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According to its chairperson, Massachusetts’ cannabis regulatory body is currently in crisis, but for some stakeholders in the state, it’s a long-simmering crisis endemic to a dysfunctional agency unable to deal with serious issues facing the Massachusetts cannabis market. One such example is what is reportedly taking place in Massachusetts with respect to the frequency of lab shopping, an issue certainly not unique to the state. From coast to coast, cannabis lab shopping is a serious problem that only a few states have seriously addressed, but what makes Massachusetts unique is the apparent lack of response by the Cannabis Control Commission (CCC) to lab shopping and other issues about which some lab operators have been seeking help from the CCC for years.
And it’s not just a lack of response by the CCC that is concerning. From the outside, its intransigence looks more like an inexplicable conspiracy to muddy the waters so that consumers and patients alike are unable to assess the accuracy of product information on the labels of cannabis they purchase legally in Massachusetts. It is unthinkable that a regulator would condone such practices, but it gets even worse when one considers that mold is also rampant in cannabis products in the state, as is the sale of illicit synthetic cannabinoids in the greater market, all of which the CCC remains complicitly silent about.
These can of course be tough problems to solve, but not addressing them is probably one of the worst solutions, and aiding and abetting is next in line, because it makes operators understandably upset, which is not what anyone wants. Operators of labs are often PhDs with little inclination to dramatic outbursts, and engaging in public spats with regulators is the last thing they want to do, especially in a competitive marketplace. When they do speak up, therefore, it tends to be for a viable reason, and in Massachusetts, a few lab operators have been energetically raising the alarm about a testing regime that is failing the public and possibly putting people’s health at risk.
Chris Hudalla, founder and Chief Science Officer of Milford-based ProVerde Laboratories, is one such operator. A mild-mannered individual who runs one of the state’s first cannabis testing labs, he rues the thought of a vindictive reaction from the regulator in the form of a retaliatory inspection to public expressions of frustration, but inaction is unthinkable under the circumstances. Taking part last month in The Young Jurks podcast, with host Michael Crawford and fellow guest Jeff Rawson from the Institute of Cannabis Science, Hudalla explained the basis for his irritation with the Commission.
“We’ve asked them point-blank for a list of approved ingredients,” he said. “What is approved for addition, what is the process for approval, and like all of our other inquiries, it went ignored. They don’t even have the courtesy of saying, ‘We’ll get back to you.’ They don’t respond at all. That’s the frustration. The frustration is that I’m looking to our regulators to regulate what I’m doing to help me do my job, and if I’m not being regulated by the regulators, what am I doing here?”
The issue extended beyond inaction to errant advice from the Commission’s director of testing, according to the podcast guests. “When I’m told that I don’t have to follow the USP guidance, which is pointed to in [Massachusetts] law, he didn’t say break the law, but that’s the underlying message that comes across, that everybody else is doing it, so you don’t have to follow the USP guidance; it’s not required.”
Hudalla elaborated, “We asked if THCV should be included as part of the THC [total amount] – because THCV is not a THC; it’s a Cannabivarin, not a cannabinol – and he said that because there’s no documentation that shows THCV is not a THC, it is permissible to include it as a THC. I responded, “We have no documentation that says vitamin B is not a THC. Can I include that in my total THC calculation?’ To which he responded, ‘I guess so; it’s a business decision.’ A business decision? After that phone call, we sent an email reiterating the conversation and asking for written confirmation of the discussion. Again, no response. They won’t put it in writing.”
“It makes you wonder what other kind of guidelines he thought of as advisory or flexible to make a business decision,” said Rawson. “I’ve collaborated with a bunch of labs here in Massachusetts, and Chris is not alone in his experience. I’ve heard from multiple lab operators that they try to contact the CCC again and again for guidance, and never get engagement or are able to talk to them about problems.”
When some labs do complain loudly and publicly, like Michal Kahn, founder and CEO of Framingham-based MCR Labs, the CCC allegedly responds with the lab version of brute force in the form of a six-hour inspection that ended up finding basically nothing. During the podcast, Reynolds asked Hudalla if that sicario concerned him.
