Upstate Elevator Supply Co., a Vermont based manufacturer of cannabis-infused products, has expanded its product line with beverages and gummies infused with fast-acting, hemp-derived Delta-9 THC created with nano-emulsified hemp extract.
The new Delta-9 beverages are sold in 12-ounce cans with either 1 or 5 milligrams of Delta-9 THC balanced with ratios of CBD. They come in four unique flavors, including Passion Fruit Seltzer, Green Mango Seltzer, Zesty Lime Ginger Ale, and Orange Pop Soda.
Cannabis Industry Journal had a quick call with Ryan Chaffin, Director of Business Development at Upstate, to learn more about their new Delta-9 beverage launch.
CIJ: What were the regulatory hurdles Upstate needed to deal with to launch the new products?
Chaffin: The biggest regulatory hurdle in selling all hemp-derived products continues to be the lack of cohesive federal regulation. Brands are forced to navigate a patchwork system of state regulations that are constantly evolving. Upstate Elevator continues to advocate for federal regulation to provide much-needed oversight in the industry and to best protect consumers.
CIJ: What testing has Upstate done for quality and safety?
Chaffin: Upstate Elevator Supply products are tested using ISO certified labs to ensure potency, consistency, and quality in every batch. All of our raw hemp ingredients are tested for pesticides, heavy metals, mycotoxins, and bacterial and fungal contaminants to maintain the maximum level of safety. We like to say that our commitment to the safety, quality, and purity of our products is emblematic of the great state of Vermont, where we’re from.
CIJ: What are Upstate’s plans beyond VT?
Chaffin: Upstate Elevator is partnering with distributors throughout New England and the Midwest to sell its Delta-9 THC beverage and gummies. Minnesota is an especially exciting market because it has the most robust regulatory framework in the country to provide safe access to hemp-derived products. We look to expand upon our portfolio of Delta-9 beverages and gummies in the coming months.
The cannabis industry is growing and evolving at an unprecedented pace and regulators, consumers and businesses continually struggle to keep up.
Cannabis businesses: How do you maintain an edge on the market, avoid costly mistakes?
Case Study: Costly Facility Build Out Oversights
David Vaillencourt will be joining a panel discussion, Integrated Lifecycle of Designing a Cultivation Operation, on December 22 during the Cannabis Quality Virtual Conference. Click here to register. A vertically integrated multi-state operator wants to produce edibles. The state requires adherence to food safety practices (side note – even if the state did not, adherence to food safety practices should be considered as a major facility and operational requirement). They are already successfully producing flower, tinctures and other oil derivatives. Their architect and MEP firm works with them to design a commercial kitchen for the production of safe edibles. The layout is confirmed, the equipment is specified – everything from storage racks, an oven and exhaust hoods, to food-grade tables. The concrete is poured and walls are constructed. The local health authority comes in to inspect the construction progress, who happens to have a background in industrial food-grade facilities (think General Mills). They remind the company that they must have three-compartment sinks with hot running water for effective cleaning and sanitation, known as clean-out-of-place (COP). The result? Partial demolition of the floor to run pipeline, and a retrofit to make room for the larger sinks, including redoing electrical work and a contentious team debate about the size of the existing equipment that was designed to fit ‘just right.’
Unfortunately, this is just one more common story our team recently witnessed. In this article, I outline a few recommendations and a process (Quality by Design) that could have reduced this and many other issues. For some, following the process may just be the difference between being profitable or going out of business in 2021.
The benefits of Quality by Design are tangible and measurable:
Reduce mistakes that lead to costly re-work
Mitigate inefficient operational flow
Reduce the risk of cross-contamination and product mix-ups. It happens all the time without carefully laid out processes.
Eliminate bottlenecks in your production process
Mitigate the risk of a major recall.
The solution is in the process
Regardless of whether you fall in the category of a food producer, manufacturer of infused products (MIP), food producers, re-packager or even a cultivator, consider the following and ask these questions as a team.
People
By standardizing and documenting safety procedures, manufacturers mitigate the risk of cannabis-specific concerns
For every process, who is performing it? This may be a single individual or the role of specific people as defined in a job description.
Does the individual(s) performing the process have sufficient education and training? Do you have a diverse team that can provide different perspectives? World class operations are not developed in a vacuum, but rather with a team. Encourage healthy discourse and dialogue.
