Tag Archives: CGMP

Bad Actors in CBD: How to Distinguish Quality Products From the Rest

By Joseph Dowling
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The success of reputable cannabis and CBD brands has inspired an influx of inexperienced and disreputable competitors in the market. These so-called “bad actors” in CBD advertise products that are not manufactured under current Good Manufacturing Practices (cGMP), which help to ensure that all products are consistently produced and controlled according to specified quality standards. cGMP helps guard against risks of adulteration, cross-contamination and mislabeling to guarantee product quality, safety and efficacy.

Joseph Dowling, Author & CEO of CV Sciences

CBD products without cGMP regulations are often inaccurately labeled and deceiving to consumers. In fact, in a test of over 100 CBD products available online and at retail locations, Johns Hopkins Medicine found significant evidence of inaccurate, misleading labeling of CBD content. The prevalence of such brands not only reduces consumer confidence in CBD but also limits the growth of the sector as a whole. Fortunately, CBD consumers and retailers can easily discriminate between a well-tested, reputable brand and inferior bad actors with a few straightforward, minimum requirements to look out for when selecting a product.

Why are “bad actors” a problem for consumers and the industry?

Bad actors in CBD sell products that are not produced under cGMP conditions and are typically not tested by third-party laboratories to ensure identity, purity, quality, strength and composition. This means they are not verified for contaminants, impurities, label claims and product specifications. This frequently results in misleading advertising with inaccurate levels of cannabinoids or traces of compounds not found on the label, like THC. To combat this, the FDA issues warning letters to actors that market products allegedly containing CBD—many of which are found not to contain the claimed levels of CBD and are not approved for the treatment of any medical condition. Still, bad actors manage to slip through the cracks and deceive consumers.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Bad actors that put anything in a bottle and make unsubstantiated medical claims hurt the reputable operators that strive to create safe and high-quality products. It is easy for consumers to be drawn to CBD products with big medical claims and lower prices, only to be disappointed when the product does not produce the advertised results. Inaccurately labeled products may contain unexpected levels of cannabinoids, including ingredients that consumers may not intend to ingest, like Delta-9 or Delta-8 THC. Along with unexpected levels of THC, many CBD products available now are not as pure as advertised, with one in four products going untested for contaminants like microbial content, pesticides, or heavy metals.

Further, inaccurate labeling of products and their compounds also prevents consumers from establishing a baseline impact of CBD on their bodies, leaving them vulnerable to inconsistent future experiences. Such a poor experience can turn consumers off to the category as a whole, drawing their trust away from not only the bad actors but also the reliable, reputable brands on the market. The saturation of the market with these disreputable brands delegitimizes a category that has only just begun to break down the stigmas, creating stagnation rather than growth as consumers remain wary of low-quality products.

How can consumers identify bad actors in CBD?

There are several simple ways to identify a bad actor among CBD products and make certain that both consumers and retailers purchase quality, reliable and safe brands in legitimate sales channels. To start, consumers should avoid all CBD products that are marketed with unsubstantiated medical claims. This is a significant area of abuse, as brands that relate any form of CBD product to a disease state, like cancer, should not be trusted. The science to support such medical claims has not been completed, yet, product marketing is years ahead of the evidence to support such claims. Unsupported medical claims could also mislead consumers that may need more serious medical intervention.

Just some of the many CBD products on the market today.

Additionally, consumers must review the packaging, which should include nutrition information in the form of a supplement fact label. The label should include the serving size, number of servings per container, a list of all dietary ingredients in the product and the amount per serving of each ingredient. All labels should include a net quantity of contents, lot number or batch ID, the name and address of the manufacturer, and an expiration or manufacturing date. These signs of a reputable brand are easy to look for and can save consumers from the trouble of selecting the wrong CBD product.

What to look for when selecting a CBD product

With this in mind, products from reputable, tested brands can be identified by a few key factors. Reputable CBD companies are already compliant with the FDA regulations on nutritional supplements, including a nutritional or supplement fact panel on the packaging—just like vitamins. The information in this panel should include all the active cannabinoids in the product, both per serving and package. Clear potency labeling allows consumers to confidently select products that suit their needs and understand the baseline impact of CBD concentration on their bodies, thus helping them to tailor their experience with thoughtful product selection.

Reputable brands also include a convenient QR code on the packaging, linking the product to a certificate of analysis that details the testing results to demonstrate compliance with product standards and label claims. In terms of specific ingredients, consumers should be skeptical of high concentration levels of “flavor of the month” minor cannabinoids, which are often associated with unsubstantiated medical claims. Current scientific research has set its focus on major cannabinoids like CBD and Delta-9 THC, leaving additional research necessary for understanding minor cannabinoids. Minor cannabinoids are typically included in full spectrum products at concentrations found naturally in the cannabis plant, which is a safer approach to consuming CBD until more research is completed.

Consumers should not let the existence of unreliable, untrustworthy brands curtail their confidence in the CBD sector—there are many high-quality, safe and trusted brands on the market. With a knowledgeable and discerning eye, consumers and retailers can easily select top-quality CBD products that millions of consumers have found to improve many aspects of their health and well-being. Looking ahead, clear federal regulations for CBD products that require mandatory product registration, compliance with product labeling, packaging and cGMP will be crucial in weeding out bad actors and will allow compliant companies to gain consumer trust and responsibly grow the CBD category.

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Fly By Night: Do Your Gummies Take the Red-Eye?

By Douglas Rohrer
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The global vitamin supplement market is projected to grow at 6.2% compound annual growth rate (CAGR) to $71.37 billion by 2028 with the most rapid growth now occurring in the gummy vitamin segment. Gummy supplements are expected to have the fastest CAGR at 12.6% to exceed $33 billion by 2028. Initially developed for youths, gummies are now preferred by all age segments as an alternative to tablets, capsules and pills.

