By Sheldon Baker12.04.19
Élan M. Sudberg is CEO of Alkemist Labs, a passionately committed contract testing laboratory specializing in plant authentication, botanical ingredient identification, and quantitative analytical services to the food and beverage, nutraceutical and cosmeceutical industries. He holds a degree in chemistry from California State University Long Beach and has authored numerous journal articles on phytochemistry and analytical techniques for the natural products and nutraceutical industry. He is a board member of the American Herbal Products Association (AHPA), as well as AHPA’s education and research on Botanicals Foundation, and former chair of the Hemp and Medical Marijuana committee.
Area Code 420 (AC 420): Tell us about the third-party THC label verification program with Nutrasource.
Sudberg: The International Cannabinoid Analysis Program (ICAP) is a certification program for manufacturers and brands that is designed to provide consumers with freely available third-party-verified testing results. We test cannabis, hemp, and their extracts or derivative products with appropriate methods to ensure they contain less than 0.20% delta-9-tetrahydrocannabinol. This the limit designated by the European regulations, and is more stringent than the U.S., which is 0.3%. This is important for many reasons, but I’ll list a few.
Consumers need to have confidence that what they are getting has the very low THC levels they expect, particularly when using the products with pets or children. With this segment of the industry growing so incredibly fast, while still being in a regulatory gray area, brands need to demonstrate that they are selling the products they claim to be.
AC 420: How did this collaboration with a Canadian company come about?
Sudberg: I have known Will Rowe and his excellent team at Nutrasource for a decade. We were on a panel together at NutraCon years ago and have great respect for each other’s companies. The idea for ICAP was his and is in line with their other excellent third-party certification programs. In seeking the best contract testing lab for the job he thought of Alkemist Labs. After a few meetings we realized ICAP could be a win-win-win and we put our teams on the project. We enjoy working with companies that have similar high standards, and we find testing cannabis interesting, so this is a great fit.
AC 420: What’s your thought about the U.S. approving cannabis like Canada?
Sudberg: I think Canada is light years ahead of the U.S. in regard to regulating cannabis, which is why we see established ingredient companies based there. Canada has established national laws for medical and recreational use of cannabis, as well as for supplements. The Cannabis Act creates a strict legal framework for controlling the production, distribution, sale, and possession of cannabis
across Canada.
The primary goals of their laws are to keep minors from having access to cannabis, to keep criminals from profiting from it, and to protect public health and safety by allowing adults legal access to it. Supplements made from cannabis in Canada are very specifically delineated. They “are only permitted to include parts of the cannabis plant that are not subject to the Cannabis Act (i.e., parts of the cannabis plant listed on Schedule 2, or cannabis derivatives produced in accordance with the Industrial Hemp Regulations that do not contain isolated or concentrated phytocannabinoids or synthetic duplicates of such phytocannabinoids), therefore these products are not subject to any of the Cannabis Act’s restrictions or prohibitions. Health Canada may request a Certificate of Analysis to identify the levels of phytocannabinoids in the above-mentioned parts.”
I think the FDA needs to do something similar in the U.S. quickly to resolve the gray area, but I think having such a CofA for each lot should
be mandatory.
AC 420: Is accurate testing a major issue?
Sudberg: Kind of ... just kidding. Absolutely. Accuracy means doing the right thing the right way. Precision means getting the same results (right or wrong) consistently. Accuracy in lab testing means your results match a standard. If you are using the wrong standard then there is no hope for good data or ensuring safe and effective products. If you use the wrong method with the right standard there is no hope for good data or safe and effective products.
Even more frightening is that the bulk of the industry don’t adequately audit their contract labs or if their product is being made by a contract manufacturer who has an internal lab, they are not being audited adequately either. We have reached the point where both FDA and consumers are requiring testing data on products, so the industry needs to get this right.
AC 420: Will this collaboration provide a source of significant growth for Alkemist?
Sudberg: This collaboration is first of its kind and will surely put Alkemist Labs even more firmly on the map as a subject matter expert and authority for cannabis testing. The fact is that this is just one more plant in our repertoire of nearly 2,000 that we test. While it’s a massive trend today and will certainly add revenue, I do fear that the hype will undo the substantiated value this plant has to offer and it, like all exciting plants, will calm down after a
few years.
AC 420: In what direction do you see the supplement industry moving regarding CBD or hemp?
Sudberg: I can’t tell right now. I am pretty sure the industry is abusing and exploiting the FDA’s “watch and see attitude” toward the hemp frenzy because they see a lot of money to be made. FDA is clearly not cool with drug claims and that’s about all they seem to be
focusing on.
I personally believe in the power of cannabis and know it has a lot of potential as a popular herb in commerce. However, its exploitation could be its undoing unless responsible companies taking a long-term view and acting responsibly emerge as more influential than those just in it for a quick buck. We’re happy to ally with those who want to do things right for long term stability.
AC 420: What are the most important decisions you make as a leader of your company?
Sudberg: I can be empathic to my own detriment in that sometimes very simple business decisions like terminating an employee weighs on my heart strings as if it is “the most important decision I have to make” because it likely feels that way to the recipient, or so I think. In truth, those tough calls sting before and during but evaporate shortly afterward because life, and work, must go on. Good leaders focus on internal culture, brand strength, and navigating the future, “Where are we going and how will we get there?” Those are the real decisions that may or may not break
an organization.
AC 420: What is one characteristic that you believe every leader should possess?
