Utah Synthetic: Lezli Engelking and FOCUS for the Audit (Part Two)

In Part 1 of this two-part look at Utah’s ongoing struggle with synthetic cannabinoids, Christine Stenquist of TRUCE, a Utah-based patient advocacy group, outlined the roots of the situation, the reasons why the issue is coming to a head, and the challenges she and others face getting the state to redress its past and present mistakes. The stakes are high for businesses and Utah, but those concerns pale next to the fact that medical cannabis patients are being sold products in licensed cannabis “pharmacies” that have not been proven safe for consumption, according to Stenquist and Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), as well as experts (and patients) brought in over the years to testify before the state on the risks posed by these products.

In this part, CBE spoke with Engelking about the role she and FOCUS are playing in this saga, and the continuing effort to help convince Utah to do the right thing. Founded in 2014, FOCUS is uniquely qualified to do the work, and as Engelking explained, she is equally determined to address the same resistance Stenquist has been facing on the ground in Utah. The entire issue, she clarified, is not about business but the health and safety of people.

The Focus of FOCUS

FOCUS was founded in an industry still inching its way toward standardization eight years later. Along the way, FOCUS has developed a reputation for the quality of its work, the integrity of its approach, and a commitment to collaboration that has not always served it well in an industry full of skullduggery. Its mission is ambitious, and Engelking made certain business decisions at the beginning in a conscious effort to ensure a spotless reputation for FOCUS and its work.

“FOCUS is a health and safety organization,” she said. “We write standards and do certifications, but the whole reason I started this is because there wasn’t anybody in the industry that really just was out for health and safety. Everybody has a different motive, and so I wanted one clean organization that was an independent third party, that didn’t have any conflicts of interest or financial stake in the industry, to be able to advocate for health and safety.

“My background is in mental health, public health,” she added of her pre-cannabis days. “I worked in the pharmaceutical industry for almost 13 years. I live in Arizona, which approved medical use in 2010. I had just left my job at Eli Lilly, and some friends wanted to apply for a license. I didn’t know anything about it. I tried cannabis, I even inhaled, but it never really stuck. It took them maybe six months to wear me down with all the information about how great cannabis was –  this was way back in the day – but eventually they did, we applied, and won the first license in Phoenix. Everything is vertical here, and in two and a half years, we built this monster company. I feel like we were kind of successful in spite of ourselves. We just kept growing.”

The company was Bloom Dispensaries, which has since been sold to Curaleaf for over $200 million. At the time, however, Engelking was running the show. “I was the executive director,” she said. “It was my name on the license, so I oversaw all the operations. I had a hand in everything, and we did everything. I loved seeing the patients being helped, and I was excited about it.”

But the bloom on the rose was tainted. “I just felt like, oh my gosh, this is not right. The states are not providing guidelines for operators. They’re providing regulations, and they don’t provide any help for the industry to meet the regulations, which is not the case in anything that’s federally regulated. The FDA puts out gazillions of guidance documents. And the whole testing situation. Why are we doing all this third-party testing? Why don’t they mandate in-house testing? Why are we testing outside of the operation three different times while making the product? None of it makes sense from a quality and safety perspective.”

I asked if it makes sense from a “we don’t trust you” perspective. “Maybe, but that doesn’t build an industry. How do you build a global industry? You have to give them guidelines and tell them how to do the things you want them to do. So, the I left in 2013, and sold all my financial interest to start FOCUS as a 501C3 nonprofit health and safety organization.”

This was long before the industry we recognize today. “It was early days. I called NCIA, and I called MPP, and I called Americans for Safe Access, all these people, and I’m like, ‘Listen, I’m thinking about starting a standards company. I would like to get your opinion and your support, blah, blah, blah.’ And everyone was like, ‘Oh, yeah, more power to you. Go ahead.’ They’re all running their own small businesses and didn’t have time to deal with standards.

“And so, I did,” she continued. “Initially, I was going to take on investment capital. I used the capital I got when I bought out of Bloom, and some of my 401K, and I was planning on taking on investment. We went through the whole dog-and-pony show with that, and lots of people wanted to give us money. But they were all people that already had a stake in the industry, and I just didn’t want to do anything to jeopardize the integrity of what I was trying to build. Coming out of Pharma, like any study that comes out, you have to look at who does it right.”

Her business model is similar to standards organizations in other spaces. “It’s very similar to a big food safety certification body or any other certification body, like an SGS, or SQF, for food,” she said. “We write the standards, we sell the standards, we provide services to the industry to meet the standards, and then we do certification and training.”

The space is competitive, and Engelking had stories too raw to relate about the ways her standards have been copied or emulated by people looking to profit from her work, which is all but useless if no one knows about it.