As one might expect, cannabidiol (CBD) gummies are also projected to grow rapidly at a 30.7% CAGR to $13.9 billion by 2028. In terms of actual number of CBD gummies produced last year, a rough estimate would be at least 1.7 billion. For perspective that equates to 53 gummies produced every second, 24 hours a day, 365 days per year. One might reasonably ask, “So where do all these gummies come from?” and “Who makes them and under what conditions and quality assurance standards?

There is no short answer to these questions nor confidence that all cannabinoid gummies are manufactured with adherence to a minimum set of safety and quality standards. Gummy recipes and ingredients are readily available online and there is no shortage of hobbyists who make small batches for family, friends and to sell at retail pop-ups and farmers’ markets. There are a number of well-known brands that started out in home kitchens and garages. In terms of production scale, on the other end of the spectrum are companies like Bloomios, Inc. (OTCQB: BLMS), that operates a 51,000-square-foot Current Good Manufacturing Practices (cGMP) compliant facility in Florida.

The Hobbyists

A variety of CBD products on the market today

For the hobbyist producer, they often begin to scale out of their home kitchen and take over part of their garage or basement and while the entrepreneurial spirit is admirable, most consumers wouldn’t be comfortable with their pharmaceuticals, supplements or even grocery items being manufactured under these conditions which often lack:

  • Rigorous sanitary practices
  • Measures to mitigate contaminants entering the production areas
  • Quarantine, chain-of-custody audit and testing of active ingredients used in production
  • Standardized and rigorous quality assurance testing of finished product
  • Certificate of Analysis (COA) for active ingredients in finished product for certainty of dosage levels
  • Labeling and packaging standards to ensure product information and volumes are correct
  • Batch record data collection, retention and audit procedures.

However, the hobbyists constitute only a very small fraction of gummy production today, and they typically take great pride in their work and show a high degree of care in production practices. Thus, when demand begins to outpace the artisanal home production capacity, many growing brands turn to contract manufacturers to assist with scaling the production side while the brand focuses on the sales, marketing and distribution side of the business. This is an ideal solution as high quality product can be produced at volume in cGMP facilities which enhances the consumer experience, confidence in the product and further grows brand value. This is a best-case scenario of small emerging brands that care deeply about their reputations and their customers’ experience scaling production and growing responsibly.

The Opportunists

The real underbelly of commercial gummy production is characterized by the pure profit seeking producers that set up semi-permanent production lines in flex-industrial spaces not suitable for food handling, with limited buildout for isolation of each production stage. This process includes: materials storage, weight/measures prep, ingredient mixing, molding, dehydration, coating, sorting and filling, labeling and finish packaging. Lacking cGMP compliant facilities and practices, they neglect or fail entirely to maintain batch records, COAs or chain-of-custody practices and have limited ability to address defective product once in the stream of commerce. Let’s refer to these manufacturers as the “Opportunists.

Opportunists see the current cannabinoid gummy market for what it is. It is an emerging market really taking form only since the 2018 Farm Bill legalized hemp derived cannabinoids. As such it is very much in its “gold rush” phase with many of the participants having just entered the sector. Many participants have adopted ad hoc practices with no standardization and no explicit federal oversight because the FDA has yet to acknowledge any cannabinoids under its generally regarded as safe (GRAS) standard.

FDAlogoIn addition, the FDA has excluded CBD products from the dietary supplement definition of the Food, Drug and Cosmetics (FD&C) Act. Under the FD&C Act, if a substance is an active ingredient in a drug product that has been approved or has been authorized for investigation as a new drug, then products containing said substance are excluded from the definition of dietary supplement. So far cannabinoid gummy demand has continually outstripped supply supporting attractive margins and with little oversight. The Opportunist mindset has focused on maximizing profits while they can before regulation increases costs, compresses margins and reduces profits.

The Opportunists have more cover to seek profit maximization as opposed to incurring the cost of setting up cGMP facilities and adhering to rigorous standards due to the fact that the brands consumers recognize are often manufactured by one or more third-party contract manufacturers. Some brands also want to maximize near-term profits and manufacturers with a lower cost structure can more effectively compete on price as opposed to quality.

As demand surges, some brands will supplement their third-party cGMP produced product with additional product sourced from Opportunists and “recycle” the valid COAs from their cGMP product without the cGMP manufacturer or consumers even knowing. With lax regulatory oversight, these brands are inclined to look the other way on their contract manufacturer’s production practices so long as the large volume orders are delivered on time and at lower cost.

GMPFor gummies produced by Opportunists, if there are product defect issues, the consumers likely won’t be able to rely on the batch record data and purported COAs linked to/from QR codes on the container, many of these COAs have been recycled from legitimate batches or simply doctored up and reproduced rather than generated on a per batch basis. There is limited to no audit trail and recalls are unlikely to be effective, if even initiated. A refund is the most likely solution a consumer has which leaves perhaps a much larger run of defective product in the market still unaddressed. Moreover, brands that suffer reputational harm due to quality issues can simply launch a substitute brand with a similar look through its same distribution channels and maintain much of its market share.

Best Practices

If today’s CBD gold rush sounds much like the Wild West, you would be correct. However, as more consumers become aware of cannabinoids’ health and wellness benefits in addition to the recreational uses, this larger and more diverse consumer base is raising the bar and demanding more transparency and certainty on manufacturing practices than ever before.

americana dummies
A roughly estimated 1.7 billion CBD gummies were produced last year

How are the leading cannabinoid nutraceutical manufacturers proactively addressing consumers’ desire for high quality, rigorously tested products manufactured in accordance with standards already imposed on mainstream nutritional supplement and prepared food manufacturers? Although the answer may be simple, the implementation and ongoing compliance is not.

