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View the July/August Issue of Cannabis Science and Technology!

MM411's Journey: From Grassroots Beginnings to Global Cannabis Education Leader

A Better Cannabis Product Testing System

Understanding Aspergillus Contamination in Cannabis Flowers and the Risks to Immunocompromised Individuals

Topics

Cannabidiol (CBD)

Quality Control and Quality Assurance (QA and QC)

1rem

Authors

This article investigates the chiral method development screening for the enantiomeric separation of synthetic CBD on polysaccharide-based chiral stationary phases with both normal-phase and reversed phase mobile phases, using HPLC and UHPLC.

The Chiral Separation of the (+) and (-) Enantiomers of Cannabidiol

This technical piece is focused on the separation of the individual enantiomers of each compound mentioned above, as well as the combined separation of the compounds from each other for a fast, reliable quantification.

The Separation of Several Minor Cannabinoids via Chiral HPLC

As the cannabis industry continues its trajectory of growth and maturation, 2024 marked a pivotal year, particularly in regulatory and compliance landscapes. With global markets projected to reach $38.19 billion and new federal and state-level initiatives reshaping the industry’s operational framework, cannabis businesses faced a year filled with challenges and opportunities.

In this blog, we’ll unpack the key events and regulatory milestones of 2024, examining how they have redefined compliance requirements, and the strategies cannabis operators must adopt to thrive in an evolving landscape.

In May 2024, the Drug Enforcement Administration (DEA) proposed rescheduling marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). This was a monumental step, signaling a federal shift in how cannabis is perceived and regulated.

The proposed rule, published in the Federal Register, launched a 60-day public comment period ending in July 2024. During this time, industry stakeholders, advocacy groups, and the public submitted extensive feedback. While the move to Schedule III could significantly reduce tax burdens under Section 280E of the IRS Code, it left hemp and synthetic tetrahydrocannabinol (THC) untouched, maintaining their unique classifications under the CSA. The new proposed hemp bill however would close many loopholes when it comes to derivative cannabinoids, but the bill has yet to be finalized. So far, the bill may redefine hemp to include "naturally occurring, naturally derived, and non-intoxicating cannabinoids." This change could remove many intoxicating derivative hemp-derived products like gummies, beverages, and edibles from store shelves nationwide.

Industry reactions were mixed. On one hand, the rescheduling offers potential relief and legitimacy. On the other, concerns linger about the pace of implementation and the implications for existing state-level regulatory frameworks.

If federal legalization does happen in 2025 this will be a major shift in the way cannabis companies are regulated. This will make compliance with Food and Drug Administration (FDA) and OSHA fundamental in the survival of cannabis businesses. As discussed many times in previous blogs, becoming compliant with FDA by becoming 

 in advance and becoming compliant with Occupational Safety and Health Administration (OSHA) standards will be key to increase the success of a business.

OSHA compliance became a hot-button issue for cannabis cultivation and manufacturing facilities in 2024. OSHA launched targeted audits emphasizing fire safety, personal protective equipment (PPE), and respiratory protection, especially in high-risk extraction facilities. Technically OSHA has always had jurisdiction over cannabis companies, but just weren’t enforcing unless there was an incident or a complaint. Now that is changing due to many incidents resulting from a lack of regulation.

For Class 1 Division 2 facilities engaged in volatile solvent extraction, ensuring adherence to Hazard Communication (HazCom) standards and implementing proper spark-proof systems became critical. Failure to comply resulted in steep fines, pushing operators to reassess their safety protocols and invest in robust employee training programs.

OSHA’s increased attention underscores the agency’s recognition of cannabis as a legitimate industry requiring the same rigorous safety standards as other manufacturing sectors. Becoming compliant with OSHA standards is not an easy task, it takes time and effort to create a safe work environment and have a company that is prepared for an audit. OSHA is the highest fining department in the federal government and can cost a company hundreds of thousands of dollars in one short visit if the correct protocols are not in place. I recommend getting into compliance with these standards as soon as possible, not only to protect your workers, but to save you from business-ending shutdowns and fines as well.

In March 2024, California unveiled a streamlined cannabis licensing process that consolidated environmental and safety compliance into a single application. This approach simplified the regulatory maze for businesses, reducing administrative burdens and expediting license approvals.

Other states took note, with similar initiatives introduced in Oregon and Massachusetts later in the year. These changes reflect a growing awareness among state regulators of the need for efficiency in fostering industry growth while maintaining public safety standards.

