Maine regulators increase audits of recreational cannabis after 3rd recall in 2 months

It took four years for Maine to issue its first recall of contaminated cannabis in the recreational market, but it only took two months for the second and third.

The Maine Office of Cannabis Policy has issued three recalls – and one recall expansion – for products that failed mandatory yeast and mold tests. And more could be coming as the office ramps up audit testing.

The first recall, for flower from Cannabis Cured, was announced Sept. 10. The second recall and subsequent expansion came shortly after, on Oct. 11 and 24, concerning products from Nova Farms. The most recent recall, issued Nov. 7, was for cannabis from Leb City Greeneries. All the recalls were for smokable cannabis ranging from flower and pre-ground flower to pre-rolls and blunts.

The office has released little information about the recalls, including which specific yeasts and molds were found in the samples, the level of contaminants (the limit is 10,000 colony-forming units per gram), and how the products made it to the market in the first place.

MORE TESTING 

While the recalls are still under investigation, the office said in an email Friday that the products were contaminated in one of two ways.

“Licensees have either made mistakes in how they take samples and/or use remediation and pre-treatment technology, or they have purposely neglected their responsibilities in these areas,” the office said.

The office has recently increased efforts to perform random-audit testing of products that have recently passed initial tests, the agency said, and this increase in testing led to two of the three recalls. The other was caught during a review process the office uses “to ensure products are properly sampled and tested.”

Not every cannabis product on a store’s shelf has been individually tested. Rather, cultivators and manufacturers are required to submit “representative” samples of each batch. Sample sizes vary based on product and batch size and must be taken from multiple parts of the product. For cannabis flower, pre-roll and trim, for example, sample sizes range from 6.5 grams for a 2.5-kilogram batch to 22 grams for a 10-kilogram batch.

Yeast and mold are the most common contaminants that cause a sample to fail a test, and mold is the hardest test to pass because it’s so prevalent in the natural world.

According to the Office of Cannabis Policy, cultivators are increasingly treating products before the initial round of testing to reduce yeast and mold contamination. In some cases, they’ve treated the samples, which respond better to treatment and are more likely to pass testing than large batches.

“It is not permissible under program rules for any sample to be treated after it has been taken from the batch,” the office said. “While OCP remains confident that the vast majority of licensees are doing the right thing and meeting their regulatory responsibilities, the audit samples and subsequent recalls have highlighted that gaps do exist for some licensees.”

The office is working to produce educational materials and opportunities to reinforce the best practices for sampling, handling and remediation.

Matt Hawes, co-founder of the Maine Cannabis Industry Association, doesn’t knock the office for the recent recalls – the increase in testing signals a shift in priorities, he said, and testing makes sense for a relatively new government agency.

The recent recalls have created a heightened awareness around testing within the industry, he said, but it’s not necessarily increasing unease.

“We’re not feeling like we have anything to be nervous about,” he said. “I think the vast majority of operators in adult-use are sincerely doing their best, but if there are cases where that is not true, I would applaud OCP for finding them.”

A WARNING TO THE MEDICAL MARKET?

Industry members have speculated that the office will use the recent recalls as evidence to back up the need for testing in the medical market.

If yeast and mold are showing up on products in the highly regulated adult-use market, in which testing is mandatory, what might show up in the medical market, where it’s not?

Last year, the office published a report that claimed up to half of the products sold in the medical cannabis market could be contaminated with pesticides, harmful microbes, yeast and mold.

The office collected 127 samples of medical cannabis from recent inspections and ran them through the same testing process required in the recreational-use program. Of the 127, 57 – or about 45% – would have failed, meaning they contained at least one banned material or substance.

John Hudak, director of the cannabis policy office, has been clear that he wants to see testing and track-and-trace mandates implemented in the medical market, but the idea has faced fierce resistance from medical providers, known in the industry as caregivers, who argue that the requirements would be onerous and costly, forcing them to either close up shop or push price increases onto consumers.

Following a 2022 law, any major substantive rulemaking from the department must be approved by the Legislature, and the Office of Cannabis Policy has not officially proposed a testing requirement for the medical market since.

But industry members fear that the increase in recalls is a sign that the office is gearing up for another attempt.

The office, however, insists the two are unrelated.

“The current recalls of adult-use products have no impact on the medical cannabis program, nor have these recalls impacted OCP’s views on the deficiencies that exist in the medical cannabis statute,” the agency said. “The Office has been clear and consistent for over five years that changes must be made to the medical cannabis statute to protect medical cannabis patients. The Office’s recommended changes have always included mandatory testing and inventory tracking. That continues to be OCP’s position.”

Many industry members – including Christopher Altomare, founder and CEO of Portland-based testing lab Nova Analytics – have questioned the state’s 10,000 colony-forming units per gram threshold and whether all the strains of yeast and mold in the panel are truly harmful at that level. Altomare said his lab plans to research that possibility.

Hudak, meanwhile, has stood firm that the state’s standard is solid. It’s used by many other states and is the threshold recommended by American Herbal Pharmacopoeia, he said.

Either way, Mark Barnett, an operator in both cannabis markets and policy director for the Maine Craft Cannabis Association, fears the results will “lead to more fear-mongering around the dangers of cannabis,” he said.

Barnett said the recalls are proof that mandatory testing can be tampered with and that an audit system would be more effective.

“That’s the only honest, scientific way to do this,” he said, noting that’s how the two recent recalls were caught.

“The products that were contaminated were found, and (if they were dangerous) I’m glad they were pulled from the shelves,” he said.

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