Minnesota pharmacy board says it’s ill-equipped to regulate hemp-derived THC edibles

The state agency that is the closest thing to a regulator of newly legal hemp-based edibles wants out of the business.

The state Board of Pharmacy, a small agency not often in the news, repeated Monday that it lacks the people, the budget and the expertise to regulate the manufacturing and sale of hemp edibles – gummies, vapes and seltzers included. Without licensing or taxation, the small board with just five inspectors doesn’t even know the size or scope of the business it is charged with overseeing.

“We’re limited in what we can do,” board executive director Jill Phillips. “These are not licensees of ours, so it is difficult to track that. We’re limited in our enforcement tools, and we weren’t given additional funding and resources, so we do the best we can.

“It is our hope in the next legislative session that we pass much more-comprehensive legislation for these products,” Phillips added. The board will ask the Legislature to give the job to some other state agency, perhaps a new board that could be created if the Legislature legalizes marijuana for recreational uses. It delivered the same message to legislative leaders last spring before the hemp edibles law passed.

Advertisement

“We were on record … to have a state agency with full regulatory authority to tax, license, discipline and enforce these laws,” said pharmacy board president Stuart Williams. “And that’s our position today and we hope to convince the Legislature.”

Without licensing those who make and sell edibles, the board instead relies on complaints from the public to identify and investigate bad actors in the new business created by legislation last spring. Or, in the case of civil litigation, it announced Monday, it responds to investigations from the federal Food and Drug Administration.

In the lawsuit, the state alleges that a trio of connected businesses based in Moorhead sold products that far exceeded the dosage limits set in the law that took effect July 1. In addition, the product called Death by Gummy Bears violates another provision against products that might appeal to children.

The companies are Northland Vapor Company Moorhead, Northland Vapor Company Bemidji and Wonky Confections. The 2022 law says edibles cannot contain more than five milligrams of any hemp-derived THC in one serving and that packages cannot contain more than 50 milligrams total. The law also prohibits the products from resembling cartoon-like characters or from looking like other products normally marketed to children.

Advertisement

The lawsuit says state and federal investigators found packages containing 2,500 milligrams of THC, 50 times that allowed by state law. The state and the FDA inspected the company’s warehouses on Nov. 8 and embargoed the products, which prohibits their sale until a court rules on the state’s requests. If successful, the products will be destroyed, and the companies will be enjoined from selling similar products.

Based on prices listed on the companies’ website, the products embargoed are worth $7 million, the state asserts. The products, now labeled “out of stock” on the company’s website, were implicated in the sickening of five students in the Des Moines, Iowa, area who ate between one-half and two of the gummies. Two students who took two gummies were hospitalized.

Phillips said anyone who has taken the products – especially children – should contact health providers via 9-1-1 right away and not wait for symptoms such as nausea and extreme paranoia to arise.

The state pharmacy board regulates drug stores and their employees, manages the insulin affordability program and runs the opioid registration and fees plan. It has a few dozen employees and just five inspectors. It didn’t ask for the new duties and would like the next Legislature to give them to another agency more equipped for it.

One example of the lack of capacity is that the board lacks testing labs that could determine whether products exceed potency limits or are unsafe. Williams, the pharmacy board president, says the agency is trying to contract with others that have that capacity.

Williams, an attorney, said the hemp edibles law gave the board only a short list of enforcement tools. It was “limited to issuing a cease and desist letter, seeking an injunction and our embargo authority.”

The board received 120 complaints regarding its pharmacy regulation this year but received 46 about the edibles market in less than six months. Phillips said the board investigates complaints, and if violations are found, it warns businesses and tries to educate them about the law. The lawsuit against Northland Vapor Company Moorhead, Northland Vapor Company Bemidji and Wonky Confections is the first such action it has taken.

In its regulation of pharmacies and pharmacy employees, the board can suspend or revoke licenses as an enforcement measure short of filing civil suits. Because licenses are required, license holders agree to provide information and cooperate with investigations, again at the risk of losing licenses.

None of that is available under the hemp-based edibles regulation.

The mismatch between the suddenly legalized business and its taxation and regulation was a byproduct of a desire by sponsors of the legislation to keep it low-key. At first, the bill was to close a gap in state regulation of hemp-based edibles and vapes that was exposed in a criminal case from 2021 called Minnesota v. Loveless. It expanded as it moved, quietly, through the legislative process.

After it took effect in July, sponsors admitted that sending the bill to taxation and governor regulation committees where more guardrails could have been applied would have drawn attention. While some GOP leaders knew the scope of the measure, others did not and accepted assertions that it was a housekeeping measure for hemp that was legalized by the 2018 U.S. Farm Bill.

“There was time for anyone to take a look,” House Majority Leader Ryan Winkler said in July. “But drawing attention to this change in the regulatory structure, I don’t think would have helped the bill pass. Sometimes having more public attention amps up the political pressure that certain people in the other party might feel.

“We had a mess to clean up. I don’t know whether more publicity early on would have made it possible to pass the bill or not,” Winkler said. Even skimpy regulation is an improvement over the no-regulation that existed before, bill backers said.

With the DFL in control of the House and the Senate, and with Gov. Tim Walz saying he would sign a recreational marijuana bill, the 2023 Legislature could pass fixes to last year’s law separately or as part of a larger bill. It could replace hemp-based edibles with cannabis-based edibles, which require far less processing to bring out the intoxicating potency of the products.

Rep. Heather Edelson, DFL-Edina, said she has been working on legislation to clean up the hemp edibles bill with regulation, licensing and specific taxation on the products sold under the law. But deciding which agency handles the regulation is dependent on what the next Legislature does about recreational marijuana.

If a bill passes to have the state legalize marijuana for non-medical purposes, she expects a new board to be created. But if that bill doesn’t pass, she said she will have legislation ready to add it to the state Department of Health, likely within the existing agency that regulated the medical cannabis program.

Edelson said she knows of the pharmacy board’s concerns, having met with them before the election.

“Jill (Phillips) knows I don’t want her to do it,” Edelson said. “Pharmacy was a short-term fix.”

Editor’s Note: Peter Callaghan wrote this story. This originally appeared Dec. 6 on MinnPost.com.

Callaghan covers the state government for MinnPost. Follow him on Twitter or email him at pcallaghan(at)minnpost(dot)com.

MinnPost is a nonprofit, nonpartisan media organization whose mission is to provide high-quality journalism for people who care about Minnesota.