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:
Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that evaluates hazards that may potentially be present in food products that can harm the consumer. The process used to manufacture the product is evaluated from raw material procurement, receiving and handling, to manufacturing, distribution and consumption of the finished product1. The documented process is what is known as HACCP plan. Although HACCP was designed to evaluate hazards in foods, it can be used to assess or evaluate hazards that may potentially be present in cannabis consumable products (edibles and vaping) that can cause harm to the consumer.
HACCP plan development requires a systematic approach that covers 5 preliminary steps and 7 principles. A systematic approach means that each step must be followed as outlined. Skipping a step will result in a HACCP plan that most likely will be ineffective to control potential hazards in the product.
The 5 preliminary steps are:
Establish a HACCP team
Describe the product
Establish the intended use of the product
Develop a flow diagram
Verify the flow diagram
The 7 Principles are:
Conduct a hazard analysis
Identify the critical control points (CCPs)
Establish critical limits (CL)
Establish monitoring procedures
Establish corrective actions
Establish verification procedures
Establish records and record keeping procedures1,2
It is important to mention that HACCP plans are supported by programs and procedures that establish the minimum operational and sanitary conditions to manufacture safe products. These programs and procedures are known as pre-requisite programs (PRP) or preventative controls1,2.
A multidisciplinary team must be established in order to ensure that all inputs of the product manufacturing process are considered during the hazards analysis discussions. The description of the product and its intended use provides detail information on ingredients, primary packaging material, methods of distribution, chemical characteristics, labeling and if any consumer might be vulnerable to the consumption of the product. A verified flow diagram is an accurate representation of the different steps followed during the product manufacturing process and will be used to conduct a hazard analysis. An inaccurate flow diagram will set the stage for an inadequate HACCP plan. Therefore, it is important that the HACCP team members verify the flow diagram. Figure 1 is a flow diagram for a fictional infused apple juice manufacturing plan that I will be using as an example.
The hazard analysis is the backbone of the HACCP plan. There are two elements that must be considered when conducting the hazard analysis:
Identification of the hazard associated with the ingredient(s) and/or the product manufacturing steps. These hazards have been categorized as: Biological, chemical (including radiological) and physical. Biological, chemical and physical hazards should be considered for each ingredient, primary packaging and process step. Also, it is important that the team is specific as to what hazard they are referring to. I often find that biological hazards are identified as “pathogens” for example. The team has to be specific on which pathogen is of concern. For example, if you are processing apple juice, the pathogens of concern are pathogenic coli and Salmonella sp. However, if you are processing carrot juice, you need to add Clostridium botulinum as a biological hazard also. If the choice of method to eliminate the hazards is pasteurization for example, the processing temperature-time combinations will differ greatly when manufacturing the apple juice vs. the carrot juice as C. botulinum is an organism that can sporulate and, therefore, is harder to kill.
Characterization of the hazard. This implies determining the significance of the potential hazard based on the severity of the consequence if it is consumed and the likelihood of occurrence in the ingredient or process step. Only steps in the process that has significant hazards should be considered further.
In my professional experience, the hazard analysis is one of the most difficult steps to achieve because it requires the expertise of the multidisciplinary team and a lot of discussion to get to the conclusion of which hazard is significant. I find that a lot of teams get overwhelmed during this process because they consider that everything in the process may represent a hazard. So, when I am working with clients or providing training, I remind everyone that, in the bigger scheme of things, we can get stricken by a lighting in the middle of a thunderstorm. However, what will increase our chances would be whether we are close or not to a body of water for example. If I am swimming in the middle of a lake, I increase my chances to get stricken by the lighting. In comparison, if I am just sitting in my living room drinking a cup of coffee during the thunderstorm, the likelihood of being stricken by a lighting is a lot less. The same rationale should be applied when conducting the hazard analysis for manufactured products. You may have a hazard that will cause illness or death (high on the severity chart) but you also may have a program that mitigates the likelihood of introducing or having the hazard. The program will reduce the significance of the hazard to a level that may not need a critical control point to minimize or eliminate it.
Clear as mud, right? So, how would this look like on the infused apple juice example? Table 1 shows the hazard analysis for the ingredients. Tables 2 and 3 show the hazard analysis for the part of the process. In addition, I have identified the CCPs: Patulin testing and pasteurization. There is a tool called the CCP decision tree that is often used to determine the CCPs in the process.
Once we have the CCPs, we need to establish the critical limits to ensure that the hazard is controlled. These limits must be validated. In the case of Patulin, the FDA has done several studies and has established 50 ppm as the maximum limit. In the case of pasteurization, a validation study can be conducted in the juice by a 3rd party laboratory. These studies typically are called thermal death studies (TDS) and provide the temperature and time combination to achieve the reduction of the pathogen(s) of concern to an acceptable level that they do not cause harm. In juice, the regulatory requirement is a 5-log reduction. So, let’s say that the TDS conducted in the infused apple juice determined that 165°F for 5 seconds is the critical limit for pasteurization. Note that the 5 seconds will be provided by the flow of the product through the holding tube of the pasteurizer. This is measured based on flow in gallons per minute.
