest and pathogens,” says Hope Jones, PhD, CEO, Adivina & ECS. “And it is this susceptibility that is so challenging to many inexperienced or undisciplined grow operations.”
Now, however, we know that there’s another culprit to add to the list: the inner parts of the plant can also be a source of endophytic cross contamination and mold.
Since it grows inside of the plant, this fungus creates high spore counts that can cross contaminate from outside, into the flower.
Treating mold in a facility
Here’s the good news:
This seemingly bad news – that there’s a new fungus to worry about, and it is inside the flower – may actually help cannabis grows struggling with mold, and those who are following the proper protocols already.
Effective mitigation protocols can include things like treating HVAC systems, controlling humidity, using products like chlorine dioxide to treat irrigation lines, enforcing protective clothing and shoe covers for employees, reducing the amount of in-and-out for employees around grow rooms.
These are important upstream and environmentally-focused integrated pest management (IPM) programs that will usually keep facilities clean and relatively mold-free.
But if these programs are in place, and there’s still an issue, Endophytic fungi may be to blame.
If you are having ongoing mold issues but have ruled out cross-contamination and a facility without proper protocol, look to the mother plant.
“Small mistakes in agricultural practices are amplified with cannabis,” Dr. Jones continues. “And today’s propagation practices of traditional cloning add to this vulnerability. Cannabis is an annual plant and by keeping mothers in a perpetual state of vegetative growth for years, and taking repetitive cuttings produces clones in a highly stressed state. This stressed state diminishes genetic potential and weakens a plant’s ability to fight disease and pests.”
Testing for and addressing endophytic fungi
If these concerns are ringing a bell, remember, there is also a way to test for Endophytic mold.
Checking cuttings from suspected mother plants over a period of time is the best way to see if the Endophytic mold is present.
A section of the mother plant cutting is placed into a solution (for example, as outlined by the article, a very concentrated hypochlorite followed by 70% Ethanol) that will kill all of the microorganisms that are present on the surface of the plant tissues.
From there, an unadulterated dissection of the internal tissues can be extracted and cultured for quantification and identification of endophytic fungi.
“Tissue culture offers a form of genetic rebooting returning the plant to its natural genetic potential and thereby strengthening its natural ability to defend against environment assault,” says Dr. Jones. “It also allows the breeder to conduct pathogenic disease testing which provides the entire industry with a higher level of scientific certainty and analysis.”
If you find this mold inside of the mother plant, your facility’s mold problem could be a systemic issue, not an environmental one.
If you do find that Endophytic mold is causing issues, of course, you may have to destroy the mother plant.
This should not mean the end of a strain. Tissue culture on a cutting is an option that can eliminate the unwanted fungi and save the genetics. Using those genetics to regrow a mother will start fresh and avoid the intrinsic mold that was plaguing the strain prior.
The practice of checking mother plants for Endophytic mold is not yet commonplace in cannabis, but the hemp business is leading the way.
They’re testing to create very clean plants, so you don’t have issues during cultivation.
Major growers in the U.S. could save millions in lost harvests with mold mitigation. If your current IPM program isn’t doing the trick, you may want to follow in hemp’s footsteps and look inside the plant.
Cannabis Industry Journal is pleased to announce our partnership with Pioneer Intelligence on this new series of articles. This is the first installment of The Brand Marketing Byte.
Pioneer Intelligence uses data to benchmark marketing performance of consumer-facing cannabis brands across three areas: social media, earned media and web-related activities. At present, Pioneer takes in over 60,000 data points each week. The company’s team of marketers and data scientists share findings through weekly generated Performance Scorecard reports as well as Brand Marketing Snapshots. Pioneer Intelligence offers reports on more than 500 U.S. cannabis brands. Ben Walters, founder of Pioneer Intelligence, says their mission is “to help cannabis industry stakeholders better understand how marketing strategies & tactics resonate with audiences.”
The Brand Marketing Byte will showcase highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies. We hope this column can serve as a resource for readers interested in branding and marketing.
In terms of scoring methodology, Pioneer Intelligence’s reporting favors “heat” over “strength” as the company prioritizes “relative change” above “absolute position.” This means that, for example when talking about social media audience size, they don’t just score brands based on the number of followers, but they also score audience growth. In fact, Pioneer’s algorithms put more value in growth figures than actual number of followers. For more insight on their methodology, along with a weekly updated index of the hottest brands, visit their website here.