“They’re copyrighted and trademarked, and they have to be cited,” she said of her standards. “But you have to make them public. They’re not of any value to anybody if people don’t have them to meet them.”

The thing about standards, she explained, is that there are always more than one. “There will always be multiple standards,” she said. “There are tons of standards out there for everything, so that’s not weird to have. Typically, they address either different segments of the market, or they go about it differently, and there are strengths and weaknesses with different ones.”

That said, even as the industry’ fortunes tighten, FOCUS is holding its own. “We’ve done okay,” said Engelking. “It’s always been a struggle because we won’t take investment money because we don’t want to jeopardize our integrity, but we’ve got a great brand. We have clients in 31 states and 15 countries, so we’re doing good.”

FOCUS also has a tall mission, to protect public health, consumer safety, safeguard the environment “by promoting integrity in the cannabis industry.” It has everybody’s back.

“The idea was nobody should be against us,” explained Engelking. “We’re here to help.”

To that end, she added, “Our standards, intentionally, are internationally based. We use U.N. and World Health Organization guidelines as the basis because, by definition, standards enable trade. Standards are the reason our ATM cards work in every bank and every language, and our camera film speeds are the same. We use standards for everything, and typically they’re international.”

FOCUS currently has only four employees – some downsizing was required during COVID – but it was never a large staff. “We’re building again,” said Engelking, “but a bunch of employees has never been my model.”

Clients are not just in states but include states. “A lot of our work for the nonprofit comes from state and government advocacy work, trying to help them build better programs. I’ve spent the last 18 months working with Utah. Nobody paid me. We have monthly calls and write reports and do reg reviews for them, because we’re a nonprofit, and we’re here to help. I’m on my way to Morocco on Monday to go help the government with their program.” Other countries FOCUS has worked with include South Africa, Israel, Canada, Mexico, and Australia.

But FOCUS also works at the municipal level. “A lot of times what we do is, when a new state is coming online and cities are given the option to opt-in or opt-out, they’ll bring us in to advise them on what are the positives, what are the negatives, what do we need to be aware of,” said Engelking. “One of the biggest benefits about FOCUS is that we don’t have a view of one state or another, or even one country or another. We look at everything from a global perspective.  So, from a lessons learned perspective, the knowledge that we have to help people build better programs is huge.”

Utah Synthetic

For Engelking, the Utah situation is not very complicated when you get down to it, but it is confoundingly unique to the state. “Utah is different because they have a regulatory program for medical, and they’ve let all these synthetics into their medical programs,” she explained. “Lots of states have a synt problem. The whole country has a problem with all these synthetics. That’s not unique to Utah. What’s unique to Utah is the state allowed those products into their regulated industry, even though we don’t have any idea how to test for them.”

Stenquist had previously explained that when she found out the threshold for contaminants in the synthetics was rising to the 10 percent level, it was time to activate the “kill switch,” raise the alarm, and reenergize opposition to an unacceptable situation that could get worse if the current 5 percent threshold for allowable unknowns is raised to 10.

“The thing is,” added Engelking, “when I say there’s no safety data, there is a lot of data, good scientific studies, that show that there are chemical conversions that create unknown chemicals in these products. And so, we don’t know what those chemicals are, we don’t know when they pass the blood brain barrier, we don’t know how they’re excreted from the body. They’re not natural, but there are a lot of chemicals like that that build up until your metabolism slows down when you’re 65, and then they can create a problem and cause cancer and other issues. So, while there is a lot of data to show there are safety concerns, there is no data to show safety, and that’s a different thing, because you cannot regulate something as safe just by the absence of data.”

She also is clear where the responsibility lies. “So, I’ve said this since day one,” she stated. “States are responsible for protecting the well-being of the citizens with their regulations, period. And if they’re not, it will come back to haunt them, and I feel like that’s exactly what’s happening here. You can’t just make decisions and not think about the outcomes to people.”

It was extremely strange that Utah sends patients to doctors with minimal training about cannabis or how to prescribe it, and then are sent to “pharmacies” with products that may contain high levels of degradants, but one cannot know for sure because of everything she just said.

Despite the challenges, Stenquist and Engelking are geared up to do right by Utah and its cannabis/hemp industry, even if it means dragging the state kicking and screaming into the future. I asked Engelking if there is something tangible Stenquist and TRUST can hand off to FOCUS as the fight gears up.

“One thousand percent,” she said, “that is what FOCUS was created to do. We will conduct a comprehensive analysis of the Utah medical cannabis program, including benchmarking regulations, interviewing patients and physicians, testing products, reviewing documentation and inspecting facilities in order to recommend the most effective and efficient way to ensure the safety of medical cannabis products in Utah and begin to rebuild trust in the program.”

