State regulations shouldn’t be the reason why infused products manufacturers have robust safety and quality standards—consumer safety is. Join Cannabis Industry Journal for a complimentary event, “Infused Products Virtual Conference”, on November 16 at 12 pm ET.
The following are some agenda highlights:
- Where to Begin: Leveraging Quality Systems to Improve Operations & Growth, with David Vaillencourt, The GMP Collective and Kathleen Mays, Triskele Quality Solutions
- 3 Steps to Create a Compliance Culture with Operational Excellence, with Dede Perkins, ProCanna
- Innovation from an Outside Perspective – For the Purpose of Building Infused & CBD Product Success, with Jerod Martin, CannGoods
- Implementing Food Safety Management Systems in Infused Products Production Facilities, with Dr. Laurie Post, Deibel Labs
- ICP-MS Analysis of Heavy Metals in Cannabis Containing Food and Cosmetics Using CRM Mixes, A TechTalk sponsored by MilliporeSigma
Register for the Infused Products Virtual Conference by Cannabis Industry Journal.
The legal cannabis-infused products industry is growing with impressive and predictable rapidity. But because the rollout of new regulations occurs in an awkward and piecemeal fashion, with stark differences from one state to another, and sometimes even one county to another, uncertainty reigns.1 Many entrepreneurs are diving headlong into the nascent industry, hoping to take advantage of an uncertain regulatory environment where government audits and inspections are rare. These business owners will see quality assurance and product safety as burdens—costs to be avoided to the greatest extent possible.
I have seen this time and time again, even in the comparatively well-regulated food industry, and it is always a mistake.
If you find yourself thinking about quality assurance or food safety as a prohibitive cost, annoyance or distraction, I encourage you to change your thinking on this issue. The most successful businesses realize that product safety and quality assurance are inextricably linked with profitability. They are best thought of not as distractions, but as critical elements of an efficient and optimized process. Proper QA and safety are not costs, they are value.
Food safety and quality assurance should be seen as important elements of the process that you undertake to enforce the high standards and consistency that will win you repeat customers. The fact that they guard against costly recalls or satisfy meddlesome auditors is only a bonus. Realizing this will make your business smarter, faster and more profitable.
Learn more about the science, technology, regulatory compliance and quality management issues surrounding cannabis at the Food Labs / Cannabis Labs Conference | June 2–4, 2020If today you cannot clearly communicate your product standards to your employees and to your customers, then you have some work to do. That’s because quality assurance always begins with precise product specifications. (A good definition of “quality” is “conformance to specifications.”) How can you assess quality if you don’t have a definitive standard with which to evaluate it? My consulting firm works with food businesses both small and large, and this is where we begin every relationship. You might be surprised how often even a well-established business has a difficult time naming and describing every one of its products, let alone articulating objective standards for them.
This may be doubly difficult for fledgling businesses in the cannabis world. Because the market is so new, there are fewer agreed-upon standards to fall back on.
When we help businesses create specifications, we always look at the relevant regulations while keeping in mind customer expectations. In cannabis, the regulations just aren’t as comprehensive as they are for conventional food and agriculture. Laws and guidelines are still in flux, and different third-party standards are still competing for market dominance. Different states have entirely different standards, and don’t even agree, for example, whether cannabis edibles should be considered pharmaceuticals or food. To some extent, it’s the wild west of regulation, and as long as the federal government remains reluctant to impose national guidelines, it’s likely to remain so.
The wild west may be a good place for the unscrupulous, but it’s not good for business owners that care about the health of their customers and the long-term health of their brand. Don’t take advantage of confusing quality and safety standards by doing the least possible to get by. At some point there will be a scandal in this country when a novel cannabis product makes dozens of customers sick, or worse. You don’t want it to be yours.
With cannabis-infused products, there is a unique additional factor at play: The strength of THC and other psychoactive compounds. Again, there are few agreed-upon standards for potency testing, and relatively little oversight of the laboratories themselves. This allows labs to get sloppy, and even creates an incentive for them to return inflated THC counts; at the very least, results may hugely differ from one lab to another even for identical products.2 Some labs are ISO 17025 accredited, and some are not. Using an unaccredited laboratory may prevent your efforts to create consistent and homogeneous products.