Access to banking services has long been a thorny issue for cannabis businesses. Despite legalization at the state level, federal restrictions left many operators reliant on cash, exposing them to security risks and complicating compliance efforts.

The SAFER Banking Act was passed by the Senate and this will provide protections for financial institutions. Hopefully these changes will help with the banking issues we have been dealing with from the beginning. 

With federal legalization on the horizon, hopefully these financial burdens will be alleviated eventually. Keep in mind, that being compliant with federal standards can also lower your cost of insurance and help local banks work with your company by mitigating their risk.

Advancements in cultivation and processing technologies played a pivotal role in compliance management. Automated tracking systems, for instance, enabled real-time monitoring of inventory, improving traceability and reducing the risk of regulatory breaches.

Similarly, innovations in laboratory testing enhanced the accuracy of potency and contaminant analyses, addressing long-standing issues like lab shopping and potency inflation. Standardized testing protocols became a focal point for regulators aiming to protect consumer safety.

Evey year more and more technology innovations change the landscape of this industry. I personally have seen an insane amount of change since I started in the industry in 2014. I am excited to see what changes in the next 10 years.

As we look toward 2025, several trends and questions emerge:

Will marijuana officially move to Schedule III, and how will this reshape the industry’s regulatory environment? We still aren’t sure if this will happen in 2025, but we do know it will happen eventually. The DEA and the FDA have publicly backed the decision to reschedule though, so there is a possibility it might happen sooner rather than later.

Can federal rescheduling efforts harmonize with diverse state-level laws, or will discrepancies persist? I believe that the cannabis industry will be regulated a lot like wholesale food manufacturers where they have to abide by local and state regulations and with federal regulations as well. You will especially be required to have an FDA registration in order to sell across state lines, and some states will still opt-out of having a cannabis program all together. cGMP and OSHA compliance will be key in the success of your company.

How will international markets respond to US regulatory shifts, and what opportunities will arise for export and collaboration? If federal legalization goes into effect, there will be international opportunities. Many of my clients are working towards cGMP Certification to the 211 pharmaceutical standard to better position themselves to be able to sell internationally when it becomes available. Depending on your desired future of your company, it might be good to keep this in mind.

With increasing scrutiny from OSHA and other agencies, proactive compliance—from documentation to employee training—will be essential for maintaining operational integrity. cGMP Certification and full OSHA compliance plans will be necessary for company survival. Better to be proactive rather than reactive when it comes to compliance.

The cannabis industry’s evolution in 2024 underscores the importance of adaptability and vigilance. Regulatory shifts, technological advancements, and a growing emphasis on safety and transparency have set the stage for a more mature and sustainable industry. For operators, embracing these changes is not just about avoiding penalties but also about building trust and credibility in a competitive market.

As 2025 progresses, the question is not whether the cannabis industry will continue to grow, but how well it will navigate the complexities of compliance to unlock its full potential. By staying informed and proactive, businesses can position themselves as leaders in a rapidly changing landscape.

 is the CEO and founder of Allay Consulting. Direct correspondence to: 

Here, we unpack key events and regulatory milestones of 2024, including rescheduling, OSHA compliance, banking, and innovations, plus we discuss the outlook for 2025.

Topic

Cannabis Compliance in 2024: A Transformative Year

With the increasing use of cannabis for both medical and recreational purposes (1), understanding 

 contamination has never been more critical. The expansion of cannabis legalization across various regions has introduced new challenges in ensuring the safety and quality of cannabis products. This comprehensive analysis explores the nature of 

, the conditions that promote its growth, the health implications of its presence in cannabis, and the advanced methods used to mitigate these risks.

 is a genus that includes over 300 species of mold, with many being pathogenic to humans and animals. Common species include 

, each with varying degrees of virulence and impact on human health. These molds are typically found in organic matter such as soil, plants, and decaying vegetation, making them a natural part of many agricultural environments, including cannabis cultivation.

 contamination can occur at multiple stages of the production process. From the initial cultivation to the drying, curing, and storage stages, various factors can contribute to the proliferation of 

. The mold's ability to produce a large number of spores, which can easily become airborne, further complicates its management in indoor and outdoor growing environments.

Aspergillosis remains the most common fungal infection in hematopoietic stem cell transplant (HSCT) recipients (2).

