Drawing from her two decades of professional experience across the pharmaceutical, mental health, non-profit, and cannabis industries, Lezli Engelking founded FOCUS, Foundation of Cannabis Unified Standards. After 12 years with Eli Lilly and as executive director of the first chain of vertically integrated cannabis operations in Arizona, Engelking’s experience in the highly-regulated pharmaceutical industry and the unregulated cannabis industry led her to develop a third-party validated, cannabis specific standards company.
When I started talking about standards in early 2014, people were afraid of me. I felt like I had a target on my back all the time. They thought I was trying to push for heavier regulations and inviting government into their business and taking away some of that freedom when it’s exactly the opposite of that. Standards are the way to create sensible regulations and to protect industry. At the end of the day, the consumer or patient is always the highest priority. We want to put something in place that the federal government can use to regulate and it’s a system they are already comfortable using in other industries. We are just here to make sure as this progresses it’s done in a safe manner.
I felt like I really wasn’t able to help patients anymore because of some of the different regulations [in pharma]. I wasn’t sure what direction I was going to take. That’s when medical [marijuana] passed in Arizona in 2010 and friends were applying for licenses and they asked me to work on that because of my background in pharma. I worked in public health in Arizona prior to pharma so I had a good feel for the regulatory climate and how it worked. At first, I said no, it literally took them a couple of months to convince me to do it just because I didn’t know anything about cannabis. I didn’t have the background and it is federally illegal. They sort of wore me down with data, I just kept reading all of these medical benefits which you don’t really hear about. If you are not in the space you don’t hear about the medical side or at least not in 2010. Once I started reading about that I thought it would be a real opportunity to help people and get myself back in a space where I felt like I was in pharma and don’t have the ability to be anymore.
Standards themselves, if they are voluntary consensus standards like FOCUS’s, are suitable for adoption into regulations through accreditation bodies. Then they are continually updated to reflect the changing needs of the industry. But as far as the core standards we developed, it took about two years. It’s not a fast process. The requirements for developing those standards guidelines are pretty intense, everybody has to have a say, you have to get balanced input from all stakeholder groups. We couldn’t just get a bunch of cannabis industry experts together and say, ‘Hey these should be the standards, let’s self-regulate.’ We had to build a safe legal cannabis industry that works on a global level.
To develop the standards that we did, we had to use stakeholders from all industry groups. And, at that point it’s 2014, people are still nervous and skeptical. I think the whole attitude toward cannabis has changed dramatically in the last few years so making sure we pulled the right experts in from other industries and do the right thing was a challenge at first.
Remember, when I set out to do this, I honestly had no idea what the hell I was doing. I don’t have a background in this. I just knew I had a really good basis of knowledge from my years and years in pharma and I knew there was a super big need for it. I did tons of research when I was developing my business plan to look at what existing organizations were out there that might be a good business model to follow.
Right now, none have finished the process but there are 14 companies going through it. If you decide to go through certification with FOCUS or any other party, it can’t happen overnight because it literally addresses every aspect of your business from top to bottom, from HR policies to product specifications. We estimate it takes about six months. We have got a lot of clients working on it. Everything we do is designed to hold hands with the business and make sure we are not just handing them a bunch of standards or a bunch of SOPs. We really want to make sure its integrated into the day-to-day activities of the business. When a state audit is conducted they give you two weeks’ notice and it’s sort of a scramble at the facility to make sure they have all of their documentation and all of their ducks in a row. Our goal is to make sure no matter what, a FOCUS-certified client could be inspected for a drop-in audit and never have a problem.
To me the most important thing in creating a certification body was to remove any implications of impropriety. If I take money from a cannabis company or from a company that is also funding the cannabis industry, that takes away some of the legitimacy of who we are. We have worked really hard to stay independent. Personally, that’s been one of the biggest challenges because I have done this through my own savings and with the help of family and friends. FOCUS is really the health and safety organization for this industry so we want to be able to back up everything we say and do.
