For food production professionals, Good Manufacturing Practices (GMPs) start on day one—they’re the set of all programs, policies, and procedures that aren’t directed at controlling specific hazards. As a matter of federal law, GMPs are laid out in the human food rule of the Food Safety Modernization Act (FSMA), but, in practice, they define the food safety culture of an organization from the first training newly onboarded employees receive. FDA, likewise, prioritizes GMP inspections.
However, the moment a food producer infuses their food with cannabinoids—which the U.S. Drug Enforcement Agency continues to classify as a Schedule 1 drug—all federal law ceases to apply to that food product, meaning that national GMPs for cannabis foods do not exist in the United States.
“Cannabis edibles do not meet the federal definition of a dietary supplement,” says Kathy Knutson, PhD, a food-safety consultant. “So, cannabis edibles are neither food nor dietary supplements, and they are not regulated at the federal level. The FDA has been very clear about how even edibles with CBD are not legal.”
Food that isn’t legal is no longer subject to inspection by FDA, nor is its production subject to the GMP standards laid out in FSMA’s Final Rule for Preventive Controls for Human Food. Instead, what little food safety oversight cannabis products may encounter occurs at the state level—and in many cases it’s minimal.
The industry has developed without an understanding of basic food safety principles, or the importance of organizational culture in effectively implementing a food safety management system.—Lezli Engelking
David Vaillencourt, CEO of Denver’s GMP Collective, says, “People unfortunately get this false sense of security that because they went to a dispensary that’s licensed by the state, it must be safe, just like if you went to Target or Walmart. But all they’re doing is making sure that you track the physical plant from every stage of the life cycle. They took a few milligrams of the product and verified that, and it passed. Is that a representative as a whole batch? Were there preventive controls put in along the line? Does anybody do any environmental swabbing? I don’t know.”
There’s little argument that the cannabis-infused food industry would benefit from the standardization of GMPs, even if they’re not dictated by a federal body like FDA. However, because every state that has legalized cannabis has done so in its own manner and has been left to develop its own oversight for cannabis edibles in the absence of federal regulation, the path to national adoption of GMPs for cannabis food and beverages is not an easy one.
As is the case with many of the complexities of American cannabis legalization, the problem begins with the division between the many states in which citizens have voted to legalize cannabis and the federal government’s firm stance on keeping cannabis criminal. When states began to legalize, beginning with Colorado in 2012, they had no federal guidelines for regulating infused food safety. “They had no support, and they had no direction,” says Vaillencourt. “The states regulate restaurants and the food service industry—they don’t regulate Nabisco and ConAgra and Pepsi; they’ve never had to deal with that, so why would you expect them to know about GMPs? They weren’t even aware.”
Lezli Engelking is president and founder of the Foundation of Cannabis Unified Standards (FOCUS), based in Scottsdale, Ariz. She notes that, while states have legislated cannabis out of an overabundance of caution, which led to fairly onerous regulations, those regulations tended to ignore food safety experience or training as well as the implementation of quality management systems.
Some states required dispensary employees to take a ServSafe course, Engelking says, but “no specific food safety guidance or regulations were required for the production, manufacturing, or processing of cannabis. This is one of the many challenges of enacting state cannabis programs without any federal guidance and oversight.”