Interview with Lezli Engelking
We are very pleased to share another insightful interview with our readers. We had the pleasure talking to Lezli Engelking. She is the founder of Foundation of Cannabis Unified Standards (FOCUS).
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Could you introduce yourself and share more about what you’re doing, what your focus is?
My name is Lezli Engelking and I am the founder of Foundation of Cannabis Unified Standards (FOCUS). FOCUS, an independent, 501c3 not-for-profit organization, was founded in 2014 as The Cannabis Health and Safety Organization. FOCUS is dedicated to developing cannabis-specific, voluntary consensus Good Manufacturing Practice (GMP) standards and providing third-party internationally accredited certification to guide operators and regulators alike and ensure only safe, consistent, quality cannabis products are available within the marketplace.
Why did you move into the cannabis industry after working for over 12 years in the highly regulated pharmaceutical industries? What was your personal motivation to focus on this industry?
Unlike others who made a conscious decision to enter the cannabis industry, I became involved more by accident and opportunity than anything else. I had recently left the pharmaceutical industry, after spending 12+ years with Eli Lilly. While I was deciding what I wanted to do with the rest of my, life, a friend asked me to take part in an application for a medical cannabis license in Arizona. At first, I was hesitant (the cannabis industry looked a lot different way back then) but after a lot of research, I decided a job in a new and upcoming industry, that allowed me to interact with patients on a daily basis and hear their incredible, life changing experiences related to cannabis, was worth exploring. During my 2.5 years with that company, I quickly realized the amazing benefits and huge therapeutic potential of cannabis – as well as all of the accompanying public health and consumer safety risks in a rapidly developing industry without any nationally accepted, accredited standards. I recognized early on that as the cannabis industry began to scale and grow up, cannabis would be governed by the same types of standards that govern any other industries. So, I sold all of my financial interest in the industry and established FOCUS to develop standards and provide third-party accredited certification.
Can you share more about FOCUS and its vision?
The FOCUS mission is to protect public health, consumer safety, and safeguard the environment by promoting integrity within the cannabis industry. While everything we do is ultimately to protect patients, consumers, and the public, we achieve this by working with both the private and public sectors. FOCUS assists cannabis business owners with standards implementation, and certification to improve operations and set the business up for long term, sustainable growth and success. FOCUS assists regulators, lawmakers, and public health officials by working with them to assure that the cannabis programs being implemented contain adequate protections for health and safety. All of our work is ultimately about achieving the overall FOCUS vision: A safe, legal, and sustainable, global cannabis industry.
Why is it so important to implement Good Manufacturing Practices?
Good Manufacturing Practices (GMP) are designed to minimize the risks involved in the manufacturing process. GMP actually involves much more than most people think. One common misconception is that GMP only covers the process of manufacturing itself. GMP actually covers all aspects of the production process:
- Record Keeping
- Staff Training
- How Complaints Are Handled
- Product Development
While GMP does require testing, testing alone is not enough to ensure consistent, safe, quality products throughout the supply chain. A basic tenant of GMP is that quality cannot be tested into a product. The quality of a product is either there or it isn’t by the time it is tested. Because US cannabis and hemp regulations rely almost solely on testing , it is critical that all products are manufactured under GMP standards to assure that quality is built into the design and manufacturing process at every step and that only safe, consistent, quality products are created.
Patients and consumers can’t determine whether a product is safe or if it will actually work through visual inspection alone. GMP certification provides assurance that the product was produced in a facility that is in good condition, on equipment that is properly maintained and calibrated, by employees who are qualified and fully trained, through processes that are reliable and repeatable.
For operators, implementing GMPs is the best way to minimize and mitigate risk. It is for this reason that insurance underwriters use the FOCUS standards to measure risk and offer FOCUS certified clients a discount across the board on their policies.
How are the FOCUS standards developed?
Since inception, FOCUS has always worked to bring legitimacy and stability to the global cannabis industry, while safeguarding public health and safety. To that end, it was imperative that the standards were developed according to international guidelines that assure they are suitable for use and adoption into regulations. The American National Standards Institute (ANSI) is the US body for the International Standards Organization (ISO), so FOCUS followed ANSI’s Essential Guidelines for standards development to assure FOCUS standards could be adopted and implemented around the globe by both regulatory agencies as well as operators.
Voluntary Consensus simply refers to how standards are developed, and who developed them. All voluntary-consensus standards are developed under the same basic principles:
Participation is open to all individuals with a stake in the standard who bring useful expertise along with the spirit and willingness to participate.