Process
Is the process defined? Perhaps in a standard operating procedure (SOP) or work instruction (WI). This is not the general guidance an equipment vendor provided you with, this is your process.
How well do you know your process? Does your SOP or WI specify (with numbers) how long to run the piece of equipment, the specification of the raw materials used (or not used) during the process, and what defines a successful output?
Do you have a system in place for when things deviate from the process? Processes are not foolproof. Do not get hung up on deviations from the process, but don’t turn a blind eye to them. Record and monitor them. In time, they will show you clear opportunities for improvement, preventing major catastrophes.
Materials
What are the raw materials being used? Where are they coming from (who is your supplier and how did you qualify them)?
Start with the raw materials that create your product or touch your product at all stages of the process. We have seen many cases where cannabis oils fail for heavy metals, specifically lead. Extractors are quick to blame the cultivator and their nutrients, as cannabis is a very effective phytoremediator (it uptakes heavy metals and toxins from soil substrate). The more likely culprit – your glassware! Storing cannabis oil, both work in process or final product in glass jars, while preferred over plastic, requires due diligence on the provider of your glassware. If they change the factory in which it is produced, will you be notified? Stipulate this in your contract. Don’t find yourself in the next cannabis lead recall that gets the attention of the FDA.
Savings is gained through simple control of your raw materials. Variability in your raw material going into the extractor is inevitable, but the more you can do to standardize the quality of your inputs, the less work re-formulating needs to be done downstream. Eliminate the constant need to troubleshoot why yields are lower than expected, or worst case, having to rerun or throw an entire batch out because it was “hot” (either too much THC in the hemp/CBD space or pesticides/heavy metals). These all add up to significant downstream bottlenecks – underutilized equipment, inefficient staff (increase in labor cost) all because of a lack of upstream controls. Use your current process as a starting point, but implement a quality system to drive improvement in operational efficiency and watch your top line grow while your bottom-line decreases.
Consistency in quality standards requires meticulous SOPs
Have you tested and confirmed the quality of your raw material? This isn’t just does it have THC and is it cannabis, but is it a certain particle size, moisture level, etc.? Again, define the quality of your raw materials (specifications) and test for it.
Remember – ranges are your friend. It is much better to say 9-13% moisture than “about 10%”. For your most diligent extractor, 11% will be unacceptable, but for a guy that just wants to get the job done, 13% just may do!
Test your final product AFTER the process. Again, how does it stack up against your specifications? You may need to have multiple specifications based on different types of raw material. Perhaps one strain with a certain range of cannabinoids and terpenes can be expected for production.
Review the data and trend it. Are you getting lower yields than normal? This may be due to an issue with the equipment, maybe a blockage has formed somewhere, a valve is loose, and simple preventive maintenance will get you back up and running. Or, it could be that the raw biomass quality has changed. Either way, having that data available for review and analysis will allow you to identify the root cause and prevent a surprise failure of your equipment. Murphy’s law applies to the cannabis industry too.
You are able to predict and prevent most failures before they occur
You increase the longevity of your equipment
You are able to predict with a level of confidence – imagine estimating how much product you will product next month and hitting that target – every time!
Business risks are significantly mitigated – a process that spews out metal, concentrates heavy metals or does not kill microbes that were in the raw material is an expensive mistake.
Your employees don’t feel like they are running around with their hair on fire all the time. It’s expensive to train new employees. Reduce your turnover with a less stressed-out team.
Takeaways
Maintaining a competitive edge in the cannabis industry is not easy, but it can be made easier with the right team, tools and data. Our recommendations boil down to a few simple steps:
Make sure you have a chemical or mechanical engineer to understand, optimize and standardize your process (you should have one of these on staff permanently!)
Implement a testing program for all raw materials
Test your raw materials – cannabis flower, solvents, additives, etc. before using. Work with your team to understand what you should and should not test for, and the frequency for doing so. Some materials/vendors are likely more consistent or reliable than others. Test the less reliable ones more frequently (or even every time!)
Test your final product after you extract it – Just because your local regulatory body does not require a certain test, it does not mean you should not look for it. Anything that you specified wanting the product to achieve needs to be tested at an established frequency (and this does not necessarily need to be every batch).
