Abstract / Synopsis:
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.