Regulation Nation

(Click to enlarge) Figure 1: Lori Dodson (at podium) led a discussion about cannabis testing and the regulatory landscape of the industry at the 2019 Cannabis Science Conference East, held in Baltimore, Maryland, April 8-10. Sitting at the table were the two other panelists: Deborah Miran (left) and Heather Krug.

In this month’s Cannabis Crossroads column, we hear from three current and former state regulators about their collaborative work in the industry, feedback from stakeholders, and how they are making the industry more productive and safer for both businesses and consumers.
 

Regulators play a vital role in an industry that is continuing to evolve. I recently sat down with current and former state cannabis testing regulators to discuss challenges, changes and emerging efforts.

Featured here are Lori Dodson, who currently serves as the deputy director for the Maryland Medical Cannabis Commission; Deborah Miran, who was a member of the Natalie M. LaPrade Maryland Medical Cannabis Commission from 2013–2016; and Heather Krug, the state marijuana laboratory sciences program manager for the Laboratory Services Division of the Colorado Department of Public Health and Environment.

These industry leaders share their unique perspectives, insights and challenges, as well as comments on how cannabis laboratories are changing their practices. 

What are some of the challenges that regulators face when crafting state regulations, given the federal status of cannabis and the fact that it is a states’ issue and regulations can vary greatly from state to state?

Lori Dodson: The obvious answer here is the lack of federal oversight leaves states essentially on their own deciding what is “safe” without cannabis data. States are left to review federal standards from United States Pharmcopoeia (USP) about botanicals, or tobacco, when trying to decide what level of contamination is considered an appropriate level. The American Herbal Pharmacopoeia (AHP) monograph was relied on pretty heavily, but the latest revision of that monograph was 2014.  The pace of the industry makes it very difficult for the science to keep up.  Additionally, the length of time required to promulgate regulations keeps states chasing the industry. I also believe there is such diversity in cannabis testing regulation because states are inadequately resourced at the staff level to scrutinize why certain regulations exist and whether or not they make sense scientifically. Many regulations are carbon copies of other states, regardless of adequacy.

Deborah Miran: The biggest challenge is a lack of a national standard for tests, methods, and specifications. Therefore, states are forced to rely on standards developed for other industries like traditional pharmaceutical testing, and medicinal herbs other than cannabis. The USP, even though they are a private, for-profit organization, is so closely aligned with the U.S. Food and Drug Administration (FDA) that they are blocked from publishing a monograph until cannabis is rescheduled.

Heather Krug: Regulators must work carefully when defining cannabis testing requirements to achieve a balance between protection of public health and safety and making testing too expensive, potentially driving black market activities. Regulatory testing requirements are best constructed upon evidence-based science, which can be difficult given the lack of currently available data specifically applicable to cannabis. This has resulted in variable regulations across states as each state has to define their own regulatory structure, with different state agencies playing various roles in that process. There have been many regulatory changes during the past few years of legalized marijuana, and the system will certainly continue to change as knowledge advances, hopefully in a way that begins to align across state lines.

What are some of the advances that you have seen over the last three years in terms of expansion of products, qualifying conditions and routes of administration?

Dodson:  I think the innovation with the processed product market is remarkable. There is a route of administration for everyone. Folks I talk to who are not familiar with medical cannabis still think the program is all about smoking a joint.  I challenge them to really take a look at the innovation; it really mimics products available in pharmacies. The challenge with the rapid innovation is the ability for laboratories to keep up with the validation of methods to support all types of new products being developed. Sample preparation is drastically different for the variety of products available, and that equipment can be pricey for laboratories.

Miran: States seem to be very accepting of cannabis in traditional pharmaceutical dosage forms, and accordingly patients have access to medicine in a variety of routes of administration that they have familiarity with. While dried flower is still popular as a finished product, the processed products continue to grow in overall market share. States seem to be approaching qualifying conditions in widely varying ways. States like Maryland took a unique approach by listing broad categories of conditions rather than specific diseases, and this gives the medical discretion to the provider and patient rather than a state mandate. Accepting cannabis use for mental health conditions such as anxiety and depression has been difficult for regulators, and thus only a few states list anxiety and none list depression. Ironically, in states that give wider discretion to the physicians, insomnia, depression, and anxiety are widely recommended.

