The Golden State’s cannabis-infused products makers have weathered some strong winds recently stemming from new testing requirements, and it’s an issue marijuana businesses in other markets should pay attention to as different states experiment with rules surrounding lab tests.
According to California’s Bureau of Cannabis Control (BCC), 32.9% of edibles, tinctures and lotions samples have failed laboratory analysis.
Compare that with 20.4% of concentrates that didn’t make the grade and 10.6% of cannabis flower samples.
Industry experts blame:
- Potency levels that are within a 10% range of the THC claims on labels. That can mean edibles companies have little room for error on products that have a maximum single-serving potency of 10 milligrams.
- A lack of standardized processes for labeling and testing products.
- Oils, fats and carbohydrates in infused products that can make it tougher to achieve homogeneity among individual servings.
That means products can be safe and contaminant-free and still not be up to snuff under California rules, said Swetha Kaul, the chief scientific officer at Cannalysis Labs, a marijuana testing laboratory in Santa Ana.
“The biggest barrier for edibles is not going to be solvents or pesticides,” Kaul observed. “It’s going to be label claims and the 10% (variance on potency levels).”
Kenny Morrison, CEO of Oakland-based, infused product manufacturer VCC Brands, pointed out it’s reasonable to expect products to fail if they’re unsafe.
“It’s another thing entirely for products to fail because fledgling regulations are overly stringent,” he noted.
Potency testing regulations require products in all categories – flower, concentrates and infused products – to demonstrate levels within 10% of the THC claims on labels. With a 10-milligram, single-serving edible, that’s a slim 1-milligram variance.
In the quality-control regulations that pertain to lab testing, laboratories are allowed to be within a 10% range of error on accuracy, Kaul reported.
That means manufacturers are burdened with providing what some may see as a perfect sample to laboratories.
“If (10%) is the allowable error for lab-to-lab variabilities, now you have essentially no room for error for manufactured goods,” Kaul said. “The fact that the label claim has to be within 10% (variance) really makes it challenging.”
New draft regulations would create a sliding scale of variance for infused products. A California Cannabis Industry Association committee is recommending 20% variance across the board – a number that would be more “achievable and practical,” Kaul said.
Certification challenges for infused products makers are compounded by the fact there are no guidelines that standardize the equipment or methods testing labs use. As a result, one sample can produce different results based on the laboratory where it’s tested.
For some in the industry, that’s the difference between passing and failing.
Jeff Koz, a co-founder of Dr. Norm’s, a California cannabis-infused cookie maker, reported he sent the same sample of a product to three labs for testing and the specimens came back with three different results with up to 40% variance. That’s well in excess of the state’s 10% limit.
“The regulation should be relaxed and allow for a bit broader variance,” he said of the 10% limit “at least until testing procedures are uniform from lab to lab.”
Rick Scarpello, co-founder and CEO of Denver-based Incredibles, a multistate infused product manufacturer, pulled his goods out of California.
He said he’s awaiting state and local governments there to “get on the same page” about testing regulations and labeling stipulations.
Label claims concerns
Manufacturers are reportedly making assertions on labels that increase the difficulty for their products to pass testing.
In California, products are required to list THC and CBD in milligrams on labels. Some add percentage of THC, too, because that number is most likely more familiar to some consumers.
The trouble is, if the milligrams of THC and the percentage of THC don’t match, the product fails testing, Kaul pointed out.
In the cannabis industry, infused product manufacturers are required to pre-label edibles and concentrates before shipping them to distributors, which send products for testing.
Testing in other highly regulated industries – including the pharmaceutical and food sectors – is done closer to the manufacturing process, Kaul noted. In those industries, products are packaged and labeled with information from their certificates of analysis (COA).
If a cannabis product fails for inaccurate label claims – potency outside the 10% variance, for example – it must be returned to the distributor to relabel. That could be costly and time-consuming, and it can delay a product getting to market.
The homogeneity challenge
Processed ingredients including oils, fats and carbohydrates in infused products complicate testing and make homogeneity difficult to achieve, Kaul said. It’s easier to apply a generic method for detecting cannabinoids in flower and concentrates because they don’t have added processed ingredients that impede testing, she noted.
The added components in edibles, topicals and lotions are considered part of a matrix separate from the cannabinoids that labs try to detect in products, and they interfere with testing, she said.
There’s no standardized method for detecting cannabinoids now because the matrixes or formulations for infused products vary.
That means the test results for infused products can be slightly less accurate than the results for flower and concentrates, Kaul said – and that makes the goal of demonstrating levels within 10% of the THC claims on labels harder to achieve.
“If I’m trying to extract cannabinoids out of a lotion, it’s going to be a lot harder and less efficient than trying to extract cannabinoids out of a concentrate,” Kaul added.
Joey Peña can be reached at [email protected]