By Mica Gross, Director of Operations at Wana Brands
Let’s step out of the cannabis industry for one moment, shall we? We spend so much time tangled up in the red tape of legalization that we sometimes forget to consider what it looks like from the outside: A federally illegal drug being produced and distributed both recreationally and medically in a number of states nationwide. Seems relatively simple, right? Not for long. Many people in the industry feel that it is inevitable that it will be federally legalized in the near future. As the DEA pushes off a decision on re-scheduling, or better yet de-scheduling Cannabis, it is important to understand how federal government involvement will alter the way this industry will run, and how we can rise to their standards before it is mandated.
Right now, the Cannabis industry is a national powerhouse operating under the guidance of state-by-state regulations. What is considered compliant in Colorado could very well be deemed illegal in California, and vice-versa. While some businesses have taken state regulations as gospel and consider themselves compliant, I am here to tell you that it is simply not enough. Consider this: In California, a medical-only state, all cannabis packaging must explicitly warn that marijuana is a “Schedule I Controlled Substance;” while in Illinois, also a medical-only state, no such disclaimer is necessary. It is this lack of consistency within policies that impact the unity and sustainability of the Cannabis industry. These inconsistencies are not only reserved for labels and packaging, but they influence almost every aspect of the production and manufacturing process.
Before a business can even package and label its product, it must go through several different tests to prove it does not contain dangerous pesticides, microbials or other harmful contaminants. This policy is a win-win for all involved. But the problem is not in the policy; it is in the testing facilities themselves. To be more specific, there is a lack of properly validated testing facilities available to Cannabis businesses. Every other industry that involves the consumption of a product has properly audited and validated testing facilities, but not for those of us who live in the legal gray area that is the Cannabis industry. Try asking your preferred testing facility for an audit of their testing processes. They simply do not exist because it is not required.
The sun is beginning to shine on a new day, however. The Food and Drug Administration (FDA) knows the federal government will recognize the Cannabis industry. Once it does, they will meticulously comb through every process the industry has fine-tuned and perfected to see what and how they can regulate. The pending FDA regulations may have some businesses heading for hills, but it does not have to be the Game of Thrones-like battle some have made it out to be. Instead, progressive businesses, like Wana Brands, are looking at the time in the interim as an opportunity. The inconsistent state-by-state regulatory system currently being upheld will keep businesses compliant for now, but we must start planning for the future.
Not if, but when the FDA becomes involved in Cannabis, there is no way to accurately predict just how their rules and policies will fit in. The best chance Cannabis businesses have at surviving these pending regulations is by upholding other standard FDA regulations now. Currently, the FDA has a set of regulatory guidelines for manufacturing food, drug and supplements that contain the framework needed to create our own infrastructure and best practices, or Good Manufacturing Practices (GMP). This code is all we have to depend on at a federal level, and it is what state agencies are currently using to craft and evolve their own policies.
At Wana Brands, we have made it a priority to thoroughly understand and implement the GMP code as best we can for the Cannabis industry. The cornerstone of this is the detailed and consistent documentation of the entire manufacturing process. We encourage you to do everything from validating your methods of manufacturing to committing to third-party testing of materials to prove your information is accurate and your materials are stable. If we are making claims on our label, we need to be able to verify that what is reflected is accurate. By tracking material through the entire manufacturing process and keeping a reliable record of it, we are putting ourselves in a position to show how this process works—which protects businesses, patients, and customers alike.
Abiding by GMP is not mandatory, but it certainly will be in time. Wana Brands commits to deploy these guidelines in a meaningful way into an industry used to doing things its own way. As we, and businesses alike, continue to implement this sometimes laborious federal code, we are positioning the industry in a way that will prepare us to work with the FDA in the future. When the other shoe finally does drop and the FDA begins its rule making process, they are required to open it up to public comments. It is at this point that the massive amount of manufacturing, testing and purchasing data we possess will become paramount in shaping the federal rules. If we can prove that we have crafted, tested and perfected best practices when self-regulated as an industry, we may have a stronger influence over the final say.