Krug: Colorado has intended-use categories that allow for production of a broad array of product types. These categories include various inhaled products, orally consumed products, and skin and body products. It seems cannabis can be put into anything. Recently, we’ve adopted rules outlining requirements for production of certain higher-risk profile products including metered dose nasal sprays, inhalers and suppositories. We also have a process that allows producers to receive an alternative-use designation for products that don’t fit into any of the prescribed intended-use categories.

Have you seen any changes in the cannabis testing industry based upon these advances?

Dodson: The testing laboratories in Maryland have all been participating in laboratory comparison testing to ensure that all laboratories are able to prep, extract, and analyze all product types available. I hope to have a stability testing program available this year that will help define expiration dating for all product types. This will be especially important with the introduction of edibles in Maryland’s medical cannabis market.

Miran:  This is an area of great concern to me. As more complex dosage forms are developed with many excipients (for example, a complex cream for topical use, and cannabis in food products), accurate and precise testing of the active ingredients (cannabinoids and terpenes) becomes more challenging. To adequately validate a testing method, the producer of the dosage form must supply a placebo product (every ingredient minus the actives) to the testing laboratory in order to complete full method validation. In my experience this is rarely, if ever, happening, and this needs to change.

Krug: There are so many different matrices for laboratories to test because of the huge variety of product types. To address this challenge, we continuously see laboratories implementing new analytical, sample preparation and clean-up techniques specific to certain products, ranging from cryo-grinding, to filtration, to matrix-matched calibration. In response to advancements in the types of products being produced, Colorado also recently established new testing requirements specific to cannabis inhalers, nasal sprays, and suppositories to address potentially hazardous containments specific to these modes of administration.

What is the biggest challenge that regulators are working to overcome at this moment?

Dodson: Bridging the gap between the rule-makers, the laboratories and the industry. I’d love for industry players to begin to use the testing laboratories as resources to troubleshoot when a certificate of analysis doesn’t reflect the numbers that they believe it should, and not just immediately assume the laboratory is wrong. We are slowly getting there.

Miran: Sadly, as hard as regulators try and honest, legitimate laboratories try, there is still an unacceptable level of bad laboratory practices in many states. Often product pricing and licensee profits are based on tetrahydrocannabinol (THC) content, so the incentive to “inflate THC results” in finished product testing exists.

Krug: From my perspective, one of the biggest challenges is trying to determine how to best protect patient and consumer health and safety in the absence of much of the data or the processes that typically exist for a non-cannabis product, such as established maximum residue levels for pesticides or approval of a new excipient. And just trying to keep up with the advancements of such an innovative and creative industry.

For newer states that are coming on-board and creating new state medical cannabis programs, what are some of the lessons learned when looking back at creation of particular commissions? What would you have done differently now?

Dodson: Adequate staffing is a must. Many different types of backgrounds are necessary to successfully regulate this industry.  Our staff has grown from 17 personnel in December, 2017, to almost 50 today, and their backgrounds range from policy development and legal development to law enforcement, scientists, data analytics, IT, regulatory, and communications, just to name a few. To successfully regulate this industry there must be diversity in the regulatory staff.  A second lesson learned is the necessity for thorough staff training. Think about it: cannabis regulators don’t come from a “pool of cannabis regulator candidates.” This industry is new and regulators across the country are still learning how to regulate appropriately. There is an inadequate amount of training for cannabis regulators that isn’t funded by the industry.  I see this as an area with great potential if we are serious about doing our jobs well.

Miran: As exemplified in Maryland, I believe that a coordinated effort between a commission staff that reports to their Department of Health or pharmacy and an independent advisory board of experts is optimal. There are plenty of excellent examples of regulations in the 33 states that now have medical programs that no one needs to reinvent the wheel. Looking back, I would have favored a smaller, committed group of experienced experts to guide the staff decisions on medical and technical matters.

