How to Ensure Quality Control in Cannabis-infused Products
Cannabis-infused products offer a convenient way for consumers to ingest or apply cannabis-based ingredients for their therapeutic and recreational effects. These products include foods, beverages, lotions, salves, and tinctures that contain a sufficient level of cannabis-derived compounds to elicit some bioactivity, whether that’s the psychoactive effects of tetrahydrocannabinol (THC) or the pain-relieving power of cannabidiol (CBD).
Because cannabis-infused products also overlap with the established food, cosmetic, and personal care industries, regulations are only beginning to catch up with the dizzying array of new products entering the market. From cannabis-infused potato chips to toothpaste, entrepreneurs and product developers in this growing space are busy capturing potential markets through every possible amalgamation.
“The current regulatory environment for cannabis-infused products is really interesting because it’s so diverse and there’s not a single answer depending on where you manufacture products,” said Michael Hennesy, vice president of innovation at Wana Brands, an infused products company headquartered in Colorado.
Regulatory frameworks from state to state and from country to country can be startlingly different and can add additional burden to businesses trying to make headway in this nascent industry. For example, some states don’t even agree if cannabis-infused products are pharmaceuticals or foods.
“There’s no federal regulation at all,” Hennesy added. “States are left to come up with their own rules.” Without guidelines from the federal government, current standards are murky and provide little guidance.
That said, rather than view quality and safety regulations as an unnecessary cost, both in time and money, new businesses in the cannabis-infused product space should see compliance as an opportunity to garner customer trust and loyalty. After all, most regulations are designed to protect consumers from the potential dangers of putting these products in their body.
“We are welcoming these requirements with open arms,” Hennesy told Analytical Cannabis. “That’s how we can provide safe, efficacious products to consumers.”
Indeed, customers that view brands as favorable due to their high-quality products are more likely to be repeat customers and provide referrals to their friends, family, and colleagues.
The importance of analytical and microbial testing
“The big six for testing are potency, microbial, residual solvents, pesticides, heavy metals, and mycotoxins,” said Camron Clifton, a quality control lead at Vertosa, a California-based ingredient manufacturer for the infused cannabis industry.
Analytical testing is necessary to confirm the presence or absence of potential hazards. Cannabis or cannabis-containing ingredients should be tested for several parameters to evaluate their quality and safety. These include the profile of key bioactives like THC and associated cannabinoids such as CBD, cannabigerol (CBG), cannabichromene (CBC), and cannabinol (CBN). Testing the levels of bioactives in a cannabis ingredient is crucial to ensure consumers are receiving the actual benefits being marketed by the infused product.
Testing should be done with ISO 17025 accredited laboratories to keep quality standards high and consistent for cannabis-infused products, as unaccredited laboratories may be sloppy, inconsistent, or inflate their numbers.
The presence of microbiological hazards like bacteria, fungi, and yeast (or their byproducts such as botulinum toxin or mycotoxins) should be determined as well. Cannabis ingredients and infused products that harbor pathogenic bacteria, like Salmonella, Clostridium, or E. coli, can threaten the health and lives of consumers. In an infamous case of Salmonella poisoning that led to the death of nine people and sickened more than 700, four former company leaders of the Peanut Corporation of America (PCA) received felony charges for their involvement in the outbreak. While cases such as this are rare, the microbial safety of edible products should remain top of mind for companies who wish to build a trustworthy reputation in the eyes of their customers.
Other potential hazards that cannabis ingredients should be tested for include pesticides and herbicides that are commonly used on marijuana crops. Because cannabis remains illegal at the federal level, each state has created its own approach to quality control for acceptable pesticide and herbicide levels. Cannabis can also pull heavy metals from contaminated soils, building up high levels of mercury, arsenic, cadmium, and lead, and should be evaluated for these toxic elements. Separation steps are necessary to ensure cannabis extracts are purified of these contaminants.
“The best way to ensure cannabis extracts are pure from contamination is chromatography,” said Jeremy Diehl, the co-founder and chief technology officer of Green Mill Supercritical, a cannabis extraction company based in Pennsylvania.
