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AUTHOR: Glenn Johnson

PUBLISHER: CANNABIS LAW REPORT

 

 

Shannon Swantek, CQA, Principal Scientist, CEO, Enlightened Quality Analytics 

 

Building the bridge between brands and the marketplace through testing and the importance of good data.

 

From a branding and marketing standpoint, I’m convinced that until we bridge the science of the medical market with the consumer’s experience in the recreational market, ignorance will linger and the market will plateau with over-saturated brands and buzzwords that deflate the meaning of efficacy. As an example, look at the bubble of CBD in the last year to see consumers swooning over science that is yet to be regulated and false or misleading packaging that profligates on shelves across the US.

If left to their own devices in Cannabis, a mixed bag of state regulations will continue to confuse the market as they rush to implement policies that are challenging for business and almost impossible for the consumer to understand. We all have to do better.

At the forefront of the market today are those that are working to create the standardizations and methodologies behind testing that will ultimately regulate that experience and allow consumers a greater understanding of what they’re purchasing.

I spoke with Shannon Swantek, principal scientist behind Enlightened Quality Analytics on the topic to see her take on what’s happening today.

 

QUESTION: What’s the state of the Cannabis business today?

 

The state of the industry today is focused on legitimization.  Attracting qualified investors, operating in established financial structures, and developing the good practices and control to compete with the well-established industries entering the market–are all necessary for existing small licensees and corporate franchises alike to mature quickly in almost every facet of their business.

 

Where it was once acceptable to cut some corners and operate “cart before the horse” due to the speed at which the dynamics were changing, businesses today must begin to establish credibility not only to their client-base, but to the potential market at large. 

 

QUESTION: Regulations, testing and brand messaging isn’t necessarily aligning in the market right now, is it? Especially in CBD/Hemp.

 

The general public is unaware of the lack of oversight in the CBD world and is therefore producing conflicting anecdotal storylines that the industry is poorly equipped to combat.

 

The data presented at the FDA hearings pointing to many “snake-oil” CBD products on the shelves that do not match their labels, contain adulterants, and/or unwanted high THC levels highlighted the way this medicine is being undermined by poor customer experiences being linked directly to CBD itself. 

 

QUESTION: Which we can see in the dangers of the current Vape crisis…

 

The vape event, indeed, shines a light on the dangers of the unregulated market. Compounding this, the lack of data from the regulated market about each unique product, from source material to formulation to final product testing is not available to quickly and adequately defend themselves against a blanket perception. These events, amongst other drivers, have shown the obvious need to regulate product safety in CBD and THC products in a holistic and standardized way. 

 

QUESTION: Talk to me about product risk in today’s market and the importance of self-regulation.

 

Unique product risk has largely gone uncaptured as early regulatory structures faced the unachievable mandate to capture any risk to public health in products that had never been studied. The early manufacturers were not equipped to capture all of the product risk that is addressed by Good Manufacturing Practices (GMP) in mature industries and this made it impossible to gather enough information to make data-based decisions.

States created “one-size-fits-all” “point of sale” testing schemes with the limited data available and hoped to capture risk by requiring every product batch be tested. Unfortunately, these schemes only capture the risk of the most common products, and only if the data is accurate.   because the g A lack of transparency in the supply chain combined with the devastating expense or product lost after production upon failure, this created financial drivers that were myopically focused on passing these tests and getting product on the shelves.

OtherFDA regulated industries do not follow a point of sale testing scheme-instead they acknowledge that there are so many unique products with unique product risk, that they must rely on the industry to capture their own risk e.g  a topical versus a suppository, can only be understood and captured by the producers themselves. From source material testing to environmental controls, only a manufacturer has the ability to collect the appropriate data to identify specific product risk and capture that risk in each product.

The corporate management familiar with the practices of other industries are starting to finally convey the value of having Good Manufacturing Practices (GMP) and an ISO compliant management systems beyond that of just meeting regulatory requirements. The very expensive lessons learned in mature industries possibly have an even bigger pricetag in cannabis – the success of the legitimate industry as we envision it.

 

QUESTION: How will this ultimately help the market?

 

By developing testing schemes at each point of product development, it is possible to more fully understand and optimize their product resulting in more cost efficient manufacturing processes.

A need for data at all of these levels and data specific to product type drives more advanced methodology in the laboratories, often resulting in a better understanding of the matrix and more accurate data. 

It’s an exciting time for the industry and those that are embracing the USDA, vape events, and FDA hearings as the catalyst that was needed to jump-start industry efforts globally into legitimacy. 

 

QUESTION: Data will ultimately translate into the consumer’s experience, and elevate a greater understanding for efficacy and controls when it comes to purchasing products, correct? 

 

The lack of education at every level of the industry, from regulators and prescribers to patients and customers, added to the misinformation that is constantly being disseminated as part of aggressive marketing practices, has been hurting the industry chances of success from the early days.

For example, creating strain names that do not match the genetics of a product, using undefined terms such as “solvent-less” and “full spectrum” inappropriately, and touting “certifications” from groups that were not granted authority to certify by any overarching industry community allows the bad actors to differentiate themselves in misleading ways. 

The lack of accurate information such as detailed, ingredient lists, and accurate label information robs the consumer of the knowledge needed to make informed choices.  This makes brand loyalty an unpredictable goal and metric as it is unclear what is driving consumer choices through the early stages of industry development. 