The answer is voluntary adoption and compliance with the same regulations applicable to non-cannabinoid dietary supplement manufacturers. Given that the FDA has not recognized cannabinoids as dietary supplements quite yet, certain aspects of dietary supplement regulation can’t be adhered to such as notifying the FDA of structure/function claims as new products are brought to market or notice of new dietary ingredients. On the other hand, many of the regulations can and should be adhered to by cannabinoid nutraceutical manufacturers to ensure its safe, transparent orderly growth.

Chief among the FDA requirements that Bloomios and other leading manufacturers adhere to are:

  • Register with the FDA as a food handling and production facility.
  • Adopt Current Good Manufacturing Practices for dietary supplements which establishes uniform standards needed to ensure quality throughout the manufacturing process and verification of the identity, purity, strength and composition of their products.
  • Undertake at least annually an independent third-party cGMP audit of their facility and procedures.
  • Comply with Code of Federal Regulations (21 CFR 101.36) supplement label requirements to ensure that the ingredients list is accurate, and the content matches the amount declared on the label among other disclosures.

The most significant challenge in adopting all of the above best practices is cGMP facility qualification and ongoing compliance. The cGMP standards require specific facility build-out features, equipment, and of course standard operating procedures. There are significant additional costs to bring a cGMP facility on-line, additional time and required experienced personnel that can implement the operating procedures and recertification every time a production line’s configuration is changed or augmented with additional equipment.

Bloomios annual cGMP audit was conducted in August and over 130 specific requirements were evaluated and graded. While Bloomios passed the audit and evaluation, what is of far greater significance is that cGMP practices become part of a company’s culture so that these high standards are maintained year-round and not rushed into practice just for the audit.

extraction equipment

Starting a Cannabis Extraction Lab? Here Are Some Key Considerations

By Martha Hernández
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extraction equipment

Cannabis sativa contains over 500 different bioactive compounds that can be separated through an extraction process. This is carried out in an extraction lab and the end result is the production of cannabis extracts with a high concentration of specific cannabinoids (such as THC or CBD) with up to 99% purity levels. Cannabis can get easily contaminated with pesticides, heavy metals, residual solvents or other contaminants and thereby pose a risk to the health and safety of consumers. In-house testing allows manufacturers to ensure that the cannabis products they put out to the market are not only potent but also are free of all sorts of contaminants.

The cannabis extraction market worldwide was valued at $9.7 billion in 2020. According to data from Grandview Research, the market size is expected to hit $23.7 billion by 2027, growing at a CAGR of 16.6%. While setting up a cannabis extraction facility can be cost-intensive at the start, the running costs are minimal, making this a profitable venture in the long run. However, you will need to consider these 7 important factors.

1. Location

7 Important Factors to Consider When Setting Up a Cannabis Extraction Facility
A schematic representation of the 7 important factors to consider when setting up a cannabis extraction facility (Figure courtesy of CloudLIMS)

Cannabis is a highly regulated industry, regardless of the country. In the U.S, it is illegal at the federal level, and therefore there’s a need for judicious selection of location to avoid run-ins with the federal government. If you are in the U.S, you will need to check the specific laws in your state. These rules dictate how close an extraction facility can be to a daycare facility, children’s park, school, residential areas, etc. The rules may also spell out how many cannabis facilities can be located in one area and how close to each other they can be. At the end of the day, you also want to ensure that the location that you settle for is readily accessible, secure and close to resources.

2. Regulatory Compliance

A cannabis extraction facility needs to meet regulations that apply to the manufacturing and production of consumable goods to ensure that the safety of workers and end consumers is guaranteed. Here are a few that are of priority:

current Good Manufacturing Practices (cGMP): The CGMP is a regulatory standard enforced by the FDA. It defines the creation, implementation and monitoring of manufacturing processes to meet the quality and safety threshold. It requires manufacturers to use technology and have systems in place to ensure product safety and effectiveness. Cannabis extraction facilities should be GMP certified for operational standardization and for performing transnational business.

National Fire Protection Association (NFPA): Extraction labs use flammable materials which can easily trigger fires. NFPA, which is a non-profit organization, has created standards and codes to minimize injuries, death, and economic losses attributable to fire accidents. The standard describes how labs should be set up and how flammable liquids should be stored and transported to prevent accidental fires.

Local Fire Codes: These are a set of codes/requirements that must be adhered to in all commercial and industrial buildings to prevent fires. They include the availability and proper use of the following:

  • Fire extinguishers
  • Extension cords
  • Smoke detectors
  • Fire exits
  • Fire signage
  • Fire assembly points
  • Sprinkler heads and pipes
  • Fire alarms

Here are some important fire codes that should be followed in a cannabis extraction facility:

  • NFPA 1: The Fire Code Handbook
  • NFPA 30: The National Code for Flammable and Combustible Liquids
  • NFPA 45: Fire Protection for Labs Using Chemicals
  • NFPA 70: The National Electrical Code
  • NFPA 58: The Liquid Petroleum Gas Code

Occupational Standards for Health and Safety (OSHA): Cannabis extraction facilities are compelled by federal law to comply with OSHA requirements for occupational health and safety, and specifically regarding biological and chemical compounds that lab staff may come into contact with during their work. OSHA standard 29CFR1910.1200 requires labs to have a written hazard safety standard for all chemicals, and the standard should be accessible to all employees at all times. Labs are required to have an inventory of all hazardous chemicals with associated details recorded in a Safety Data Sheet (SDS).

