Regulators Knew This Marijuana Product Was Harming People. It Stayed on Shelves for More Than a Year.

In March 2022, Colorado public health officials started getting startling reports of liver damage tied to a new marijuana-based sleep aid that had quickly become a top seller in the state.

But it wasn’t until June 2023, nearly 15 months later, that the state’s Marijuana Enforcement Division would warn consumers that the danger had become so serious that the manufacturer had halted production of the sleep pills, called 1906 Midnight Drops, after more reports of “acute liver injury.”

The delay highlights a slew of weaknesses in the system for protecting consumers from hazardous products in the nation’s first regulated recreational marijuana market.

The health complaints had prompted the division to investigate, but the agency decided it didn’t have the power to pull the drops from the stores in this situation. If the agency had dug deeper, it might have found what the state attorney general’s office later discovered: The manufacturer, Sima Sciences, began receiving complaints of harm shortly after it launched 1906 Midnight Drops and two years before health officials ever did.

Instead, the enforcement division took four months after the first report of liver damage to the state to post a notice on its website. But the agency didn’t call it a health and safety warning, which would have advised people not to consume the product. It released a more neutrally named “informational notification.” While there had been reports of “adverse health events,” the notice said, regulators didn’t find any violations. The manufacturer had reformulated the product, the notice added, and no additional issues had surfaced.

Jenifer Chatting didn’t even see it.

A surgical assistant at an oral surgeon’s office, Chatting wanted a safe, natural alternative to pharmaceuticals to treat her insomnia. So she was relieved when a local marijuana dispensary suggested a sugar-free option made of cannabis and herbal extracts that the manufacturer touted as the “the best sleep aid on the market.” She began taking the Midnight Drops nightly the same month that the state health department received its first complaint.

Unaware of the enforcement division’s notification, she didn’t worry when she started having full-body cramps and became lactose intolerant in September 2022, about six months after she started taking the drops. She thought she just needed to drink more water.

She continued taking the drops for nine more months until her dispensary stopped stocking them. Now, despite never having liver problems before, according to her medical records, she has liver damage at age 53; her doctor says she will ultimately need a transplant.

Colorado’s failure to get Midnight Drops off the market or to warn consumers to stop taking it despite repeated reports of harm was not an anomaly, The Denver Gazette and ProPublica found.

The division has limited authority to force companies to recall products. The agency instead relies on posting health and safety advisories on its website to warn the public, and on sending news releases to local media outlets.

Yet, in the cases for which the news organizations were able to identify the date of a complaint or the start of an investigation, it took regulators an average of more than seven months to issue a warning. That’s an incomplete snapshot because the division refused to release data on when investigations began. Complaint dates were private, it said, because the probes were ongoing — even years after the warnings were issued and some companies had surrendered their licenses.

Still, The Denver Gazette and ProPublica were able to identify initial complaint or investigative start dates for 23 of the 83 advisories the agency issued over the past five years by reviewing other licensing violation records. 

Seven months is a long time for products that are typically smoked or ingested within days of purchase, industry insiders and consumer safety experts said. In comparison, federal investigators have criticized the U.S. Food and Drug Administration for taking an average of two months after learning of a potential hazard to not just warn consumers but to get companies to recall contaminated food.

Kimberly Anzarut, a former Denver marijuana regulator and now an industry consultant, said the delays mean Colorado consumers aren’t getting vital warnings while products are still on shelves.

“When you take a really long time to get a bulletin out to tell people about these issues, a lot of time, people have already consumed the product,” she said.

Lab directors said it generally takes only three days to return test results identifying contaminants, and if there’s an emergency, they can do so in a day.

But MED spokesperson Heather Draper said in a statement that it’s more complicated than just getting test results and that it takes time to build a case that leads to a health and safety advisory.

“This most often requires investigative resources to evaluate the scope of concerns, gather evidence of potential product safety concerns, and receive test results that indicate a contaminated product has been sold to consumers,” she said. 