 

QUESTION: You’ve mentioned to me previously that as an industry, we must become informed, speak out against the rampant misinformation, and  demand more as consumers from our producers—can you explain this more?

 

Due to the lack of quality management systems mentioned above, producers and processors are not soliciting feedback from their clients and do not have the ability to refine and optimize the formulation of their products to meet client needs when they are identified. This creates marketing and branding strategies that are disconnected from the actual market which results in factors such as “THC %” being the sole price point when it is well known that products with a diverse cannabinoid and terpene profile are more desirable to consumers. 

In addition, the false sense of security and trust in product safety and control, is aggravated by a lack of education and available information on the regulatory and enforcement side.

With reliable sources of information being drowned out by industry “noise”, it is difficult to sift through the misinformation to find the science and data needed for regulators to crack down on false label claims, unregulated or unlisted ingredients, and just plain false advertising.

The lack of consumer confidence only furthers the ability for the bad actors of the industry to continue to keep the playing field leveled to their advantage as they understand that there is not reliable oversight and enforcement from the regulators, internally in the industry, nor from the market they are trying to fool.  

 

QUESTION: You and your team at Enlightened Quality Analytics work across different categories, from Cannabis to dietary Supplements, Pharmaceuticals, and Environmental fields, why is that important to you?

 

Enlightened Quality Analytics is joining the two pieces necessary for any long-term successful business by bringing technical and quality support to the cannabis industry in a holistic package.

The days of easy money and wild west operations have proven to be costly for the industry, not only in product risk, but in operational costs and the often gross mis-valuation of businesses. 

Organizations are running to keep up with demand and often grew so quickly that they did not have the time or resources in the beginning to build Quality Management Systems (QMS) with standardized procedures ensuring they were producing their brand in the same way each time.  

In addition, they did not create the tracking systems and records with the evidence to demonstrate that those procedures were effective in reaching the brand’s objectives.  Without in-process testing to specifications, inconsistent products are common which carries a large amounts of risk.

We have the top team of experts from each technical sphere in the industry with extensive backgrounds not only in cannabis but in the industries that cannabis businesses must start to emulate in order to flourish, such as the pharmaceutical, agricultural, and nutritional supplement industries.

Our team also has extensive experience and networks on the regulatory side of the business – having drafted policy and legislation at the state, federal and international levels. 

Finally, we help organizations work with their laboratories for the right testing schemes, data quality objectives, and to produce data that can be validated in the event of litigation or dispute. 

 

QUESTION: The Cannabis industry is evolving quickly for better or worse, how do you see it continuing as we look ahead toward more states coming online and eventual Federal regulation?

 

The industry is starting to understand that the requirements in a federal scheme will be very different than the “state by state” regulations that were put together, often hastily. This understanding is actually coming behind the realization that industry on an international level already demands quality management systems that are compliant to the same standards of mature industries.

These standards,  such as ISO 9001:2015, ISO/IEC 17025:2017, and Good Manufacturing Practices (GMP) need to be in place for an organization to be prepared for the changes this dynamic market is facing.

At Enlightened Quality Analytics, we support businesses at every stage to develop components of these essential quality systems. – from facility design review for cross-contamination risks to helping producers design testing schemes that help them understand their unique product, control it, and optimize it. 

 

QUESTION: What’s an example of a company doing it right?

 

Gary Herman from TagLeaf holds our shared vision of true success for the cannabis industry that you and I have been talking about. This success is based on product safety and making data-based decisions which is why he developed TagLeaf and why it continues to grow in functionality and support of the industry past laboratories and into all areas of quality.  TagLeaf’s platform employs specific modules that ultimately work together, integrating regulatory, compliance, product quality, validation & verification, and track & trace technology, allowing industry participants to manage the entirety of their supply chain.

Most cannabis laboratories cannot afford the complex and expensive LIMS systems in the market. TagLeaf is making quality accessible with a better product that is actually priced so that all size players in the industry can afford to implement proper data quality practices. This increases the quality level playing field across the industry but is not prohibitive for smaller operations; flying in the face of industry culture that keeps IP close to the chest and furthering the idea that sharing technical advances only supports the progress of the whole industry.

I firmly believe this is the only viable way for the industry to move forward independently without interference from regulatory or big business interests.  The drive for quality has to come from within.

 

For more about Shannon, visit https://www.enlightenedquality.com/

 

About Glenn Johnson

I am a Marketing, Branding and Communications Consultant w/ experience in high-touch luxury consumer marketing in the travel/hospitality, wine/spirits, fashion/beauty/grooming and Cannabis categories. My talents include Branding & Brand development, Business Building, Strategy and Brand Storytelling. I excel in working with Founders, funders, start-ups, and small brands.

CONTACT ME via email at: glenn.johnson@gmail.com

Connect with me on  LINKEDIN: https://www.linkedin.com/in/glenn-johnson-8018944/

About Glenn Johnson

I am a Marketing, Branding and Communications Consultant w/ experience in high-touch luxury consumer marketing in the travel/hospitality, wine/spirits, fashion/beauty/grooming and Cannabis categories. My talents include Branding & Brand development, Business Building, Strategy and Brand Storytelling. I excel in working with Founders, funders, start-ups, and small brands.

CONTACT ME via email at: glenn.johnson@gmail.com

Connect with me on LINKEDIN: https://www.linkedin.com/in/glenn-johnson-8018944/