Repeat, and record all of your extraction parameters.
Review, approve and set a system in place for monitoring any changes.
Congratulations, you have just gone through the process of validating your operation. You may now begin to realize the benefits of validating your operation, from your personnel to your equipment and processes.
ImEPIK is a research-based online training company that is known for digital safety training in the food industry, offering courses on things like preventive controls. The company announced last week that they are launching their first class dedicated to the cannabis industry.
The two-part Cannabis Edibles Safety Course is designed to help edibles manufacturers put the quality and safety of their products above all. Part I, “GMPs and the Pyramid of Edible Safety” is now live and includes three modules covering cannabis edibles production under a food industry framework. The course gets into prerequisite programs, the principles of hazard analysis and provides an intro to the company’s “Pyramid of Edible Safety.”
The course is intended for employees that are new to the production of cannabis-infused products, those who are on the front lines of a production facility, or for those who might need a refresher on the basics.
“Part I of the Cannabis Edibles Safety Course prepares cannabis employees to support the sanitation, production and QA managers and the facility’s compliance with regulatory and safety goals,” says Kathryn Birmingham, Ph.D. ImEPIK’s chief operating officer. “The course reflects not only the ‘tried and true’ practices from the food industry, but the nuances of cannabis edibles production are also accounted for in ImEPIK’s course.” Birmingham says the course is designed for employees who work at both large and small facilities.
“ImEPIK has a reputation for providing engaging food safety training that gives production employees the technical knowledge they need to make safe products,” says Jill Droge, ImEPIK’s chief creative and business development officer. “It’s more difficult than ever to make time for training, yet it is one of the most impactful things that manufacturers can do to ensure that their products are safe and will be well received by the market.”
Part II is expected to launch in early November and is designed for supervisors and managers. Keep an eye on imepikcannabissafety.com for the latest course releases.
The Brand Marketing Byte showcases 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.
In this week’s Byte, we’re taking a look at the top edibles companies in the country. Using a scoring methodology that factors in a wide variety of data sets, Pioneer’s algorithm tracks brand awareness, audience growth and engagement. Using more than 80,000 relevant data points per week, they analyze business activity across social media, earned media and web-related activities.
For April 2020, here are the top 25 hottest U.S. edibles brands:
To ask this author to identify the top five trends in 2020 for cannabis is akin to asking her to name only five of her favorite Coldplay songs. With so much energy for both topics, a selection of the absolute most favored components of either passion presents quite a challenge. But like the cannabis industry has done for 20 years under its state-legal regime and entirely illegal federal one, this author will endure under the confines of such limitations.
Consolidation
In any new industry this is bound to happen. Particularly one with such massive government oversight and equally massive consumer demand. Original license holders are cashing out. And they should. They were the risk-takers. The originals. They raced to government buildings across the country with boxes of background checks accompanied by teams of forensic accountants, lawyers and lobbyists to walk down a path only recently paved with legalization to seek a license to directly violate federal law. They drew a line in the sand and said, “I’m in.” And the stars have aligned for them to move on in many states due to changes in ownership structures, particularly ones that now provide for out-of-state interests. They deserve to sell that to the next highest bidder for all of the pressure, investment, stress and risk that permeates the foundation of this industry. With state law changes have come multistate operators, many of whom do not necessarily understand cannabis and have probably never used it, but they know an opportunity when they see it. These companies are buying up licenses across the country and creating brand awareness among consumers with an eye toward changes in federal law that would allow for the transportation of cannabis across state lines. Once that happens, the cannabis industry will be treated like every other American producer with massive distribution centers across the country that will mimic the likes of alcohol and tobacco overnight.
Infused Products
The report further found that the edibles category could be worth more than $4.1 billion in Canada and the United States by 2022.No one wants to go to work and smell like cannabis, unless, of course, you work in a grow facility. And even then, maybe you don’t. And employers aren’t exactly excited when employees are present with the distinct aroma when it’s time to clock in. So, what’s a cannabis consumer to do? Eat or drink the product instead. In a world full of energy drinks, dietary supplements, bubbly water infused with fruit (which still doesn’t taste like anything, let’s be honest), it should surprise no one that cannabis is making its debut in a myriad of consumption applications. While most states prevent the mixing of cannabis-infused beverages and alcohol for sale by retailers (consumers can—and do—mix the products on their own), there are no limits on other targets for cannabis products. Most popular: food and drinks.