Monitoring is essential to ensure that the critical limits are met. A monitoring plan that outlines what, how, when and who is responsible for the monitoring is required.
Ideally, the system should not fail. However, in a manufacturing environment, failures can happen. Therefore, it is important to pre-establish steps that will be taken to ensure that the product is not out of the control of the facility in the event of a deviation from the HACCP plan. These steps are called corrective actions and must be verified once they are completed. Corrective actions procedures must address the control of the product, investigation of the event, corrective actions taken so the deviation doesn’t reoccur and product disposition.
Verification activities ensure that the HACCP plan is being followed as written. Typically, verification is done by reviewing the records associated with the plan. These records include but are not limited to monitoring records, calibration records, corrective action records, and preventive maintenance records for equipment associated with the CCPs. Record review must be done within 7 working days of the record being produced.
Finally, establishing records and record keeping procedures is the last step on developing HACCP plans. Records must be kept in a dry and secure location.
Table 4 show the summary of the HACCP plan for the infused apple juice example.
For more information on how to develop a HACCP plan for your facility, read the resources below:
If you missed the Cannabis Industry Journal’s 3rd Annual Infused Products Virtual Conference last week, one of the speakers, Ellice Ogle, founder and CEO of Tandem Food presented on Food Safety Culture in the Cannabis Industry. An overview of the information in the presentation can be found here, Concentrate On a Food Safety Culture In Your Workplace. Below are answers to some of the post-presentation questions we received, but were unable to answer during the Q&A session. To get your additional questions answered or for a complimentary consultation for your company, specially provided to readers of Cannabis Industry Journal, contact Ellice Ogle at Ellice@tndmfood.com.
Question: What are some recommended digital programs for internal auditing?
Ellice Ogle: Before looking at the tools for conducting an internal audit, understand the goal of the internal audit. One key aspect of internal auditing is knowing which standard(s) to audit against. For example, regulatory audits for cGMP certification are different than optional third-party certifications such as any GFSI scheme (SQF, BRC, PrimusGFS, etc). While the standards ultimately have the same goal of food safety with varying focuses, it is important to have an experienced food safety specialist conduct the audit as realistically as possible. The experienced specialist will then be able to recommend an appropriate tool for internal auditing moving forward, whether it is software such as FoodLogiQ, SafetyChain, Safefood 360°, among many others, or simply providing a template of the audit checklist. Overall, the risk of foodborne illnesses can be minimal, but it takes persistence and commitment to achieve a successful food safety culture. Metrics can assist in assessing the commitment to food safety and, as a result of these efforts, you will minimize the risk of compromising the health and safety of your guests, employees, foods and business. If you want a specific example, I’d like to direct you to a case study in partnership with Heylo LLC in Washington state, posted on the Tandem Food website.
Q: What are examples of ways to share environmental monitoring results to enhance a good edible safety culture?
Ellice: In the Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance (2017), the FDA states that “a well-designed environmental monitoring program promotes knowledge and awareness of the environmental conditions that could result in product contamination and is a more effective program than product testing alone.” In other words, environmental monitoring programs and results can identify environmental conditions within a facility that could cause potential contamination. Publishing these findings, for example in the form of a case study or sharing the details of the practice, can enhance the food safety culture in the specific niche industry. For example, to borrow from the meat industry, Tyson Foods, Inc developed and shared environmental monitoring programs that are used by their peers, promoting a unified food safety culture, rather than competitive, guarded secrecy.
Q: Are the food safety requirements the same for retail and manufacturing?
Ellice: The food safety requirements are not exactly the same for retailers and manufacturers. The difference is inherent that retailers are working with finished product while manufacturers are working with raw ingredients and the manufacturing process to develop the finished product. Let’s take a closer look at cannabis regulation in Washington state. Chapter 314-55-104(12) states “Processors creating marijuana extracts must develop standard operating procedures (SOPs), good manufacturing practices (GMPs), and a training plan prior to producing extracts for the marketplace.” Compare this to the requirements for retailers, 314-55-105(11) which states “A marijuana producer, processor or retailer licensed by the WSLCB must conduct the production, processing, storage, and sale of marijuana-infused products using sanitary practices.” While SOPs and GMPs are not explicitly mentioned for retailers as they are for manufacturers, sanitary practices could be documented as Sanitation Standard Operating Procedures (SSOPs). Proper storage practices can also be an overlapping food safety concern with respect to temperature control or pest management systems. Overall, food safety should remain a top priority in maintaining the integrity of the products throughout the supply chain.
Q: To your knowledge, has there been a food safety outbreak associated with a cannabis-based product?