Even in comparatively well-regulated states, such as Colorado, it is ultimately your responsibility to create products that are safe and consistent. And in the states where the politicians haven’t even figured out which department is regulating cannabis products, your standards should be tougher than whatever is officially required.
And so we look to the more established world of conventional food and agriculture as a guide for the best practices in the cannabis industry.
The most constructive way to look at food safety, and the way your (eventual) auditors and regulators will view it, is to look at your product and process from the perspective of the potential hazards.
Some day, when regulation finally gets sorted out, you are likely to be asked to implement a Hazard Analysis and Critical Control Points (HACCP) safety system. HACCP framework recognizes three broad categories of hazards:
- Physical hazards: Foreign material that is large enough to cause harm, such as glass or metal fragments.
- Chemical hazards: Pesticides and herbicides, heavy metals, solvents and cleaning solutions.
- Biological hazards: The pathogens that cause foodborne illness in your customers, such as E. coli, and other biological hazards, such as mycotoxins from molds.
All of these hazards are highly relevant to cannabis-infused product businesses.
The HACCP framework asks us to consider what steps in our process offer us the chance to definitively and objectively eliminate the risk of relevant hazards. In a cannabis cookie, for example, this might be a cooking step, a baking process that kills the Salmonella that could be lurking in your flour, eggs, chocolate or (just as likely!) the cannabis extracts themselves.
A good HACCP system is merely the capstone resting atop a larger foundational system of safety programs, including standard operating procedures, good manufacturing practices, and good agricultural practices. It’s important to use these agreed-upon practices and procedures in your own facility and to ensure that your suppliers and shippers are doing the same. Does your cultivator have a culture of safety and professionalism? Do they understand their own risks of hazards?
HACCP offers a rigorous perspective with which to look at a process, and to examine all of the places where it can go wrong. The safety system ultimately holds everything together because of its emphasis on scrupulous documentation. Every important step is written down, every time, and is always double-checked by a supervisor. It sounds like a lot of paperwork, but it is better viewed as an opportunity to enforce consistency and precision.
When you thoroughly document your process you’ll create a safer product, run a more efficient business, and make more money.
- Rough, L. (2016, March 4). Leafly’s State-by-State Guide to Cannabis Regulations. Retrieved from https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations
- Jikomes, N. & Zoorob, M. (2018, March 14). The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products. Retrieved from https://www.nature.com/articles/s41598-018-22755-2
Visibility, accountability and traceability are paramount in the agriculture industry, says Allison Kopf, founder and CEO of Artemis. In a Q&A with Food Safety Tech, Kopf explains how growers can take advantage of cultivation management platforms to better arm them with the tools they need to help prevent food safety issues within their operations and maintain compliance.
Food Safety Tech: What are the key challenges and risks that growers face in managing their operations?
Allison Kopf: One of the easiest challenges for growers to overcome is how they collect and utilize data. I’ve spent my entire career in agriculture, and it’s been painful to watch operations track all of their farm data on clipboards and spreadsheets. By not digitizing processes, growers become bogged down by the process of logging information and sifting through old notebooks for usable insights—if they even choose to do that.
I was visiting a farm the other day and the grower pulled out a big binder. The binder contained all of his standard operating procedures and growing specifications for the varieties he’s grown over the past 20 years. Then he pulled out a pile of black notebooks. If you’ve ever worked on a farm, you’d recognize grower notebooks anywhere. They’re used to log data points such as yield, quality and notes on production. These notebooks sit in filing cabinets with the hopeful promise of becoming useful at some point in the future—to stop production from falling into the same pitfalls or to mirror successful outcomes. However, in reality, the notebooks never see the light of day again. The grower talked about the pain of this process—when he goes on vacation, no one can fill his shoes; when he retires, so does the information in his head; when auditors come in, they’ll have to duplicate work to create proper documentation; and worse, it’s impossible to determine what resources are needed proactively based on anything other than gut. Here’s the bigger issue: All of the solutions are there; they’re just filed away in notebooks sitting in the filing cabinet.