“We’re always prepared for a visit,” said Hudalla. “That is part of their responsibility, to visit the labs, and unannounced visits are fine. What I do fear is the retaliatory visit, one where they come in and try and find anything they can to try and make our lives miserable because we’re challenging the lack of regulatory guidance being provided. Whether or not those visits to the other labs were based on retaliatory rationales, there’s some thought by some people in the industry that they were. I don’t know that to be the case, but one could suspect that, and I do worry about speaking out against the Cannabis Control Commission.”
Hudalla included several slides during the podcast from the deck he put together for regulators and others to explain the issues surrounding potency inflation, and why it needs to be addressed. “Some of the potency percentages are in the high 40s,” he said. “I think we’ve seen 48 or 49 percent. When that goes viral on social media, Massachusetts is the laughingstock of the nation when they started seeing some of these numbers being reported, because they’re just not botanically relevant numbers. Is that fraud or is it laboratory incompetence? I don’t know.”
The distinction might be moot in Massachusetts. “I was frustrated with the widespread laboratory reporting that I considered fraudulent in Massachusetts,” explained Hudalla, “but after having conversations with the Cannabis Control Commission, I realized that if the rules are that you can report whatever you want, then I don’t think it’s fair for me to call it fraud, because it’s not fraud if it’s part of the rules of the game and the CCC says, ‘You can report whatever you want for potency, and it doesn’t really matter.’ The irony is that we are using essentially using the same analytical instrumentation and the same methodologies, and we are probably all generating the same raw data. It’s just how that data is being manipulated or handled.”
It is also a situation unique to cannabis. “We’re so frustrated,” said Hudalla. “If you just look at the consumer market, whether you’re looking at food, pharmaceutical, nutritional supplements, household cleaning products, everything has a label, and on that label they tell you what’s in the package. The Commission basically says we don’t know how to report potency. But why would anyone choose any process for reporting potency that is not consistent with the product in the package. It just baffles my mind.
“I hear regulators point out that Massachusetts program is a model for the nation, and when I hear that I wonder what program they’re looking at,” continued Hudalla. “Massachusetts has the first cannabis worker fatality. We frequently hear that any issue we raise goes under investigation, but where do investigations go? This issue with the corydalis. They opened an investigation on that a year ago. Did the investigation get closed? Are they still investigating it? I think investigation is just code word for ‘because it’s an open investigation, we don’t have to talk about it.’ I don’t think they’re being a very transparent organization when they say that. I think that’s disingenuous. They’re very vocal about their data transparency, but it’s only data that they want to be transparent and that is convenient for them to show.
“So, when you talk about transparency, I would like to know how many investigations are ongoing, and what are those investigations pertaining to,” he added. “I realize some of the content of those investigations should be confidential, but I’d like to know how many are open, how long have they been open, are they ever actually closing an investigation, and what is the rate of closure? A lot of the things that I hear about investigations are that they go on for years and are never addressed. And, like Jeff, we have an open FOIA request that has been ignored. We know they got it because they sent an email confirming receipt of the request, but it’s been over a month and not denied or granted. I think under state guidelines they have 10 days to address it, and we just get ignored.”
The Problem with Potency
During the podcast, Hudalla explained the fluid nature of dealing with the question of consistent and accurate testing for potency. “With potency,” he said, “there is some ambiguity and some questions, such as should we moisture-correct flower? Some states, like Montana and Michigan, prohibit moisture correction, while New York requires it. I’m personally against moisture correction because it leads to inflation over the product that’s in the package, and the number that’s on the label is what consumers use to inform their purchasing decision, and what they’re expecting to get in the package. If moisture correction is being used to inflate those numbers, they’re being misled and they’re paying higher prices for it because it has higher potency. We have proposed to different members of the CCC as well as to the cannabis advisory board, ‘If you have flower values that are, let’s say, 32 or 35 percent, maybe it requires a second lab test.’ In Montana, you can’t even have flower over 35 [percent [THC] or it fails.
“I would hate to see that level of regulation here in Massachusetts,” he added. “Maybe somebody does have a strain that comes in at 35 percent, but all it takes is a second lab to confirm that. If the state ever has a reference laboratory, that could be part of the reference lab’s responsibility, but building and validating and getting accreditation for a state reference lab is at least a year and a half to two years away, so that’s not a short-term fix.”
