Government could regulate the edible cannabis industry just like making soda
One of the most difficult challenges of my life was convincing my parents that my career in legal cannabis was legit. They probably wondered things like, “How cramped and filthy is this edibles kitchen?” “Are all of his coworkers on drugs?” “Is he paid all in cash and tiger blood?”
It’s understandable. Doing what I do in Kansas will get you thrown in prison.
At some point, they accepted it, but uncertainty lingered. That is, until I told them about how my employer was manufacturing its products according to quality standards used by the federal government. That changed everything. My parents are smart people, and these standards impressed them like a seal of trust. Something that could protect their first-born from harm or wrongdoing.
The regulation of cannabis in Colorado is shared between state and local governments. Similarly, the rules marijuana infused product manufacturers (MIPs) follow are a mix of state and local rules. In Denver, the city applies the Denver Rules and Regulations Governing Food Establishments, the same code it applies to restaurants, to MIPs.
You can thank them for: requiring that food contact surfaces be “easily cleanable” (which they define); that handwashing sinks continuously provide running hot water (between 100 and 120 degrees); or that measures are taken to prevent insects, rodents, and other pests from making their creepy, crawly ways into your food (dead or alive).
These regulations are enforced through the Denver Department of Public Health and Environment Public Health Inspections Division. Danica Lee, its director, explains her department's mission.
“Our agency’s mission is to support regulated industries while safeguarding the health of consumers through effective regulation and enforcement. The legalization of marijuana without an established set of federal standards creates an unprecedented challenge for health authorities. As Denver’s local health department, we evaluate any gaps in information or regulation to try to ensure that consumers are protected from unsafe products. The rapid innovations of the marijuana industry present special challenges to understanding product hazards, so we work closely with businesses to review their processes and ensure the right controls are in place.”
Current Good Manufacturing Practices (CGMPs) are the federal standards that would apply if there were any. That’s because the Food and Drug Administration (FDA) is already enforcing them against companies like Coke. Broadly speaking, CGMPs are rules that enable a business to produce food or drugs safely. As the cannabis industry matures and greater numbers of people consume it, systems like CGMPs will be needed to ensure the safety and reliability of mass-produced cannabis products. Again, the way Coca Cola has tasted the same way your entire life.
Enter Bronnor, a 25,000-square-foot private contract manufacturer in Denver, CO.
At first glance, the facility is like any other MIP. Its warehouse has concrete floors and scaffold shelves. There’s an array of finished goods, like tinctures and disposable pens, destined for imminent shipment. The stereotypical forklift is parked neatly in the distance. However, once you cross the threshold into the production area things are starkly different.
Everything is white, sparkles clean, and appears highly regimented. Suddenly, it doesn’t seem like any MIP around. That’s because here, CGMP’s reign supreme.
Chad Wittman, operations manager at Bronnor:
"Look at it like security zones, most of us in the industry have clearly defined security areas i.e., reception, retail, secured product. This means you have to have different levels of clearances to get into different areas, so the more secure the area the more restricted the access is. The same principle applies to CGMP. While picking up in Bronnor’s loading dock shorts are perfectly acceptable. If you wanted to enter our product storage area you’d have to change into jeans; and to enter our production floor, you’d have to put on a hair net, beard net, smock, and wash/sanitize, all before even being allowed to enter the room.”
It might come as a surprise that Bronnor is not technically CGMP-compliant. It’s complicated. First, CGMP compliance is different depending on the industry. For example, drug manufacturers are inspected for CGMP compliance before they can make a drug. In contrast, food and supplement manufacturers are inspected only on a random or post-complaint basis. The prevailing reason, however, is that cannabis is illegal in the U.S., so the FDA is not inspecting places like Bronnor in the first place.
Interestingly, CGMP standards are developing even faster in other countries with legal cannabis—like Canada, Australia, and some European countries. The U.S. cannabis industry doesn’t have to lag behind, though. There are organizations, like SAI Global, that certify American companies for compliance with CGMP-like standards. It recently made headlines for helping a cannabis producer in Florida, Liberty Health Sciences, receive CGMP certification for their green house and production facility.
Donavan Bennett is the co-founder of Cannabis Quality Group, a cloud-based Quality Management System (QMS). He explains how cannabis companies will soon be attaining CGMP-like compliance.
“GMP is essential to an organization’s Quality Management System (QMS). The assumption of CGMP is that quality should be implemented throughout the lifecycle of the product being manufactured (i.e. harvest, packaging, processing, etc.). When basic CGMPs are implemented and followed, recalls are minimized, and the consumer is receiving a safe and consistent product. As more quality assurance professionals enters the cannabis industry, attaining third party validation of your QMS will become an industry standard. Our Canadian counterparts are already spearheading this initiative. What are you doing today to prepare for Cannabis 3.0?”
CGMP’s are the exception now, but we’re still in the early stages of Big Cannabis. Big Cannabis, like Big Pharma, will have quality systems like CGMPs. Bold prediction? Maybe, but consider these recent developments.
In Colorado, consolidations are happening at an increasing pace. And everywhere, bigger and bigger money is getting involved. For example, Coors, the maker of Corona, and the founder of Blue Moon have all announced their intentions to make cannabis-infused beverages.
So here’s the thing: if Corona, Blue Moon, and Coors have been made in CGMP-compliant facilities, wouldn’t their cannabis-infused counterparts be, too?
In July, there was workgroup in Colorado in which CGMPs were central to the discussion. Basically, the Marijuana Enforcement Division is considering whether pharmaceutical methods of consuming cannabis warrant special regulations. These methods include include nasal (for nasal sprays), pulmonary (for inhalers), vaginal and rectal (for suppositories), and other non-traditional methods.
In the draft rules, the “Manufacturing Process” section for each of these categories requires the products with CGMP compliance per the Food, Drug, and Cosmetic Act. Draft rules or not, this is the kind of thinking that is driving cannabis manufacturing policy in Colorado at the moment. What’s more, this kind of thinking is percolating at the federal level.
In an historic bill that was passed several weeks ago requiring the Justice Department to issue more cultivation licenses for research, a little publicized amendment mandated “good manufacturing practices for growing and producing marijuana.” So there you have it, the feds want CGMP’s for growing government weed. Might it have something to do with the quality?
For places like Bronnor, having CGMP-like rules might seem like a big gamble. They’re costly, require continual monitoring, and for now, nobody is awarding them a gold star for it. However, the cost of being wrong is not only nil, for now at least, it’s a competitive advantage.
According to Paul Bohannan, CEO and founder of Honu Edibles, most of Colorado’s existing facilities couldn’t be retrofitted for CGMP-compliance if they had to be. Having Honu manufactured at Bronnor was an easy choice.
Paul Bohannan, “Everything we prepare is done carefully and as though it were somebody’s medicine. Our processes are based on cleanliness, consistency, and high quality. Without one, they all fail. Good manufacturing practices support this ethic.”
To Mr. Bohannon’s point, all the pieces to Bronnor’s bigger picture are coming together.
Consumers increasingly want their cannabis coming from clean and closely monitored facilities with proven systems in place. Countries, like Canada, are already implementing CGMPs. And now, the U.S., with states like Colorado in the lead, is on the brink of full-fledged legalization. It’s not a matter of if, but when. Who’s ready for Cannabis 2.0?