Minnesota’s experiment legalizing synthetic-THC edibles was just two weeks away from launching this summer when a key state official confessed to her colleagues that no one really knew if the products about to hit Minnesota shelves were safe.
“We have essentially created an adult use market, with no licensing, less stringent testing and high public risk due to lack of compliance & enforcement capacity,” Chris Tholkes, director of medical cannabis at the Minnesota Department of Health, wrote in an internal email on June 15.
“It’s really not known what is in these products and whether or not they are safe,” she noted in a second email.
Minnesota went ahead anyway, opening a market for gummies and drinks infused with THC — the compound that gives cannabis its high. The market has taken off since the law took effect July 1. Yet questions around exactly what’s in the products and who’s watching to make sure they’re safe have largely gone unanswered.
With little state oversight, experts say Minnesotans have no way to know precisely what’s in the edibles and drinks. Internal state emails obtained by MPR News show Minnesota officials shrugging off basic questions around the law just before it took effect.
The emails also show the law’s author, Minnesota House Rep. Heather Edelson, DFL-Edina, online during the early morning of July 1 floating ideas to state officials on how to change what, at that point, was an hours-old law.
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Right now, Minnesota has no way to tell if an edible was made by a multimillion-dollar lab operating across multiple states or if it was created by a fly-by-night outfit operating out of a trailer. Tholkes said in an interview that she worries the lack of licensing will make it difficult to determine who is selling which products in the state.
“No other state has products like these available, except in a largely regulated adult use market,” she said. “We just don’t have a handle on what’s out there right now.”
Tholkes said cannabis regulators from other states said the best approach would be to ban the products.
National observers say Minnesota’s statute is poorly constructed and potentially dangerous.
“There’s been a lot of bad cannabis laws passed in states across the country ... but this takes the crop for sure,” said Lezli Engelking, founder of the Foundation of Cannabis Unified Standards, a group that advocates for health and safety around cannabis products. “We’ve got legislators writing legislation to attempt to solve an immediate problem that are creating bigger problems.”
Complaints and poisonings
There’s good reason to be concerned. Public health officials, cannabis experts and chemists have warned Minnesota doesn’t have the enforcement capability to clamp down on potentially dangerous products. That lack of enforcement could mean unsafe products are being sold and used.
Their worries include:
A study that found the THC dosages listed on packages are often incorrect, meaning the edibles may be much more potent than consumers expect.
Poisoning cases involving edibles increased dramatically between 2017 and 2021, and experts expect the numbers to spike in Minnesota.
The chemical byproducts from synthetic cannabinoids haven’t been extensively studied and may be harmful to human health. One expert called them “Frankenstein” compounds.
With little enforcement power, state officials will have difficulty determining who is selling cannabis products in the state and consumer complaints may result in little or no penalties against retailers.
The state entity tasked with oversight of the goods was overwhelmed as it prepared for its new responsibilities. Days before the law took effect, the state agency specifically tasked with oversight acknowledged it was not prepared.
“We do not have the resources to investigate these complaints,” Jill Phillips, executive director of the Minnesota Board of Pharmacy, wrote in an email to the Minnesota Attorney General’s Office on June 27, 2022. “Furthermore, surveyors are not trained/equipped to investigate these types of complaints.”
Phillips declined interview requests to discuss the board’s oversight role. In a response to written questions, she claimed there were 39 complaints to the agency about THC-related products but wouldn’t offer specifics because she claimed the complaints are under active investigation.
She added that her office is now redeploying resources to handle complaints.
Accidental poisoning reports related to THC among children 12 and younger in Minnesota have jumped this year, with 96 cases reported through Nov. 13.
There was just one such case reported in 2017.
“The scenario that's most common that we see is a small child that encounters an edible consumes the edible, and then pretty rapidly becomes unconscious and comatose,” said Jon Cole, with the Minnesota Poison Control Center. He said most cases involve a child who accidentally took a dose intended for an adult.
Cole said he expects Minnesota to follow the trends of other states that have legalized edibles.
“The experience almost uniformly is that accidental poisonings go up,” he said. “We expect that to be the case in Minnesota.”
THC poisonings rarely lead to death, but it is possible. A grand jury in Virginia indicted a 30-year-old woman last month for murder and child neglect after her 4-year-old son died from ingesting a “large amount of THC gummies” that were in the home. A doctor told detectives that the child’s death could have been prevented if medical intervention occurred shortly after ingestion, the sheriff’s office said.
Poisoning cases related to hemp have increased nationwide since the 2018 Farm Bill legalized the products. The number of accidental poisonings among young children who took an edible increased eight-fold since 2017, according to data from America’s Poison Centers.
‘There is a lot of money at stake here’
The 2018 federal farm bill allowed for the cultivation and sale of hemp nationwide. Since then, retailers have been selling THC-related products derived from hemp, a cousin of the cannabis plant.
Chemists had discovered that they could extract and synthesize chemicals from hemp that deliver a similar high as cannabis. Those synthetic THC products started being sold at vape shops, CBD stores and other retail establishments.
Chris Hudalla has spent the past nine years testing cannabis-related products for consumers and businesses for ProVerde Labs in Massachusetts. Since he started the company, Hudalla estimates he’s worked with roughly 200,000 samples. The work became so routine, he said, that he could do it with his eyes closed.
But in 2018, Hudalla started seeing something unusual when he tested synthetic cannabinoids. He calls them Frankenstein molecules.
“When they made Frankenstein, they took arms and legs and a head and torso of different bodies and stitch them all together,” Hudalla said. “Similarly, these atoms are arranged and stitched together in a way that was never thought of by nature.”
That stitching required a mixture of chemical byproducts that Hudalla couldn’t identify.
