Tag Archives: CBD

Cori Goldberg, Reed Smith
FST Soapbox

USDA Publishes Hemp Rules: Will It Impact Food?

By Cori Goldberg, Adam Brownrout, John Kendzior
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Cori Goldberg, Reed Smith

On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.

Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal

However, the rule does state that additional hemp is necessary to support the growing CBD market, and it notably put pressure on FDA by stating that if “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market.”

So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:

  1. Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
  2. Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
  3. Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
  4. Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
  5. Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
  6. In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).

So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.

Resource

  1. “Establishment of a Domestic Hemp Production Program”. (October 31, 2019). Federal Register. Retrieved from https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.
Laura Nelson, Alchemy

Changing Consumer Preferences and Employee Compliance Training Driving Industry Evolution

By Maria Fontanazza
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Laura Nelson, Alchemy

The food industry is undergoing considerable change, especially as consumers become increasingly more vocal about their preferences and concerns, and as technology improvement and adoption plays a larger role in the conversation. In a recent Q&A with Food Safety Tech, Laura Dunn Nelson, vice president of food safety at Alchemy, shares her thoughts about current industry trends and how they are impacting food companies, where more help is needed, as well as ways in which companies can help advance food safety culture internally.

Food Safety Tech: The food industry is rapidly evolving. What are some of the trends you’re seeing and are these posing different challenges to food manufacturers?

Laura Dunn Nelson: The food industry is rapidly evolving in three key areas: Who produces our food, the variety of our food, and how consumers access our food.

As consumers continue to shift their food preferences toward an increase in healthy ingredients, locally sourced products, and clean labels, companies in turn continue to innovate and reformulate. Mergers and acquisitions continue as larger companies look to partner with niche companies that are focused on products marketed to the health-conscious consumer. Companies like Impossible Foods and Beyond Meat are expanding rapidly, reaching both vegans and meat eaters in the United States and expanding into international markets. Ever-changing consumer preferences create challenges for the industry to accelerate their research and development processes in order to remain competitive in the marketplace.

Changes in product formulas and increases in product lines create the need for new ingredient procurement, changes in production schedules, and new operating procedures. There has been a proliferation of start-up companies using CBD as an ingredient for food and beverages despite the lagging food safety regulations forcing some city and state regulators like New York City to create their own ban of CBD products. As the FDA explores future regulations, producers and consumers are left to determine the safety of these products.

Home delivery of food continues to be a hot trend as the market continues to grow for companies like UberEats, Grubhub, retailers and foodservice companies like Domino’s Pizza where you can Tweet your pizza order. The home delivery service area presents new considerations for food safety including monitoring appropriate product temperatures.

Finally, discussion around blockchain technology continues to gain prominence as companies work to develop transparency within their supply chain. For many companies, this will translate into a significant shift in technology adoption and a move away from disparate data sources and therefore an investment in not only the technology but in revising their procurement processes.

Laura Nelson, Alchemy
Laura Nelson is vice president of food safety at Alchemy and currently serves as the vice-chair of the Food Safety Culture Professional Development Group (PDG) for IAFP.

FST: What are the areas in which you feel companies need a bit more guidance?

Nelson: How we effectively train our employees to ensure learning and comprehension is paramount to our success in the future. IBM Institute for Business Value recently completed their study “The Enterprise Guide to Closing the Skills Gap,” and noted “120 million workers in the world’s biggest economies may need to be retrained as a result of artificial intelligence (AI) and automation in the workplace.” Reskilling will be the new norm as new technologies and automation of equipment disrupt the current state.

Deloitte noted that “reinventing the way people learn” was the number one trend in the 2019 Global Human Capital Trends Report. Many companies are focused almost exclusively on mandatory compliance training and conducting the training the same way they have for years. Typically, orientation food safety training is provided during the employee’s first week of work and annual refreshers are given every year. In the Global Food Safety Training Survey that Alchemy provides to the global industry with Campden BRI, we consistently find that 67% of responding QA managers report that employees do not follow their food safety programs, despite their food safety training. Unfortunately, the emphasis on food safety is often relegated to that one day a year of refresher training with little reinforcement the remaining 364 days of the year. The ‘noise’ of competing priorities of production and customer expectations often distracts employees from their food safety responsibilities.