Thuy Vu, Denver’s former head of marijuana inspections and enforcement, said regulators should act more quickly and that “time is of the essence,” because the safety problems reported to regulators are almost always a fraction of the harm a product is causing.

“Seven months, eight months, that’s ridiculous,” she said.

The delays mean contaminated marijuana products often remain on sale for a long time, with no public warning. In addition to complaint dates, The Denver Gazette and ProPublica were able to get sales start dates for nearly all the health and safety advisories and found that Colorado regulators also take, on average, more than seven months from the first sale of a contaminated marijuana product to warn the public.

The news organizations found that warnings take a long time in part because Colorado lacks measures adopted in many other legalized marijuana markets to improve testing procedures and prevent contaminated marijuana from going to stores. 

And when the state does discover a problem in a product already on shelves, it gives manufacturers multiple chances to disprove the agency’s finding. Though the MED can require companies to stop distributing flagged products, industry lawyers and manufacturers said manufacturers often continue selling them while challenging the findings.

Chatting’s husband, Luke, is now fearful of losing his wife and critical of what he calls insufficient warnings about Midnight Drops. The couple is suing the company, which has denied their claims. The lawsuit is pending.

“Why weren’t there big banners in front of the dispensaries about these things?” he asked. “The state makes millions and millions and millions of dollars off of the taxes for the marijuana, but they don’t do any regulation at all.”

“My Patients Were Swearing by These”

The person behind Midnight Drops is Peter Barsoom, a wunderkind of Wall Street finance who left New York in 2014 to co-found a recreational marijuana company called Sima Sciences.

Soon he was turning up in splashy magazine profiles. The 1906 product line was a nod to the year the U.S. government enacted the Pure Food and Drug Act, which he said led to the first federal regulation and eventual prohibition of cannabis. 

His initial focus was high-end marijuana-infused truffle chocolates. 

“Our competitors are chardonnay, Xanax and coffee, not other edibles,” he said during an interview in 2017. 

In 2019, he branched out into the sleep tablet line and also manufactured other “drops” meant to help with sex, anxiety, energy, focus and bliss.

By 2023, his company, based in Henderson, Colorado, was manufacturing 81% of the pills sold in dispensaries in the state, according to the cannabis analytics firm BDSA.

Vu, the former Denver regulator, worked for about a year as Barsoom’s head of regulatory compliance and said Barsoom wanted her to bend the rules on inventory reporting and product safety, though she stressed that she was unaware of the problems with the Midnight Drops, which were made after she left. They clashed, and he fired her in 2016, she said.

Barsoom declined interview requests and did not respond to detailed questions. His company’s lawyers also did not respond to requests for comment. But in court filings in response to personal injury lawsuits, they stated that “injuries, damages and losses, if any, may have been caused by plaintiff’s own comparative negligence.”

To promote the Midnight Drops, the 1906 website said the pills were infused with corydalis, an herbal extract, which, it said, “has been used for millennia.” It claimed the extract had sedative qualities and would help people stay asleep because it targeted body pain and tension.

A relative of the poppy, corydalis also contains a compound that researchers have linked to severe and potentially fatal liver injury.

Following reports about liver problems, the company reformulated Midnight Drops and added a warning label stating the product should be taken in consultation with a physician. But the new herbal supplement was also primarily composed of a compound with the same chemical makeup as the one in corydalis that had been tied to liver risks, regulators eventually concluded. 

One doctor reported to the enforcement division in December 2022 that he continued to “see an uptick in patients with elevated liver enzymes,” which he believed was caused by Midnight Drops. He warned the agency that he had seen four such patients in the past two months and knew of other doctors treating more, state records show.

Dr. David Cristin, a gastroenterologist, said he was exasperated because patients kept using Midnight Drops despite his concerns. He said he registered a complaint through the company’s website, detailing the issues he had found, but was never contacted.

“The thing that was frustrating was my patients were swearing by these,” he said.

By May 2024, the Colorado Department of Public Health and Environment would receive 52 reports of harm involving Midnight Drops, at least 20 severe enough to require medical care. Of those reports, 25 occurred before the MED’s second notification. While the health department often does the initial review, records show it typically finished gathering information within days, which would trigger an automatic referral to the MED.