ArcView Research and BDS Analytics recently identified that consumer spending on cannabis-based food and drink reached an estimated $1 billion in 2017 in the United States and Canada, representing about 11.4% of the total $9.1 billion in consumer spending on consumable cannabis in those two markets. The report further found that the edibles category could be worth more than $4.1 billion in Canada and the United States by 2022.
There are countless food products and infused beverages on the market in America and anticipated this year, which dovetails perfectly with the American predilection for happy hours, brunch, and after-work drinks; minus the hangover, some might suggest. Any cannabis company owner will tell you the future is infused products, whether consumers are buying the oil themselves to infuse at home or asking a company to infuse something for them. The future of cannabis is, indeed, on a menu.
Movement in Washington, D.C.
When the SAFE Banking Act passed off the House floor with 324 yes votes, 91 of which were from Republicans, a collective cheer and wave akin to an invigorated football stadium engulfed the industry. A huge moment. One long-awaited and most needed. Momentum. Movement. Finally, a sigh of relief. One would be naïve to assume such a success in the House will be mirrored in the Senate. It will not. But that sort of statement from one chamber is a message to the other: this issue is not going away. It matters. It’s bipartisan. And employees/owners in the cannabis industry need relief from the heavy hand of the federal government when they go to work every day in full compliance with state law. With every passing day, lawmakers on both sides of the aisle are being educated by the cannabis industry about how to responsibly regulate the products and what true regulation looks like. It’s only a matter of time until these state-level practices are adopted by federal policymakers. Because let’s be honest, elections matter. And 33 states have said yes to cannabis. It’s only a matter of time until the members of Congress from those states take up the issue in a real way. And many already have.
State Legalization
In the last 10 years, 20 states legalized cannabis for medical purposes and 13 legalized it for adult use. Several national polls suggest this trend will only continue in 2020. And unlike the polling in most recent national elections, the predilections on cannabis seem to be accurate. In 2020, adult-use cannabis measures will definitely appear on the New Jersey and South Dakota ballots. Adult-use measures could also appear in Arizona, Arkansas, Missouri, Montana, New Jersey, North Dakota and Oklahoma. Idaho, Mississippi, Nebraska and South Dakota are likely to vote on medical cannabis as well.
Of note, the South Dakota measure would also legalize hemp, which has yet to get the blessing of the Mount Rushmore state. In Mississippi, voters will likely be asked their opinions on legalizing medical cannabis. This is interesting since the University of Mississippi has had the only DEA license to grow their own cannabis for research purposes since 1968, but the rest of the state has been squarely in prohibition with zero allowances for cultivation or possession.
The future is bright for the cannabis industry and its players. For a final ounce of perspective on state legalization, only three states have no legal cannabis of any kind: Idaho, Nebraska and South Dakota. And if Idaho and South Dakota’s polling is any indication, they won’t be on this short list for much longer.
Maturation
Once upon a time, drug dealers applied for legitimate cannabis licenses. They were denied. And some tried to dodge the regulated marked to continue selling on street corners and out of back doors. Some still do. But now we have a cannabis industry with true regulation and what this author likes to call “adult supervision in the room” on the cannabis conversation and those leading it. A week doesn’t go by without a Wall Street investor or Silicon Valley tycoon asking for advice on where to invest in the cannabis industry. Huge retailers are calling to ask if they can sell it. Alcohol and tobacco interests are hugely, well, interested. And the industry is being led by the likes of former baby car seat manufacturers, former food and beverage lobbyists, young entrepreneurs, and tech geniuses. Now that these individuals are invested and committed, they will continue to professionalize the industry by leading on public-facing initiatives teaching consumers how to use cannabis responsibility, how to determine a much-needed standard for impairment, and to overall improve the reputation of a product once fully illegal, and now partially legal, and soon on its way to fully legal.
The future is bright for the cannabis industry and its players. Only daylight ahead and the billows of bureaucratic smoke are parting hopefully—eventually—with regard to the incongruity between state and federal law on the issue. That’s a lot of ink to say that the next few years will be monumental for the cannabis industry. And if you’re a Coldplay fan, you just caught the reference to my favorite song from the legendary Brit ensemble.