The short-term fix is almost absurdly simple. “An immediate fix would be dissemination of a bulletin that says potency will be calculated like this and give the equation that they’re expecting,” said Hudalla. “The director of testing says they can’t just issue a bulletin. However, when they changed the limits for hydrocarbons from one ppm to 12 ppm, they did that via a bulletin not even sent to the labs. They posted it on their website. There was no change to the regulatory guidance until a month later; they made an immediate change based on issuing a bulletin, and I would expect that they could do the same thing for potency. Just issue a bulletin that says, ‘You have to follow the law. The law says to follow the USP guidance. Here’s the USP guidance.”
“The CCC is not very effective at policing the one fairly obvious problem that has been well documented and discussed now for a long time in this state, and relatively easy to address,” noted Rawson. “They can’t even get to the point of enforcing the straightforward guidelines.”
With inaction on simple problems, how can more complicated ones be addressed? “When it comes to microbial contaminants, that is actually a regulatory challenge, because there are different methods of testing and different requirements from one state to the next,” said Hudalla. “Some of the labs in Massachusetts are multistate operators and have testing methodologies that are appropriate for other states but maybe not necessarily for the Massachusetts regulations for microbial contaminants. I don’t expect the CCC to take that one on in the near future, because it is a very complicated topic. We go to conferences, and there’s groups of PhDs that don’t agree and are wrestling with these decisions. The potency thing seems like a no brainer.”
Hudalla noted that some states have found ways to deal with the potency problem. “Some states just don’t address it, and it’s assumed that it doesn’t happen,,” he said, “but Michigan went so far as to say you can’t dust your sample with kief before it goes to the lab, you can’t play with the data, and you can’t manipulate it by moisture, so they’re very clear about what is and what is not permissible. Producer manipulation of the sample is prohibited, and laboratory manipulation of the data or the sample is prohibited.”
“That’s all we need Massachusetts,” said Crawford.
“But it’s already all in the USP guidance,” countered Hudalla. “And it’s amazing that we can’t disseminate that procedure to the labs and use it. It just highlights some of the lawsuits that are happening in multiple states. This is not a Massachusetts issue,. Potency inflation, lab shopping is a serious problem in every single market that we see. In most states. I have seen either some recalls or lab closures based on some of the shenanigans that are found. But in Massachusetts, I think I’ve seen one recall, and that product recall occurred six months after the contaminants were identified. If it truly was a consumer safety issue, why wasn’t that product recall issued at the time that the problem was identified rather than waiting six months? In Massachusetts, we don’t see any kind of enforcement action, but who knows, maybe it’s all behind the scenes.”
“It’s a very important question how some of these concerns are going to be investigated, and who’s going to do it,” said Rawson. “We know that the legislature is looking at the CCC right now, and I hope they’re going to make a really forceful move to install some better oversight.”
“In any other commercial operation, people typically would have a supervisor to report to,” said Hudalla. “If I’m at a restaurant and I get terrible service, I might speak to the manager. When things go wrong, there should be somebody that is ultimately responsible for accountability, and the CCC has shown that they’re above that accountability. As far as I understand, there’s no oversight, so if they don’t do a good job, who are they accountable to?”
“Demand open data,” advocated Rawson. “Having an internal auditor of the CCC is also essential. I think there are enough questions now about some of the conflicts of interest that may apply to some of the staff who are in really important positions right now, and I don’t see how you can resolve that and resolve some of these open investigations without third-parties involved. So, I would urge people to tell their legislator, and complain.”
“There are also bills both in the Senate and the House regarding data transparency and making some of the METRC data publicly available,” noted Hudalla. “In other states, it led to some lab closures because there were indications of shenanigans or fraud that could be gleaned from a review of the data, so having transparent data would be a huge benefit. The other bill regards accountability, somebody with some oversight capability over the commission.”
Massachusetts’ problems with potency testing were also delineated in a December 2022 article in Commonwealth magazine, which did its own test of cannabis products for an article titles, “Marijuana content labels can’t be trusted.” ProVerde Labs was one of the labs used by Commonwealth to determine accurate results.