What if the legislature raises the acceptable level, I asked. “How do you make an acceptable level of something that’s toxic,” responded Engelking. “The hope is that before the legislative session starts, we can put something in front of the legislators and say, ‘Look, you can make all these decisions and try to pass all these bills, but why are you doing that with your eyes closed? Here is a solution.

“The problem is the legislators are pushed by the lobbyists, and the legislators don’t have a clue about what’s safe and not safe,” she added. “They just listen, and they pass bills, and so we need to get them educated on why they can’t do this. Christine’s already got a lot of those connections. She’s started these discussions. So really, it’s just a matter of putting the information into a package they can understand and get behind.”

What about the argument that synthetic products should be pulled from the shelves? The other side is screaming that it will bankrupt them, so where is the middle-ground?  “First, getting all these products pulled is not going to happen,” said Engelking. “It’s ideal, but it’s never going to happen. They could stop allowing the sale of them, don’t let them produce any more, but they cannot pull them. There’s just no way. And as much as that flies in the face of public health, they have a responsibility to provide access to patients, so they can’t just pull.”

Does FOCUS have an answer to this conundrum? “The answer is there isn’t a good answer,” replied Engelking. “But here’s the thing. The safety of these products needs to be established, and that’s the reason we believe going in and testing and letting them defend their certificate of analysis is the right way to do it. Because if they want to, they can do the safety studies. But here’s the other part of it. This is a risk to health and safety. It isn’t about business. If you think about the Tylenol scare way back when, sure, it hurt Tylenol, but you still pulled all the product. Nobody gets that in cannabis. We don’t have that because while there are people getting sick from these products all the time, there’s nothing so in your face that makes people do this.”

Engelking believes that the population can be somewhat protected if standards are established and products tested, but we’re not there yet. “The problem is, when you send a delta-8 product to most labs, it’s going to come out looking fine, because they don’t know what they’re testing for,” said Engelking. “Think about drug testing. If you go to the doctor and they do a test to see if you’ve been smoking weed or using opiates, whatever tests they use has to be specific to what they’re looking to measure. We don’t have those tests for chemicals that are created during manufacturing because the process is always different. We don’t know every downstream chemical that can be made, so how can we say that they’re safe?

“I don’t believe we need to ban synthetics,” she added. “I truly believe that they will be a huge part of medicine going forward, and they should be. We want that. We just want to do it in a safe way. I have no problem with people growing weed and selling weed. We know the safety of that. But we don’t know that when we’re making chemical products.”

I asked if she supports home grows. “I want there to be home grow,” she insisted. “I say this to the regulators all the time, growing cannabis at home is not a risk. People have been doing it forever. What’s the risk? Somebody peed on the plant while it was growing? That’s not a risk. The risk comes by producing cannabis at scale. It comes from the people involved in the process. It comes from a lack of control. It’s the same with food. It’s the same with anything. So, it’s not the plant. Home grown should always be allowed. That’s just a fear thing. This is about if you’re going to produce things at scale. It’s when things get big that the problems happen.

“I’m also a big supporter of small business,” she added. “I believe that we need the standards so that there is a level playing field. One of the things that we’re working on right now is trying to revamp our certification process so that it’s longer and it takes three or four years, but it’s cheaper and it’s done in phases, so that small businesses can take it in mouthfuls and get through it easier.”

Future FOCUS

Whatever happens in Utah, FOCUS will keep its eye on the ultimate prize, established and accepted standards that serve the entirety of the industry. The only way to get there is by bringing people together.

“Our biggest partner is the Association of Food and Drug officials (AFDO),” explained Engelking. “We’ve been partnered with them since 2016. We’re their cannabis regulatory partner. AFDO is a nonprofit that’s been around since the 1800s. They have all these programs and things that they do, and FOCUS has worked closely with them since ‘16.

““We collaborate on all their cannabis education, training, conferences, and right now we’ve got a project to build a federal framework for cannabis that we started in September of last year,” she added.

Will this process result in actual policy? “The idea is, all these proposals for federal legalization are like, ‘Let’s look at alcohol, let’s look at tobacco, let’s do this tax,’ and not one of them has any considerations for public health. But if we’re going to regulate this, let’s regulate it the right way, and everything that’s been proposed would knock out portions of the industry in one way or another.

“What we’re saying is, no, there’s a way to do this,” she added. “Think about if we regulated corn just as food, and we didn’t use it for ethanol or penicillin. The idea is to build a framework that can utilize the plant in all its different capacities that can fit within existing structures, that gives a level playing field for business, that protects public health, and that still generates revenues.”

And how does this synthetics issue ultimately get resolved? “For that you will have to stay tuned. The Framework project will be making formal announcements early in the new year.”