FOCUS was designed to be a collaborative organization. We are not competitive, we always want to work with other people because the best thing for this industry is to have one set of unified standards that people can use as a baseline, which is the reason we are so excited about collaborating with ASTM [American Section of the International Association for Testing Materials], and development of their standards. It’s one of the largest standards development organizations in the world; it predates ISO [International Organization for Standardization] and they recently decided to move into this space and work on cannabis standards. They have asked FOCUS to contribute our standards as the baseline for development of their standards. It truly is a global harmonization effort to bring standards to this industry but also to regulatory bodies around the world so that everybody can work under the same framework.
We are working with a lot of different agencies around the world to bring unity to this. My goal is to see third-party certification as a part of this industry to give regulators the confidence they need. At the end of the day, it’s the patients and consumer who need to be sure they have a safe, consistent quality product and I don’t think we are there yet. Now we are just trying to get out there and get the certification processes happening. We would really like to work with consumer organizations to help drive awareness and the importance of a certified product whether its FOCUS-certified or any other agency.
Standards, in general, in any industry are the baseline and the international language for trade. They are the reason why our bankcards work in in every bank machine around the world even if it’s in a different county and a different language. There is a reason why import and export can happen. If you look at Canada, Holland, Israel and all these other countries, they are already exporting and importing and creating alignments in other countries. The only way to do that is prove that your product was produced in a manner that was appropriate and was safe and effective and that you have got a recall process in place so that if someone were to go wrong, you could pinpoint the problem and find out why and who was effected by it. I definitely think a globally harmonized standard is the best thing for this industry.
Standards in the cannabis industry are all over the place with all the different regulations in different jurisdictions across the U.S. To go into other states, you have to partner with someone and you don’t know what their ethics and values are or what their practices are, so truly standard regulations will make everything so much easier for this industry. It also gives guidance on how to do things. The state regs. regulate who can buy it, who can sell, but they don’t tell you anything about how to make that product safe and that’s kind of the difference in standards.
Certainly, this industry is being disruptive. The hope is that if we can regulate it properly it would be disruptive or destructive to the black market. I don’t think we are there yet. As for pharma, we are never going to change the need for pharmaceutical, pharmaceuticals change lives. Cannabis is not going to replace all that but it certainly has a place in the treatment of many many ailments. FOCUS standards are like cannaceuticals in how to make cannabis standards similar to a pharmaceutical standard. But you don’t go and look at pharmaceutical standards to do that because they are not applicable to whole-plant medicine. The FDA can’t see through that whole plant medicine idea. If you look at the nutraceutical industry or dietary supplements they have had so many problems with quality and safety that we really want to put an important framework into place so we don’t have those issues with cannabis as medicine.
The biggest surprise to me was that there were no quality and safety standards like there are in other industries. My background is in compliance and to find out this entire industry exists on a global level as well across the U.S. and there were no quality and safety measures behind it — that is crazy. That was the reason for starting FOCUS. How is it that something that is called medicine, that people are using who have compromised immune systems, does not have any of the controls for quality and safety in place and still be called a medicine? FOCUS standards aren’t for medical only. In my mind, you need one standard. We don’t want people who are using cannabis recreationally to turn into patients because their immune system is compromised because of tainted cannabis. It’s for everyone but, certainly, on a medical level that’s an even more important factor.
Getting this industry to think about standards in the first place. When I started this people were so afraid of me, they thought I was trying to overregulate them. So, I had to step back and say clearly there is some education needed here. So, I quit talking about FOCUS for a year-and-a-half and started talking about the difference between standards, regulations, laws and what standard-based regulation looks like, and why that’s important to an industry. I certainly wouldn’t take credit for it all happening because of me. The development and growth in the industry and all the problems we have seen with the recalls has definitely expedited that understanding and created a demand and need for it but I think that’s probably the biggest thing I have been able to contribute, changing some thinking around that. We are here to talk about health and safety. We are in a really good position to change some of that dialogue and education is the key to doing that.