Labor is the number one expense for commercial growing operations. Unless you’re a data analyst and don’t have the full-time responsibilities of managing a complex growing operation, spreadsheets and notebooks won’t give you the details needed to figure out when and where you’re over- or under-staffing. Guessing labor needs day-to-day is horribly inefficient and expensive.
Another challenge is managing food safety and compliance. Food contamination remains a huge issue within the agriculture industry. E. coli, Listeria and other outbreaks (usually linked to leafy greens, berries and other specialty crops) happen regularly. If crops are not tracked, it can take months to follow the contamination up the chain to its source. Once identified, growers might have to destroy entire batches of crops rather than the specific culprit if they don’t have appropriate tracking methods in place. This is a time-consuming and expensive waste.
Existing solutions that growers use like ERPs are great for tracking payroll, billing, inventory, logistics, etc., but the downside is that they’re expensive, difficult to implement, and most importantly aren’t specific to the agriculture industry. The result is that growers can manage some data digitally, but not everything, and certainly not in one place. This is where a cultivation management platform (CMP) comes into play.
FST: How are technologies helping address these issues?
Kopf: More and more solutions are coming online to enable commercial growers to detect, prevent and trace food safety issues, and stay compliant with regulations. The key is making sure growers are not just tracking data but also ensuring the data becomes accessible and functional. A CMP can offer growers what ERPs and other farm management software can’t: Detailed and complete visibility of operations, labor accountability and crop traceability.
A CMP enables better product safety by keeping crop data easily traceable across the supply chain. Rather than having to destroy entire batches in the event of contamination, growers can simply trace it to the source and pinpoint the problem. A CMP greatly decreases the time it takes to log food safety data, which also helps growers’ bottom line.
CMPs also help growers manage regulatory compliance. This is true within the food industry as well as the cannabis industry. Regulations surrounding legal pesticides are changing all the time. It’s difficult keeping up with constantly shifting regulatory environment. In cannabis this is especially true. By keeping crops easily traceable, growers can seamlessly manage standard operating procedures across the operation (GAP, HACCP, SQF, FSMA, etc.) and streamline audits of all their permits, licenses, records and logs, which can be digitized and organized in one place.
FST: Where is the future headed regarding the use of technology that generates actionable data for growers? How is this changing the game in sustainability?
Kopf: Technology such as artificial intelligence and the internet of things are changing just about every industry. This is true of agriculture as well. Some of these changes are already happening: Farmers use autonomous tractors, drones to monitor crops, and AI to optimize water usage.
As the agriculture industry becomes more connected, the more growers will be able to access meaningful and actionable information. Plugging into this data will be the key for growers who want to stay profitable. These technologies will give them up-to-the-second information about the health of their crops, but will also drive their pest, labor, and risk & compliance management strategies, all of which affect food safety.
When growers optimize their operations and production for profitability, naturally they are able to optimize for sustainability as well. More gain from fewer resources. It costs its customers less money, time and hassle to run their farms and it costs the planet less of its resources.
Technology innovation, including CMPs, enable cultivation that will provide food for a growing population despite decreasing resources. Technology that works both with outdoor and greenhouse growing operations will help fight food scarcity by keeping crops growing in areas where they might not be able to grow naturally. It also keeps production efficient, driving productivity as higher yields will be necessary.
Beyond scarcity, traceability capabilities enforce food security which is arguable the largest public health concern across the agricultural supply chain. More than 3,000 people die every year due to foodborne illness. By making a safer, traceable supply chain, new technology that enables growers to leverage their data will protect human life.
On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.
Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal
However, the rule does state that additional hemp is necessary to support the growing CBD market, and it notably put pressure on FDA by stating that if “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market.”
So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:
- Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
- Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
- Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
- Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
- Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
- In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).
So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.
- “Establishment of a Domestic Hemp Production Program”. (October 31, 2019). Federal Register. Retrieved from https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.
There’s a reason you can eat or drink pretty much anything you want from American grocery stores and not get sick. Food manufacturing is highly regulated and subject to rigorous quality control.
Before food and beverages hit store shelves, the manufacturer must have a Hazard Analysis Critical Control Point (HACCP) system in place. The HACCP system requires that potential hazards—biological, chemical and physical— be identified and controlled at specific points in the manufacturing process. In addition, fresh foods undergo a kill-step. This is the point in the manufacturing or packaging process where food is treated to minimize and remove deadly pathogens like bacteria, mold, fungus and E. coli.
