Educating everyone in the company—not just about what the GMPs are but also why they exist—is fundamental to Engelking’s approach. “A company’s values must be integrated into all activities, including daily team meetings, operating procedures, internal and external communications, etc. All members of the team—employees, managers, and executives—should receive training on good manufacturing practices as well as the importance of organizational culture. There really isn’t a cannabis business that can afford not to implement GMP standards.”
However, she says, there are plenty that won’t, and will wait until they’re forced to do so by law, which is inevitable. “Regulations will continue to evolve, and will eventually mandate GMP, at both the state and federal level. States will begin to require it just as they now require ISO 17025 accreditation for analytical testing laboratories.”
What’s Changing
The good news is that all over the U.S., independent organizations are working to develop standards. Last year, the 200-year-old nonprofit U.S. Pharmacopeia published a standard of quality attributes for cannabis flower products in their Journal of Natural Products. “I think it’s now in the top 5% of citations in the history of the Journal of Natural Products, which for an article that’s only 14 months old, that’s big,” says Vaillencourt.
At the same time, standardization body ASTM International has approved more than 20 standards, thanks in part to the work of thousands of volunteers across 30 countries.
Most importantly, Vaillencourt says that a coalition of state groups and representatives from the federal department of agriculture, working in conjunction with the National Institute for Standards and Technology (NIST), are finalizing a food safety guide for cannabis edibles production.
But it remains to be seen what sort of final shape GMPs for cannabis might take. Vaillencourt suggests that producers adhere to the Global Food Safety Initiative and Safe Quality Food Program. And then there’s ISO 22000: the food safety management systems. Hopefully we don’t go down the GFSI road; between SQF, BRC… there are so many groups in there it’s so complicated to have 10 different systems to harmonize. I hope we can just have one system.”
The Final Picture
Vaillencourt cautiously predicts it will take between two and five years before the U.S. sees anything like a nationally coherent set of GMPs for infused foods, but Engelking isn’t willing to make a ballpark prediction. “With any luck, the continued advancement of state programs and the changing perceptions of Americans around cannabis will expedite this process,” she says. “The global cannabis industry is hampered by the lack of American federal regulatory development, just like the domestic industry. Most of the world would prefer to follow U.S. standards and regulatory leadership, especially with respect to quality and safety, as well as compliance with international treaties.”
Cannabis standards have not emerged from the federal level, but rather from the 36 states that have legalized it so far, and Vaillencourt thinks those states will be hesitant to accept advice from the federal government, which left them to work their standards out alone. Dr. Knutson agrees. “I don’t think there’s any consensus anywhere,” she says, adding that she sees the clearest path to food safety for infused foods in either rescheduling cannabis on the DEA list or descheduling it completely. “As many little steps as we can take forward, I think there’s going to be greater progress in the long run, even though it’s painful at every little step.”
Engelking argues that cannabis’s Schedule 1 status—reserved for drugs with no medical potential and high likelihood of abuse—has created the vacuum for guidance and oversight at the federal level. She thinks Schedule 1 status is both the biggest obstacle to the development of the U.S. cannabis industry as a whole, and also the biggest stumbling block on the path to implementing GMP nationwide standards.
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