Hudalla said he was initially pleased to see chemists thinking outside of the box with new cannabinoid compounds like Delta-8, THC-O and THC-P. But over time, he started worrying that the chemical byproducts could be a threat to human health.
“I would never give it to a family member,” he said of synthetic cannabinoid products. “I would never give it to a pet.”
Hudalla isn’t the only one expressing worries.
The U.S. Food and Drug Administration has issued warnings about Delta-8 related products after receiving 104 reports of adverse events in patients who consumed the products between Dec. 1, 2020, and Feb. 28, 2022.
The agency has also sent warning letters to five companies that it claimed were making unapproved treatment for various medical conditions and other therapeutic uses.
At least a dozen states have banned products containing Delta-8.
But Minnesota went in a different direction. While it’s illegal to sell products that contain THC extracted from marijuana, the state allows the sale of products containing cannabinoids derived from hemp.
Minnesota’s law does require product testing for mold, residual solvents, pesticides, fertilizers and heavy metals. Testing is also required to confirm the cannabinoids in the product match the label.
But the state doesn’t require manufacturers and retailers to apply for a license so it’s difficult to determine where the products are being sold. The state also doesn’t have a specific tax on cannabis products so it’s difficult to gauge how many products are being sold in the state.
Other states that have legalized marijuana or hemp products have a more robust regulation.
For example, Oregon requires retailers, producers, wholesalers and labs to get a recreational marijuana license. The names of the licensees are made public along with the number of violations and licensing restrictions.
But even in states with more stringent enforcement, there are shortcomings.
Chemists who study the products say they’ve found differences between what’s labeled on the package and what’s actually in the product.
Michelle Peace, an associate professor in the Laboratory for Forensic Toxicology Research at Virginia Commonwealth University, conducted a study of edibles, vape cartridges, dietary supplements and other products containing cannabinoids.
Her study, released last March, found that some products contained little to no THC. Others contained far greater amounts than what was listed on the package.
In Minnesota, there have been 96 accidental poisoning reports related to THC edibles among children 12 and under this year. There was just one such case reported in 2017.
“Even if they think that they’re controlling their dose, there’s no way to control a dose in these products if consumers don’t know what’s in it,” Peace said. “Consumers have the absolute right to know what it is that they're consuming, and they do not.”
Peace said the cannabis industry has characterized her as a villain for voicing concerns. The industry has grown so quickly that it has pushed back on any criticism of the products and calls for additional oversight, she said.
“There is a lot of money at stake here,” she said. “I think the industry has gotten ahead of itself.”
‘What is our responsibility?’
The Minnesota Board of Pharmacy has historically been a sleepy agency. With just 23 employees, the agency focuses mostly on pharmacist licensing and inspecting licensed facilities.
But in May, the Legislature gave the Board of Pharmacy oversight of hemp-derived cannabinoids. The directive came with no additional funding and the board was required to come up with regulatory guidance in less than two months.
Public records obtained by MPR News show that pharmacy board employees were apprehensive about their roles in the weeks leading up to the sale of the new products on July 1.
“In my humble opinion we do not want to advertise that we will embargo, issue cease and desist, or investigate complaints and obtain samples,” Michele Mattila, pharmacy surveyor and complaint coordinator, wrote in an email to her colleagues on June 23, just before the law kicked in. “We don’t have the resources for this and it does not fit within the mission statement.”
Others wondered why there were no age restrictions on those selling products. Pharmacy surveyor Sarah Favour worried about investigating complaints and obtaining samples.
“I am afraid this could quickly snowball with consumers filing complaints about side effects and then what is our responsibility? Get a sample? Cost? Who processes?” Favour wrote. “This seems like muddy waters that we are not equipped to handle. There are new shops/online ventures cropping up like weeds.”
In an email response to questions, Phillips claimed the board is working with other agencies to “educate and enforce the new law.” But she also said the board needs more money.
“The board is limited in terms of administrative tools to enforce the new law,” Phillips wrote. “Most importantly, however, these businesses, manufacturers, distributors, and retailers are not licensed and therefore, we are not able to identify all of the players.”
Phillips is also calling for the state to create a state cannabis management office to oversee edibles, medical marijuana and help cultivation.
Some cities and counties have taken their own steps to regulate the products by either banning sales or licensing retailers. The League of Minnesota Cities, the main lobbying group representing Minnesota cities and towns at the Capitol, is pushing the Legislature to create a more uniform system.
As it stands now, the state law limits the sale of high-potency products and forbids THC products from being smoked or vaped. It allows for the sale of edibles and drinks that contain a serving of no more than 5 milligrams of THC derived from hemp, and packaged goods that contain no more than 50 milligrams of THC.
The need for change appeared clear to Edelson hours after the bill she’d guided into law took effect. Emails show her asking state officials for updates on the rollout in the wee hours of July 1. She was already floating ideas on how to change the law.
She sent three rapid fire emails before sunrise to legislative staff and state employees with oversight over the sale of edibles, cannabis expertise and knowledge in hemp farming. Her first batch of suggestions included a licensing fee, how many products should be sold to one consumer and the allowance of regulatory checks on retailers.
In a second message, she wanted to make sure edibles weren’t appealing to children. “I want to discuss the candy like color and appearance and what other states are doing to ensure it doesn’t get into the hands of kids.”
She also wanted to discuss “a special cannabis tax like other states have… And how old a person must be to actually sell the product.”
In an interview, Edelson said that before her bill the uncertainty around hemp products was causing problems in Minnesota and that the edibles statute was an attempt to clarify what is legal. She and other DFLers will likely look to legalize recreational marijuana in the next legislative session. The edibles law was viewed as a first step.
She said she’s focused on finding a safe way to balance demand and safety issues around edibles. “I didn’t think the right thing to do was to pull it from the shelves.”