Generally speaking, when cannabis hits dispensary shelves, a less stringent set of rules apply, despite the fact that cannabis is ingested, inhaled and used as medicine. Cultivators are required to test every batch, but each state differs in what is required for mandated testing. Compared to the way food is regulated, the cannabis industry still has a long way to go when it comes to consumer safety—and that poses a considerable public health risk. In the early stages of legalization, the handful of legal states did not have rigid cannabis testing measures in place, which led to inconsistent safety standards across the country. State governments have had a reactionary approach to updating testing guidelines, by and large implementing stricter standards in response to product recalls and customer safety complaints. While local regulators have had the best intentions in prioritizing consumer safety, it is still difficult to align uniform cannabis testing standards with existing food safety standards while cannabis is a Schedule I substance.
The stark differences in safety measures and quality controls were first obvious to me when I moved from the food and beverage industry into the cannabis industry. For five years, I operated an organic, cold-pressed juice company and a natural beverage distribution company and had to adhere to very strict HACCP guidelines. When a friend asked me for advice on how to get rid of mold on cannabis flower, a light bulb went off: Why was there no kill step in cannabis? And what other food safety procedures were not being followed?
What to know more about all things quality, regulatory and compliance in the cannabis industry? Check out Cannabis Industry Journal and sign up for the weekly newsletterThe current patchwork of regulations and lack of food safety standards could have dire effects. It not only puts consumer health in jeopardy, but without healthy crops, growers, dispensaries and the entire cannabis supply chain can suffer. When a batch of cannabis fails microbial testing, it cannot be sold as raw flower unless it goes through an approved process to eliminate the contamination. This has severe impacts on everyone, starting with the cultivator. There are delays in harvesting and delivery, and sometimes producers are forced to extract their flower into concentrates, which really cuts into profits. And in the worst cases, entire crop harvests may have to be destroyed.
So, what do cannabis cultivators and manufacturers have to fear the most? Mold. Out of all the pathogens, mold is the most problematic for cannabis crops, perhaps because it is so resilient. Mold can withstand extreme heat, leaving many decontamination treatments ineffective. And most importantly, mold can proliferate and continue to grow. This is commonplace when the cannabis is stored for any length of time. Inhaling mold spores can have serious adverse health effects, including respiratory illness, and can even be deadly for immunocompromised consumers using it for medical reasons.
What the industry needs is a true kill step. It’s the only way to kill mold spores and other pathogens to ensure that they will not continue to grow while being stored. States that mandate microbial testing will benefit from the kill step because more cultivators will be in compliance earlier in the process. In states that don’t require comprehensive microbial testing, like Washington and Oregon, the kill step is a critical way to provide consumers with a preemptive layer of protection. Microbial testing and preventative decontamination measures encourage customer brand loyalty and prevents negative press coverage.
Adopting a HACCP system would also build additional safeguards into the system. These procedures provide businesses with a step-by-step system that controls food safety, from ingredients right through to production, storage and distribution, to sale of the product and service for the final consumer. The process of creating HACCP-based procedures provides a roadmap for food safety management that ultimately aligns your staff around the goal of keeping consumers safe.
It’s high time for the cannabis industry to adopt FDA-like standards and proactively promote safety measures. Cannabis growers must implement these quality controls to ensure that their products are as safe to consume as any other food or drink on the market. Let’s be proactive and show our consumers that we are serious about their safety.
When it comes to mainstream consumer food brands, customers expect to receive the same product each time they buy it. That consistency brings consumers back to the same brands over and over again. Unfortunately, the same can’t be said about products sold in the cannabis industry. Consumers aren’t building long-term relationships with brands because consumers don’t have consistent product experiences and often take their business to other brands.
This inconsistency plaguing the cannabis industry can be attributed to an unreliable supply chain, which plays out in multiple ways.