Nearly a year after issuing its first “informational notification,” the MED and the health department issued the second one in June 2023, warning that Midnight Drops had continued generating reports of “acute liver injury.” 

At that time, Sima announced it was stopping production. But Barsoom and his companies continued marketing Midnight Drops for several more months and did not adequately warn dispensaries to stop selling them, according to a Colorado attorney general’s office investigation.

Chatting didn’t see the second MED notification either. A couple of weeks after it was posted, she went into a dispensary but learned the drops were no longer in stock. She said a dispensary staffer told her they had been pulled because consumers had been abusing the product. She hadn’t been, so she didn’t worry.

But that summer, bloodwork during a routine checkup revealed Chatting’s liver enzymes had soared to abnormal levels, indicating potential damage.

The MED’s lawyers have refused to release any of the agency’s investigative files about Midnight Drops, making it difficult to assess why the agency didn’t act sooner. Draper, the spokesperson, said that when regulators were fielding complaints about Midnight Drops, their powers were limited: They could put a hold on products and require companies to issue recalls only for specific violations. She said because of a 2023 statute change, regulators can now place holds on products over safety concerns to prevent their sales, even without a violation.

Still, even with that change, the time it takes to warn consumers after the first complaint as well as after the date when a product goes on sale have both gotten longer, according to the news organizations’ analysis. Draper said the agency “has improved its Health & Safety Advisory processes and this work continues.” She added that agency officials do not believe that the newsrooms’ analysis is “an accurate representation of our process and progress in these areas,” but she did not say why or provide any evidence disputing it.

Loopholes in Safety Rules

The continued time lag in public warnings from regulators is another blow to consumer safety for Colorado’s marijuana industry, which has loopholes in safety rules other states have closed to make it less likely that contaminated products end up in dispensaries.

In one of the longest cases, it took regulators three years to warn consumers from the date of the first sales of marijuana products made by Pueblo County-based Boone Farms that were contaminated with yeast, mold and aspergillus, which can damage lungs and cause asthma, fungal infections and, in rare instances, death. Draper said she could neither confirm nor deny if there was any other investigation. The owner of the company declined to comment but previously said it was a small amount of product and that some of it sold before the state set standards for aspergillus.

An MED investigator had similar suspicions about contamination in products made by Boulder-based Range Street, but “due to other priorities and bandwidth,” had to put the investigation on the “backburner,” according to the investigator’s synopsis obtained through a public records request. The MED eventually found yeast, mold and aspergillus. But it didn’t warn the public until 410 days after the first sales. Range Street, whose former owner declined to comment, has since surrendered its medical marijuana cultivation license.

Unlike other states, Colorado operates largely on an honor code, with manufacturers free to choose the samples and the labs that conduct contaminant tests required before products can be sold. Colorado regulators in January said they were considering requiring lab personnel to collect samples, which would bring Colorado in line with 26 of the 42 state marijuana markets. But the agency backed away from the proposal after top manufacturers argued it would increase costs.

Colorado also allows marijuana manufacturers to test their products far less frequently if they can show consistent compliance, something only one other state does. And the time frame for demonstrating that compliance can be as little as a few weeks.

Colorado’s regulators acknowledged at a 2023 industry forum that the reduced testing program “potentially poses risks to public health and safety,” as problems with the program were “a common occurrence” in investigations.

This January, the enforcement division noted in an industry bulletin that problems with that program persist, leading to recalls and advisories for unsafe levels of pesticides. The division told manufacturers in July that it is reviewing the reduced testing program as it considers a broader overhaul of testing rules. 

Colorado also has historically relied on complaints to identify tainted marijuana once it is actually in the marketplace, rather than randomly sampling products on shelves. The Cannabis Regulators Association recommends random sampling, and other states like Oklahoma have such programs. Colorado only this year launched a pilot program to randomly sample dispensary products, but the program has run into delays, and the state hasn’t identified a long-term funding source.