Some companies still define training as classroom training when, in fact, employees are being trained each and every day by their supervisors and peers. Companies that put additional emphasis in not only their training but validation of training through observations of employees’ food safety behaviors achieve higher food safety compliance. The power of two-way conversations between the employee and the supervisor as a coach creates an environment of communication and trust.

Alchemy worked with independent researchers to determine the effect of active coaching with prescribed behavior feedback on the plant floor. The results were conclusive: every facility included in the study revealed a 38% improvement in aligned employee behaviors.

Ultimately, companies need to evaluate their current learning organization for effectiveness and focus on job competencies and their ongoing assessment of compliant employee behaviors.

FST: What maturity level are you seeing in the industry related to food safety culture and the related implementation of best practices?

Nelson: The food industry is still relatively new to the concept of a mature food safety culture, and even how to define that. The industry focus of this topic has largely been driven by efforts within the GFSI community, particularly with the publication of the position paper “A Culture of Food Safety.” Pioneers in food safety culture research, like Dr. Lone Jespersen, and emerging training assessment tools are working toward pushing these newer concepts to the mainstream of our industry.

As with many important constructs, the QA/QC team is typically tasked with introducing this concept to their organization, defining their company’s level of food safety culture maturity, and establishing a continuous improvement plan. This is a tough ask from individuals who typically have a technical education background with little experience in behavioral science. To address these challenges, there are a growing number of consultants, books, and resources to help define a company’s food safety culture maturity and establish improvement strategies.

To help frame the benefits of a mature culture, a recent publication by Lone Jespersen et al, “The Impact of Maturing Food Safety Culture and a Pathway to Economic Gain,” notes the value of a mature food safety culture in reducing the cost of poor quality and food safety risks. Research indicates that many companies are currently in mid-maturity of their food safety culture. Suggested best practices to help an organization mature their food safety culture include:

  1. Foster cross-company ownership of food safety.
  2. Move from compliance driven operations to risk reduction through continuous improvement.
  3. Improve engagement skills of technical staff.

The first step is an assessment to understand the company’s unique performance gaps, either through an internal review or an external assessment. Once the specific gaps are identified, companies can develop their food safety culture improvement plan and execute. It’s helpful to conduct a reassessment over time to ensure the established improvement strategies are successful.

The effort can be challenging but research confirms that a more mature food safety culture will deliver improved food safety performance of food safety behaviors, improved product quality, and a reduction in food safety risks.

Aaron Riley, CannaSafe
In the Food Lab

How To Ensure Cannabis and CBD Edibles And Beverages Are Safe

By Aaron Riley
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Aaron Riley, CannaSafe

As cannabis and CBD edibles and beverages gain in popularity among consumers, the rush to cash-in on market opportunities has resulted in an influx of unregulated and untested products. Recently the FDA increased its scrutiny of cannabis and CBD company websites and social media accounts to make sure they were not making unverified or misleading marketing statements about their products.

To exacerbate the problem of unregulated products, recent scares around vape-related hospitalizations have flooded the news, and the public is looking to the cannabis industry for answers about what it will do to ensure CBD and cannabis products are safe for consumption.

The first step the cannabis business community can take is educating the public on the two types of edibles— tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is heavily regulated. Every batch must be tested before it is released to retail ensuring labeling and dosages are consistent.

Since CBD does not have psychoactive properties, most products do not go through the same testing standards and are far less regulated. An estimated 75% of CBD-only companies do not test their products. Even worse, independent testing has shown that CBD labels are often incorrect or inconsistent with its dosage and ingredient labels.

Both cannabis and CBD companies must advocate for a more regulated and legitimate market. Stricter regulations and testing standards will eventually weed out the bad players who are hoping to make a quick buck from those that intend to manufacture quality products that can benefit the health of consumers.

Short Cuts To Boost Profits

The current vape pen crisis underscores the lack of regulation and inconsistency in the CBD market. CBD-exclusive vapes are more likely to use cutting agents, whereas licensed THC vape companies are more likely to use pure cannabis oils and are required to undergo quality control testing.

Using cutting agents may lower operating costs, but often results in an inferior or dangerous product. Cutting agents also inhibit crystallization in CBD oils and increase the shelf life of a product. The cost of production for pure THC or CBD oil is $5–6 per gram, but a cutting agent can reduce the cost down to $0.10–$2 per gram.