3. Staff Management

Lab staff need to train on all hazards in the facility and be given first aid measures in case of an accident. The staff will need to sign that they have received training on the same.

4. Waste Management

Cannabis waste in an extraction facility includes plant trimmings, leftover extraction chemicals, disposed of samples and other debris left behind. Waste needs to be segregated according to hazardous or non-hazardous categories and disposed of accordingly. The lab needs to put measures in place for proper waste segregation so that the waste does not get mixed.

5. Worker Safety

Worker safety in an extraction facility is of paramount importance and should be based on the kinds of risks that each staff gets exposed to in the line of duty. This makes it necessary to have a Job Hazard Analysis (JHA) to assess hazards and put measures in place to avert accidents and injuries.

Laboratory Software for CBD/THC laboratories
A laboratory software for CBD/THC laboratories to schedule staff training and manage staff competency (Figure courtesy of CloudLIMS)

6. Equipment Selection and Management

Cannabis extraction equipment can cost anywhere between $5,000 to $100,000, depending on the type and scale of extraction. When choosing the equipment, you need to factor in the cost efficiency, output, and the final product. All equipment used in an extraction lab should be Underwriters Laboratories Listed (UL-Listed). The equipment also needs to undergo regular maintenance to ensure maximum efficiency and productivity, and to prevent accidents and minimize wear and tear. National Recognized Testing Laboratory (NRTL) certification is necessary to achieve this.

7. Supply Chain Management

Supply chain management refers to the strict monitoring of the entire workflow to ensure effectiveness, eliminate wastage, and boost productivity and profitability. This means tracking raw materials from the time they are received by the extraction facility to when they are released as cannabis extracts. A Laboratory Information Management System (LIMS) comes in handy to support supply chain management in an extraction facility.

Role of a LIMS in Setting Up a Cannabis Extraction Facility

A laboratory software for CBD/THC laboratories, also known as a Laboratory Information Management System (LIMS), helps automate workflows, and thereby improve efficiency and productivity in an extraction facility. A laboratory software for CBD/THC laboratories streamlines in-house testing processes and guarantees that the final extracts produced are potent and free of impurities. A LIMS also comes in handy in managing Standard Operating Procedures (SOPs) and human resources, tracking samples and lab inventory, scheduling equipment calibration and maintenance, and ensuring compliance with the necessary regulations.

When setting up a cannabis extraction facility, sufficient time needs to be allocated to the planning to ensure all-important considerations are in place. This starts with finding an ideal and compliant location, ensuring regulatory compliance, ensuring worker safety, efficiently managing staff, inventory, and waste, and the careful selection of equipment. A laboratory software for CBD/THC laboratories ties these factors together to ensure a smooth workflow and maximum productivity of the facility.

Milan Patel, PathogenDx
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The Need for More Stringent Testing in Cannabis

By Milan Patel
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Milan Patel, PathogenDx

As the demand for legal cannabis continues to rise and more states come online, it is imperative to enact more rigorous and comprehensive testing solutions to protect the health of consumers. People use cannabis products for wellness and to find relief; they should not be susceptible to consuming pathogens and falling ill. Especially for immunocompromised consumers, the consequences of consuming contaminated cannabis or hemp are dire. Of course, there should be federal standards for pathogen testing requirements like we have for the food industry. But right now, as cannabis is not yet federally legal, testing regulations vary between states and in many states, testing requirements are too loose and enforcement is minimal. It is up to state legislators, regulators and cannabis operators to protect the health of consumers through implementing more stringent testing.

From the outset, the environmental elements needed to grow cannabis – heat, light, humidity, soil – make cannabis ripe for pathogens to proliferate. Even when growers follow strict sanitation procedures through the supply chain from seed to sale, contaminations can still occur. Cannabis companies need to be hypervigilant and proactive about testing, not just reactive. The lack of regulations in some states is alarming, and as the cannabis industry is highly competitive and so many companies have emerged in a short time, there are unfortunately unscrupulous actors that have skated by in a loose regulatory landscape, just in the game to make a quick buck, even at the expense of consumer health. And there are notable instances where states do not have enforcement in place to deter harmful manufacturing practices. For instance, there are some states that don’t mandate moisture control and there have been incidents of companies watering down flower so it has more weight and thus can be sold at a higher cost – all the while that added moisture leads to mold, harming the consumer. This vicious circle driven by selfish human behavior needs to be broken by stricter regulations and enforcement.

While in the short term, looser testing regulations may save companies some money, in the long run these regulatory environments carry significant economic repercussions and damage the industry at large, most importantly injury or death to customers and patients. Recalls can tarnish a company’s brand and reputation and cause sales and stock prices to tank, and since cannabis legalization is such a hotly contested issue, the media gloms onto these recalls, which opponents to legalization then leverage to justify their stance. In order to win the hearts and minds of opponents and bring about federal legalization sooner, we need safer products so cannabis won’t be cast in such a dangerous, risky light.

Certainly, there’s a bit of irony at play here – the lack of federal regulations heightens the risk of contaminated cannabis reaching consumers, and on the flip side recalls are used by opponents to justify stigmatizing the plant and keeping it illegal. Nevertheless, someday in the not-too-distant future, cannabis will be legalized at the federal level. And when that day happens, federal agents will aggressively test and regulate cannabis; they’ll swab every area in facilities and demand thorough records of testing up and down the supply chain; current good manufacturing practices (cGMP) will be mandated. No longer will violations result just in a slap on the wrist – businesses will be shut down. To avoid a massive shock to the system, it makes sense for cannabis companies to pivot and adopt rigorous and wide-sweeping testing procedures today. Wait for federal legalization, and you’ll sink.