The Cannabis Cultivation Environment and 

Cannabis cultivation, whether done indoors or outdoors, presents several challenges in preventing 

 contamination. The environment in which cannabis plants are grown plays a crucial role in either mitigating or exacerbating the risk of mold growth. Key environmental factors such as humidity, temperature, and air circulation must be carefully controlled to prevent the conditions that allow 

One of the most critical aspects of preventing 

 contamination in cannabis cultivation is maintaining optimal humidity and temperature levels. 

 spores thrive in environments where the relative humidity is above 60%. During the flowering stage, when cannabis buds are developing, growers must be particularly vigilant. High humidity levels can cause moisture to accumulate within the dense structure of cannabis flowers, creating microenvironments where 

Temperature also plays a significant role in mold proliferation. 

 prefer temperatures between 20°C and 40°C (68°F and 104°F), which overlaps with the ideal growing conditions for cannabis. Therefore, maintaining a balance where the temperature is optimal for cannabis growth but not conducive to mold growth is a delicate task that requires continuous monitoring and adjustment.

Proper air circulation is another crucial factor in preventing mold growth. Stagnant air in a cultivation environment can create pockets of high humidity, particularly around the dense foliage and flowers of cannabis plants. Installing adequate ventilation systems that ensure consistent airflow can help reduce the risk of 

 contamination by preventing moisture buildup and the disbursement of any airborne spores that might be present.

Beyond environmental controls, stringent sanitation practices are essential to minimize the risk of 

 contamination. This includes regular cleaning and disinfecting of the cultivation area, equipment, and tools. Growers must ensure that any organic matter, such as dead leaves or plant debris, is promptly removed, as these can serve as breeding grounds for mold. Additionally, using protective clothing and proper hygiene by workers can reduce the risk of introducing contaminants into the growing environment.

 contamination is vital for early detection and intervention. Visual inspections can help identify symptoms of mold growth, such as discoloration of the buds, wilting leaves, or a musty odor. However, these signs often appear when the contamination is already advanced. Therefore, integrating more sophisticated monitoring techniques, such as environmental sensors that track humidity and temperature, can provide real-time data and alert growers to potential issues before they become problematic.

 in cannabis is not merely a quality control issue; it poses significant health risks, particularly for individuals with weakened immune systems. The primary route of exposure to 

 from cannabis is through inhalation, either by smoking or vaporizing contaminated products. When 

 spores are inhaled, they can lead to various health problems, depending on the individual's immune status and the specific species of 

 spores may result in allergic reactions. These reactions can range from mild to severe and may include symptoms such as sneezing, runny nose, itchy eyes, and skin rashes. Individuals with asthma may experience worsening symptoms, including increased wheezing and difficulty breathing. Allergic bronchopulmonary aspergillosis (ABPA) is a more severe allergic reaction that can occur in individuals with asthma or cystic fibrosis. ABPA is characterized by lung inflammation, leading to symptoms such as coughing, shortness of breath, and permanent lung damage in severe cases.

The most severe health risk associated with 

 contamination is invasive aspergillosis. This serious infection occurs when 

 spores invade deeper tissues, such as the lungs, and spread throughout the body. This condition primarily affects individuals with severely compromised immune systems, such as those undergoing chemotherapy, individuals with HIV/AIDS, or organ transplant recipients on immunosuppressive therapy.

Invasive aspergillosis is a life-threatening condition that requires prompt medical intervention. The infection can spread rapidly, leading to complications such as lung tissue damage, blood clots, and in some cases, death. Symptoms of invasive aspergillosis include fever, chest pain, coughing up blood, and difficulty breathing. Diagnosis typically involves imaging studies, such as a chest CT scan and laboratory tests to identify the presence of 

Chronic pulmonary aspergillosis (CPA) is another serious condition associated with 

 contamination. CPA typically affects individuals with preexisting lung conditions, such as chronic obstructive pulmonary disease (COPD) or tuberculosis. This condition is characterized by the slow progression of lung damage over time, leading to symptoms such as persistent cough, weight loss, fatigue, and shortness of breath. CPA can be challenging to diagnose and treat, as it often mimics other chronic lung conditions.

The Role of Immunocompromised Individuals

Immunocompromised individuals are at the highest risk for developing severe 

-related infections. This group includes individuals with conditions that weaken the immune system, such as cancer, HIV/AIDS, and autoimmune diseases, as well as those who are on immunosuppressive medications following organ transplantation. For these individuals, exposure to 

-contaminated cannabis can have devastating consequences (4).