First, cannabis companies are having difficulty meeting state regulations. This happens because the legal cannabis industry is still relatively young and there isn’t a substantial institutional knowledge about regulatory compliance, nor are there any standardized best practices in place. Regulation is expensive and requires human and financial capital that most cannabis companies don’t have in place. Complicating things further, regulations keep changing, making it more difficult for compliant businesses to keep up, even when they have the best intentions.
Second, testing of cannabis products has been complicated. Because cannabis isn’t federally legal, standardized testing guidelines have not been developed, leaving individual states in charge of dictating their own requirements and enforcement framework. There have been numerous reports in the past few years of labs in California either improperly reporting testing results, or worse, submitting fraudulent results.
Third, problems also arise on production end of the supply chain—not only with consistency, but also with consumer safety. According to an estimate from New Frontier Data, approximately 80% of sales are still conducted through the black market. Many growers are using banned pesticides in amounts way beyond recommended levels. In addition, as the recent vape issue has demonstrated, black market manufactured products are being adulterated with toxic substances that pose significant health hazards to consumers.
Given these consistency challenges, the standardization of the supply chain—especially compliance, testing and safety measures—should be a top priority for new cannabis brands. Luckily, many best practices and standardized procedures can be adopted from the food, agriculture and pharmaceutical industries, where companies have successfully developed protocols to ensure safe and reliable products.
In addition to standardization and best practices, cannabis companies should also utilize the following recent innovations in transaction technology to provide peace-of-mind to both new brands and consumers that cannabis products are tested and safe.
Modernized Retail POS systems. Common in other consumer packaged goods industries, such as food, wine, beverages and soft drinks, RFID tags can be used throughout the supply chain to track products from seed to sale. These tags, like the “chips” on credit cards, hold electronically stored information about a product that can be accessed to verify compliance and safety.
QR Codes. While QR codes are mostly used today as marketing gimmicks, they actually have potential to provide true value for curious customers. Batch-specific QR codes could be applied to cannabis products to show detailed information about when and where it was made, what strains of cannabis were used, and testing results. This technology could be used to increase transparency between companies and to consumers.
Data Informatics. A strong information technology infrastructure can be put in place to collect and store inventory and customer data. That data can then be run through algorithms, AI and machine learning systems to help cannabis brands make better decisions about how to optimize the production of their products and how to achieve better results on future batches.
Video Surveillance. Granted, this is a more ‘low-tech’ approach, but effective, nonetheless. Video cameras can go way beyond security purposes. Footage can be viewed and compared to collected data sets to gain a deeper understanding of product flows, personnel movement and logistics that might impact a company’s final product. Video can also be analyzed automatically using AI to provide important insight to help a company fine tune their business strategies.
Consumers want to know that the cannabis products they purchase are safe, compliant and tested. Consumers also have a right to know what they are buying and expect product consistency over time from companies they trust. Ensuring supply chain consistency is key to making this happen as the industry matures. An experienced and trusted supply chain partner can help companies across different cannabis sectors, ranging from medical to food, and ensure product safety and consumer trust today through standardization and consistency. Ultimately, cannabis businesses want to cultivate a culture of excitement, not fear or uncertainty, to help the market flourish and bring quality products to our customers.
As cannabis and CBD edibles and beverages gain in popularity among consumers, the rush to cash-in on market opportunities has resulted in an influx of unregulated and untested products. Recently the FDA increased its scrutiny of cannabis and CBD company websites and social media accounts to make sure they were not making unverified or misleading marketing statements about their products.
To exacerbate the problem of unregulated products, recent scares around vape-related hospitalizations have flooded the news, and the public is looking to the cannabis industry for answers about what it will do to ensure CBD and cannabis products are safe for consumption.
The first step the cannabis business community can take is educating the public on the two types of edibles— tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is heavily regulated. Every batch must be tested before it is released to retail ensuring labeling and dosages are consistent.
Since CBD does not have psychoactive properties, most products do not go through the same testing standards and are far less regulated. An estimated 75% of CBD-only companies do not test their products. Even worse, independent testing has shown that CBD labels are often incorrect or inconsistent with its dosage and ingredient labels.
Both cannabis and CBD companies must advocate for a more regulated and legitimate market. Stricter regulations and testing standards will eventually weed out the bad players who are hoping to make a quick buck from those that intend to manufacture quality products that can benefit the health of consumers.