The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.
Jenna Rice, Director of Operations at Gron Artisan Chocolates
The track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas.
Ben Gelt, board chair of the Cannabis Certification Council, is moderating a panel titled What’s In My Weed? that will delve into issues like supply chain, production and other difficulties in creating cannabis products and the challenges inherent in teaching consumers to be more discerning.
Ben Gelt, Board Chair of the Cannabis Certification Council
Kimberly Stuck, Founder of Allay Compliance Consulting
Ben Gelt and the Cannabis Certification Council orchestrated the development of this panel to help promote their #WhatsInMyWeed consumer awareness and education campaign. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
Before Kim Stuck founded Allay Compliance Consulting, she was the first Marijuana Specialist for a public health authority in the nation, where she was working with regulators in Denver, Colorado. She is currently a cannabis food safety expert and a Certified Professional of Food Safety (CP-FS) through NEHA. She has helped Colorado and California develop cannabis food safety requirements. “I will discuss pitfalls we have experienced in the regulation of cannabis in Denver and what mistakes not to make,” says Stuck. “I’d also like to talk about how to be prepared for when those regulators start to come in to facilities.”
Kristen Hill, MIP Director at Native Roots Dispensary
Kristen Hill is the MIP Director at Native Roots, arguably one of the largest dispensary chains in the world. She oversees 30 employees in Native Roots’ MIP facility where product testing and quality assurance of products are all led under her guidance. Her background includes managing quality assurance and regulatory compliance with FDA regulations, among other areas. She said she’s particularly excited to talk about implementing manufacturing best practices in the cannabis space. “Cannabis is maturing and is beginning to shape operations around long standing best practices in other industries,” says Hill.
Leslie Siu, Founder and CEO of Mother & Clone
Leslie Siu brings to the panel 17 years of liquor, tobacco and pharma marketing and operational oversight plus global digital and experiential campaigns. Her company, Mother & Clone, produces infused, sublingual cannabis sprays. Based in Colorado, Mother & Clone’s team of biochemists are Merck alumni, currently working towards GMP standards in preparation for Canada, slated to be on shelf in the spring of 2019. Her main consideration for cannabis product development comes from what she has learned from the FDA in traditional industries- what they will and will not tolerate.
To sell more cannabis products, you must build trust with your customers. Design Shack Magazine explains: “Trust is a key component of user loyalty, and a reason why people come to your company or brand.”
If you don’t get your package design right, people might simply ignore your cannabis products.But building trust is a big challenge for new medical cannabis businesses. That’s where good design can help:“While a lot of trust comes from past performance and a brand’s track-record, it also comes from the design. How a website, poster or package looks can impact how users feel about it and whether they take the leap from casual looker to brand loyalist.”
For a cannabis health supplement business, the product packaging design is one of the most important ways to reassure consumers and build trust.
When a prospective customer first sees your product, they see the packaging before they can touch or see the product. Good product packaging can raise concerns or instill comfort and confidence in a potential buyer.
If you don’t get your package design right, people might simply ignore your cannabis products.
So, let’s take a look at what your business can do to create great product packaging designs that will win over the skeptics and gain customers.
Include the Right Content On Product Packaging
Designing packaging that inspires trust starts with including the right content.
Start by telling people exactly what’s inside your packaging. For example, specify what your product is (CBD Extract Oil vs. Full-Spectrum Hemp Oil Caplets), how much of it there is, a production lot number and a potency level.
Include any qualifiers that may reassure your customers – such as “Organic,” “Non-GMO” or “CO2-Extracted.”
Image courtesy of Kannabia Seed Company
Communicate this information in clean, concise language that shows you have nothing to hide. And, speaking of not hiding – include contact information for your business. Many businesses bury their contact info on their websites and packaging. Don’t do that.
People trust businesses that are transparent and easy to reach. Customers want to know that if they have a question or something goes awry with an order that they can get help.
Including your web address, support email and phone number is a powerful way to reassure clients that your business is legitimate and trustworthy.
And, no packaging is complete without branding elements to help customers identify who your business is and what you’re about. This should include your company’s logo, identifying brand colors and any other small visual elements your brand may use.
