Regulatory compliance is an ongoing headache for plant-touching and ancillary cannabis brands alike — if a brand doesn’t properly follow regulations, for example, it faces fines or in the worst of cases, losing its business entirely. Brands in such highly regulated industries typically hire expert consultants to assess their operation and provide working solutions to help them get compliant, no matter the state of their operation.
Kim Stuck, the CEO and founder of Allay Consulting, left her job with the Denver Department of Public Health and Environment after identifying a need for compliance consulting in the cannabis space. We recently interviewed Kim about the founding of Allay, how her team stays fresh on the regulations in each region, the compliance complexities faced by companies in the cannabis, hemp, and psychedelics industries, and more!
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Ganjapreneur: Why did you choose to go into cannabis consulting following your work with the Denver Department of Public Health and Environment?
Kim Stuck: I saw a huge gap in knowledge when it came to overall compliance with Denver’s cannabis regulations along with health and safety. It made more sense for me to work directly for cannabis companies rather than the government—I could make a much larger, overall positive impact. I saw that most companies weren’t out of compliance because they were being malicious, it was just a lack of knowledge and understanding. So now that’s what I help companies with every day.
What sets Allay apart from other consulting firms?
The Allay team stands out in a lot of ways—first, we have been in the industry since 2014 and have a regulatory background, which is obviously valuable and unique. We are all accredited as certified professionals of food safety (CP-FS) and certified quality auditors (CQA), which provides a degree of additional operations expertise not common in the consulting space. Secondly, all of our employees at Allay are full-time workers, not 1099 contractors. This means we can hold higher internal standards than contractor-based firms when it comes to consultancy, customer service and professionalism. Lastly, everyone on the team is very passionate about the industry and truly loves what they do. They all have their different areas of expertise and knowledge when it comes to cannabis, and their own personal relationship with plant medicine. We’re driven to help businesses overcome obstacles; our success is based on their success.
You mentioned that the team all has different areas of expertise and knowledge, what are the specific focus areas of Allay?
The Allay team covers a variety of fields—we work in all 50 states in the hemp, THC cannabis, and psychedelic spaces, so there are a lot of areas to keep up on. At this time Allay’s focus is on operational compliance that includes; all state regulatory requirements for THC cannabis, FDA, cGMP Certification, OSHA Compliance, Fire Code Compliance, ISO 9001/22000 Certifications, Organic Certification, and GAP/GACP Certification for cultivation facilities. Each member of our team is a certified professional on food safety (CP-FS) and certified quality auditors (CQA), and we are all ex-cannabis regulators. We assist with audits, writing SOP’s, documentation, logs, staff training, and with the entire certification process through accredited certifying bodies.
Allay has a lot of certifications like HACCP, SERVSafe, Metrc Certification, HAZWOPER, Six Sigma Black Belt Efficiency, and more. How does the company decide which certifications to pursue?
The certifications we hold at Allay are guided by what state and local health authorities require of their own employees. For example, to work for most health departments, you must be a certified professional of food safety (CP-FS). We are also certified quality auditors (CQA), meaning we are trained to assess any operational standards and objectively identify their strengths and weaknesses. We have to do a lot of continuing education for all of our certifications. The ones listed in this question aren’t rare, and most people can get them online. However, the CP-FS and CQA require years of experience, a seven-hour-long test and continuing education to remain certified. I will say that there are a lot of certifications offered that don’t hold a lot of water, so we do our research to know which ones are actually valuable.
When should a cannabis company bring Allay in for a consultation? Can an already established company benefit from your services?
Allay works with companies of all sizes and can come in at any point in their business journey. Many companies bring us in early on so that they can have certain compliances in place from the beginning in their operating procedures, or get a floor plan review during construction. Longtime operators hire us to address a specific compliance concern, or to get a certification like current good manufacturing practices (cGMP) or a quality management system (QMS) like ISO 9001/22000. We can enter a company at any time and be effective.
How do the compliance challenges that hemp and cannabis companies face differ? What are the similarities?
Companies licensed for state-regulated medical cannabis or adult-use markets are more focused on state regulations and receiving certifications that make their brand stand out such as cGMP, GACP and ISO 9001/22000. In the hemp sector, companies are more concerned with FDA /cGMP compliance and certification. Occupational Health and Safety Administration (OSHA) compliance is also top of mind since hemp is federally legal, and these entities could start regulating any day now. All of our clients on both sides are working toward some kind of long-term compliance goal and are trying to prepare for the future. Becoming compliant with these standards now will save them time, money and reputation when federal cannabis legalization goes into effect.
What is the most common compliance error that you see in cannabis and/or hemp facilities?
Common issues we see at Allay include standard operating procedure (SOP) compliance, batch number systems, staff training, proper logging of activities and overall health and safety in facilities. It is very hard to be completely compliant without third-party audits or outside assistance, and it’s just going to get more complicated in the future.
How does the team stay informed on the nuances of regulations from state to state?
At Allay, we have a number of different resources and regulatory contacts in every state that keep us up to date on shifting regulatory landscapes. Truly, we are just really skilled at reading and understanding regulations. If we don’t know something, we are very good at finding the relevant information and giving the most updated and accurate answer to our clients as possible. Since regulations change so often, we each read about 60 pages of regulations a day on average.
Is there a one-size-fits-all compliance strategy for cannabis companies in the same state?
I would love to tell you that it was that simple. In order to actually be compliant, your company has to have SOPs and other documents specifically written for your facility. A packet of SOPs purchased online is not a good choice—each company needs distinct items from different documents depending on products made, extraction methods and so on. At Allay, we have a structured way to evaluate companies and create a plan for them, and each plan is unique since each company is unique. We always conduct an initial gap analysis, then create an individualized plan for the company. We’ve done it so many times, we have it down to a science at this point.
Why is it so complicated for well-intentioned cannabis companies to be compliant and how could the industry members/consumers advocate to resolve these complexities?
Compliance is always complicated as almost any cannabis business owner knows. There are a lot of moving parts when it comes to operational compliance and a lot of different regulatory bodies to be compliant for. For instance, in the state of Colorado you have to be compliant with the cannabis regulatory regulations (MED), on top of that you have the fire department, building department, excise and license, local health department, and state health department. Additionally, if cannabis is legalized on a federal level, companies will also have to comply with FDA regulations and OSHA. Our job at Allay, is to make sure our clients are compliant with the regulations they have to be compliant with now and to prepare them for federal legalization. All of these regulations are hard to comply with by themselves, it’s almost impossible to be compliant with everything all the time. Having experts come in to do the heavy lifting is what most company owners are finding as the easiest and most cost effective solution.
What is The Canna Consortium and how does it serve the cannabis industry?
The Canna Consortium is a group of ancillary cannabis companies and nonprofits, including equipment providers, operations consultants, research advocates and others that have joined forces to be more efficient in assisting clients and helping the overall industry. The six founding members, including Allay, worked together for years and eventually decided to start a group of trusted and dedicated ancillary companies that are working together to better serve the ever-growing cannabis and hemp industries. Together, we are boosting these sectors by supporting B2B relationship building and efforts to destigmatize and normalize cannabis and hemp.
Big thanks to Kim for answering our questions! Learn more about Allay Consulting at allayconsulting.com.