Without further ado, here is a data-led, shallow dive on the California brand, Legion of Bloom:
Legion of Bloom – Content Strategy
Legion of Bloom (LOB) was founded in Northern California in 2015 when five independent growers joined forces. As one of the more widely recognizable brands in the region, they produce craft, high-quality cannabis products and are well known for their vape cartridges. The company has superior genetics and sustainable practices, which they capitalize on in their marketing efforts.
LOB has invested heavily in generating content, which appears to be fruitful. Their website has an in-depth introduction to terpenes for consumers and they utilize their blog section well with a high volume of quality content throughout the second half of 2019. It’s worth mentioning their website features full laboratory test results for all of their products, highlighting their commitment to transparency, consumer trust and brand recognition. Through looking at a few key metrics like indexed keywords, site strength and visit duration, it is apparent that LOB has increased their audience engagement significantly.
All of those factors combined, LOB has used a variety of content tools to grow their website consistently and sustainably, earning them #38 spot on last week’s Pioneer Index, a ranking of the hottest U.S. cannabis brands.
The Center for Food Safety is a non-profit public interest and environmental advocacy organization. They work to protect public health and the environment by helping curb the use of harmful food production and promoting organic production and other sustainable agriculture practices. Earlier this month, the Center for Food Safety launched a new campaign in the hemp and CBD space: their Hemp CBD Scorecard evaluates some of the widely-known hemp and CBD companies on their production and processing methods, testing protocols and transparency to consumers.
Medterra is a CBD products company founded in 2017. They are one of a handful of companies to receive an ‘A’ letter grade on the Center for Food Safety’s Hemp CBD Scorecard. Jay Hartenbach, CEO of Medterra, says 3rd party testing, validation and strict quality standards are the key to earning recognition from organizations like the Center for Food Safety. We sat down with Jay to hear more about how his company is leading the industry in the space of self-regulation, transparency and sustainability.
Cannabis Industry Journal: Tell us a bit about the history of Medterra – how did it become the brand it is today?
Jay Hartenbach: I’ve always had a passion for entrepreneurship and science. At Duke, I focused on Engineering Management and earned my B.S. in Biomedical Engineering from Miami University in 2012.
In 2016, I received a call from my former college mate J.P. Larsen who pitched me the idea to start a CBD company. After recognizing the potential of CBD to help a variety of issues, we set up shop in my living room and started building out Medterra in 2017.
With this growing need for trusted products without THC at affordable pricing, our startup of two expanded to nearly 100 employees in less than three years. We currently operate out of our headquarters in Irvine, California as one of today’s leading global CBD brands.
From the beginning, we recognized the power of CBD to help all walks of life. With so many companies prioritizing profits over their consumers, we saw an opportunity to stand out with world class customer service, affordable pricing, and efficacious amounts of CBD.
These priorities have remained unchanged for us as a company and it makes decision making easy for us. If you focus on prioritizing your customers, there is not any ability to cut corners or be content with the status quo of the industry. Consumers know they can trust the Medterra brand and we are continually pushing ourselves to make more effective products.
CIJ: Tell us about your quality standards – what do you do to ensure safety, quality and transparency with consumers?
Jay: We are consistently recognized in the industry for adhering to only the strictest standards for quality. From cultivation to finished product, we test our products multiple times to ensure quality standards are met and there are no unwanted compounds. Medterra CBD has always committed itself to manufacturing CBD products consumers can feel confident in.
In addition, Medterra is proud to be one the first 13 CBD companies to be given the U.S. Hemp Authority’s Certification Seal. This is currently the most stringent 3rd party certification in Hemp. With audits on cultivation, manufacturing and final products, the US Hemp Authority Seal signifies that we as a company meet the highest standards in the industry.
Furthermore, our partnership with Baylor College of Medicine was the first of its kind. Focused on testing both current products as well as validating new products, our partnership with Baylor allows us to provide the most efficacious products to our consumers.
CIJ: Tell us about your farming, processing and testing practices.
