Good Manufacturing Practices Set Cannabis Edibles Producers Up for Success
Pathways Toward Cannabis Regulation: Developers of cannabis-based foods and beverages can set themselves up for success by establishing sound GMPs.
While the federal American government has yet to provide a clear pathway toward regulation and oversight of legal cannabis foods and beverages, product developers and processors can set themselves up for success by establishing current good manufacturing practices (cGMPs) that adhere to widely accepted standard for process safety and reliability.
Cannabis food and beverage companies already have a comprehensive body of regulatory guidelines to help set themselves up for long-term success in this industry—but often with some tailored guidance specific to the unique properties of working with cannabis.
“We aren’t reinventing the wheel here,” says Kimberly Stuck, founder/CEO, Allay Consulting LLC, Denver. “Cannabis consumables are food products that the public is going to consume. If we follow good food safety, companies are minimizing the risk of sickness for their consumers while protecting their brand. By following current wholesale food regulations, cGMP standards and all-around good sanitary practices, a company can get ahead of the curve before FDA regulations are put in place—first for the hemp industry, and then for THC cannabis.”
All cannabis manufacturers must follow cannabis-specific GMPs in all operations throughout the supply chain, says Lezli Engelking, founder, Foundation of Cannabis Unified Standards (FOCUS), Scottsdale, AZ. “Quality needs to be built into operating budgets and prioritized by all levels of management and corporate leadership. In-house quality teams are necessary at each manufacturing location. Quality divisions must have full authority to make critical decisions related to the quality and safety of cannabis-containing products.”
A top priority is to protect the safety of consumers. “Establishing and maintaining comprehensive risk assessments and continually assessing hazards with the product and within the industry are critical,” says Engelking. “Proper HACCP programs, along with SSOPs and SOPs, should be customized and continually updated to remain current. Operations should install preventive controls from seed to sale and include traceability of all micro, minor and major components, and packaging materials.”
These measures align with current traceability requirements in the food industry. “Supply chain control and supplier accountability are critical components, as it’s crucial for traceability to be followed from receipt to end user, and that proper documentation be maintained,” says Engelking. “Third-party audits by accredited bodies should be conducted at least annually, but preferably bi-annually. Recall plans must be implemented and tested prior to selling products. Training must include product/food safety, as well as quality, sanitation, food defense, GMPs and cross-contamination topics, and must be done at least annually. All product safety programs should include validation and verification of product handling systems, sanitation programs, microbial control methodologies and post-lethality treatments.”
Guidance from NCIA
In October, the National Cannabis Industry Association (NCIA), Washington, D.C., released a whitepaper on “Adapting a Regulatory Framework for the Emerging Cannabis Industry” that provides some suggested pathways toward establishing a framework for regulating use of cannabis in foods and beverages, among other product formats. The NCIA suggestion includes relegating oversight of products that have psychoactive properties (+0.3% THC) to the U.S. Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau, and products without psychoactive properties (-0.3% THC) to FDA. To review the complete details of this publication, visit https://thecannabisindustry.org/reports/adapting-a-regulatory-framework-for-the-emerging-cannabis-industry.
Companies currently working in this industry cannot rely solely on state-based authorities to cover their bases. “States attempt to control for quality and safety through the mandate of third-party testing, which flies in the face of the basic tenants of GMPs,” says Engelking. Quality must be built into the product during every stage of the manufacturing process. “Testing alone is not adequate to ensure quality. It’s important that products are manufactured under GMP conditions to assure that quality is built into the design and manufacturing process at every step. Yet, across the board, these systems are not required in state cannabis programs.”
Stuck notes that some state health departments are conducting routine health inspections, but that others are not. “In some of the states where the state health departments aren’t regulating, some local health departments have taken it upon themselves to make sure their community is protected.” Unfortunately, in many cases, she notes, neither the state nor local health department is actively regulating, often due to tight budgets or bandwidth, so the companies in those areas are widely unregulated when it comes to public health.
Having any food safety guidelines in place in your facility will greatly help your company protect consumers, says Stuck. In doing so, companies help reduce the risk of costly recalls, product disposals and a subsequently tarnished reputation.
There are many nuances when it comes to cannabis food safety. Cannabis food safety experts continue to work to make FDA officials aware of the specific food safety dangers that cannabis can pose, notes Stuck. “I’m hoping that they listen to the industry, and past/current cannabis food safety regulators, so that they can create regulations that encompass everything that they need. I would suggest companies reach out to health departments that are regulating cannabis to know what they should be following, hire an expert to assist them, or do research to understand how to make a safe cannabis product.”
Looking to current FDA/cGMP standards, including ISO 22000 guidelines, is a great start, says Stuck.
“It’s in an operator’s best interest to, at the very least, meet FDA requirements as minimum standards,” says Engelking. “However, there are definitely cannabis-specific issues that fall outside of existing food safety programs that must be addressed in order to adequately protect patients, consumers, workers and the public.”
- Because cannabinoid levels, including THC, are affected by heat, it’s critical to understand how the manufacturing process affects individual products
- Unlike other items in the food and beverage market that may have a serving size “suggestion,” cannabis products require a dosage specification, as well as detailed instructions and warnings for consumers, like other drug products
- Cannabis extracts cause residual biofilms and resins, which are not water-soluble, and dramatically reduce the efficacy of traditional sanitizers and disinfectants
- Pesticide contamination and mycotoxins produced by molds can exist on the plants
- Food and beverage developers need to source suitable ingredients, confirming they were processed in a safe, GMP-certified facility, and research how the manufacturing process affects ingredients
The goal is to indoctrinate sound, comprehensive standards for cannabis food and beverage production. “Cannabis edibles and beverages should be part of the Codex Alimentarius, with global product safety requirements to ensure consistency for consumers around the world,” says Engelking. “Businesses should be establishing a solid team of experts they can rely on, even if the company needs to contract outside small to mid-size enterprises to fill these roles.”
Right now, this level of regulatory guidance isn’t required in most areas where cannabis products are being developed and manufactured, notes Stuck. It’s up to the manufacturers to selectively implement what they want. But those days are numbered.
“Eventually, a governing body will step in—whether it’s your local or state health department, or the FDA after federal legalization,” says Stuck. “Either way, having some kind of food safety plan in place will minimize risk and increase the chances of a cannabis company staying in business.”