Frankly, the current landscape of cannabis regulation is scary and the consequences are largely yet to be seen. Just a few months ago, a Michigan state judge reversed part of a recall issued by the state’s Marijuana Regulatory Agency (MRA) on cannabis that exceeded legal limits of yeast, mold and aspergillus, bringing contaminated cannabis back to shelves without even slapping a warning label on the packaging to inform consumers of the potential contamination. This is a classic case of the power of the dollar prevailing over consumer safety and health. Even in well-established markets, the lack of regulations is jarring. For example, before this year in Colorado, testing for aspergillus wasn’t even required. (Aspergillus inhalation, which can cause Aspergillosis, can be deadly, especially for people who are immunocompromised). Many states still allow trace amounts of aspergillus and other pathogens to be present in cannabis samples. While traces may seem inconsequential in the short term, what will happen to frequent consumers who have been pinging their lungs with traces of pathogens for 30 years? Consistently inhaling trace amounts of pathogens can lead to lung issues and pulmonary disease down the road. Look what happened to people with breathing and lung issues during the last two years with COVID. What’s going to happen to these people when the next pandemic hits?

We need state regulators and MSOs to step up and implement more aggressive testing procedures. These regulators and companies can create a sea of change in the industry to better protect the health and well-being of consumers. Just complying with loose regulations isn’t good enough. We need to bring shortcomings around testing into the limelight and demand better and more efficient regulatory frameworks. And we should adopt the same standards for medical and adult use markets. Right now, several states follow cGMP for medical but not adult use – that’s ridiculous. Potentially harming consumers goes against what activists seeking legalization have been fighting for. Cannabis, untainted, provides therapeutic and clinical value not just to medical patients but to all consumers; cannabis companies should promote consumer health through their products, not jeopardize it.

For best practices, companies should conduct tests at every step in the supply chain, not just test end products. And testing solutions should be comprehensive. Most of the common tests used today are based on petri dishes, an archaic and inefficient technology dating back over a century, which require a separate dish to test for each pathogen of interest. If you’re waiting three to five days to see testing results against fifteen pathogens and a pathogen happens to be present, by the time you see results, the pathogen could have spread and destroyed half of your crops. So, not only do petri dishes overburden state-run labs, but due to their inherent inefficiencies, relying on these tests can significantly eat into cannabis companies’ revenues. At PathogenDx, we’ve created multiplexing solutions that can identify and detect up to 50 pathogens in a single test and yield accurate results in six hours. To save cannabis companies money in the long run and to make sure pathogens don’t slip through the cracks, more multiplexing tests like the ones we’ve created should be implemented in state labs.

Right now, while the regulatory landscape is falling short in terms of protecting consumer health, better solutions already exist. I urge state regulators and cannabis companies to take testing very seriously, be proactive and invest in creating better testing infrastructure today. Together, we can protect the health of consumers and create a stronger, more trustworthy and prosperous cannabis industry.

Following Up: Questions From The Infused Products Virtual Conference Answered

By Ellice Ogle
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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, founder and CEO of Tandem Food

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?GMP

Ellice: One example of a specific effort to develop a food safety-oriented standard for the cannabis industry includes TraceTrust A True Dose™ & hGMP™ certification. However, there are efforts for other standards that have food safety included. Take organic certification, there are several companies creating and auditing against their own standard such as Clean Green Certified, Oregon Sungrown Farm Certification, or Washington Sungrowers Industry Association. The California Department of Food and Agriculture (CDFA) is also preparing a cannabis program comparable to the USA National Organic Program.

Q: Can you assist with cGMP certification?

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.

control the room environment

Food Safety: What it Means and How ERP Helps Edibles Manufacturers

By Daniel Erickson
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control the room environment

The diverse cannabis industry has experienced tremendous growth, especially in the popular edibles market whether consumed recreationally or medicinally. Since these cannabis-infused food and beverage products come in a variety of forms, including candies, baked goods, energy drinks, chips, chocolates and teas, food safety questions and concerns for companies manufacturing these products can seem daunting. ERP software solutions designed for the cannabis industry play an imperative and necessary role in addressing key food safety issues for edibles producers, helping to fill in the gaps where new and established businesses struggle. By mitigating the potential for damaging effects of a food safety event, companies can prevent, or greatly lessen the impact, to both their reputation and public perception, as well as limit the financial liability and legal penalties.

What is safety?

On a fundamental level, safety is the state of being protected from undergoing or causing hurt, injury or loss. As a manufacturer of cannabis edibles, it is critical that products are consistent, labeled appropriately and safe for consumers. Forward-thinking companies are employing ERP solutions to help ensure their products are not harmful to their current and future customers.

FDAlogoA lack of safety in the cannabis edibles market stems from the unregulated nature of the industry on a federal level, despite consumers’ expectations otherwise. Similar to products in the food and beverage industry, safety issues with inaccurate labeling, food-borne pathogens and disease outbreaks are all concerns within the manufacturing environment. Particularly to cannabis businesses, extraction methods, bacteria and mold growth, pest and pesticide contamination, chemical exposure, improper employee handling and the unintentional consumption or overconsumption of edibles are all potential safety concerns. In states where edible products are legal, local municipalities and state governments each have their own unique regulations – requiring manufacturers to comply to different guidelines. With the absence of federal regulations, many cannabis companies have adopted a more conservative approach to food safety. Following U.S. Food and Drug Administration (FDA) guidelines and Food Safety Modernization Act (FSMA) best practices allows manufacturers to address key current food safety issues and prepare for future regulation.