Short Cuts To Boost Profits
The current vape pen crisis underscores the lack of regulation and inconsistency in the CBD market. CBD-exclusive vapes are more likely to use cutting agents, whereas licensed THC vape companies are more likely to use pure cannabis oils and are required to undergo quality control testing.
Using cutting agents may lower operating costs, but often results in an inferior or dangerous product. Cutting agents also inhibit crystallization in CBD oils and increase the shelf life of a product. The cost of production for pure THC or CBD oil is $5–6 per gram, but a cutting agent can reduce the cost down to $0.10–$2 per gram.
With edibles, untested CBD products can introduce Salmonella or E.coli into the supply chain. This oversight could severely hurt the reputation of growers and manufacturers if a serious outbreak occurred.
Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry JournalThe Solution Is in Testing
Unlike food manufacturing, where quality controls are in place at the plant, the quality measures for edibles happens in a lab, after a product is manufactured.
Labs test edibles for potency. Both THC and CBD are used for medicinal purposes, and potency testing is critical for accurate dosing. A patient under or over dosing, or taking a poor quality CBD product with additives could detrimentally affect their long-term health.
They will also test for product contamination. Both CBD and THC cannabis can become contaminated with microbes (i.e., mold, mildew, bacteria and yeast), pesticides and heavy metals throughout the process of growing, cultivation and processing. Contamination is especially concerning because many medical marijuana patients are immunosuppressed and cannot fight off potentially dangerous infections and illnesses arising from these contaminants.
But even for the general population, cannabis and CBD contamination can cause serious health issues. Molds and bacteria such as aspergillus, Salmonella and E. coli present safety risks, and toxicity from sustained exposure to heavy metals can lead to high blood pressure, heart issues and kidney failure, among other issues. Fortunately for consumers, cannabis products sold in licensed dispensaries must all undergo contamination and quality control testing per state regulations.
However, because quality control measures are not required for edible manufacturers, there is no oversight that food-grade ingredients are used or that practices to avoid cross-contamination are used.
What Companies Can Do To Win Back Trust
Customers around the country are rightfully concerned about the safety and quality of their cannabis and CBD products in light of recent news surrounding vape-related illnesses. This is the perfect opportunity for manufacturers and consumer brands to seize on the subject and educate consumers about cannabinoids so they aren’t turned off from incorporating CBD into their lifestyles.
- First and foremost, test all products. At a minimum, companies should be adhering to state cannabis market regulations, even if they are just producing CBD. As the FDA rolls out more concrete regulations for CBD, which was only federally legalized last year, it is in the best interest of all CBD companies to meet FDA guidelines preemptively so products can pass inspection at a later date.
- Find a good credible lab to help with formulations and inputs. With edibles and beverages, there is more room to introduce contaminants within that scope.
- Hire food safety experts to help elevate safety standards and meet FDA regulations. Some forward-thinking companies are starting to hire quality experts from food manufacturing to get ready for broader federal acceptance.
- Help educate consumers on why the brand is better, based on inputs and testing.
Consumers should also conduct their own research regarding individual CBD companies’ supply chains and manufacturing standards. Transparent companies will do this proactively, providing cultivation information and lab results for their customers.
In the end, the safest place to buy cannabis and CBD products is a licensed dispensary. It is the responsibility of growers, distributors, manufacturers and retailers to keep the legal market safe and free from contaminants that could threaten the industry. The regulated cannabis space has advanced significantly in the past few years, and companies must set the highest manufacturing standards to maintain this forward momentum. Education and testing are the best solutions to ensure a safe and trusted cannabis marketplace.
Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.
Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.
Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.
Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.
Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.
Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”
Is CBD legal in America? The answer is: “It’s complicated.”
The Details Behind CBD, Legalization and Marketing
CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”
The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.
The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.
Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.
According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.
Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.
Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.
In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.
Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.
The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.
This year the Cannabis Quality Conference & Expo is co-located with the Food Safety Consortium | October 1–3 | Schaumburg, ILCannabis Edibles Defined
Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.
Safety and Quality Concerns
An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.
How ERP Can Help
Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.
The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:
Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.
Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.
Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.
Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.
Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.
Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.
Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.
With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.