Crisis Brewing
In a conversation with Hudalla on Monday, the ProVerde Labs owner told Cannabis Business Executive the situation remains “politically very delicate. I feel like I’m walking on eggshells, because our Cannabis Control Commission has demonstrated their vindictiveness and their retaliatory inspections.”
Hudalla asked me, “Do you know who is ultimately in charge of the Cannabis Control Commission? Who has the most power?”
I did not. “Well, neither do they,” he shot back. “Literally, a week and a half ago, we met with the chair of the commission, Shannon O’Brien. And we don’t understand how our own Commission works. Is the chair of the commission the top authority, or is the executive director, because they have different roles? So, we asked her, and she said she doesn’t know. She said it’s been a power struggle, and they don’t know internally who’s in charge.”
Hudalla further explained that the opportunity to speak with O’Brien came at a recent business event where ProVerde had a booth. “We’re horribly frustrated by regulatory incompetence,” he said. “We can’t get anything done, and we can’t even get the Commission to say what potency means. My potency deck explains how much confusion there is. Massachusetts consumers are utterly confused and don’t trust any lab, and they don’t trust the product on the shelves. There’s so much moldy product.
“So, we took the opportunity to ask her as much as we could, because you only get about five minutes,” he added. “We asked her, ‘Who is actually in charge?’ And she just kind of laughed, and said, ‘I don’t know.’ She thinks she’s in charge; Shawn [Collins] thought he was in charge, and ultimately I think there was a power struggle. I mean, they have open meeting laws, but there were recent occasions where you’d log on to the open meeting and they would officially go behind closed doors. So, they have to open the meetings publicly, but then they say that they’re going to go behind closed doors to sort out some things, and I have a feeling some of it was organizational challenges. Who’s in charge? Who’s calling the shots?”
Curious about how all of this could come about, I asked Hudalla if this problem extended back to the medical-only era? “No, I don’t think so,” he replied. “Originally, the Department of Public Health was in charge, and they took over the responsibility for medical. When adult-use came into legalization, they created the Cannabis Control Commission, and initially all of the medical testing regulations were replicated. They have different regulatory documents, but they’re almost word-for-word the same except one will talk about recreational marijuana and one will talk about medical. Essentially, they took all of the Department of Public Health documents and duplicated them for the Cannabis Control Commission, with one version for medical and one for adult use. The few differences between them were subtle – how much a patient can buy, and what is the maximum dosing – but the majority of the regulatory framework was identical for medical and adult-use. So, in the early days, because the Department of Public Health did a very good job, the first year or two seemed to go very smoothly. But as the industry grew and more licenses were issued, there were shenanigans, and in my opinion, the CCC didn’t know how to address them.”
Does that mean there was a point in time when it was clear what potency meant for labs and consumers? “Absolutely,” replied Hudalla. “In the days of the Department of Public Health, there were only two other labs besides us, and we met on a monthly or bi-monthly basis with the DPH and the state’s chief toxicologist. There were probably eight of them in the room, including lawyers, because you can never have a regulatory conversation without a lawyer in the room to witness what is being said.
“We had the opportunity to ask questions, to raise concerns, to talk about bad practices or good practices, what works, what we’re concerned about,” added Hudalla. “In one of those meetings, we said, ‘There’s some ambiguity in the written regulation, and can we please clarify what that means.’ And without changing the written regulation, that Department of Public Health clarified to labs how to test and report for potency, and all the labs adopted that. It was so simple, and I don’t think anyone even thought that we had to go back and rewrite the written regulations, because the ambiguity is still in the written regulation.”
Those were unfortunately the halcyon days. “When the Cannabis Control Commission took over, there were now all these new labs. Nine new labs were licensed under the Cannabis Control Commission that never got that verbal clarification, and so as these nine new labs came on, there’s this ambiguity in the written regulations, and they were allowed to interpret it however they want. Well, this was going on for probably a year or two, and we’re struggling because we are losing business all the time. I’m like, how can that be? And my customers say, ‘Well, these guys report potency 30 percent higher than you.’ I’m like, that’s impossible for the same flower. How can they do that?”