The increasing use of medical cannabis among immunocompromised patients highlights the importance of ensuring that cannabis products are free from 

 and other contaminants. Medical cannabis is often used to manage symptoms such as pain, nausea, and loss of appetite in individuals undergoing chemotherapy or living with chronic illnesses. However, if the cannabis is contaminated with 

, it could exacerbate the patient's condition and lead to life-threatening infections.

Preventative Measures in Cannabis Cultivation

Given the severe health risks associated with 

 contamination, cannabis cultivators must implement comprehensive preventative measures throughout the cultivation process. This includes not only controlling environmental factors but also adopting best practices for sanitation, monitoring, and early detection.

As previously discussed, maintaining optimal humidity, temperature levels, and proper air circulation is crucial for preventing mold growth. Growers should invest in high-quality environmental control systems allowing precise adjustments and continuous monitoring. Additionally, dehumidifiers, fans, and heating, ventilation and air conditioning (HVAC) systems can help maintain the desired environmental conditions, reducing the risk of 

Stringent sanitation protocols are essential to minimize the risk of contamination. This includes regular cleaning of the cultivation area, equipment, and tools as well as the use of disinfectants that are effective against mold spores. Growers should also implement protocols for workers, such as requiring protective clothing, gloves, and masks, to prevent the introduction of contaminants into the growing environment. Regular training on sanitation practices can help ensure that all workers know the importance of cleanliness in preventing mold contamination.

Integrated Pest Management (IPM) is a comprehensive approach to managing pests and diseases in cannabis cultivation, which can also help prevent mold growth. IPM involves using multiple strategies, including biological controls, cultural practices, and chemical treatments, to manage pest populations and prevent the conditions that promote mold growth. For example, introducing beneficial insects that prey on mold-spreading pests, for example, spider mites, can help reduce the risk of 

 and other contaminants are essential for early detection and intervention. This includes visual inspections and more advanced methods, such as microbial testing of the growing environment and the plants themselves. Growers should implement a testing schedule that includes routine checks for mold spores in the air, on the plants, and in the soil. Environmental sensors that track humidity, temperature, and CO

 levels can also provide valuable data for preventing mold growth.

Despite the best preventative measures, there is always a risk of contamination during the post-harvest phase. Therefore, it is essential for cannabis producers to implement effective decontamination methods to ensure the safety and quality of the final product.

X-ray Irradiation (Photonic DecontaminationTM)

X-ray irradiation, also known as photonic decontamination, is one of the most effective methods for eliminating 

 spores from cannabis flowers. This technique uses high-energy photons to penetrate the cannabis buds and inactivate mold spores at the DNA level. Unlike other decontamination methods, X-ray irradiation does not leave behind chemical residues or alter the sensory qualities of the cannabis, making it an ideal choice for preserving the therapeutic properties of the product.

The process of X-ray irradiation involves exposing the cannabis flowers to a controlled dose of radiation, which is sufficient to inactivate mold spores both on the surface and deep within the packed bud without damaging the cannabinoids and terpenes. This method has been widely used to ensure food safety by destroying microorganisms and insects that cause spoilage and foodborne illness. In the medical industries, irradiation is used for both safety and sterilization purposes and has since been adapted for use in the cannabis industry. The benefits of X-ray irradiation include its ability to penetrate dense flowers, ensuring that even spores located deep within the buds are effectively neutralized. This process does not damage the natural integrity of the flower (5).

Gamma irradiation is another decontamination method that uses high-energy gamma rays to eliminate mold spores. While gamma irradiation is effective in killing 

 and other pathogens, it can have a negative impact on the sensory qualities of cannabis, such as its taste and aroma. This is due to the higher energy levels used in gamma irradiation, which can cause some degradation of the plant's terpenes and cannabinoids.

Some cannabis users have claimed that irradiation changes the taste and/or smell of the cannabis during smoking or vaporizing (6). Despite its drawbacks, gamma irradiation is still widely used in the cannabis industry, particularly for products that are not consumed for their flavor, such as cannabis extracts and concentrates. However, for premium flower products, where preserving the natural flavor and aroma is a priority, gamma irradiation may not be the best option.