With edibles, untested CBD products can introduce Salmonella or E.coli into the supply chain. This oversight could severely hurt the reputation of growers and manufacturers if a serious outbreak occurred.

Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry JournalThe Solution Is in Testing

Unlike food manufacturing, where quality controls are in place at the plant, the quality measures for edibles happens in a lab, after a product is manufactured.

Labs test edibles for potency. Both THC and CBD are used for medicinal purposes, and potency testing is critical for accurate dosing. A patient under or over dosing, or taking a poor quality CBD product with additives could detrimentally affect their long-term health.

They will also test for product contamination. Both CBD and THC cannabis can become contaminated with microbes (i.e., mold, mildew, bacteria and yeast), pesticides and heavy metals throughout the process of growing, cultivation and processing. Contamination is especially concerning because many medical marijuana patients are immunosuppressed and cannot fight off potentially dangerous infections and illnesses arising from these contaminants.

But even for the general population, cannabis and CBD contamination can cause serious health issues. Molds and bacteria such as aspergillus, Salmonella and E. coli present safety risks, and toxicity from sustained exposure to heavy metals can lead to high blood pressure, heart issues and kidney failure, among other issues. Fortunately for consumers, cannabis products sold in licensed dispensaries must all undergo contamination and quality control testing per state regulations.

However, because quality control measures are not required for edible manufacturers, there is no oversight that food-grade ingredients are used or that practices to avoid cross-contamination are used.

What Companies Can Do To Win Back Trust

Customers around the country are rightfully concerned about the safety and quality of their cannabis and CBD products in light of recent news surrounding vape-related illnesses. This is the perfect opportunity for manufacturers and consumer brands to seize on the subject and educate consumers about cannabinoids so they aren’t turned off from incorporating CBD into their lifestyles.

  1. First and foremost, test all products. At a minimum, companies should be adhering to state cannabis market regulations, even if they are just producing CBD. As the FDA rolls out more concrete regulations for CBD, which was only federally legalized last year, it is in the best interest of all CBD companies to meet FDA guidelines preemptively so products can pass inspection at a later date.
  2. Find a good credible lab to help with formulations and inputs. With edibles and beverages, there is more room to introduce contaminants within that scope.
  3. Hire food safety experts to help elevate safety standards and meet FDA regulations. Some forward-thinking companies are starting to hire quality experts from food manufacturing to get ready for broader federal acceptance.
  4. Help educate consumers on why the brand is better, based on inputs and testing.

Consumers should also conduct their own research regarding individual CBD companies’ supply chains and manufacturing standards. Transparent companies will do this proactively, providing cultivation information and lab results for their customers.

In the end, the safest place to buy cannabis and CBD products is a licensed dispensary. It is the responsibility of growers, distributors, manufacturers and retailers to keep the legal market safe and free from contaminants that could threaten the industry. The regulated cannabis space has advanced significantly in the past few years, and companies must set the highest manufacturing standards to maintain this forward momentum. Education and testing are the best solutions to ensure a safe and trusted cannabis marketplace.

Cannabis, gavel

CBD Marketplace: How Should We Navigate It?

By Richard Blau
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Cannabis, gavel

Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.

Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.

Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.

Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.

Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.

Cannabis, gavel
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.

Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”

Is CBD legal in America? The answer is: “It’s complicated.”

The Details Behind CBD, Legalization and Marketing

CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”

The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.

The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.

Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.

According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.

Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.

Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.

In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.

Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.

Pages: 1 2

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

This year the Cannabis Quality Conference & Expo is co-located with the Food Safety Consortium | October 1–3 | Schaumburg, ILCannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

Kimberly Stuck, Allay Consulting
FST Soapbox

Cannabis Edibles and Food Safety: Buy At Your Own Risk

By Francine L. Shaw, Kimberly Stuck
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Kimberly Stuck, Allay Consulting

Cannabis edibles—i.e., capsules, chewable gummies, lollipops, cookies, etc. —are becoming more popular and commonplace as laws legalizing cannabis are passed in certain states. Some people are consuming these edibles simply for pleasure, while others are ingesting it for medical reasons, such as reliving epilepsy symptoms, easing chronic pain and combating nausea from chemotherapy. While safety regulations are in place for the foods we eat, who is responsible for the safety of these cannabis consumables?