Ellice: One possible cannabis-related death investigated in 2017 uncovered deadly pathogens in medical cannabis. However, to my knowledge, I have not seen a food safety outbreak associated with a cannabis-based product. There might be any number of reasons that this is so, for example, possibly because a food safety outbreak associated with a cannabis-based product might not have had a large impact to make headlines. Although, with the cannabis industry already misunderstood and a stigma so prevalent to even promote fake news, it is better to prevent an outbreak from ever occurring. One thing to note is that ultimately cannabis is just another ingredient in existing products, of course with special properties. So, the common food safety offenders are present: listeria, Salmonella, E. Coli, among others. On the plant, cannabis food product manufacturers must minimize the risk of mycotoxins produced by molds, pest contamination, and pesticide contamination. For products that contain cannabis infusions or extractions as an ingredient, there is the possibility of the growth of Botulism toxin. Many of these pathogens can be minimized by appropriate heat treatment or maintenance of refrigeration, testing, and by practicing preventive measures. Arguably, the largest potential for pathogenic contamination is due to improper employee handling. To refer to what we discussed earlier, employee training is key, as well as proper enforcement. Having a strong food safety culture ensures that people have the knowledge of food safety risks and the knowledge of preventing outbreaks.
Q: Do any of the panelists know of any efforts to develop a food safety-oriented standard for the cannabis industry?
Ellice: Yes, Tandem Food LLC is positioned to consult on cGMP certification for manufacturing facilities in the cannabis industry. First, a gap assessment can be conducted to obtain useful actionable data for you, rather than be an intimidating experience. Working from the identified baseline, Tandem Food will work with you to create and implement all related documentation and programs, providing training as necessary. Overall, with the right commitment, cGMP certification can take 6-12 months.
In the midst of a global pandemic with schools closing, businesses asking employees to work from home and events being canceled left and right, we have one event that will remain scheduled: The Infused Products Virtual Conference on March 31. The event is complimentary for attendees to register. Click here to sign up for this virtual conference.
On March 31, the event will begin with a presentation from the folks at Cresco Labs: Applying Food Science Principles to Cannabis Edibles. Marina Mincheva, Director of Manufacturing Quality Assurance and Stephanie Gorecki, Director of Food Sciences at Cresco Labs will deliver this talk. They will discuss what a research and development process looks like for creating cannabis-infused edible products, how to then commercialize those products and developing CPG products with input from marketing and quality.
Ellice Ogle, CEO & Founder of Tandem Food LLC, will deliver a talk on the importance of food safety culture in the cannabis space. Kathy Knutson, founder of Kathy Knutson Food Safety Consulting, will follow that talk with a discussion of GMPs, HACCP and how cannabis companies can apply preventive controls. The last presentation on the schedule is The New Canadian Edibles Market, where Steven Burton, Founder & CEO of Icicle Technologies, will discuss edibles regulations in Canada, a current state of affairs of the Canadian infused products market, as well as what US edibles companies can expect when it comes to new regulations.
Now that cannabis edibles have been legalized nationally in Canada, many existing and aspiring license holders have been surprised to discover that they must comply with food safety regulations. This became crystal clear when Health Canada published their Good Production Practices Guide For Cannabis in August 2019.
With this development, it should be obvious to everyone that Good Manufacturing Practices (GMP) certifications are simply not enough.
HACCP is a methodology that is all about identifying biological, chemical and physical hazards and determining how they will be controlled to mitigate the risk of injury to humans. Recently, bio-terrorism and food fraud hazards have been added to the list and it is a good idea to address quality hazards as well.
The process of developing a HACCP program involves identifying these hazards with respect to ingredients, materials, packaging, processes and cross-contamination points (explicitly required in Canada only). However, it is a specific ingredient hazard that I’d like to talk about here.
As this market has emerged, I’ve met with many cannabis companies as the onerous levels of knowledge and effort required to build and maintain an effective HACCP program manually has dawned upon the industry. Many are looking for technological solutions to quickly solve this problem. During these discussions, a curious fact has emerged that set off the food safety alarm klaxons around here.
Most people alive today are too young to remember this but, with few exceptions, the standardization of ingredients is a relatively modern phenomenon. It used to be that the fat content of your milk varied from season to season and cow to cow. Over time, the food industry standardized so that, amazingly, you can now choose between milks with either 1% or 2% fat, a level of precision that would border on miraculous to someone born in the early 20th century.
The standardization of ingredients is important in terms of both quality and safety. Take alcohol for example. We know that a shot of spirits generally contains 40% alcohol. Different products may vary from this standard but, if I pour a shot of my favourite Bowmore No.1 single malt in Canada or Tasmania, this year or 10 years from now, I can expect a consistent effect from the 40% alcohol content of the quantity I’ve imbibed.
Imagine a world in which this was not the case, where one shot would be 40% but the next might be 80%. Things could get out of control quite easily at the 80% level so, to avoid this, distillers monitor and blend their product to ensure they achieve the 40% target, which is called the “standardization marker”.
With respect to cannabis, the obvious standardization marker is THC. During the manufacturing process, edibles manufacturers do not normally add cannabis flower directly into their products but instead add a THC concentrate produced during previous production steps. However, we’ve found that the wisdom of standardizing these concentrates has not yet dawned upon many in the industry, which is alarming at best and dangerous at worst.
The reason for this is that, since cannabis is inherently a heterogeneous plant, one cannot precisely achieve a particular marker value so the outcome of the concentration process is variable. The food industry long ago overcame this problem by blending or diluting to achieve a consistent marker concentration, but the cannabis industry has not yet adopted this advance.