Standards development participants must represent a balance of interest from all stakeholder groups. (Focus stakeholder groups include industry, regulatory, quality assurance, medical, law enforcement, business, research, consumers, patients and the general public)
Standards are developed by volunteers who are not paid for participating
Lack of Dominance| No stakeholder group has dominant representation or influence, to the exclusion of fair and equitable consideration of other viewpoints.
Through the amazing dedication and hard work of 200+ volunteers over 3 years, FOCUS standards were created following these essential guidelines.
Is the industry welcoming the idea of standards and certification?
It has been a truly incredible journey watching the cannabis industry come to understand the critical importance of standards and certification to its long term success. For the first 2-3 years after I embarked on this journey, more often than not, I felt like I had a big bullseye target on my back. Operators lacked understanding of the differences between standards, regulations, and laws, which created fear that my intent was to try and overregulate them… Nothing could be further from the truth! Since day one, my intent has been to partner with all aspects of the industry to help them build their businesses in a sustainable manner that prepares them for the inevitable expansion and scaling that would be required for long term success in any legitimate industry.
Flash forward 6+ years though, and the attitudes and responsiveness to FOCUS are definitely looking very different. While I like to believe my constant and continued efforts to educate the industry on the importance of standards played a role in this shift of attitude, other contributing factors are definitely involved. Think: federal oversight, international commerce, license revocations, recalls, vape crisis, and hemp being legalized through the 2018 Farm Bill. Hemp operators have realized very quickly what it looks like to suddenly have federal oversight suddenly in place…and most wish they had prepared in advance to meet these additional requirements. There is a huge opportunity for the cannabis industry to learn from the hemp industry’s experience – if they are willing to recognize and act now to take advantage of the situation.
What does a business have to gain by adopting your proposed standards?
Proper implementation of FOCUS cannabis specific good manufacturing practice standards positively impacts every aspect of a cannabis business and dramatically increases the likelihood of overall, long term business success. Standards Implementation, in any industry, provides operators with information essential to maintain regulatory compliance, ensure manufacturing specifications, effectively apply risk management principles, and objectively assess the quality, safety, consistency and effectiveness of its products, systems, and processes.
Certification offers incredible value to cannabis companies by embedding preventative steps into operational processes. The proactive nature of certification provides bottom line cost savings through the minimization of errors and waste, thus decreasing costs while improving profitability and performance. Certification provides a marketing advantage in a highly competitive environment and improves the ability to expand into new markets. Certification dramatically increases the likelihood of producing safe, quality, consistent products and overall brand and business success.
Organizations that recognize this will achieve benefits that greatly exceed any cost or effort. In the wake of the vape crisis and the continually growing problems with product safety, quality and consistency, not to mention the sheer number (and costs) of recalls occurring, standards implementation and certification is crucial to the future success of the cannabis industry.
Do you think in 5 years the industry will be all under regulations mandatory governmental or voluntary? What do you think is the most likely scenario?
In general, I tend not to speculate on anything related to the cannabis industry- especially where it concerns the US federal government. That said, this question I have no problem answering, because it really isn’t speculation at all.
As any industry grows, expands, and matures, additional issues and concerns continue to arise. As a result, mandatory regulations are put into place to address these issues and concerns. The cannabis industry is no different. The vape crisis is a perfect example of this. Prior to the vape crisis, regulatory agencies – both state and federal – lacked the knowledge and concern about the risks of vaping to take action. Yet, we saw swift and definitive action from both state and federal regulatory agencies as the vape crisis unfolded.
So, the answer to your question is a definitive yes – there will absolutely be more mandatory governmental regulations in 5 years. I’d be thoroughly surprised if it is even 5 years away. Which is why smart operators are preparing their operations now.
Can you comment on CBD’s current legal situation in the US?
As things stand today, the regulatory situation around CBD in the US is extremely murky and difficult to navigate space. The confusion stems from a lack of understanding about which federal laws pertained to CBD prior to the passage of the Farm Bill.
While the US cannabis and hemp industry has been permitted to expand and flourish under state regulated programs, federal laws have always applied, and will continue to apply. This is one of the many reasons standards are so critical to a developing industry like cannabis. The time is now to become compliant with all governing laws – state, federal, and international – as well as what is required to create a safe, quality, consistent product that is approved for sale across state and international borders.