Once a contaminated product gets to dispensaries, Colorado regulators face challenges in getting the product off the shelves. Colorado expects manufacturers to voluntarily recall products. Regulators in Colorado can only force products to be recalled in a public health emergency, but regulators can encounter hurdles to quickly establishing that one exists.

Even when testing finds contaminants, manufacturers say marijuana that’s already in dispensaries often remains for sale. That’s because Colorado allows the manufacturer to retest the marijuana, and the rules don’t specify a time frame for when those tests have to be done. The rules state that the MED “may” require manufacturers to refrain from selling items during retesting.

In contrast, Missouri immediately puts a hold on all marijuana products that fail mandatory contaminant testing. Manufacturers there can have the products reanalyzed, but dispensaries can’t sell those products until retesting shows the original analysis was incorrect.

In an industry bulletin in January, Colorado regulators said the agency had seen “increased instances” of marijuana manufacturers taking advantage of the retesting rule to cover up the use of banned pesticides.

“Health Isn’t Really Their Primary Concern”

Tess Eidem, a research professor at the University of Colorado who has a federal grant to analyze the division’s health and safety bulletin process, said she worries the state prioritizes protecting the financial viability of the marijuana market over consumer safety.

She pointed out that the MED isn’t part of the state’s health department but instead is in the state’s revenue department. 

“So health isn’t really their primary concern,” she said.

In September 2024, a little over a year after Chatting stopped taking Midnight Drops, she and her husband went on a dream vacation to England, where they lived on a houseboat. The trip was such a success that they began planning to retire there, projecting that in about a decade they could downsize and spend their golden years traveling the canals through the English countryside where Luke was born.

A month later, Jenifer got a call from a doctor. Because she’s a former smoker, she had gone in for a routine lung screening. Her lungs were fine, but the X-ray detected something suspicious with her liver. A follow-up ultrasound detected cirrhosis.

Chatting’s gastroenterologist ruled out alcohol consumption, noting in her medical records that Chatting had always been a light drinker, and instead cited an herbal sleeping aid as a likely factor. After she stopped taking the drops, her liver enzymes came back into normal ranges, but the damage was already done, her medical records show.

Two days before Thanksgiving, Luke couldn’t sleep and rose about 2 a.m. to Google information about cirrhosis. He said it was then that he finally discovered the MED’s notifications about Midnight Drops.

He started slamming his fists on the armrests of his desk chair. One armrest broke, and his fist hit jagged plastic, fracturing his left hand.

“Jen, they killed you,” he recalled shouting.

She has few symptoms now, other than body cramps, but her gastroenterologist has warned that her condition will inevitably deteriorate and she will require a liver transplant in as little as five years.

Struggling to come to terms with the diagnosis, Jenifer now stays mostly indoors, building elaborate Lego artwork and spending time with their rescue pug mixes. 

“It’s hard because you think you’re doing something good for yourself and healthy and all natural,” she said. “And then it ends up being, you know … .” She stopped and gathered herself. “Just because something’s all natural doesn’t mean that it’s good for you.” 

Last September, Barsoom and his companies settled with the attorney general’s office to resolve the office’s investigation. Barsoom and his companies denied that they had violated consumer protection laws. But they agreed to pay $400,000 in fines, and the settlement bars them from selling cannabis products in Colorado until at least 2027. 

Barsoom also agreed to issue an apology. 

“We’ve always believed that great products should improve people’s lives,” his statement read. “When we learned that Midnight Drops wasn’t meeting that standard for everyone, we realized we had let our customers down. We are sorry that we didn’t act faster and communicate better with both our customers and regulators.”

The Chattings said Barsoom’s apology doesn’t amount to much for them, and they wish Colorado regulators had acted faster and communicated better with consumers.

“How are people supposed to know this?” Luke asked. “The only way I found this stuff was by digging and digging and digging on the internet.”

The post Regulators Knew This Marijuana Product Was Harming People. It Stayed on Shelves for More Than a Year. appeared first on ProPublica.

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