The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker.Instead, manufacturers simply keep track of the strength of each batch of concentrate and then adjust the quantity added to their recipes to achieve the desired THC content. This seems logical on the surface but presents a serious risk from the HACCP perspective, namely a chemical hazard, “Excessive psychoactive compound concentrations due to human error at levels that may be injurious to human health”.
The reality is that workers make mistakes, which is why it is imperative to mitigate the risk of human error insomuch as possible. One of the best ways to do this is to standardize to avoid the scenario where a worker, faced with a row of identical containers that are differentiated only by a tiny bit of text, accidentally grabs the wrong bottle. The error isn’t caught until the product has been shipped, consumed, and reports of hospital visits start coming in after the authorities trace the problem back to you. You must bear the costs of the recall, your reputation has been decimated and your company is floundering on the financial rocks.
US-based Drip More, LP recently found this out the hard way after consumers complained that their product tasted bad, bitter and/or harsh. An investigation determined that excessive nicotine content was the source of the problem and a voluntary recall was initiated. Affected product that had already been sold in 26 states. The costs of this recall have not been tallied but they will be staggering.
The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker. This strategy is cheap, easy and you’ll never be sorry.
You’ve survived seasons of cannabis cultivations, bringing in quality plants in spite of mold, mites, drought and other challenges that had to be conquered. Extraction methods are sometimes challenging, but you are proud to have a cannabinoid extract that can be added into your own products for sale. Edibles are just waiting to be infused with the cannabinoids, for consumers demanding brownies, gummies, tinctures and almost any food and beverage imaginable. You’ve been through the fire, and now the rest is easy peasy, right?
Actually, producing edibles may not be so seamless as you think. Just as in the rest of the food industry, food safety practices have to be considered when you’re producing edibles for public consumption, regardless of the THC, CBD, terpene or cannabinoid profile. Once you’ve acquired the extract (a “food grade ingredient”) containing the active compounds, there are three types of hazards that could still contribute to foodborne illness from your final product if you’re not careful- Biological, Chemical and Physical.
Biological hazards include pathogenic bacteria, viruses, mold, mildew (and the toxins that they can produce) that can come in ingredients naturally or contaminate foods from an outside source. Chemical hazards are often present in the kitchen environment, including detergents, floor cleaners, disinfectants and caustic chemicals, which can be harmful if ingested- they are not destroyed through cooking. Physical objects abound in food production facilities, including plastic bits, metal fragments from equipment, staples or twist ties from ingredient packages, and personal objects (e.g., buttons, jewelry, hair, nails.)
There are three main safety precautions that can help control these hazards during all the stages of food production, from receiving ingredients to packaging your final products:
1. Avoid Cross Contamination
Prevent biological, chemical or physical hazards from coming into contact with foods
Keep equipment, utensils and work surfaces clean and sanitized.
Prevent raw foods (as they usually carry bacteria) from coming into contact with “Ready-to-eat” foods (foods that will not be cooked further before consuming).
Keep chemicals away from food areas.
2. Personal Hygiene
Don’t work around foods if you’re sick with fever, vomiting or diarrhea. These could be signs of contagious illness and can contaminate foods or other staff, and contribute to an outbreak.
Do not handle ready-to-eat foods with bare hands, but use a barrier such as utensils, tissues or gloves when handling final products such as pastries or candies.
Wash hands and change gloves when soiled or contaminated.
Wear hair restraints and clean uniforms, and remove jewelry from hands and arms.
3. Time & Temperature control
Prevent bacterial growth in perishable foods such as eggs, dairy, meats, chicken (TCS “Time and Temperature Control for Safety” foods according to the FDA Model Food Code) by keeping cold foods cold and hot foods hot.
Refrigerate TCS foods at 41˚ F or below, and cook TCS foods to proper internal temperatures to kill bacteria to safe levels, per state regulations for retail food establishments.
If TCS foods have been exposed to room temperature for longer than four hours (Temperature Danger Zone 41˚ F – 135˚ F,) these foods should be discarded, as bacteria could have grown to dangerous levels during this time.
As cannabis companies strive for acceptance and legalization on a federal level, adopting these food safety practices and staff training is a major step in the right direction, on par with standards maintained by the rest of the retail food industry. The only difference is your one specially extracted cannabinoid ingredient that separates you from the rest of the crowd… with safe and healthy edibles for all.
Project Yosemite, a cannabis product innovation and brand development company, announced earlier this month the appointment of Jennifer Raeder-Devens as their new Chief Scientific Officer. Raeder-Devens is a veteran of the MedTech industry, working for companies like Becton Dickinson, Cardinal Health, Medtronic and 3M.
Prior to joining Yosemite, she was the Vice President of Research & Development at Becton, Dickinson, where she oversaw product development and technology strategies to launch infection prevention products including the ChloraPrep first-in-the-US sterile solution patient preoperative topical antiseptic. She was previously the Vice President of R&D, Strategy and Innovation at Cardinal Health. She’s also held roles at Medtronic, 3M Drug Delivery Systems and 3M Skin Health Division and she has a number of patents in drug delivery and medical devices.
