Keeping Cannabis Compliant
Sitting Down With... Savino Sguera, Founder and Chief Scientific Officer, Digamma Consulting
What was your route into the cannabis industry?
I’ve been in the industry for nine years now. I graduated in biomedical engineering in 2008, soon after the markets had crashed, and there were very few science jobs near my home in New York. I went out to California to visit some high school friends who were working in dispensaries. I became intrigued by the emerging market in cannabis testing and went to visit Steep Hill Labs. After striking up a conversation with the then-owners we stayed in contact and eventually I joined them as the Lab Director.
I worked in several different testing companies before starting my own consultancy business with Co-Founder Marco Troiani. At Digamma, we help analytical laboratories, manufacturers, and formulators around the world optimize their method development, validation, and SOPs.
What are the greatest challenges facing the field?
Regulation is a major issue – US and international regulations on cannabis trade and research have been the main limiting factor for the industry. Right now, there is a steep learning curve happening among cannabis companies. They need to reach a point where everything they do is legally defensible – every certificate of analysis and every product – and that is proving to be a challenge.
Unlike food or environmental testing, there are no standard, validated methods for cannabis laboratories to follow. Federal regulations prohibit instrument companies from working with cannabis, so when they develop methods for their instrumentation they have to use a substitute.
The cannabis matrix is much more complicated than many matrices studied in other industries and there are many interferences that have similar molecular weights to the compounds of interest (for example, pesticides). As there is currently no “out of the box” method to help scientists get around those interferences, method development has to be creative – and that makes it difficult to compare results between labs. And some labs are not testing at the level of accuracy required by law...
How much that affects consumer health and safety is questionable because the limits set by regulators are somewhat arbitrary; however, if you say you’re doing something, you must follow through.
What changes would you like to see?
There definitely needs to be a change of legislation on the federal level to deschedule cannabis, give companies access to banking, and remove unnecessary tax codes. Cannabis companies should be allowed to operate like any other business.
Next, we need to introduce more scientific integrity into processing and testing; I think that has started to happen in states such California, where they have a huge market and regulations are tightening up. It’s not perfect – some of the testing limits are very strict and the system can be bureaucratic – but it does seem to be working to improve testing standards.
In the longer term, we need standard methods. It is slow progress, but I think we are getting closer. The number of scientists who are participating in the industry has grown exponentially in the last ten years, and several organizations and accrediting bodies are working with laboratories to validate their methods.
What’s next for cannabis analysis?
Over the next three years, I think we’re going to see a lot more standardization as many labs realize how far they are from compliance. Methods that were previously considered proprietary information will become public knowledge and we will see convergence. Once we can compare datasets from different laboratories, different regions, and different products, things will get really exciting!
The cannabis industry is an early adopter of new technologies and new practices. Already, pioneers in this space are delving deep into the biology and chemistry of cannabis. In some respects, we know more about cannabis than any other consumer product (we don’t routinely test every wine for its flavor profile chemicals). Testing labs are already generating a huge amount of data and, if we can start to aggregate it, we will have a powerful tool to learn more about this amazing plant.
Will attitudes to cannabis change too?
I’ve seen perceptions change rapidly in the years that I have been a part of the cannabis industry. When I first joined the industry, few scientists wanted to get involved at all; they saw it as a career killer. As the opportunities have grown, that taboo has lifted. Now, people are curious. I get phone calls all the time from friends and family back home asking if they should try cannabis products for various ailments. I hope that level of interest will lead to a demand for more clinical trials – if there is enough public support, I believe the law will eventually follow.