Finally, make sure to follow the FDA guidelines for dietary supplement labels.
Your content checklist for product packaging
Include the essential details
What’s inside?
How much?
What’s the potency and dosage?
When does it expire?
What’s the lot number?
Include reassuring qualifiers that your audience will value
Organic, CO2-Extracted, Full Spectrum, Contains Less Than 0.3% THC, etc.
Include your company’s contact info
Web Address
Customer Support Email
Customer Support Phone number
Include your visual branding elements
Logo
Tagline
Brand Colors
Small branded graphic elements
Keep the Packaging Design Simple
Clean, simple design is reassuring and inspires trust.
Image courtesy of Receptra Naturals
That’s because simple design makes it easy for customers to find what they need or want to know.
It’s easy to miss information in a cluttered design – and people know this.
People naturally mistrust the dense chunks of text at the bottom of many advertisements and product packages. On the other hand, clean, easy-to-read fonts and plenty of white space ensure that your audience can read your product packaging and find the information they want quickly without too much trouble.
With fewer words and graphics competing for attention, the important stuff naturally stands out. And, a simple design also sends the message that there are no hidden loopholes or secrets that may work against your customers.
Keep the Design Of Your Product Packaging Professional
It doesn’t matter how great your product is if your business comes across as unprofessional. And, for medical cannabis businesses, the bar for establishing professionalism is even higher than for most companies.
Keep these tips in mind to communicate professionalism and reliability.
Image courtesy of Sagely Naturals
Make sure your packaging is error-free
Mistakes don’t look professional. How many times have you wondered how an error could have passed through so many hands unnoticed that it made it onto the final version?
Consumers notice errors in your packaging design. They see typos and often, discover incorrect or misleading information. Errors make customers think that your business is incompetent. Or worse – they might think that your business is deliberately misleading them. Make sure you proof-read everything before your packaging goes to production.
Showcase Your Cannabis Products Well Against Competitors
People buying your cannabis products will have other options. Don’t ignore your competition and be sure to understand how other dietary supplements and medicine is packaged.
Want to build trust by encouraging consumers to group your CBD products with other trusted medical brands? Follow these tips:
Provide a list of ingredients and instructions for safe dosing and usage. People expect this from reputable medicinal brands. Your product packaging should dothis too. And, remember to follow the FDA’s labeling requirements for dietary supplements.
Incorporate a safety seal into your packaging design. You’ll notice that most medicines, vitamins, and supplements have a safety seal to protect the contents. Whether you opt for a shrink-wrapped seal over the lid or a foil seal under the cap, adding a safety seal shows that your product has not been tampered with and implies that it’s safe to use.
Incorporating these elements will create a mental link between your product and other trusted medicinal products.
Be authentic to your cannabis brand
Last, but not least, your packaging design must align with your brand. When consumers sense a disconnect between the brand identity they’ve come to identify with your business and the packaging design for your products, it creates discomfort.
Image courtesy of Direct Cannabis Network
But packaging that is in line with (or expands upon) the brand identity consumers have come to know will create comfort and trust.
Your brand’s packaging design must reflect your company’s story, product, and values. If your packaging claims a “simple” snack product with dozens of ingredients, consumers are going to be left with a disingenuous feeling about your products and company. By ensuring that your messaging, design, and visual impact is in line with your company and your consumer’s preferences, you can build instant trust.
So, ensure that your packaging design is consistent with your existing visual identity. This includes the name of your business or cannabis product, your cannabis business logo, website, and marketing design.
A united and cohesive visual brand presence looks professional and helps to build familiarity – which is key to developing trust. Ultimately, many people judge products based solely on the product packaging. That’s why it’s essential to make sure your product packaging sends the right message.
The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.
The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:
Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.
The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.
Complications with dosing inaccuracies in the cannabis industry has always been a hot topic. In 2014, The Cannabist tested several Colorado infused products only to find that the results were different from what was indicated on the label. While the industry has come a long way at the state level since then, a study published in The Journal of the American Medical Association this past November found that 26 percent of CBD products sold online contained less CBD than the label. Similar to when you buy a bottle of wine or ibuprofen, people should be able to trust product labels.