In November of 2018, Project Yosemite launched their first product, OLO, which is an infused, controlled-release sublingual strip. Part of Raeder-Devens’ new role at the company is the continued development and expansion of the OLO sublingual strip technology platform. Andrew Mack, CEO and founder of Project Yosemite, says he’s thrilled to have Raeder-Devens on the team. “Jennifer is an extremely accomplished scientist and engineer with extensive experience driving innovation and R&D in the pharmaceutical and medical device industries,” says Mack.
We caught up with Jennifer over the phone to talk about her background in the MedTech space, why she decided to jump ship to join the cannabis industry and what she’s excited to work on now.
Cannabis Industry Journal: Can you tell us about your background, including your work with 3M and Medtronic?
Jennifer Raeder-Devens: I’m coming directly from Becton Dickinson, a global med tech company, where I supervised the development of drug-device combination products for topical antiseptics. I spent about 10 years there, mostly in topical drug and combination product development. Prior to that, I was at 3M and Medtronic working in drug-device combination products. At 3M, I was supervising a team of technology developers for the 3M Drug Delivery Systems business. I had experience working with designing and manufacturing transdermal, nasal, buccal and inhalation drug delivery mechanisms for pharmaceutical partners.
I worked on implantable drug delivery systems at Medtronic, which included working on the biocompatibility of things like pacemakers and drug infusion pumps and optimizing them to reduce infection and enhance healing after the implantation procedure.
CIJ: What made you consider joining the cannabis industry?
Jennifer: With my work in topicals, transdermal and inhalation drug delivery, I had an easy understanding of the different routes of administration we see today in the cannabis industry. And so, from the technology standpoint, I thought this was a place I could contribute to immediately. And then what got me really excited about it was thinking about cannabis, and just like any other drug, with oral drug delivery, you’ve got first class metabolism and side effects from the 11-Hydroxy-THC that are undesirable and you’d rather not have delivered through the gut.
I got excited when I saw the development of things like sublingual strips that were focusing on alternatives to smoking that would preserve that relatively fast onset and mitigate some of the side effects of edibles.
The other thing I really like about the cannabis industry: Previously I have been very focused on known drugs that are already approved and repurposing them into a new delivery system. What really interests me about the cannabis industry is the active cannabinoids and terpenes are somewhat known and somewhat unknown, so there is this really interesting challenge there of trying to separate the wheat from the chaff in terms of producing therapeutic effects.
It is a really interesting space where the indications of certain molecules are evolving along with the delivery technology. So, it is a really exciting and eye-opening way to take the next step in my career and have this wide-open space in front of me, both in terms of the different cannabinoids, their effects and the delivery systems we can use.
CIJ: How might you be prepared, given your background, for some of the challenges in the cannabis space?
Jennifer: I think the challenges in cannabis delivery are not different from the challenges in pharmaceutical drug delivery. It’s just that we have this additional complexity of the entourage effect. We can be engineering not just the main ingredient of THC, but also all the other cannabinoids and terpenes. So, for example, with my background in infection prevention, we build a product that we know reduces the risk of infection, but we are really challenged to actually prove it reduces the risk of infection. We have a similar situation in the cannabis industry, where we can get the THC, or CBG or CBN where we want it to go, but then we are really challenged to figure out how we can find, what we call in the pharmaceutical industry, a surrogate end point for efficacy, so that we can test that product and really believe that when we put the product on the market, even though we haven’t tested thousands of users or conducted large randomized clinical trials, that the effect will be shown. We are networking and partnering with a good scientific community to build the right product and do some testing at a small scale that really demonstrates the product achieves the effect that we are really looking for.
CIJ: Can you tell us a little about your new role with Project Yosemite?
Jennifer: My job description falls into three buckets: The first part is that we are forming a scientific advisory board and we are working with some of the leading cannabinoid researchers around the country and around the world. These are the people identifying whether or not certain cannabinoids could reduce cancer cell metabolism or whether cannabinoids contribute to weight loss or diabetes control and other things of that nature. We are trying to reach as far upstream as we can to grasp the emerging understanding of the performance of cannabinoids and terpenes in the endocannabinoid system. So, part of my job is to chair that scientific advisory board, get the thought leaders together in the room and have them bring their knowledge and explore with our own knowledge what cannabis can really do.
I have worked in topical, transdermal, buccal, nasal, inhalation drug delivery. In the second bucket of my job, we are trying to understand a given indication or experience that our users want to have, what would be the right route for them. We are challenging our sublingual delivery mechanism to see how fast of an onset we can really get. Right now, we are at 10 minutes for drug delivery in sublingual and we are still trying to get an even faster onset time for the sublingual strip.
For other indications, like chronic pain, we may want to think about a sustained release, so sort of aligning the different indications with which different cannabinoids and terpenes will work for it and see which delivery platform will work for what we are trying to accomplish in each indication. So, we do not plan to remain solely a sublingual strip company, but will build out additional delivery platforms as we develop new indications.
Right now, we are working upstream with the growers and the processors to get cannabis oil and extracts. Some of the growers are working on different genetics in their cultivars to grow plants that have different ratios of different cannabinoids that we know from the emerging research will have an impact on people’s experience. Now we are working with growers to really get ahead of the curve on how to formulate products with various cannabinoids.