Jay: Medterra provides customers with true seed-to-sale purchases. Our industrial hemp is grown and extracted in accordance with the strict guidelines of the Kentucky Department of Agriculture. Each and every product that leaves the facility must be third-party tested to ensure consistency, quality and safety.
CIJ: How do you think the Hemp CBD Scorecard helps move the industry forward?
Jay: Given the unclear federal regulatory landscape, this is an important step in the right direction for CBD companies, because it allows consumers to be confident in the products they use. The more 3rd party testing and verification of CBD companies the better. With these presented to the public, CBD companies are less likely to cut corners and are forced to act in their consumer’s best interest. The Hemp CBD Scorecard helps move the industry forward because it forces accountability.
CIJ: How do you think the hemp/CBD industry will evolve with respect to product safety and transparency without government regulation?
Jay: We at Medterra will continue to go the extra mile and take steps to ensure consumers are getting only quality ingredients. Through these efforts, we hope to remove the stigma associated with cannabis cultivation and educate consumers on the efficacy and sustainability of hemp-derived CBD.
The American Association for Laboratory Accreditation (A2LA) published a press release yesterday announcing the accreditation of Green Leaf Laboratory, a cannabis testing lab based in Portland, Oregon. According to that press release, they are the first cannabis testing lab in the state of Oregon to achieve the ISO 17025:2017 accreditation.
Rowshan Reordan, founder of Green Leaf Laboratory, says they have been a leader in the cannabis market since for more than nine years, since their launch in 2011. “Receiving our ISO/IEC 17025 accreditation, in addition to required state accreditation, affirms our commitment to quality science and leadership in this industry,” says Reordan. “Working with A2LA and being recognized as the first A2LA accredited laboratory in Oregon has been a great experience. We appreciated the thoroughness in their accreditation process and their commitment to excellence. We look forward to a successful future with A2LA and continuing our commitment to leadership and excellence in the industry.”
“We congratulate Green Leaf Laboratories on becoming the first cannabis testing laboratory accredited to ISO/IEC 17025:2017 in the state of Oregon”, says Anna Williams, Accreditation Supervisor at A2LA. “A2LA is excited to see testing laboratories think outside of the box and elect to use our services in states not mandating them.”
The recent decision in Germany on the reclassification of CBD (kudos to the European Industrial Hemp Association) as something other than “novel” has now opened an interesting new discussion in Germany and by extension, Europe.
It basically means that hemp plants, if they are European in origin, can be grown (under the right regulatory structure starting with organic) and even extracted without ever being considered a “novel food.”
Look for (hopefully) similar discussions now across Europe and the UK where the Food Safety Authority is also examining similar policies.
What this ultimately means, however, is that the market is clearly opening on the CBD front, but only for products that make the grade.
What should the average producer or manufacturer from North America think about when setting up a supply chain for export?
Thanks to the new treaties in place between the United States, Canada and Europe right now, there are market openings in the cannabis industry in Europe. Starting with the fact that the cannabis bug has clearly hit the continent, but there is actually not enough regulated product to be found yet and just about anywhere.
This is keeping prices high right now, but do not expect that to last.
Regardless, pricing of imports will not be like anything you have experienced if your background is state or even national market in the U.S. or Canada. There are higher regulations in every direction in Europe. Understanding how to translate the same into equivalencies that do not bankrupt you, overprice your products, or worse, get you in trouble with authorities is a critical first step, and not one to be taken lightly.
Get professional guidance from the country you are hoping to export to, at minimum. And that includes the legal kind. Every step of the way, you have to be certified with, at minimum, federal if not at an international certification.
No matter what cannabinoid is in the mix, this is ultimately a plant-based product. All rules one would normally think about when talking about other food products (for starters) are in the room.
While it is far from “this easy” (although thanks to the USDA’s decision about hemp, not to mention the FDA update on its own deliberations, there are now federal standards), think about the problem this way: If you were the world’s best chocolate bar, or even tomato juice, how would you hit Europe right now?
They have tomatoes here, and unbelievably great chocolate already. What is it about your offering that can stand out? This is the million-dollar question. There are a few people and companies doing this right now, but it takes experience, and understanding the multiple regulatory guidelines involved. Once you figure that out, then you need to look at your supply chain, piece by piece and literally from the plant through end production for where you fit, and where you might not, into the regulatory discussion and market you hope to enter.
