While cannabis-infused foods are not yet legal at the federal level, an increasing number of states allow for edibles, beverages, and other foods that contain THC and CBD as ingredients.
As cannabis becomes legal in more and more states across the U.S. and as the U.S. Drug Enforcement Agency (DEA) moves to reclassify it as a schedule 3 substance—a move that would make it a less dangerous drug, but not legalize it for recreational use—food manufacturers need to ensure that their production practices are sound and validated. This is why it’s vital for these companies to meet food safety guidelines and focus on quality when creating new products.
Kathy Knutson, PhD, a food microbiologist, chair emeritus for the education committee for the National Cannabis Industry Association, and president of Kathy Knutson Food Safety Consulting, is seeing more cannabis beverages in the market as consumers grow more comfortable with drinking those products. However, edibles remain the primary focus for most manufacturers. “Really, any food could be an edible,” she said. “In Canada, meat products are now allowed. I’ve heard about ice cream, taffy, popcorn, chocolate, and many savory bakery products. There’s a lot of work being done on the food side.”
While she appreciates the entrepreneurial spirit in the industry, she notes that food safety may not be the first thing manufacturers think about when creating and releasing their products. “My colleagues and I are always pushing those in the cannabis industry to have a dedicated quality manager and for the company to recognize how important it is to implement quality management systems and build a savvy food safety plan,” Knutson said. “Everything that’s expected of the food industry should be expected in the cannabis industry.”
Roberta Wilson, co-founder of California-based cannabis edible company Dr. Norm’s, which manufactures brownies, cereal treats, and cookies sold at more than 300 compliant California dispensaries, understands the importance of adhering to all food safety regulations. “Being a cannabis-infused food company does not in any way alter the way we operate compared to a traditional food company,” she said. “All of our employees have to go through food safety training and adhere to all applicable regulations.”
She explained that cannabis-infused food products have food safety standards and regulations that are even more stringent and challenging to comply with than traditional food safety regulations.
Chad Frey, owner of a Washington D.C.-based cannabis-derived consumer goods company with three brands—Flowerz for gummies and mints, Karma for caramels and baked goods, and Anytime for infused seltzers—noted that he takes food safety very seriously. “We’re constantly staying at the forefront of R&D, new scientific developments, and leading studies with universities to explore adverse effects,” he said. “We utilize existing food safety regulations and third-party analytical testing with DEA-registered labs. This ensures that the labeling of products matches the accuracy in potency and packaging.”
Compliance Challenges
Pat Bird, cannabis lead for bioMérieux, a diagnostics company that provides food quality and safety testing solutions for the cannabis food and beverage industries, noted one of the most concerning issues with the cannabis industry is the lack of consistent and standardized measures for ensuring compliance with food safety regulations. “Good manufacturing procedures, risk analysis, and hazard controls have been a part of food testing for over two decades, and these principles are not universally adopted within the cannabis industry,” he said. “This can lead to products produced in facilities without proper environmental monitoring programs and using production practices that are not sufficient to protect consumers from contaminants.”
He explained that infused product testing is often performed by compliance laboratories that lack the experience and expertise to fully analyze food products. “The expertise required to navigate inherent challenges associated with commonly infused food matrices (chocolate, gummies, beverages) is not always present in compliance testing, as labs are built quickly with a focus on flower analysis,” Bird said. “As more complex matrices are introduced, methods must be further validated to obtain accurate results.”
Different Protocols
There are several differences in food safety protocols between traditional food processing and cannabis-infused food production. “The biggest difference with cannabis vs. traditional food manufacturing is that weight would not affect food safety in traditional manufacturing,” Wilson said. “In cannabis, since weight determines the dosage of the product, we have to be meticulous about weighing every single piece of edible we manufacture to ensure that it is the stated dosage, making it ‘safe’ for consumption.”
The law provides for a 10% variance on dosing, which requires adherence to very rigid manufacturing practices involving weighing every piece of product before it gets packaged for distribution. Meanwhile, with traditional food manufacturing, only package weight needs to be adhered to.
Another main difference is that within the food industry, testing is performed from farm-to-fork. “Raw materials, environmental monitoring, and finished products are all evaluated in a risk-based approach to minimize the chance that hazards may be present,” Bird said. “For cannabis-infused products, only the minimal required compliance testing on finished product is performed, which can increase public health risks associated with contamination from the environment or in the raw materials of the product.”
Lab testing required by law in cannabis also screens for pesticides, heavy metals, and other harmful substances that traditional food testing is not subjected to. If products fail lab testing, the entire batch becomes unusable.
While regulations differ among states, manufacturers need to understand the basics to ensure they are compliant. “It is very challenging to navigate the regulatory landscape in the cannabis business,” Wilson said. “The regulations are different in every state, making it like setting up an entirely new business in every state. I can’t think of a single other industry where this is the case.”
Navigating the patchwork regulatory landscape can be very difficult for food manufacturers. “Multi-state operators—producers active in more than one state—often implement separate QA programs at each facility, which adds complexity to managing from a corporate standpoint,” Bird said. “These groups often rely on a senior regulatory advisor to help with navigation, but these individuals traditionally have a cannabis background, not a food safety background. This process helps ensure compliance with regulations but can result in less focus on implementing traditional food safety procedures.”
Thankfully, in many states, cannabis commissions will directly engage with manufacturers to proactively work toward better production and quality procedures.
Working with Suppliers
It isn’t uncommon for manufacturers to find issues working with suppliers because cannabis is still federally illegal. “We have had issues with being able to buy directly from large suppliers through wholesale accounts, as they don’t want to sell to cannabis companies,” Wilson said. “As such, we are forced to buy most products at retail. This is a huge issue with COGS, as they could be much lower if purchased through wholesale agreements.”
Knutson notes that while a few big players deal with everything in the supply chain the same way as normal food companies, the majority of cannabis manufacturers are still very small, operating more on the level of a restaurant kitchen or a pilot plant with small production. “So it’s a different scenario, and these companies are more likely to go to big box stores to get their ingredients,” she says. “That’s more common. Every cannabis company is still doing their product development and fine-tuning recipes, and flavors are evolving. They don’t have the consistency of purchasing, but that will change as the companies grow.”
What’s Ahead
Cannabis-infused producers that fail to invest in a strong quality assurance (QA) plan often have the most difficulty producing consistent and safe products.
Bird notes three goals that can help producers overcome pitfalls: identifying a manufacturing director with experience in food production; increasing quality control testing of raw materials and finished products beyond the bare minimum compliance requirements; and establishing robust environmental monitoring programs.
He believes a singular standardized approach that incorporates many of the GMP principles from pertinent industries (dietary supplements, food, pharma), while establishing guidance specific to the cannabis industry, will help streamline how companies can manufacture safer products for consumers in the future.
Even with the potential for federal legalization of cannabis-infused foods in the future, many predict food safety regulations won’t change for what will become a larger market. “It would just mean much greater ease of manufacturing product in one central location with the ability to sell it across state lines,” Wilson says. “Scaling up in a central manufacturing facility would pose the same issues as any traditional food manufacturing facility in adhering to food safety regulations.”
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