We have an R&D team in house that I supervise. We are always working with our production team to make small improvements such as the faster onset and the dissolution rate and things like flavors, which covers a downstream focus as well.
To say that there has been explosive growth in the cannabis edibles market is an understatement. In the next 5 years, edibles are expected to become a $5.3 billion industry according to the Brightfield Group, a cannabis market research firm. Skyrocketing demand for cannabis infusion in food and beverage products, both recreational and medical, has prompted concern for the health and safety of consumers due to the lack of federal legality and regulatory guidelines for these products. Edibles consumers assume the same level of safety and quality present in other food and beverage products in the market. Progressive cannabis operations are opting to follow current food safety guidelines to mitigate hazards despite not being legally required to do so. Utilizing these guidelines, as well as incorporating an industry-specific ERP solutionto automate processes, enables cannabis businesses to provide quality, consistent products and establish standards to support the eventuality of federal cannabis legalization.
Edibles consumption has grown not only in a recreational capacity but also for medicinal use to treat chronic pain, relieve epilepsy symptoms, decrease nausea, combat anxiety and other health issues. Cannabidiol (CBD) infused products take many forms including candies, baked goods, chocolate, oils, sprays, beer, soda, tea and coffee. Their popularity is partly due to their more socially acceptable use, creating an appeal to a wider audience. While the Food and Drug Administration (FDA) is responsible for overseeing food and beverage safety for products sold in the United States, their regulations are not enforced in the cannabis-infused marketplace. Without federal regulatory standards, there exist inherent food safety concerns that create risks to consumers. The average cannabis edibles customer is likely unaware of the “consume at your own risk” nature of the products.
There are many consequences of not addressing food safety hazards, as the possibility of food-borne illnesses resulting from unsafe and unsanitary manufacturing facilitieshave become increasingly likely in an unregulated market. In addition to these concerns, problems particular to cannabisgrowing and harvesting practices are also possible. Aflatoxins (mold carcinogens) on the cannabis bud, pesticide residue on plants, pest contamination, improper employee handling and training and inaccurate levels of CBD all contribute to the risk of outbreaks, hefty fines, recalls or business closure. To mitigate the risk of exposure, it is recommended that edible manufacturers employ a proactive approach of observing proper food safety standards that encompass the growing, manufacturing, packaging, handling, storing and selling of products. With a focus on safety, cannabis edible manufacturers utilizing an ERP solution and vendor with experience in food safety management will reap the benefits that food and beverage businesses have experienced for decades.
Following established food safety protocols and guidelines of the food and beverage and dietary supplement industry, allows manufacturers of cannabis-infused edibles to implement a proactive approach by focusing on safety and reducing the risk to their operations. Food and beverage manufacturing best practices include: maintaining supplier list, quality control testing, sanitary handling of consumables, maintaining clean facilities and mitigating cross-contamination. Successful food and beverage manufacturers also incorporate a food safety team, preventative controls, and a food safety plan (FSP) including a detailed recall plan into their safety initiatives.
Establishing and maintaining a supplier list with approved quality ingredients is an essential building block for reducing food safety hazards and can be easily maintained within an ERP. Documentation of vendor information and recording of stringent testing results ensures that specific quality standards are met. Conducting extensive research regarding the source of the ingredients for use in cannabis edibles allows companies to confirm that raw ingredients were processed in a safe environment. The importance of supply chain visibility cannot be understated, as suppliers are in control of potential hazards. Quality processes and regularly performed testing is automated through the workflow of an ERP solution in the manufacturing facility – enabling noncompliant raw materials to be quarantined and removed from production. The ERP solution allows for management of critical control points to catch non-compliance issues and set-up of alternate suppliers in case of supplier-related issues. Maintaining approved supplier lists is an industry best practice that provides current and accurate information in the event of possible consumer adverse reactions.
Following current Good Manufacturing Practices (cGMPs) should underlie efforts to address food safety concerns in the cannabis edibles industry. An ERP solution assists with documenting these quality initiatives to ensure the safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes evaluating equipment status, establishing cleaning and sanitation procedures and eliminating allergen cross-contamination. Employee training is conducted and documentation maintained in the ERP solution to ensure hygienic procedures, allergen awareness, illness reporting and required food or cannabis handling certifications.
Cannabis businesses can benefit from establishing a food safety team tasked with developing a Hazard Analysis Critical Control Points (HACCP) plan to provide effective procedures and protect consumers from the hazards inherent in edible cannabis products – including biological, chemical and physical dangers. Automating processes within an ERP solution prevents and controls hazards before food safety is compromised. Since HACCP plans have historically been used by food and beverage manufacturers to ensure a safe product for the consumer, cannabis edibles manufacturers can apply the lessons from these food safety protocols and procedures in their initiatives.By utilizing food safety best practices partnered with an ERP solution, cannabis businesses can avoid the negative consequences resulting from failure to address food safety hazards in manufacturing, storage and packaging.