Krug: It’s important to include a variety of perspectives, including industry, scientists, law enforcement, and public health professionals in the discussion. Without the right expertise at the table, it’s easy to overlook elements critical to successful and balanced policy.

Additionally, what are some of the successes that you participated in, and for which you are personally proud, that you would recommend being implemented in other states?

Dodson: I wrote the “Technical Authority for Medical Cannabis Testing” guidance document and hope it has been helpful for Maryland’s laboratories as well as other state testing programs that are coming on board. This document was written to provide a supplement to the regulations, and is meant to be revised as testing standards develop. We’ve also implemented a successful laboratory comparison testing program in Maryland. This program allows registered laboratories to compare their methods and analytics with other laboratories in the state (everyone is blinded, of course) on a variety of matrices. I see this program as a supplement to the proficiency testing requirement from ISO 17025. The sample preparation component can be very tricky when dealing with cannabis testing, so it’s critical that laboratories are able to use the appropriate matrix in addition to proficiency testing samples supplied by proficiency testing (PT) vendors when comparing testing competency.

Miran: Remember, I began regulating in 2013 and much has changed and improved since that time. Having said that, we accomplished many “firsts” in Maryland such as 1) requiring independent sampling of the product for testing, 2) requiring quality assurance (QA) retain and stability samples to be collected and tested as needed, and  3) adopting the FDA approach to the use of guidance documents for the details of testing rather than in regulations which are slow to revise when science advances.

Krug: We have made very deliberate efforts to engage our stakeholders in regulation and policy development. This has ranged from rulemaking, to designing and executing a multi-laboratory study on pesticide detection limits in cannabis, to establishing various work groups to focus on finding solutions to various issues. In August of 2018, we created the Marijuana Science and Policy Work Group whose purpose is to share ideas and information in a collaborative environment regarding the many scientific questions of relevance to the cannabis industry, to public health, and to public safety. Through public and private collaboration and study, it is hoped that the work group’s research, resources, and recommendations will be of value to industry, to regulators, and to policy makers even outside of Colorado. I’m proud to have been a part of all of these efforts. Not only do I think it’s allowed Colorado to be a leader in cannabis regulation, but it will allow us to help shape the cannabis industry of the future.

About the Interviewees

Deborah Miran, a former state commissioner, was a member of the Natalie M. LaPrade Maryland Medical Cannabis Commission from 2013-2016. While serving on the commission, she was also a member of the executive committee, policy, and research subcommittees, and was chair of the education subcommittee. She was responsible for developing education programs for doctors and patients, and was also an integral part of crafting the current regulations. Prior to the commission, she was president and founder of Miran Consulting, Inc.

Heather Krug is the State Marijuana Laboratory Sciences Program Manager for the Laboratory Services Division of the Colorado Department of Public Health and Environment. In this role, Krug oversees inspections of Colorado Retail and Medical Marijuana Testing Facilities for suitability for certification and compliance with the Code of Colorado Regulations. She acts as the technical contact for the Marijuana Enforcement Division of the Colorado Department of Revenue, to whom Krug provides technical assistance, regulatory and policy assistance, and enforcement recommendations. She is also responsible for the state Marijuana Reference Laboratory housed within the state public health lab.

Lori Dodson currently serves as the Deputy Director for the Maryland Medical Cannabis Commission. During her time with the commission, Dodson has been actively involved in developing policy and regulation for the medical cannabis industry, as well as developing testing criteria for the laboratories registered to analyze medical cannabis. Prior to coming on board at the commission, Dodson was a program coordinator for the Maryland Department of Health and Mental Hygiene-Office of Health Care Quality, where she was responsible for regulating and inspecting forensic and clinical laboratories in Maryland. Dodson has a Masters of Science in Biomedical Research from the University of Maryland-Baltimore, and a Bachelors of Science in Medical Technology from Wichita State University.

About the Columnist

Joshua Crossney is the columnist and editor of “Cannabis Crossroads” and a contributing editor to Cannabis Science and Technology magazine. Crossney is also the president and CEO of CSC Events. Direct correspondence to: josh@jcanna.com.

How to Cite This Article:
J. Crossney, Cannabis Science and Technology 2(3), 28-32 (2019)