The Medical Discussion
There is now the possibility of exporting medical grade hemp and hemp extracts from the United States to Europe. However, everything must be GMP-certified to a medical standard, from organic production on up. This is an international standard, not an American one.
That qualification does not exist much in the cannabis industry in the United States (although ISO very much is) yet. Although it is dawning. On the Canadian side, there are plenty of companies in the discussion, because there is already a beaten path to export.
As the German cultivation bid proved, European certification, certainly is a high barrier to reach. Indeed, it is not only GMP certification in the room on the medical side but also rules about the import of all plant products.
From this perspective, it is also easier to import “finished” product rather than plant.
The Recreational Discussion
Before anyone gets too excited about recreational reform, the reality is that Europe is not going to step ahead of the UN (which has now pushed its next deliberation on the topic to the end of 2020). Yes, there are trials in a couple of places, but far from earth-shaking (recreational trials in the land of the coffee shop anyone?)
More interesting, of course, is what has just happened on the CBD side. But before American hemp farmers get too excited about this, they have hemp and farmers in Europe. And quite a few people have seen the light on this one already.
Sure New York state exports to Europe are probably in the offing, but so are hemp exports from the Southern states where the weather is warmer and the labor cheaper.
Certified labs, processing and extraction, and labelling are all in the mix. And every step must be documented as you go.
How to Proceed?
Whatever your crop or product is, take stock of the certifications you have now. If your plant was not organic, forget export anywhere. You are out of the international game.
However, with this taken care of, look at the certification requirements in Europe for extraction, processing and import of food and plant products and obtain production partners with the same – either in the US or abroad.
With luck, patience, skill and knowledge, yes, the doors are slowing opening, even to U.S.-based cannabis trade of the international kind.
Just don’t expect it to be easy, and leave lots of time for workarounds, pivots and even re-engineering at every point of the way.
It’s a different world growing cannabis in California- in fact, it’s a completely different experience than it was even four years ago. It can be overwhelming to begin the process, which is where an experienced cultivation consultant can help. This article will highlight 5 factors to keep in mind before you begin growing in California’s regulated recreational market.
Start Up – Costs, needs & endless variables
So you’ve decided to begin a recreational grow, here are the factors to consider before you get started.
Permitting, the necessary pre-cursor to cultivation, can be time- consuming, extremely expensive, and overwhelming. General experience dictates that any grow will take longer than planned and cost way more money than you ever expected or anticipated. Always account for more money and time than you think you need. Working with an experienced consultant can help you plan and account for all the costs and variables you may not have considered, prior to beginning cultivation, in order to ensure your success.
Equipment. When choosing what equipment to use, stick to reputable equipment manufacturers. Don’t just go with the latest high-tech gear because you see it on Instagram being advertised by a big, fancy grow operation. Stick to what you know best. Do your homework and research the equipment as much as possible, prior to purchase. Use equipment that has been tested and well documented with success. Some questions to ask yourself: is this necessary? Is it cost effective? Will it help me reach my goals?
Grow your business slowly and naturally. Getting too big too quick will most likely expose inefficiencies in your operating plan, which will be further compounded when production increases. Don’t sink before you can swim and start out on a massive scale before you have perfected your process.
Cultivation – It pays to design it right the first time
Success begins in the grow room. Never forget that. A properly engineered cultivation plan can be the difference between 3 and 6 harvests per year. Again, it is imperative here to do your homework. A well-thought-out plan can make or break you, and that is where an experienced cultivation consultant can help.
Set realistic expectations. Understand that growing boutique style cannabis is very difficult on a large scale, consistently. Don’t expect to grow perfect cannabis every time – it is unrealistic and can ultimately lead to failure if your financial model depends on it. Growing a plant, while mostly in your control, involves too many variables to rely on a perfect outcome round after round. You can do everything in your power, yet something unexpected can still happen and be detrimental to your yield, and therefore your profit. You must expect and plan for this.
Automating as much of your grow as possible is always a good idea. This will greatly reduce labor costs and more importantly, minimize human error. In some instances, it will even allow you to review data and information remotely, in real time, allowing you to ensure your cultivation site is always running as efficiently as possible, even when you aren’t there.