The HACCP safety system
“What we’re doing is taking a lot of practices that are standard practices across other industries, such as good manufacturing practice (GMP) and hazard analysis and critical control points (HACCP),” said Lauren Tamburro, vice president of research and development at Vertosa.
“The best situation is to be operating under whatever the best practices are for that industry.”
Borrowed from the food industry, the HACCP safety system is a foundational approach to addressing potential hazards in infused products. The HACCP system recognizes three major types of hazards: physical, chemical, and biological. Physical hazards consist of material or objects that can cause physical injury, such as broken glass or metal shards. Chemical hazards include foreign components such as solvents, detergents, pesticides, and contaminated water. Biological hazards refer to microorganisms, viruses, or biotoxins that can affect human health, like mycotoxins, Listeria monocytogenes, or noroviruses.
“Any food product to me, regardless of whether I’m putting in cannabis in it or not, is food and should be following the code of federal regulations,” said Tamburro.
The HACCP framework calls upon its users to identify points during the manufacturing process where hazards can be introduced into a product, and to implement strategies that can reduce the chance of hazards harming consumers downstream. As an example, a cannabis-infused brownie may be at risk of growing Listeria due to the introduction of contaminated milk into the batter. What may be called for is both a refrigeration step for the milk and a baking step at a sufficiently high temperature to kill off the Listeria.
Or an extraction solvent could remain in the cannabis extract, and so a vacuum evaporation step would need to be included to ensure that all the solvent is removed. On the solvent front, advances in supercritical carbon dioxide extraction may be the path forward towards improving quality of downstream cannabis products.
“Carbon dioxide is a very cheap solvent to manage compared to organic solvents,” Diehl mentioned. “You don’t have the added infrastructure for flammable liquids and gases. You don’t have the [same] regulations to follow here.”
Good manufacturing practice
As previous mentioned, another adoption from the food and pharmaceutical industries is GMP. This system of practices conforms to guidelines recommended by federal and state agencies to ensure consistent high quality from batch to batch with the intent to prevent harm from occurring to the end user.
GMP covers all aspect of production from the starting materials, manufacturing facility, and machinery to the sanitary habits of personnel. The system calls on manufacturers to create a detailed written set of procedures for the processes involved in the production of goods, such as infused cannabis products, that could affect the quality of the products. These detailed steps must then be followed and documented each time as a means of creating high quality products that are safe, pure, and effective.
“We’re ensuring we are manufacturing under GMP so that when the industry does become federally regulated, we’re already compliant,” Tamburro mentioned to Analytical Cannabis.
The spirit of GMP is to support companies in the process of producing products while minimizing or eliminating errors, contamination, or improper controls so that ultimately consumers are protected from ineffective or even dangerous products. Due to the general and open-ended nature of GMP, it is up to each manufacturer to decide how to apply this quality-first mindset to their manufacturing process.
While monitoring for product safety and quality may seem onerous, brands known for their high quality can be a powerful differentiator in the young cannabis industry.
“What we’re seeing a lot is that the industry is already pulling from these established industries,” said Clifton. “There’s aspects of many different industries, and with so many new players in this space, everyone is trying to get an edge and learn what is the best way to make products.”
At the end of the day, the guidelines set by state and federal regulators are designed to help manufacturers create high-quality products that consumers can trust. While federal regulations are not yet set in place, they can be a source of science-backed guidance in the Wild West that is the infused-cannabis product industry.
“We’re learning quickly that no one wants a three-month shelf life,” said Tamburro. “The person selling it and the person buying it, neither of us want that.”
“Food is not new. Cannabis is not new. Combining the two is not new. But doing it and selling it to other people is new.”
Existing industries are a rich source of best practices that can help cannabis brands stand out, creating the same trusting relationships that customers enjoy with the food, pharmaceutical, and personal care industries. As more brands and companies continue to set the bar for higher standards of quality, the entire cannabis industry will win together, as customers become accustomed to these products being a part of their lives without the potential risk of harm or incident.