Compliant packaging and labeling can get tricky in a highly regulated industry like cannabis.
This became evident last month, when the Oregon Liquor and Cannabis Commission (OLCC) issued recalls for mislabeled cannabis tinctures produced by Cura CS LLC and sold under the company’s Select brand. Curaleaf, Cura’s parent company, acknowledged that the company mixed up its THC and CBD tinctures, ultimately labeling the THC drops as containing only CBD and labeling the CBD drops as containing 17.25 mg of THC per serving.
RELATED: Mislabeled Cannabis Products Result in Hospitalizations, Lawsuits in Oregon
California-based cannabis operator Papa & Barkley also produces both CBD- and THC-based products, and Guy Rocourt, the company’s co-founder and chief product officer, has worked diligently to avoid this kind of product mix-up.
Here, Rocourt offers tips to streamline the packaging and labeling process when producing both THC and CBD product lines.
1. Consider separate manufacturing locations for THC and CBD products.How do you avoid mixing up THC and CBD products at your processing facility? For Papa & Barkley, the simplest solution is to manufacture the products in separate facilities—and in different states.
The company produces CBD products for its national product line at partner facilities in Oregon, Colorado and Vermont, while manufacturing its THC products at Papa & Barkley’s facility in its home state of California.
“The way we’ve been able to avoid any cross-contamination, if you will, is by simply having it in two facilities in different states, for that matter,” Rocourt says. “There’s zero chance at Papa & Barkley that we will accidentally have a CBD product labeled as a THC product or vice versa because they’re in separate houses.”
2. Live by your SOPs.Many cannabis companies may not have the ability to set up shop in different states, however, and in that case, Rocourt encourages operators to establish and follow robust standard operating procedures (SOPs) to create consistency and minimize mistakes.
“We should know, as an industry, that GMP certification is coming,” he says. “Robust SOPs, chain of custody of the supply chain, compartmentalization of these over-the-counter secured inputs—we need to have those SOPs.”
Papa & Barkley has trained its staff to respect the company’s SOPs and not cut corners, Rocourt says, and the company records its day-to-day operations separately, outside of Metrc, the state’s seed-to-sale tracking system, to build some redundancy into the process.
“If in fact I need to recall something or find something, I can find every single unit down to the gram,” he says.
Ultimately, Rocourt says cannabis processing facilities should mirror manufacturing facilities in other industries.
“Inputs, especially ones that are active ingredients like cannabis, [should be] heavily tracked, not just through Metrc with the state, but through your own internal purposes so that you render it impossible for your employees to make a mistake like having the wrong active ingredient in a differently labeled bottle,” he says.
Photo courtesy of Papa & Barkley
Papa & Barkley produces CBD products for its national product line at partner facilities in Oregon, Colorado and Vermont, while manufacturing its THC products at Papa & Barkley’s facility in its home state of California.
3. Test all ingredients.The cannabis industry is all too familiar with testing, but at times, this testing may only extend to the cannabis itself—and this is a mistake, Rocourt says.
“For us, it’s important that all things are tested before they go in,” he says. “Things should be tested separately because we want to know what’s in them, so when we do our final formulation and we get that final form testing, we know where these things are coming from.”
Papa & Barkley retains certificates of analysis (CoAs) for all the ingredients that go into its formulations, which Rocourt says forces the company’s employees to take greater care with each input.
“We put compliance testing out there as this big goal because as we scaled, our batches have become bigger and bigger and bigger,” he says. “[When we were] moving five-, six-, seven-, even 100- or 1,000-unit batches, if we had to empty those bottles, it was tortuous but not the end of the world. But now, as our batches have eclipsed 5,000 units per production run, remediation can’t happen, so we have to get it right. When we go to fill final form, it has to be the right product.”
The overall strategy, Rocourt says, is to put as many hurdles and double-checks in place as possible to ensure every ingredient that goes into a product is safe—and that it is the right ingredient for that particular product.
“All the ingredients are pre-weighed out and laid out in front, and then the operating shift supervisor can check that blend, and then it gets blended,” he says. “Then, of course, we always do our R&D test, too. So, after we blend it and it’s finished in the blend room, [the products] go out for a test before we bottle them to make sure that the potency is right, that no mistakes were made. … Then, that gets a big label on it and that’s standing by for filling. Before it gets filled, the same thing happens. … It’s verified by the [quality assurance] staff and the shift manager.”
4. Balance compliant labeling with marketing.Once the product has been tested and packaged, it must be labeled for sale. In the cannabis industry, this largely means ensuring that all the safety and warning labels are in place to comply with state regulations, often before branding and marketing components are considered.
For the THC products that Papa & Barkley produces in California, Rocourt says “it’s crazy that we end up having to put an outside box” as part of the packaging, but he says the additional packaging is necessary to fit all the required labels.
“Here it is we’re trying to have sustainable packaging, and we end up having to have extra packaging because in order to have all the compliance information, we need the space,” he says.
No matter the size of the product or packaging, Rocourt says Papa & Barkley must include a half-inch warning label on its packaging under California law, in addition to a Proposition 65 label that includes a cancer warning.
Cannabis packaging in California must also include a batch label with the batch ID and a QR code or link to the product’s CoAs.
“There’s lots of stuff to put on packaging before we can actually get to the good stuff that the consumer actually wants to read,” Rocourt says. “On the national [CBD product] side where we would normally have more room, we proactively made sure that we put as much of the FDA-style warnings and we’re just trying to do best practices now.”
While CBD remains largely unregulated on the state and federal level, Papa & Barkley has implemented best practices for labeling its CBD products. These procedures are based on U.S. Food and Drug Administration (FDA) guidelines for over-the-counter (OTC) drugs, Rocourt says.
“We have, of course, a nutrition label if the product dictates it,” he says. “We put in a QR code that has access to our CoAs so somebody can see it’s tested.”
5. Prepare for federal regulation.Federal legalization is imminent, Rocourt says, adding that “companies would be smart to keep their eye on the feds because … the feds will … put in some guardrails.”
Cannabis companies would be wise, he says, to get their facilities and practices ready for these guardrails.
“Look ahead and realize what we’re doing,” Rocourt says. “We are creating medicine, even on the recreational side. … From a production standpoint, as a product maker, you have to do it safely. We should assume that our safety protocols or the regulations [that] are coming with federal legalization [are] going to be on that level of OTC and prescription drugs. In a way, we should want that.”
Rocourt says that while the industry has done a fairly good job of self-regulating thus far, it should develop some basic standards, especially when it comes to SOPs surrounding packaging and labeling.
“It’s easy to make 100 products, a little harder to make 1,000 products,” he says. “When you start to get into the tens of thousands, it’s not you that’s making a mistake—it’s just the sheer numbers of it, and you need to put processes in there to not make the mistake. … Scaling is difficult because you need attention to detail and it’s easy to do a one-off, but to recreate something reproducible in a scalable, sustainable way is difficult and it usually requires a motivated team whose head is in the game, paying attention to detail.”
“If I were starting a manufacturing apparatus right now, I would try to get my product out to market, but I would keep it top of mind that when I’m doing the first ones and I’m handing them out to folks, OK, that’s easy,” Rocourt adds. “But as I get traction, the better I get, the harder it should be so that by the time I’m making a million units, it’s a huge, convoluted process geared to make sure that the millionth product is as good as the first one.”