Utilize Best Practices and ERPGMP

Introducing current Good Manufacturing Practices (cGMP’s) traditionally implemented in the food and beverage industry help to form a foundation for cannabis edibles safety in 9 key areas:

  1. Personnel – As an often-overlooked aspect of cannabis edibles manufacturing, adequate training on procedures to ensure disease control and proper cleanliness is required to maintain a company culture of safety. Advocating for quality standards with proper safety procedures should be a priority for every employee.
  2. Manufacturing Environment – Effective management of the manufacturing environment ensures that facilities are controlled to prevent the contamination of finished goods – restricting extraneous materials such as glass, metal, rubber, etc. from the production floor. Warehouse and office lighting should be adequately maintained so that employees are able to inspect equipment, by-products and finished goods and conduct their jobs effectively.
  3. Sanitary Operations – Physical facilities and all equipment must be maintained in clean and sanitary conditions and kept in good repair to prevent food and beverages from becoming contaminated. Cleaning processes should protect ingredients, work in progress, finished goods and workspaces from potential contamination.
  4. Sanitary Facilities and Controls – Effective control of water, plumbing, sewage disposal and drainage are essential. Staff must have access to adequate handwashing and restroom facilities and employee changing rooms. Restrooms and break rooms should be clean and stocked at all times, while garbage is handled properly and disposed of in a timely manner.
  5. Equipment and Utensils – Properly cleaning and maintaining vats, conveyor belts, shrink wrap machines, blenders, etc. to avoid contamination and allergen cross-contact ensures safe procedures are being followed. A robust sanitation program with defined cleaning schedules should be followed for the sanitizing of utensils and equipment.
  6. Processes and Controls – The manufacturing of edible products should be done in accordance with best practices established in the food and beverage industry, taking account of sanitation, quality control and protection from allergens and contamination. Ongoing testing is conducted to identify sanitation failures and contamination occurrences and ensure items are discarded properly.

    control the room environment
    Personal Protective Equipment (PPE) can reduce the risks of contamination
  7. Warehousing and Distribution – Establishing proper storage and transportation processes protects the products from contamination, allergen cross-contact and container deterioration – ensuring proper handling procedures throughout the growing, manufacturing and distribution steps.
  8. Defect Action Levels – Quality control is used to minimize defects by requiring an action response when a problem is discovered. An established response plan demonstrates the proper procedures to follow when defects occur during production.
  9. Holding and Distribution of By-products for use as Animal Food (if applicable) – This applies to food and beverage facilities that either donate or sell a by-product for use as animal food. By-products used for animal consumption that are managed properly remain free from contamination. Accurate labeling should identify by-product by the common or usual name and denote not for human consumption when distributed.

Cannabis-specific ERP solutions efficiently provide the structure, integration and processes to follow cGMP’s to address food safety concerns in all phases of growing, manufacturing and distribution. By automating the documentation of audit trails, edibles companies are equipped with the same tools that food and beverage manufacturers have utilized for decades. Validated procedures and best practices incorporate safety initiatives from cannabis cultivation to the sale of edible products and beyond, offering greater efficiency than manual methods. Since cGMP’s provide a foundation for Hazard Analysis Critical Control Points (HACCP) planning, edibles manufacturers are able to take advantage of incorporating control points into the ERP solution to prevent and control hazards before they affect food safety. Having a HACCP Plan, along with proper implementation and adherence to cGMP’s, helps to minimize food safety hazards for edibles manufacturers in the cannabis industry.

Quality and safety in the cannabis edibles market is an area that cannot be ignored, as the consequences for failing to handle hazards are potentially devastating. Savvy cannabis companies are employing best practices of food and beverage manufacturers, including the 9 addressed above, in tandem with an ERP software solution, to effectively navigating this highly competitive market. Paving the way with their commitment to quality and in delivering safe and consistent products to the market demonstrates to customers and investors alike their preparedness for growth.

GMP

What Does GMP Mean? And How Is This Different From EU-GMP?

By Marguerite Arnold
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GMP

The cannabis industry is on the road to legitimacy, no matter the bumps, globally. No matter what, and no matter what happens next, that is a good thing. Issues like supply chain transparency, privacy, consumer and patient safety, and of course energy and water use have long been in the room just about everywhere.

Cleantech Is Cannatech

The modern cannabis industry was birthed and given significant shape in deserts (Israel, California, Nevada). In California, as of 2014, producers were warned, yet again, that they could not avail themselves of federally overseen aquifers of groundwater. The legitimizing industry trucked in what it needed.

On the medical discussion, in Europe, in particular, such issues are now in the room. All medical cannabis must be grown indoors. No exceptions.

That means low energy, high efficiency production is on the rise, not the wane.

What Does GMP Mean?

The overall regulations and operating procedures that surround this discussion are known as “Good Manufacturing Practices,” or GMPs for short. But like all the best acronyms, what the standards are, who sets them, and where they are equivalent is still a shifting picture.

Further, GMPs, and even more particularly EU-GMPs, are specifically referred to this way to distinguish the medically bound product from other consumer protection regulations that include novel food.

european union statesThat said, “GMP practices” differ widely from industry to industry. The idea behind them, however is to prevent harm from occurring to the user, including that the end product is free from contamination, and the packaging as well as manufacture has been well documented. Additional requirements include that personnel are properly trained.

And while the practice, at the pointed end of enforcement can get nerdy, detail-oriented and specific, that is precisely the point. That is also why you might catch another variant of this acronym (cGMP – or current GMP guidelines), to denote a world that is changing fast.

Contamination of the supply chain if not the carbon impact of the same, for all food and plant-based pharmaceutical products is a 21st century problem that is exploding on the scene as fast as the planet warms and cannabis legalizes.