The passage and signing into law of the 2018 Agricultural Improvement Act (Farm Bill) removed hemp from the Controlled Substances Act (CSA), making hemp legal in the US. Additionally, the Farm Bill moved federal hemp oversight authority away from the Drug Enforcement Agency (DEA) and into the hands of the Department of Agriculture.
Removing hemp from the CSA and DEA did not eradicate other existing laws or the regulatory authority granted to other federal agencies. The CSA was never the only law governing hemp and hemp derived products. Likewise, the DEA was never the sole agency charged with overseeing these products. Laws do not exist in a vacuum- so while the CSA and DEA may no longer apply, there are additional, longstanding federal laws granting regulatory authority to other agencies that still do apply.
The Food, Drug, and Cosmetics Act (FD&C) and the Public Health Service Act of 1944 (PHSA) both grant regulatory authority to the FDA, giving FDA the authority to oversee the safety of all food, drugs, medical devices, and cosmetics. The PHSA provides the FDA further authority to take legal action to stop the interstate commerce of products which involve a health or safety risk.
The FD&C specifically prohibits adding an active pharmaceutical ingredient (API) into any food or beverage (including animal products) intended for interstate commerce. It also prevents products containing an API from being marketed as dietary supplements.
By law, an active pharmaceutical ingredient is defined as any ingredient contained in previously approved drugs, as well as ingredients used in drugs that have undergone substantial clinical investigations.
CBD is the active ingredient in the FDA approved drug Epidiolex; THC is the active ingredient in Marinol and Syndros (both also FDA approved drugs). As such, the FDA has concluded that adding THC or CBD into any food or beverage product (including those intended for animals) that is intended for interstate commerce and marketing products containing CBD or THC as a dietary supplement are prohibited.
So, while the Farm Bill legalized hemp, other federal laws are still in place that prohibit CBD from being used in the following ways:
- marketed as a dietary supplement or a drug
- added to any food or beverages that are involved in interstate or international commerce
- making any type of health or safety related claims
Do you see any increase in inquiries to FOCUS from CBD companies?
We have absolutely seen an increase in inquiries from CBD companies since the Farm Bill passed. Most US hemp companies were not adequately prepared to meet federal requirements. So, regardless of the specific project they reach out to FOCUS about, they are all related to struggling to meet federal regulations as quickly as possible in order to become compliant.
What are key topics & challenges CBD companies reach out about?
Primarily, CBD companies are most typically asking for assistance in meeting federal requirements that will permit them to legally participate in interstate and international trade – so they are looking to achieve certification as soon as possible. FOCUS standards include the requirements from federal food, drug, and supplement laws – making certification a terrific option for CBD companies – regardless of where CBD is ultimately classified.
Other inquiries come from CBD companies that are just entering the industry that are in the process of designing facilities, purchasing equipment, and developing formulations. They reach out to FOCUS seeking assistance to assure their buildings, equipment, systems, processes and products are developed in a compliant matter from the outset. This is something FOCUS recommends to all cannabis clients in order to prevent costly delays and expenses related to remodels and process improvements down the road.
Other services CBD companies reach out to FOCUS about include: website and social media account reviews, as well as drafting and updating of and procedures to assure all of these things meet current federal and regulatory requirements.
Where do you see the future going with both, medical cannabis and CBD in the US and worldwide?
That’s a huge question! I’ll say this, the future is bright and absolutely unlimited if the industry can assure products and operations do not jeopardize public health and consumer safety.
Do you foresee CBD being mainstream in cosmetics and food in 5 years from now?
CBD is already included in assorted mainstream cosmetics and food products today, even though it is not legal in any products crossing state lines. Once the FDA and other federal agencies involved with the regulation and oversite of CBD come to an agreement on how to classify, we will definitely see an increase in legal products, both in and outside the US.
Do you believe in health benefits of CBD in cosmetics/food or is it just an overrated hype?
Ultimately, my personal beliefs on whether or not there are health benefits to CBD in cosmetics and food are irrelevant. That said, I would have never entered the cannabis industry in the first place if I didn’t believe there were therapeutic benefits. Ultimately, this question must be answered through further research and scientific exploration.
Is there anything else you would like to share with our community we might have forgotten to ask?
FOCUS is here to partner with cannabis companies to build their business into everything they want it to be. While the requirements in our standards are extremely thorough, they are designed to help cannabis operators gain control over all aspects of their business, allowing them to operate proactively, instead of drinking from the fire hose on a daily basis. We are here to help!