The Commonwealth magazine article opened his eyes to what was going on. “The reporter in her investigation, and in some of the conversations we had, enlightened me as to how these other labs were manipulating the data. I thought it was just cheating. I thought labs were making numbers up and being totally unethical, but I came to find out that they’re doing calculations and data manipulations that the CCC is aware of and permitting. I have emails saying this is the way to report, and then six months later, I asked them, and they’re like, ‘You don’t have to follow that original guidance we gave you. Now you can do whatever you want.”
I asked Hudalla if Shannon O’Brien seemed aware of the potency issue when they spoke with her a week earlier, or if it seemed new to her. “No, it wasn’t new at all,” he insisted. “There’s a cannabis advisory board made up of scientific-minded people or lawyers, and they basically review the regulations, hold public meetings, and put together a series of recommendations that they present to the commissioners before revising the regulations. I have spoken multiple times to the cannabis advisory board, and they know I’m very frustrated.
“There are at least three issues that I’m horribly frustrated with,” he elaborated. “Number one is potency manipulation. Number two is the huge amount of moldy product in the Massachusetts marketplace because they allow a test that has been prohibited in multiple states because it is prone to false negatives, and we have tons of data that I’ve shared with [the CCC] to support that. The third thing is products on the market in Massachusetts that contain ingredients that are of toxicity concern. People are adding things to their products that are potentially harmful. We’ve asked the Control Commission, ‘What about people putting things in these products that are detrimental to people’s health?’ and they don’t do anything about it.”
In terms of CCC priorities, he thinks potency will be dealt with first to get it off the front burner. “Because there’s so much publicity around potency, I think that they will deal with it,” said Hudalla. “Potency is such an easy one for them to address. State law clearly states that Massachusetts regulations will be based on USP guidance, and the guidance is very clear on what total THC is and what potency is. But the CCC director of testing says, ‘We don’t agree with your interpretation of the USP guidance.’ I said, “But the USP guidance is so clear. He says, ‘Well, in the USP guidance, it says total THC may be defined as; it doesn’t say shall be defined.”
But that distinction does not hold water, said Hudalla. “I explained to the director that the USP is not a regulatory body, so they cannot regulate. They are a standards body, so they cannot ’shall’ anyone. They can’t tell the state what to do. USP says they may be defined this way because they’re providing their recommendation, but it’s the Massachusetts legislators who said the regulations shall follow USP.”
That argument also fell on deaf ears with James Kosis, the director of testing for the Cannabis Control Commission. “The take home message from that meeting – and I had witnesses there, otherwise I wouldn’t feel comfortable talking about it because it’s unbelievable – was that I felt like I was being told to break the law. I was so disturbed that I wrote back to him and copied every single one of the commissioners on there. I said the guidance we were provided with was inappropriate, and it was contrary to the law. I said I would like to rehash this meeting, but I want one of the commissioners. The commissioners isolate themselves, so they don’t have to weigh in on important topics, but I asked for another meeting to include at least one of the commissioners so that I could have a commissioner present when I was being given guidance to break the law. And they basically said no. They said, ‘You can meet with the director whenever you want, but there will be no Commissioner present.”
Hudalla concluded, “Shannon O’Brien was very well aware because she was copied on the email where I was expressing my extreme concern for being given guidance which is contrary to the law. The potency issue is super easy for them to fix, and they are afraid to touch it, so they’re never going to touch the problems with microbial testing. We believe that probably 60 percent of flower in the Massachusetts marketplace is contaminated with mold. We even started offering free ESA mold testing to consumers because what they’re buying is contaminated, and people are starting to post this on social media.”
I asked Hudalla why these seemed to be such a complete divergence of priorities between lab operators and regulators, as if they lived on different planets. “The CCC – and again this is my opinion – has a list of priorities, and in those priorities are things like diversity, equity, inclusion, and diversion,” he suggested. “But they rarely talk about consumer safety or employee safety. Lorna McMurray from Trulieve was first cannabis industry worker death in the United States. What she died from was under investigation by the CCC two months before she died. When the CCC puts something under investigation, that’s synonymous for we don’t ever have to talk about it publicly again.