What Do GMP Guidelines Include?

These are guidelines, not steps. As a result, from a bird’s eye view, all international and sovereign national GMP standards include a few basic principles no matter how much they may differ in the weeds. Namely:

  • That manufacturing processes are clean, controlled and processes are verifiable and repeatable. Changes to any and all must also be clearly documented.
  • Record keeping, accurate accounting (of product and on the financial side) must be kept, including complete batch history through manufacture and distribution to the end user. Audits are a way of life.
  • Recall procedures must be in effect.
  • All complaints about products must be examined.

The World Health Organization (WHO) version of GMP is what’s used by pharmaceutical regulators worldwide. The European Union’s EU-GMP standards are seen as roughly equivalent, as are those now practiced in the U.S. by the FDA. That does not mean that confusion does not reign as standards are changing (across Europe, for example, between individual countries, there is still disagreement). However similar GMPs are used in countries including Australia, Canada, Japan, and Singapore. The UK, of course, is slightly different than anyone else but still has regulations that are roughly equivalent and referred to as “The Orange Guide” (in honor of the color of the book’s cover).

You Know It When You See It

Well, not quite. Beyond GMP, there are of course, other classifications for the kind of plant or product being made, manufactured and distributed. And here, along with international treaties about who can trade with whom, also impact this discussion.

It is not correct, however, for example, to claim that what are known as GACP guidelines (good agricultural and collection practices) are equivalent to GMP. Bio, or pesticide free production (in other words) is just one of many steps in meeting much higher standards now in the room for medically bound cannabis.

What Is GMP “Like”?

All industries have “best practices.” For example, the building industry has all sorts of codes and guidelines. However, in addition to this, about a decade ago, LEED (or green building) certification began to be implemented widely. In the U.S., in particular, there was much discussion about how honest such certifications actually were. The term “greenwashing” was frequently used to describe practices that were sold as energy efficient, but in the end cost more, environmentally and otherwise, than they should.

Like LEED, GMP is not a prescribed set of steps but rather best practice guidelines and regulations meant to guide industries on producing safe products – from seed to sale.

How Does This Differ From WHO Guidelines on GACP for Medicinal Plants?

The World Health Organization’s GACP guidelines are highly controversial in this context, especially when it comes to cannabis. Especially because they refer specifically to plants used as medicine that are “grown in the wild.” I.e. not greenhouse. How these guidelines are interpreted by different countries, however, within the context of the interpretation of “medical cannabis” not to mention pharmaceutical GMPs, are very different.

GACP guidelines, in other words, are sometimes the first step in qualification – but certification under the same (starting with outdoor grown crops produced without pesticides for example) is not likely to pass European medical standards any time soon.

Food Safety Hazards for the Cannabis Industry: ERP Can Help

By Daniel Erickson
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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 solution to automate processes, enables cannabis businesses to provide quality, consistent products and establish standards to support the eventuality of federal cannabis legalization.

FDAlogoEdibles 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.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

There are many consequences of not addressing food safety hazards, as the possibility of food-borne illnesses resulting from unsafe and unsanitary manufacturing facilities have become increasingly likely in an unregulated market. In addition to these concerns, problems particular to cannabis growing 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.HACCP

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.

GMPFollowing 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.

Steven Burton
Soapbox

Which Safety Standards Work Best for the Cannabis Industry?

By Steven Burton
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Steven Burton

Now that governments are legalizing cannabis around the world, the question looms for cannabis businesses seeking legitimacy in the new industry: what safety standards should apply? This question is more difficult as different jurisdictions grapple with defining and implementing legal requirements and struggle to keep up with the pace of growth.

For visionary cannabis business, it makes sense to anticipate requirements – not only from governments, but also from consumers and partners. Most regulations currently focus on security and basic health issues but, in the long-term, the industry that may offer the best model for cannabis businesses isn’t pharmaceuticals, but food. Cannabis (especially edibles) share similar hazards and traceability challenges with food products, so taking the lead from the food industry will be much more applicable and could offer greater benefits.

marijuana buds drying in racks biotrackthc
Dried cannabis curing with RFID tags as part of a traceability system.

Companies that achieve the highest and most flexible certification will enjoy a crucial competitive advantage when it comes to winning market share, popularity and consumer trust. Let’s take a quick look at the different options of food safety (and quality) certifications that cannabis businesses may consider. But first, let’s clarify two important definitions that are necessary to understand the food industry.

Basic Concepts from the Food Industry

The first acronym you should be aware of is GFSI, the Global Food Safety Initiative. GFSI is a food industry-driven global collaboration body created to advance food safety. When it comes to understanding GFSI, the important part to note is that certifications recognized by GFSI (like SQF, FSSC 22000, and BRC) are universally accepted. Companies operating under GFSI-recognized certifications open the most doors to the most markets, providing the highest potential for growth. For this reason, cannabis companies should be aware of and seriously consider seeking GFSI certifications

HACCPSecondly, many food safety programs are built around Hazard Analysis Critical Control Points, or HACCP. While many people may talk about HACCP like it’s a certification in and of itself, it is not actually a certification like the others on this list, but rather a methodology that helps companies systematically identify and control biological, chemical, and physical hazards that may arise during food production, handling, and distribution. Companies that adopt this methodology end up with a HACCP plan, which must then be followed at all times to avoid and address health and safety issues. It’s often required for food businesses and is generally required in most of the world, except where ISO 22000 is more common, primarily in Europe and countries whose primary export market is European. Since HACCP plans are also incorporated into most of the other achievable certifications, developing a HACCP program early will build a strong foundation for higher levels of certification.