A comprehensive FSP, as required by the FDA’s Food Safety Modernization Act (FSMA), identifies food safety hazards and guides the development of a company-specific, validated plan. This plan documents processes throughout the manufacturing, processing, packaging and storage stages of the operation. ERP software provides real-time, forward and backward lot traceability from seed-to-sale with the ability to track materials, document recipes and accurately label products. This detailed level of traceability provides an automated system that implements and documents food safety policies throughout the manufacturing process. With a trained Preventative Control Qualified Individual (PCQI) implementing the FSP, preventative controls, recall plans and employee training records are maintained in an integrated system.
The cannabis market’s tremendous growth has driven edibles manufacturers to follow the same guidelines as mainstream food and beverage companies to ensure safety is afforded equally to consumers of cannabis edibles. By utilizing food safety best practices partnered with an ERP solution, cannabis businesses can avoid the negative consequences resulting from failure to address food safety hazards in manufacturing, storage and packaging. At the end of the day, it’s up to cannabis manufacturers to be proactive in ensuring cannabis edibles are safe to consume until regulations are mandated.
Are you a product designer in the edible cannabis market? Well, you live at the intersection of the food and pharmaceutical industries and need to know both worlds, utilizing best-practice product development principles, regardless of which industry you are working in. In the cannabis industry, this means knowing your chemistry principles, food science, food safety, Good Manufacturing Practices (GMPs, applicable to the food industry) along with the more intense records and documentation requirements of the pharmaceutical industry.
California is the most recent state to implement legal recreational cannabis. It is estimated to deliver $7.7B in sales by 2021, including a reduction of medical use cannabis and an uptake of adult recreational use. How often do you live at the inception of such a potentially enormous market? Not often, so product developers, here is an opportunity. However, with that opportunity comes the responsibility. A recent emergency legislation adopted by the California Cannabis Safety Branch states:
Operational Requirements Licensees must have written procedures for inventory control, quality control, transportation, security and cannabis waste disposal. Descriptions of these procedures or Standard Operating Procedures (SOPs) must be submitted with the annual license application. Cannabis waste cannot be sold, must be placed in a secured area and be disposed of according to applicable waste management laws. Good manufacturing practices must be followed to ensure production occurs in a sanitary and hazard-free environment, cannabis products are contaminant free and THC levels are consistent throughout the product and within required limits. Extractions using CO2 or a volatile solvent must be conducted using a closed-loop system, certified by a California-licensed engineer. Volatile, hydrocarbon-based solvents must have at least 99% purity. Finally, volatile solvent, CO2 and ethanol extractions must be certified by the local fire code official.
Once developers have decided on a product, research and education to develop a good understanding of the regulatory environment is a must. For example, in order to develop compliant cannabis edibles, compliance with state, and in some cases local regulations, for food and cannabis must be met. Proactive compliance is a big part of designing a successful product in the most efficient manner.The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.
As a product developer you must first know the incoming cannabis plant characteristics to determine what type of cannabinoids they contain to determine what types you wish to source. This requires a strong and well documented supplier program that can identify reliable suppliers of high purity and consistent cannabis raw materials, the same principles that are typically required of food manufacturers. When looking for examples of credible ingredient supplier programs, looking at those used by the food industry is a good start. Make sure supplier management programs apply to all the raw materials and direct-contact packaging that you plan to use in your new product.
Once reliable sources of raw material have been secured, the next challenge is to conduct periodic tests of cannaboids levels found in your incoming cannabis. With this information, you need to adjust blending amounts to reflect the correct cannaboid dose in the finished ready-to-eat (RTE) product. Like any other medicinal product, the active ingredient dosage will directly impact the effect on the consumer, thus it is important that you, the manufacturer, are completely aware of the exact cannaboid levels in your incoming ingredients, your blending amounts and your final product levels. This will require a robust either in-plant or commercial laboratory testing program. There is a great deal of technology and chemical analyses available to help dose the product accurately. This must also include robust testing and verification steps. If a consumer of your product were to over-consume from “normal” consumption rates of your cannabis-based food product, the liability, both financial, civil, ethical and criminal would fall on your company. The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.
design your products with commercial manufacturing viability in mindOnce regulatory responsibilities for manufacturing and marketing a cannabis-based food product have been met, so that you may sell a compliant and consistent product, it is time to add some creative juices and make the product interesting and enjoyable to consumers. With cannabis edibles, for example, explore what sort of food is appealing to consumers. Consider when, where and with whom your potential customers would be eating that food. Evaluate the best packaging design and size to suit the occasion. Ensure the packaging is child resistant yet practical for adult consumers. And above all manufacture a food that is delicious. Curiosity will attract your customers for the first time but quality and consistency will keep them coming back.
Product developers are usually fantastic at developing great lab scale products, but part of a developer’s job is to ensure that the design and manufacturing process is scalable for consistent and compliant commercial manufacturing. So design your products with commercial manufacturing viability in mind. Try to minimize the number of ingredients whilst still making a consumer-desirable product. Finally, rationalize your ingredients across your portfolio to avoid overcrowding the warehouse and risking expired ingredients.