Steam sterilization is a traditional method for eliminating mold spores by exposing the cannabis to high-temperature steam. This process kills 

 spores on the surface; it does not penetrate inside a packed bud. It can also degrade certain cannabinoids and terpenes, leading to a loss of potency and flavor. The high temperatures involved in steam sterilization can cause the decarboxylation of tetrahydrocannabinolic acid (THCA) to tetrahydrocannabinol (THC), altering the psychoactive properties of the cannabis.

Steam sterilization is generally not recommended for high-quality cannabis products. Still, it may be used for other applications, such as producing cannabis-infused edibles or topicals, where the impact on flavor and potency is less critical.

Ozone treatment is another method used to decontaminate cannabis by exposing it to ozone gas, a powerful oxidizing agent. This treatment is typically used in commercial deodorizing and sanitizing applications. Although Ozone effectively destroys 

 spores on the surface of cannabis flowers, it does not fully penetrate the dense cannabis flower. Ozone requires careful control to prevent excessive degradation of cannabinoids and terpenes.

Ozone treatment is often used in conjunction with other decontamination methods to ensure comprehensive coverage and reduce the risk of contamination. However, due to its potential impact on quality, it is not the best choice for decontaminating premium cannabis products.

Regulatory Perspectives and Industry Standards

As the cannabis industry continues to grow and mature, the importance of establishing and adhering to regulatory standards for product safety becomes increasingly apparent. Various regions with legalized cannabis have implemented regulations to ensure cannabis products are free from harmful contaminants, including 

. These regulations often include mandatory testing for microbial contamination with specific limits set for the allowable levels of mold spores in cannabis products.

In the United States (US), cannabis regulations vary by state, with each state setting its own standards for microbial testing and decontamination. Numerous states, such as California, Colorado, and Oregon, have implemented stringent testing requirements, including limits on the presence of 

 in cannabis products. These regulations typically require cannabis producers to test their products for various contaminants, including mold, bacteria, pesticides, and heavy metals, before they can be sold to consumers.

The US Food and Drug Administration (FDA) has not yet established federal regulations for cannabis, as it remains classified as a Schedule I controlled substance under federal law. However, the FDA has provided guidance on the use of irradiation in food and medical products, which serves as a reference for cannabis producers using irradiation methods for decontamination.

In Canada, where cannabis is federally legal, Health Canada oversees the regulation of cannabis products. Health Canada has established strict guidelines for microbial contamination, including specific limits for 

species. Cannabis producers are required to submit their products to licensed laboratories for testing, and any product that exceeds the allowable limits for mold contamination cannot be sold.

Health Canada also provides guidance on the use of irradiation as a decontamination method for cannabis. The agency recognizes irradiation as a safe and effective method for reducing microbial contamination and has approved its use for cannabis products sold in Canada.

In Europe, cannabis regulations vary by country, with some countries allowing medical cannabis use and others still prohibiting it. In countries where medical cannabis is legal, such as Germany and the Netherlands, stringent testing requirements are in place to ensure product safety. These requirements often include testing for 

 and other microbial contaminants, with specific limits set for the presence of mold spores.

The European Medicines Agency (EMA) provides guidance on the use of irradiation for the decontamination of herbal medicines, including cannabis. The EMA recognizes irradiation as a safe and effective method for ensuring the microbial safety of herbal products and has established guidelines for its use.

The article "Medical Marijuana In Cancer: Harmful Or Harm Reduction?" written by Alexandra Thielmann and Paul J. Daeninck examines the historical and modern use of cannabis in cancer treatment. Cannabis has long been used for its medicinal properties, but its legality was challenged in the early 20th century. The discovery of cannabinoids has led to increased research into their benefits for cancer patients, particularly in managing pain, nausea, vomiting, and cachexia. While there is promising evidence of its therapeutic potential, concerns remain about the risks, such as psychosis and impaired driving. The article calls for more research and a shift in public perception to recognize cannabis as a legitimate medical treatment, using Canada's regulatory experience as an example of the challenges and considerations involved (4).

Aspergillus, a genus of mold that is abundant in our environment, has become a significant concern in the cannabis industry, particularly due to the health risks it poses to consumers. This mold, which thrives in various environments, including soil, decaying vegetation, and even in the air, is not inherently dangerous to healthy individuals. However, its presence in cannabis flowers, whether during cultivation, processing, or storage, can lead to severe health risks, especially for immunocompromised individuals.

Weston J. Umstead

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