“We never see results from investigation,” he added. “In other states, there are numerous recalls when moldy products are found, when labs are cheating, when producers are cheating, or when something’s not safe. There are recalls all the time in every state, but Massachusetts has only had one recall, and it was retaliatory. The CCC has a secret shopper program, and the regulations permit them to pull the product off the shelf and have it tested, but they have never used it. Why not? It just baffles the mind. The CCC, in my opinion, has done little to ensure consumer safety, and they’ve done little to ensure worker safety.”\
And now there is the implication of internal power struggles leading to a high-level resignation, and in response the regulators are circling the wagons, a common occurrence throughout the nation as markets falter and states come under fire for problematic programs that are increasingly in crisis themselves.
“I think they’ve been under crisis for years and didn’t even realize it,” said Hudalla of the CCC. “Their house was on fire, and they were totally oblivious to it.”
But are we approaching a tipping point? Is the “crisis” a sign of this pressure? “I don’t have any insight into that,” said Hudalla. “I think the commission has been very ineffective, but I don’t know if it was a power struggle, I don’t know if it was [Shawn], and I don’t know if it’s Shannon O’Brien. It does seem like there’s a significant amount of discord even publicly in their meetings. I don’t know if animosity is the right word, but they seem to be extremely ineffective.”
He paused before continuing. “My world doesn’t revolve around how much money is made, or how many patients sign up,” he said. “My world revolves around consumer safety. Is the product safe, are the labs providing adequate testing, are they reporting similarly? And in my world, everything that I see has been nothing but pure dysfunction and regulatory incompetence. In 2018, we started seeing synthetic Delta-8 THC permeate the hemp market, and we started seeing synthetics in the regulatory market in Massachusetts, producers who were making THC out of CBD. Three years ago, I asked the Commission point blank if synthetics are permissible in the Massachusetts regulatory program. I’ve pinged them back numerous times over the last three years, and I get no response.”
These are the same synthetic products wreaking havoc (and profit) in states throughout the nation, an issue certainly not exclusive to Massachusetts except for how it deals with the problem or refuses to deal with it.
“These [products] are not that different than Spice,” said Hudalla. “They’re chemical compounds that don’t exist in nature, and now you’re going to permit them under the regulatory program. So, I asked, ‘Are those permitted?’ And I can’t get an answer after three years. There’s a gummy with a chemical in it that won’t be approved by the FDA because of liver toxicity. I asked the state, “Is this permissible?’ They won’t answer me. After I notified the state, it put out a warning letter to the producers, and there’s a bulletin open, but nobody reads the CCC bulletins. Consumers don’t, and there’s no warning on the packaging, and no warning in retail, and they weren’t required to pull them off the shelf. So, people are buying products that could be harmful to their health, and the CCC is silent on the issue other than they put out the one bulletin, but they didn’t call it called the chemical by name. They called it by one of its names, but there’s other names, so when they put out that bulletin, producers just changed the labeling on their packaging to call it a different name.”
It’s a stalemate stuck in bureaucratic hell. “Under our Department of Agriculture, these products are illegal,” explained Hudalla. “We see Delta-8 products at vape shops all over the place, but the Department of Agriculture has no regulatory bite, and can’t do law enforcement.”
I asked Hudalla if he thought what occurred at the recent CCC hearing would make any difference in terms of addressing his concerns. “I don’t think it’s going to have any impact,” he said. “They were so dysfunctional I’m not sure if this will represent an improvement. I don’t know what the problem was. I don’t know why they were so dysfunctional. Was Shawn Collins the problem and now he’s gone? I don’t know. I can hope that he was part of the problem, and with an obstacle removed, the CCC will actually be a little bit more effective in their regulation. But I don’t know that. It baffles the mind that they have been so unresponsive. When they deal with hard questions, it’s almost like analysis paralysis, so they deal with easy questions. Should veterans have free patient cards? That is so easy, and they will debate for two hours on it in their meetings. Why is this even a debate? If you put it up for a vote, everyone will give veterans free access to medical cannabis.”