Certifications for the Cannabis Industry

Now that we understand the basics of GFSI and HACCP, we can see how the certifications that have been developed by and for the food industry may apply to cannabis companies – and which you should consider necessary for your business.

GMP: Good Manufacturing Practice Certification

GMP (or sometimes cGMP) certification requires that companies abide by a set of good manufacturing processes for food and beverage products, pharmaceuticals, cosmetics, dietary supplements and medical devices. Since it really only covers basic sanitation and employee hygiene, it is considered the lowest level of certification in the industry. It is not recognized by GFSI, but GFSI does require all the standard benchmarks of a GMP be met before granting GFSI certification.

While GMP certification is often required, it is far below the standard that should be upheld by any serious businesses. It doesn’t cover many of the different types of hazards associated with food production – that I have argued will become increasingly relevant to cannabis producers – and doesn’t provide a systematic approach to identifying and controlling hazards like a HACCP program would. It’s really just about providing the basic procedures and checks to ensure that the facility is clean and that employees aren’t contaminating the products.GMP

Final Verdict: Recommended, but as the bare minimum. GMP is not sufficient on its own to adequately control the risk of recalls and foodborne illness outbreaks, and it limits a company’s market potential because it lacks the GFSI worldwide stamp of approval.

Some companies consider GMP certification a good place to start if you’re on a tight deadline for distribution in markets where only GMP is required by regulators. I would argue that striving for the minimum standards will be costly in the long run. Health, safety and quality standards are the foundations upon which winning companies are built. It’s critical to develop a corporate culture that will lead to GFSI-recognized programs without major organizational overhaul. Start on the right foot and set your sights higher – obtain a certification that will stand the test of time and avoid the pain and risks of trying to change entrenched behaviors.

SQF: Safe Quality Food Program Certification

SQF is my number one recommendation as the best certification for the cannabis industry. One of the most common certifications in North America, SQF is a food safety management system recognized by retailers and consumers alike. It is administered by the Food Marketing Institute (FMI) and, importantly, recognized by GFSI, which gives companies a huge competitive edge. SQF focuses on the whole supply chain.

SQF was also the first to develop a cannabis program and is currently the leader in this market segment. It is also the scheme that best integrates food safety with quality. Since it is recognized worldwide, SQF provides the greatest leverage to accelerate a company’s growth. Once obtained, products with SQF certification can often jump the queue to enter different regulatory markets.

Final verdict: Highly recommended. A cannabis company with an SQF certification has the greatest advantage because it offers the broadest worldwide reach and keeps companies a step ahead of competitors. It’s also achievable – just this past April, Curaleaf Florida ostensibly became the first cannabis company to achieve SQF certification. It is tough, but fair and practical.

Other Certification Standards

SQF is the top certification that should be considered by cannabis companies, especially outside of Europe. However, the food industry has several other major types of standards that, at this time, have limited relevance to the cannabis industry today. Let’s take a quick look.

When considering GFSI-recognized programs, the main choice for food companies is between SQF, which we’ve covered, and BRC (the British Retail Consortium Certification). BRC has the most in common with SQF but, while SQF was originally developed for processed foods, BRC was developed in the UK for meat products. Today, they are quite similar, but BRC doesn’t focus quite as much on the quality component as SQF does. While BRC could be a good option, they don’t have a program for cannabis and, thus far, do not appear to be as friendly toward the cannabis industry.The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages 

Across the pond, there are a few other certification standards that are more common than SQF. One of these is ISO 22000, which is the certification for the food-related standard created by the International Organization for Standardization (ISO) in Europe. It is not recognized by GFSI but is the primary system used in Europe. If your market is exclusively in the EU, it might be a good choice for you in the future. However, to date, there is no indication that any cannabis company has achieved ISO 22000 certification. Some cannabis companies have attained certification for other ISO standards like ISO 9001:2015, which specifies requirements for quality control systems, and ISO/IEC 17025 for laboratory testing. These are generally more relevant for the pharmaceutical industry than food and beverage, but still apply to cannabis.

There is the perception that cannabis is more accepted in EU countries like the Netherlands, but the regulatory attitude to cannabis is complicated. In the Netherlands, for example, cannabis isn’t actually legal – “coffee shops” fall under a toleration policy that doesn’t include regulation. Medical cannabis in the Netherlands is all produced by one supplier and several countries in the EU allow for licensed distribution and import, but not domestic production. Various EU countries are trying to keep up with the legalization trend, however. The Czech Republic, Germany, and others all recently introduced legislation for domestic production of cannabis for medical use. For companies with their eye on the EU, it is crucial to watch which regulatory requirements will be implemented in each market and how.

The last certification standard to mention is the result of a compromise between ISO and the more HACCP oriented programs like SQF. FSSC 22000 (Food Safety System Certification) tries to address the gaps between ISO 22000 and GFSI-recognized certifications by introducing another component called PAS 220. Since it is recognized by GFSI, FSSC 22000 is starting to get more traction in the food industry because it makes products a bit easier to export to the EU. FSSC 22000 satisfies the EU ISO standards but isn’t as closely tied to HACCP. We will be keeping an eye on this one.

Final Takeaway

The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages – but it’s difficult for cannabis companies to understand all the options available and how each apply to their specific products. While markets adjust beyond the preliminary issue of legality, it’s crucial for companies to look forward and comply with safety and quality standards like SQF. Companies who strive for SQF certification (or other GFSI-recognized certifications as they become available) will find themselves far better prepared to seize market share as cannabis markets blossom.

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking
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In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

  • Why (identify the why, this is your preventative, overarching strategy)?
  • How (addresses the “why question” with products, services and training)?
  • What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.