engelking.jpgLezli Engelking understands the role medical cannabis can play in patients’ lives, but with the lack of oversight on cannabis-infused food and beverage manufacturing, she also understands the risks.

A 12-year veteran of pharmaceutical company Eli Lilly, Engelking co-founded Bloom Dispensaries in Phoenix, AZ in 2012. The company serves medical cannabis patients and operates much like a clinic, employing an intake counselor and tracking patients’ symptoms and side effects.

Through her work in the dispensaries, she discovered gaps in the regulation, which emphasizes logistics over quality control, as well as in food safety knowledge among producers and manufacturers, many of whom came from the black market.

That concerned Engelking, whose business supported many vulnerable customers.

“We had a lot of people with really compromised immune systems coming in,” she says. “It freaked me out there were none of the traditional protections for quality and safety like there have been in other industries.”

Engelking took matters into her own hands, launching FOCUS — Foundation of Cannabis Unified Standards — in 2014 with the goal of providing comprehensive guidance to operators across all facets of the cannabis industry. She offered insights she’s gained and examples of cannabis-specific food safety concerns during Cannabis Products Exchange, presented virtually July 30-31.

Engelking turned to the Commission on Accreditation of Rehabilitation Facilities (CARF), a nonprofit accreditor for health and human service providers, as a model for FOCUS. With help from more than 200 professionals across several industries, they pulled relevant regulations from US 21 CFR, ISO, OSHA and HACCP, as well as from global cannabis regulations and WHO and WTO guidelines, to develop standards for the cannabis industry.

“We didn’t want to recreate the wheel,” Engelking says. “We wanted to use everything that was existing and make it specific to cannabis.”

The committees originally covered cultivation, retail, extraction, infused products, laboratory, security, sustainability and packaging and labeling. But after putting the proposed standards up for a 30-day public review under the American National Standards Institute (ANSI) input process, FOCUS consolidated them into four areas of certification: cultivation/primary production, manufacturing/processing, retail and laboratory.

And while testing for potency, homogeneity and contaminants is important for developing safe cannabis products, Engelking notes mandated testing is many states’ only attempt at regulating for quality — and it may not be benefitting producers or consumers.

“(Testing is) daunting, first of all,” she says. “It’s expensive and drives up costs for patients and operators. The reality is, if cannabis operators were basing their business on good manufacturing practices and standards, they wouldn’t need as much testing and certainly not as much third-party testing.”

Engelking also points to the significance of having validated standard operating procedures (SOP) and robust employee training so manufacturers are sure their processes will deliver safe, quality products every time. 

As an example, she cited a gel cap manufacturer that was using food-safe pesticides thinking they’d meet the company’s needs, but they were designed for outdoor use and not water-soluble, so the pesticides built up in the manufacturing system over time. After years of successful production, the products began testing over pesticide limits.

Engelking also presented a photo of a cannabis-infused truffle one of her employees purchased that contained mold. After notifying the manufacturer, she said the company repurchased all the compromised product from dispensaries as patients rather than issuing a formal recall.

“It becomes a scary situation,” she says. “It’s really why standards, certifications, quality management systems and GMP are so critical to this industry.”

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