I asked Hudalla what he thought Shannon O’Brien meant by the Commission being in crisis. “I think her comment is pretty simple to understand,” he replied. “They’ve got a lot of irons in the fire, they’re trying to rewrite the regulations, they’re trying to hire some key staff positions, and they are trying to deal with worker safety.” He clarified, “They say behind the scenes that they’re working on it. We have seen no effort on that at all but based on what happened at Trulieve and that fatality, I have to imagine that there are directives to address worker safety. So, they have a lot of stuff going on, it’s a very busy time for them, and then the executive director basically resigns with no notice. Maybe [O’Brien is] upset because all of a sudden all of that dumps onto her plate, and she’s in crisis mode now because it’s too much to handle for one person. I think she was disappointed that she didn’t get more notice. My feeling is that she just feels like she was dumped on.”
The scenario of an overwhelmed executive with a dysfunctional staff is more probable than one in which a nest of corrupted politicos runs roughshod over a previously well-run program. “I never got the sense that there’s a huge amount of corruption,” said Hudalla. “To me, it’s just more about incompetence, and I don’t even think it’s the Commission itself, but the people that they’ve hired into key positions.” In a few cases, he added, individual conflicts of interest extend well beyond incompetence, with accountability conveniently wanting. “What I can’t understand is when it comes to light, why they don’t do anything about it,” said Hudalla.
MCR Labs
We also spoke recently with Michael Kahn of MCR Labs, which was surprise-inspected by the CCC in what may have been a retaliatory inspection by the Commission. It would be easy to paint Kahn as a firebrand under the circumstances, but the moniker does not fit the man. If anything, Kahn seems to want nothing more than to avoid the spotlight in favor of the business of science. I asked if there has been any resolution with the CCC since the inspection.
“It’s hard to say,” he replied. “There has been some interaction and those interactions are not great. There’s [been] no call to apologize or anything like that. They have continued not visibly addressing the issues that we have, and the harassment is kind of at a stalemate. I guess I have no idea. I don’t have any authority or power. I can’t ask them what any of it means.”
It is the same helplessness in the face of a stultifying bureaucratic malaise expressed by Hudalla. When I asked why his rapport with the Commission went awry, he said similarly, “It’s hard to know because the Cannabis Control Commission does not share their thoughts or information, or any reasoning behind anything they do. So, I don’t know. I have my perspective, but I always worry that I’m missing something important, and they might have a good reason for some of the stuff that they do. They never communicate it, but I want to preface that I think they might have a legitimate side. Though I can’t think of what it could be, and I have asked many times.”
As with ProVerde, the early years of the medical program were not divisive times for Kahn and MCR Labs, which today has locations in Massachusetts, Maine, and New York. “The medical law in Massachusetts was passed in 2012,” he recalled. “We opened in 2013, and by about 2015, the Department of Public Health took over the medical marijuana program, and promulgated testing regulations. In fact, they were the first in the nation to require testing. They met with all of the labs. Every six weeks or so we would all come to downtown Boston to discuss the issues, possible solutions, and they would give us occasionally advice. There was a very collaborative relationship where the head of the program would always be there, with compliance and toxicology, in very productive meetings.
“In 2016,” he continued, “Massachusetts passed the adult-use program and established the Cannabis Control Commission. Authority went to the Commission both for the adult-use program and for the medical program, and away from the Department of Public Health. At first, it was pretty optimistic. I did meet with several commissioners., and with executive staff from time to time. But over time, they got more distant. Yes, there’s a lot of context to provide here. We would over-communicate. If we ever had even a small quality control hiccup in the lab, we would communicate it to them just so that they would know, and they would routinely kind of blow up about that. There wasn’t a positive feedback loop with them.
“We started sharing concerns and needed additional clarification on some of the testing requirements,” he added. “One example is that there were new testing entrants in the marketplace who almost never found contaminants in products that we routinely found mold in, and those new entrants into the market began to take a lot of market share, because it’s very preferable for all our mutual clients to not find contaminants, and it doesn’t make financial sense for them to keep testing with a laboratory that doesn’t want to solve their problems.”
Taking that as a given, Kahn sees little reason for people not to lab shop. “The way I see it is that in this market, there is a very strong financial incentive to find the lab that doesn’t find problems and find the lab that improves potency,” said Kahn. “And there is no incentive built into the system for accuracy or honesty. It’s like whack-a-mole. I hate using these terms, but the root problem is that there is still an incentive not to find contaminants and to increase potency, and if a lab is smart enough, they will find a different way to inflate potency and not find contaminants.