Processing – Don’t skimp on the process
If you are going to be harvesting cannabis for flower, it is imperative to have a properly built facility for drying, curing and storing your product. You must consider that this building will need to be large enough to house and properly store all of your harvest at once. This can make or break your crop at harvest time. If you don’t have the capacity to handle your harvest properly, it can lead to disastrous issues such as mold or too quick of a cure – conditions which make your cannabis unsellable in the regulated market.
Although costly, if done correctly, you can also design this area to serve as your propagation, trimming, and breeding areas, which will ultimately save on costs in the long run.
Also keep in mind, hand trimmed cannabis will always look more appealing to the consumer than machine trimmed cannabis. However, hand trimming can be time-consuming, labor-intensive, and therefore far more costly than machine trimming. These are factors you will need to consider and budget for when deciding how to proceed. If you use a machine, you may save money up front, but will you be able to sell your cannabis at full price?
Distribution – Have a plan
It is a good idea to have a plan for distribution, prior to start up. If you have an agreement with a retail outlet (or contract with a distributor) in writing, you will protect yourself from financial failure. Cannabis will never grow more valuable over time, therefore, you want to have a plan in place for distribution, as soon as the cannabis is harvested and processed. Just as was the case in the black-market days, you never want to hold on to your cannabis for long periods of time.
Do not distribute without agreements in writing! While some oral agreements may be enforceable, it will be extremely costly to litigate. Therefore, you should plan to hire a lawyer beforehand to create fail-proof agreements that will hold up in court, should a distributor not pay you for your product.
Sales – Build your brand, but be realistic
Building your brand is important. And if you don’t produce your own high-quality flower you cannot expect to have a product up to your standards. Your brand will not be successful if you cannot consistently provide consumers with high quality cannabis. Relying on other growers to produce your cannabis for you is risky to your brand. Even if you are a manufacturer, you may not be able to rely on other suppliers to maintain the quality volume you need in order to manufacture your products consistently.
The regulated market in California is new. Therefore you must necessarily account for a great degree of price fluctuations in the market. When creating your budget at the outset, you must account for fluctuations in profit. Knowing when prices are going to be at their lowest can help you avoid having an oversupply of inventory. It can also help you avoid such situations by planning your cultivation/harvest accordingly.
There are both consumer and government influenced market trends that can affect your bottom line. These must be accounted for at the outset.
On the consumer level, you must know what people are buying and how they are consuming. And these factors can change quickly with the introduction of new technology, methods or new devices intended for cannabis consumption. You must stay on top of these trends.
The government regulations can also affect these trends. Products used for cultivation can become banned, i.e. products you once relied on in your cultivation can be found to have contaminants known to cause test failures, even in “approved products.”
Ultimately, all of these factors can make or break your success, and therefore, must be considered, researched and accounted for prior to beginning your cultivation in the regulated market. Working with a consultant with over 20 years of grow experience, and more importantly, extensive experience in large scale cultivation in the regulated market, can help you achieve the success you desire. Cultivation in the regulated market is costly, but working with a consultant can help you cut costs at the outset, and save you from unexpected expenses in the long run.
On March 5, 2020, the U.S. Food and Drug Administration (FDA) issued a press release to the public about their work on devising a regulatory framework for cannabidiol (CBD) products. The FDA also submitted a report to Congress on their rulemaking progress.
The main theme of the report is the same story we’ve been hearing from the FDA for a while now: They are still working on figuring out how to regulate CBD products and wants to do more research before they tackle the rulemaking.
The most intriguing new development from this report is the FDA’s newfound interest in regulating CBD products like dietary supplements:
“FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary supplements, but FDA has the authority to create an exemption through notice-and-comment rulemaking that would allow products containing CBD to be sold legally as dietary supplements.”