Process validation in action at the Stratos facility (image credit: Lucy Beaugard)
There are processes that cannabis-infused product manufacturers can adopt to solve this issue. Incorporating process validation establishes reproducible customer experiences while in-process controls create product consistency and potency reliability. These operational and compliance techniques originated in the pharmaceutical industry and will undoubtedly become the future gold standard for best practices with cannabis manufacturers.
Product testing alone cannot assess quality for an entire lot or batch of product; therefore, each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP). Process validation is an aspect of GMPs used by the pharmaceutical industry to create consistency in a product’s quality, safety and efficacy. There are three main stages to process validation: process design, process qualification and continued process verification. Implementing these stages ensures that quality, including dosing accuracy, is maintained for each manufactured batch of product.
Validation: Step 1
Process design, the first phase of process validation, defines the manufacturing process based on previous product development and process research. The appropriate equipment, instruments and materials are selected as part of process design. Both standard operating procedures for equipment and operations as well as batch records for manufacturing steps are also finalized during this phase. The batch record must include critical process parameters (CPP), the parameters that must be maintained in order to produce product that consistently meets specified criteria. Mixing speed and time, temperature, pressure and flow rate are examples of common CPP. Training production personnel is also defined and performed as part of process design. Operators are trained on operating procedures and batch records in order to learn how to make the product successfully.
Process validation can help ensure accurate dosing. (image credit: Lucy Beaugard)
Validation: Step 2
Process qualification, the next stage of process validation, is performed to evaluate the capability of a process for reproducible and robust manufacturing. Because reproducibility of a process cannot be fully assessed with a single batch, evaluation is typically performed on a minimum of three separate batches. For each batch included in the process qualification, the frequency and number of samples are increased over normal sampling to provide a more thorough assessment of each batch. The testing includes visual inspection for defects as well as quantitative tests such as weight or volume and potency. In addition to composite sampling, which is performed by combining samples from multiple time points throughout a batch (e.g. beginning, middle and end) to assess a batch as a whole, stratified sampling is performed. Stratified samples are taken from specified points throughout a batch, and rather than being combined, the samples are tested separately to indicate consistency throughout a given batch.
The Stratos product lineup- validation helped produce each of these consistently.
In addition to evaluating the reproducibility of a process, tests for robustness are performed during process qualification to demonstrate how changes in a process may impact the product. It is important to use different operators for performing manufacturing steps to ensure changes in personnel do not affect product quality. Switching out equipment and instruments will also reveal any sensitivities in a process. For example, when a different oven, mixer or tablet press is used, are the appearance, texture and potency impacted? If the product remains the same, that points toward the process being robust. Challenging the CPP will also provide important feedback regarding a process. If a step requires a temperature range of 50° – 70°C, it is recommended that the process be tested at the low end and high end of the range, to ensure the final product meets all required specifications. If the range assigned to a unit’s gross weight is 500 g ± 5%, then testing at 475 g and 525 g will offer more insight into how much variance the process truly can withstand.
Validation: Step 3
Once the process has been assessed for reproducibility and robustness, it transitions to continued process verification, which is the third and final stage of Process Validation. Performance of quality checks during each batch for the life of a product is part of this final stage. For infused products such as tablets, these checks include appearance – the tablets are the color and shape indicated by the batch record and they include the required imprint(s); weight – the tablets are within the specified weight range, which indicates correct tablet size and consistency of ingredients; hardness – tablets will dissolve/disintegrate for proper dosing; and friability – tablets will withstand stress of routine handling.
As your company grows in manufacturing volume, each of these three steps will become critical to safeguard against any inconsistencies. As we know in this industry, our most valuable asset is our license and success can be negatively impacted based on meeting compliance. Dedicating an internal role within quality and compliance will serve to future-proof your business against additional rules and regulations that are likely to come.
In Part 3 of this series on HACCP, Critical Control Points (CCPs), validation of CCPs and monitoring of CCPs were defined. When a HACCP plan identifies the correct CCP, validates the CCP as controlling the hazard and monitors the CCP, a potential hazard is controlled in the manufacturing and packaging of cannabis-infused edibles. The food industry is big on documentation. If it’s not documented, it did not happen. The written hazard analysis, validation study and monitoring of CCPs create necessary records. It is these records that will prove to a customer, auditor or inspector that the edible is safe. Here in Part 4, more recordkeeping is added on for deviation from a CCP, verification and a recall plan.