“I’m a chemist,” he added. “I know a dozen ways to do so without anybody finding out. It’s not that hard, and you can use one excuse or another in the imperfections of the regulations. But, as long as the root problem of there being literally no incentive for accuracy remains, and as long as that’s not addressed, people will find a way around it.”
For the labs willing to cut those corners, there is a payoff, he noted. “A lot of labs use low fail rates and high potency as a business plan to acquire a large market share, and then probably sell their laboratories before they get found out,” said Kahn. “It’s happening all over the country, and there are lawsuits, but on its face, the business plan makes a lot of sense if you’re in and out quickly enough, and you don’t actually care about consumer safety.”
It’s devastating for the consumer, though. “It is,” concurred Kahn, “and for any honest operator too because the spiral gets out of control pretty quickly. If you’re not cutting corners, you’re left behind and absolutely cannot compete. Eventually, you’re left with this impossible choice: do I stay in business and use this approach, or do I just fold up shop?”
Who is ultimately responsible for that, I asked. “I would say the ball is in the regulator court, because the regulator’s sets those requirements,” he said. “The only reason all of us labs are around because it’s in the regulatory requirements. If it weren’t, it would be a pretty different landscape. Because it’s a regulatory requirements, the only incentive for anybody to even use the laboratories to meet the regulatory requirements is so they can sell their product. Therefore, they want, they just based on that alone, there are very good actors in the space as well, they want to have their products tested for all sorts of really good, correct altruistic reasons, but the regulatory requirement is the main one that unites all.
“The requirement is that you pass the mold test, you have this potency screen, you pass a heavy metals test, and so forth,” he continued. “And as long as that is a regulatory requirement, you will want to take the easiest path to meet that requirement, which is currently finding a lab that will pass you and keep you competitive in your potency, even if your actual product isn’t all that great. And as long as that dynamic exists without a market incentive or some kind of incentive for accuracy, we’re going to keep having different versions of the exact same problem. Though I think Washington state has done a really good job largely solving the problem with a program that a lot of people trust, and that program is based on the public release of all testing data.”
The fight over potency testing is far from trivial, he added. “Consumers currently believe that a battery of tests is a requirement before you can even sell these products,” said Kahn. “So, every product that they buy, they assume it has actually passed this battery of tests. I am not immune compromised, but I know patients who are and make purchases based on these assumptions. They might have a problem with moldy cannabis being sold to them. I might be fine smoking this joint, but they might not be, and the fact that somebody is routinely passing moldy cannabis as though it is not moldy actually does put those people in danger.”
But as much as Kahn is clear about the problems he sees, and as intrusive and unnecessary was the inspection by eight inspectors over six unfocused hours was, Kahn only wants peace. “I’ve been pushed into this position,” he insisted. “I do not want to fight. I want to collaborate with them. I think there’s really important to work to do. Lab shopping is a hard problem to solve. I want to solve it with them. I have reached out so many times constructively, privately, without doing anything public. It was just one-on-one or in small groups trying to get them to pay attention to this problem.
“I’ve given them dozens of examples of obviously fraudulently or mislabeled products, products that were over 100 percent potency total when you added up the label claims. It was 104 percent total THC, and their response was, ‘How do you know that you’re right and they’re wrong.’ I don’t know what else to tell them. You can’t have anything over 100 percent potency.”
Did Kahn see any significance in the events at the Friday meeting, the imminent loss of the executive director, and the cry of crisis? “I can speculate just as well as you can, but I don’t know,” he said. “I just hope that this change energizes further and better change at the CCC to take this issue a lot more seriously. It’s really important, and I hope this this kind of brings about that change, and I think we do need a change in focus from the CCC.
“I think establishing additional oversight is generally a good idea, because it’s important that we have a regulator that works well,” he added. “But my job is to run a lab. First is my lab. Second is to create an environment where the lab can thrive, which would be an environment where lab shopping is more or less solved. And a pretty distant third is my concern for solving any internal structural problems at the CCC. They’re all related to each other, and I think they’re not solving lab shopping because they have structural problems, but my real concern is lab shopping.”
The threat is nothing less than existential. “If this isn’t fixed,” said Kahn, “every honest lab is in jeopardy.”
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