The 2018 Food Safety Consortium features a Cannabis Quality track | November 13–15 | Learn MoreSince customers can order cannabis edibles online from just about anywhere (including Amazon), they assume these products must be safe. But, as it turns out, that’s not necessarily true. Currently, there’s no regulatory standard for edible cannabis products. Very few consumers realize that it is a “buy-at-your-own-risk” market.

The FDA makes certain that foods sold in the United States are safe and properly labeled. But, currently, they do not regulate cannabis edibles.

Cannabidiol (CBD) infused edibles seem to be more “socially acceptable” than smoking cannabis because they sidestep some of the stigmas, such as the odor. This makes them appealing to a wider audience.

It’s entirely possible that some of the edibles you purchase aren’t manufactured from food-grade ingredients. A document from the Denver Department of Public Health and Environment recently noted that some CBD products being sold in the United States are coming from unregulated, unsafe and unsanitary manufacturing facilities. Further, some of these edibles contain unapproved ingredients, have been produced in unsafe conditions, and had unsubstantiated health claims on their labels.

In many cases, the edibles being sold and consumed in the United States may:

  • Not have the desired effect that consumers are seeking.
  • Be dangerous for consumption, due to inappropriate levels of CBD.
  • Contain ingredients that are not food grade and are, therefore, unsafe to ingest.
  • Be hazardous due to cross-contamination or cross-contact issues.
  • Transmit foodborne illnesses due to poor sanitation and hygiene in the facilities where they were produced.

There have been a number of cases of foodborne illness (and potential hazards) in cannabis edibles recently. In August 2017, Dixie Brands voluntarily recalled six cannabis products after the Denver Department of Public Health and Environment discovered they were produced with potentially unsafe, non-food-grade oils. That same summer, The Growing Kitchen recalled MaryMint Tincture, a breath spray product, after a health inspector found it being stored on a shelf at room temperature (not refrigerated). There was concern about whether the oil was shelf stable, and the potential botulism risk from the unrefrigerated oil in this product.

Another company, At Home Baked, made bubble hash, a form of cannabis concentrates, in its cannabis edibles. Their recall included a variety of products, including their brownie mixes, blondie mixes, rice krispy treats, and Stixx candy. It seems they were manufacturing their products in a washing machine that was in poor working condition (eroding, rusted and containing substantial amount of mold.) Unregulated “facilities”— such as old, moldy, rusty washing machines—are dangerous and extremely concerning in terms of public health and safety.

Denver is one of a few areas in the United States that is regulating the production of edibles on a food safety level. And in Denver alone, there has been a tremendous number of cannabis investigations in recent years, many of them ending in recalls. However, most U.S. jurisdictions are choosing not to regulate food safety around the production of cannabis and edibles. As a result, many unsafe cannabis edibles are being produced and sold to the public, which presents a significant risk to consumers.

Since these products (and the cannabis industry in general) are not regulated, many people producing edibles have not had even the most basic food safety training. Numerous production facilities overlook the most basic food safety rules: They don’t wash their hands, they don’t prevent cross-contamination, and they don’t pay attention to critical items like time and temperature control, proper storage, pest control, sanitation, etc. Yet, they are preparing consumable products and selling them to the public, who believe the edibles are safe.

Because there’s no federal regulation, lab testing varies among each state that permits the use of medical and recreational cannabis. Unfortunately, that means there aren’t consistent safety standards in the cannabis industry, as there are in the food service industry.

The FDA requires a (HACCP) plan for most food manufacturing and food service industries. This means that food businesses will take great strides to only sell food that is safe for consumption, and will not cause injury or illness. As the cannabis industry continues to produce cannabis-infused edibles and other products, people in the business can learn from the existing food safety protocols and procedures. Particularly, they should look to maintain compliance with food safety regulations and take all necessary steps to ensure a safe product for consumers (e.g., clean facilities, food-grade ingredients, no cross-contamination, proper labeling, etc.)

Fortunately, there are a growing number of CBD and THC edible producers that are hiring food safety and cannabis experts to help them elevate their safety standards before the FDA starts to regulate. As with all industries, there are many producers that are ready, willing and trying to do the right thing.

As more people purchase and consume cannabis edibles, it’s becoming increasingly important to buy from reputable companies that follow proper safety protocols. Cannabis companies should produce and handle edibles like food businesses produce and handle food – with the utmost attention to safety.