Take Corrective Action When There Is a Deviation from a Critical Control Point
Your food safety team conducts a hazard analysis, identifies CCPs and decides on monitoring devices, frequency and who is responsible for monitoring. You create an electronic or paper record of the monitoring for every batch of edible to document critical limits were met. Despite all your good efforts, something goes wrong. Maybe you lose power. Maybe the equipment jams. Nothing is perfect when dealing with ingredients, equipment and personnel. Poop happens. Because you are prepared before the deviation, your employees know what to do. With proper training, the line worker knows what to do with the equipment, the in-process product and who to inform. In most cases the product is put on hold for evaluation, and the equipment is fixed to keep running. The choices for the product include release, rework or destroy. Every action taken needs to be recorded on a corrective action form and documents attached to demonstrate the fate of the product on hold. All the product from the batch must be accounted for through documentation. If the batch size is 100 lb, then the fate of 100 lb must be documented.
Verify Critical Control Points Are Monitored and Effective
First, verification and validation are frequently confused by the best of food safety managers. Validation was discussed as part of determining CCPs in Part 3. Validation proves that following a CCP is the right method for safety. I call validation, “one and done.” Validation is done once for a CCP; while verification is ongoing at a CCP. For example, the time and temperature for effective milk pasteurization is very well known and dairies refer to the FDA Pasteurized Milk Ordinance. Dairies do not have to prove over and over that a combination of time and temperature is effective (validation), because that has been proven.
I encourage you to do as much as you can to prepare for a recall.A CCP is monitored to prove the safety parameters are met. Pasteurization is an example of the most commonly monitored parameters of time and temperature. At a kill step like pasteurization, the employee at that station is responsible for accurate monitoring of time and temperature. The company managers and owners should feel confident that CCPs have been identified and data are being recorded to prove safety. Verification is not done by the employee at the station but by a supervisor or manager. The employee at the station is probably not a member of the food safety team that wrote the HACCP plan, but the supervisor or manager that performs verification may be. Verification is proving that what was decided by the food safety team is actually implemented and consistently done.
Verification is abundant and can be very simple. First, every record associated with a CCP is reviewed by a supervisor or manager, i.e. someone who did not create the record. This can be a simple initial and date at the bottom of the record. Every corrective action form with its associated evaluation is verified in the same way. When HACCP plans are reviewed, that is verification. Verification activities include 1) testing the concentration of a sanitizer, 2) reviewing Certificates of Analysis from suppliers, 3) a review of the packaging label and 4) all chemical and microbiological testing of ingredients and product. The HACCP plan identifies CCPs. Verification confirms that implementation is running according to the plan.
Verification is like a parent who tells their child to clean their room. The child walks to their room and later emerges to state that the room is clean. The parent can believe the word of the child, if the child has been properly trained and has a history of successfully cleaning their room. At some frequency determined by the parent, the room will get a parental visual check. This is verification. In the food industry, CCP monitoring records and corrective action must be reviewed within seven days after the record is created and preferably before the food leaves the facility. Other verification activities are done in a timely manner as determined by the company.
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers.
Write a Recall Plan
In the food industry, auditors and FDA inspectors require a written recall plan. Mock recalls are recommended and always provide learning and improvement to systems. Imagine your edible product contains sugar, and your sugar supplier notifies you that the sugar is recalled due to glass pieces. Since you are starting with the supplier, that is one step back. Your documentation of ingredients includes lot numbers, dates and quantity of sugar.You keep good records and they show you exactly how much of the recalled lot was received. Next you gather your batch records. Batches with the recalled sugar are identified, and the total amount of recalled sugar is reconciled. You label every batch of your edible with a lot code, and you identify the amount of each affected lot and the customer. You have a press release template in which you add the specific information about the recall and affected lots. You notify every customer where the affected edible was shipped with a plan to return or destroy the edible. When you notify your customers, you go one step forward.
How would your company do in this situation? I have witnessed the difficulties a company faces in a recall when I was brought in to investigate the source of a pathogen. Food safety people in my workshops who have worked through a recall tell me that it was the worst time of their life. I encourage you to do as much as you can to prepare for a recall. Here are two good resources:
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