If successful, your consumers will desire your product, your compliance team will be satisfied, your manufacturing partners will be thankful, the State of California will determine that you are fully compliant and your sales team’s job will have great business and professional success. In the end, you will have developed and launched a successful legacy product!
Parts One and Two in this series have defined Good Manufacturing Practices, introduced Hazard Analysis and Critical Control Points (HACCP) and explained the first HACCP step of hazard analysis. A food safety team will typically work from a flow diagram to identify biological, chemical or physical hazards at each step of processing and packaging. Once the hazard is identified, the severity and probability are debated. Hazards with severe consequences or high probability are carried through the HACCP plan as Critical Control Points (CCPs).
Critical Control Points definedHACCP is a do-it-yourself project.
Where exactly will the hazard be controlled? CCPs are embedded within certain steps in processing and packaging where the parameters, like temperature, must be met to ensure food safety. Failure at a CCP is called a deviation from the HACCP plan. The food safety team identifies where manufacturing problems could occur that would result in a product that could cause illness or injury. Not every step is a CCP! For example, I worked with a client that had several locations for filters of a liquid stream. The filters removed food particles, suspended particulates and potentially metal. We went through a virtual exercise of removing each filter one-by-one and talking through the result on controlling the potential hazard of metal. We agreed that failure of the final filter was the CCP for catching metal, but not the other filters. It was not necessary to label each filter as a CCP, because every CCP requires monitoring and verification.
Identification of a CCP starts more documentation, documentation, documentation.
Do you wish you had more reports to write, more forms to fill out, more data to review? No. Nobody wants more work. When a CCP is identified, there is more work to do. This just makes sense. If a CCP is controlling a hazard, you want to know that the control is working. Before I launch into monitoring, I digress to validation.
CCP validationThis is where someone says, “We have always done it this way, and we have never had a problem.”
You want to know if a critical step will actually control a hazard. Will the mesh of a filter trap metal? Will the baking temperature kill pathogens? Will the level of acid stop the growth of pathogens? The US had a major peanut butter recall by Peanut Corporation of America. There were 714 Salmonella cases (individuals) across 46 states from consumption of the contaminated peanut butter. Imagine raw peanuts going into a roaster, coming out as roasted peanuts and being ground into butter. Despite the quality parameters of the peanut butter being acceptable for color and flavor, the roasting process was not validated, and Salmonella survived. Baking of pies, pasteurization of juice and canning all rely on validated cook processes for time and temperature. Validation is the scientific, technical information proving the CCP will control the hazard. Without validation, your final product may be hazardous, just like the peanut butter. This is where someone says, “We have always done it this way, and we have never had a problem.” Maybe, but you still must prove safety with validation.
The hazard analysis drives your decisions.
Starting with the identification of a hazard that requires a CCP, a company will focus on the control of the hazard. A CCP may have one or more than one parameter for control. Parameters include time, temperature, belt speed, air flow, bed depth, product flow, concentration and pH. That was not an exhaustive list, and your company may have other critical parameters. HACCP is a do-it-yourself project. Every facility is unique to its employees, equipment, ingredients and final product. The food safety team must digest all the variables related to food safety and write a HACCP plan that will control all the hazards and make a safe product.
Meeting critical limits at CCPs ensures food safety
The HACCP plan details the parameters and values required for food safety at each CCP.The HACCP plan identifies the minimum or maximum value for each parameter required for food safety. A value is just a number. Imagine a dreadful day; there are problems in production. Maybe equipment stalls and product sits. Maybe the electricity flickers and oven temperature drops. Maybe a culture in fermentation isn’t active. Poop happens. What are the values that are absolutely required for the product to be safe? They are often called critical limits. This is the difference between destroying product and selling product. The HACCP plan details the parameters and values required for food safety at each CCP. In production, the operating limits may be different based on quality characteristics or equipment performance, but the product will be safe when critical limits are met. How do you know critical limits are met?
CCPs must be monitored
Every CCP is monitored. Common tools for monitoring are thermometers, timers, flow rate meters, pH probes, and measuring of concentration. Most quality managers want production line monitoring to be automated and continuous. If samples are taken and measured at some frequency, technicians must be trained on the sampling technique, frequency, procedure for measurement and recording of data. The values from monitoring will be compared to critical limits. If the value does not reach the critical limit, the process is out of control and food safety may be compromised. The line operator or technician should be trained to know if the line can be stopped and how to segregate product under question. Depending on the hazard, the product will be evaluated for safety, rerun, released or disposed. When the process is out of control, it is called a deviation from the HACCP plan.
A deviation initiates corrective action and documentation associated with the deviation. You can google examples of corrective action forms; there is no one form required. Basically, the line operator, technician or supervisor starts the paperwork by recording everything about the deviation, evaluation of the product, fate of the product, root cause investigation, and what was done to ensure the problem will not happen again. A supervisor or manager reviews and signs off on the corrective action. The corrective action form and associated documentation should be signed off before the product is released. Sign off is an example of verification. Verification will be discussed in more detail in a future article.
My thoughts on GMPs and HACCP were shared in a webinar on May 2nd hosted by CIJ and NEHA. Please comment on this blog post below. I love feedback!
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