If you’ve been living under a rock for the past couple years, here’s a recap: In June of 2018, the FDA approved GW Pharma’s drug, Epidiolex, for the treatment of rare forms of epilepsy. This allowed a drug containing CBD to go to market, but only through the agency’s drug approval process. When the 2018 Farm Bill (Agricultural Improvement Act of 2018) was signed into law in December later that year, the federal government removed cannabis (hemp) with less than 0.3% THC from the Controlled Substances Act, essentially legalizing it on a federal level. Congress tasked the FDA with figuring out how to regulate the market. Without any FDA guidance in the early days, the subsequent market growth created mass confusion for the industry and consumers alike, with no one really knowing if selling CBD products is legal or not. In May of 2019, the agency held a comment period and public hearing on CBD, which included a lot of discussion around the benefits, the risks and further research on CBD. Throughout 2019, the FDA sent a large number of warning letters to companies marketing CBD products with unsubstantiated health claims. Towards the end of 2019, Congress passed a bill mandating that the FDA update them on their progress to regulate the market within 60 days. That deadline came and went, and then the FDA issued the public update and submitted the report mentioned above to Congress last week.
The FDA says they intend to take a number of steps towards providing some market clarity, while still protecting the public from unknown risks. Firstly, they want to educate the public more about potential risks associated with CBD. “We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” reads the update. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.” Those concerns mentioned above include potential liver injury, drug interactions, reproductive toxicity and more benign side effects like drowsiness.
The agency also wants to try and close knowledge gaps in the areas of safety and potential benefits. In this section of the update, the agency asks industry stakeholders for help. “We’re seeking reliable and high-quality data.” The agency is requesting data on sedative effects, impacts of long-term use, pharmacokinetics, safety of various drug delivery mechanisms, safety for animals, different processes for full or broad spectrum or isolate derivation, among other areas of interest. They plan to re-open the public docket from the public hearing back in May 2019, extending the comment period indefinitely as a tool for stakeholders to share information with the FDA.
As far as enforcement actions go, the agency wants to take a risk-based approach to it. While there is still no official enforcement policy, the FDA is working on it. Their biggest concern is with companies marketing CBD products using drug and health claims, which could “deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.” The agency is also worried about potential contamination risk and consumer exposure to things like residual solvents and heavy metals. Their last concern in this area involves truth in labeling, like making false label claims, not listing every ingredient or incorrectly stating the amount of cannabinoids in the product.
“Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”
Overall, the public update and the report don’t disclose anything groundbreaking. They do, however, provide some much-needed guidance for the CBD market on how stakeholders can help the FDA’s efforts. The fact that they are investigating dietary supplements as a path toward a regulatory framework is the by far the biggest take away from all this.
EDGARTOWN, MA, March 11, 2020 – Innovative Publishing Co., the publisher of Cannabis Industry Journal and organizer of the Cannabis Quality Conference & Expo is announcing the agenda release for the Cannabis Labs Conference. The event will address science, technology, regulatory compliance and quality management as they relate to the cannabis testing market. It will take place on June 3–4 at U.S. Pharmacopeia in Rockville, MD.
Two keynotes for the Cannabis Labs Conference are listed in the agenda: Rowing in the Same Direction: The Biggest Safety Issues Facing the Cannabis Industry & How We Intend to Tackle Them – this talk will be delivered by Andrew Kline, Director of Public Policy at the National Cannabis Industry Association (NCIA). The second keynote is titled Cannabis Testing in Maryland: Protecting Patient Safety – this talk will be delivered by Lori Dodson, Deputy Director of the Maryland Medical Cannabis Control Commission.
The event will begin on June 3 with an opening general session with Charles Deibel speaking to both the cannabis and food lab testing industries: The Evolution of the Lab Testing Market: A History of Food and Cannabis Testing & How Far We’ve Come
Other notable presentations include: Building a Comprehensive Analytical Testing Program for Hemp by Grace Bandong, Global Scientific Strategy Leader at Eurofins; FDA Compliance for Cannabis- Stories from a Cannabis Public Health Investigator by Kim Stuck, Founder of Allay Consulting; Evaluation of Cannabinoids Reference Standards by Shiow-Jyi Wey, Reference Standard Scientist at the US Pharmacopeia; and more.
The event is co-located with the Food Labs Conference, which will focus on regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. More information about this event is available on Food Safety Tech. Some of the critical topics include a discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.
“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Cannabis Labs Conference.
To learn more about the agenda, speakers and registration pricing, click here. The early bird discount of $395 expires on March 31.
Innovative Publishing Company, Inc., the organizer of the conference, is fully taking into considerations the travel concerns related to the coronavirus. Should any disruption occur that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. More information is available on the event website.