Sudberg: Reciprocity is a foundational value of mine and treating people as you want to be treated makes the world a better place. I believe every leader should be able to have an “out of body experience” with themselves towards enlightenment with the sole purpose of being able to say out loud, “I’d love to work for me.” If you can’t say that then something needs to change fast, as you will be spending your days re-staffing your team over and over again. Leaders also need to be tenacious, compassionate, quick-thinking, and empathic as you convince people with families and mortgages to trust in you and follow you into battle.
Sheldon Baker is CEO of the Baker Dillon Group LLC and has created numerous nutraceutical brand marketing communications and public relations campaigns for many well-known supplement and food industry companies. For interview consideration or brand marketing consulting, contact him at Contact@The420AreaCode.com.
Area Code 420 (AC 420): Tell us about the third-party THC label verification program with Nutrasource.
Sudberg: The International Cannabinoid Analysis Program (ICAP) is a certification program for manufacturers and brands that is designed to provide consumers with freely available third-party-verified testing results. We test cannabis, hemp, and their extracts or derivative products with appropriate methods to ensure they contain less than 0.20% delta-9-tetrahydrocannabinol. This the limit designated by the European regulations, and is more stringent than the U.S., which is 0.3%. This is important for many reasons, but I’ll list a few.
Consumers need to have confidence that what they are getting has the very low THC levels they expect, particularly when using the products with pets or children. With this segment of the industry growing so incredibly fast, while still being in a regulatory gray area, brands need to demonstrate that they are selling the products they claim to be.
AC 420: How did this collaboration with a Canadian company come about?
Sudberg: I have known Will Rowe and his excellent team at Nutrasource for a decade. We were on a panel together at NutraCon years ago and have great respect for each other’s companies. The idea for ICAP was his and is in line with their other excellent third-party certification programs. In seeking the best contract testing lab for the job he thought of Alkemist Labs. After a few meetings we realized ICAP could be a win-win-win and we put our teams on the project. We enjoy working with companies that have similar high standards, and we find testing cannabis interesting, so this is a great fit.
AC 420: What’s your thought about the U.S. approving cannabis like Canada?
Sudberg: I think Canada is light years ahead of the U.S. in regard to regulating cannabis, which is why we see established ingredient companies based there. Canada has established national laws for medical and recreational use of cannabis, as well as for supplements. The Cannabis Act creates a strict legal framework for controlling the production, distribution, sale, and possession of cannabis
across Canada.
The primary goals of their laws are to keep minors from having access to cannabis, to keep criminals from profiting from it, and to protect public health and safety by allowing adults legal access to it. Supplements made from cannabis in Canada are very specifically delineated. They “are only permitted to include parts of the cannabis plant that are not subject to the Cannabis Act (i.e., parts of the cannabis plant listed on Schedule 2, or cannabis derivatives produced in accordance with the Industrial Hemp Regulations that do not contain isolated or concentrated phytocannabinoids or synthetic duplicates of such phytocannabinoids), therefore these products are not subject to any of the Cannabis Act’s restrictions or prohibitions. Health Canada may request a Certificate of Analysis to identify the levels of phytocannabinoids in the above-mentioned parts.”
I think the FDA needs to do something similar in the U.S. quickly to resolve the gray area, but I think having such a CofA for each lot should
be mandatory.
AC 420: Is accurate testing a major issue?
Sudberg: Kind of ... just kidding. Absolutely. Accuracy means doing the right thing the right way. Precision means getting the same results (right or wrong) consistently. Accuracy in lab testing means your results match a standard. If you are using the wrong standard then there is no hope for good data or ensuring safe and effective products. If you use the wrong method with the right standard there is no hope for good data or safe and effective products.
Even more frightening is that the bulk of the industry don’t adequately audit their contract labs or if their product is being made by a contract manufacturer who has an internal lab, they are not being audited adequately either. We have reached the point where both FDA and consumers are requiring testing data on products, so the industry needs to get this right.
AC 420: Will this collaboration provide a source of significant growth for Alkemist?
Sudberg: This collaboration is first of its kind and will surely put Alkemist Labs even more firmly on the map as a subject matter expert and authority for cannabis testing. The fact is that this is just one more plant in our repertoire of nearly 2,000 that we test. While it’s a massive trend today and will certainly add revenue, I do fear that the hype will undo the substantiated value this plant has to offer and it, like all exciting plants, will calm down after a
few years.
AC 420: In what direction do you see the supplement industry moving regarding CBD or hemp?
Sudberg: I can’t tell right now. I am pretty sure the industry is abusing and exploiting the FDA’s “watch and see attitude” toward the hemp frenzy because they see a lot of money to be made. FDA is clearly not cool with drug claims and that’s about all they seem to be
focusing on.
I personally believe in the power of cannabis and know it has a lot of potential as a popular herb in commerce. However, its exploitation could be its undoing unless responsible companies taking a long-term view and acting responsibly emerge as more influential than those just in it for a quick buck. We’re happy to ally with those who want to do things right for long term stability.
AC 420: What are the most important decisions you make as a leader of your company?
Sudberg: I can be empathic to my own detriment in that sometimes very simple business decisions like terminating an employee weighs on my heart strings as if it is “the most important decision I have to make” because it likely feels that way to the recipient, or so I think. In truth, those tough calls sting before and during but evaporate shortly afterward because life, and work, must go on. Good leaders focus on internal culture, brand strength, and navigating the future, “Where are we going and how will we get there?” Those are the real decisions that may or may not break
an organization.
AC 420: What is one characteristic that you believe every leader should possess?
Sudberg: Reciprocity is a foundational value of mine and treating people as you want to be treated makes the world a better place. I believe every leader should be able to have an “out of body experience” with themselves towards enlightenment with the sole purpose of being able to say out loud, “I’d love to work for me.” If you can’t say that then something needs to change fast, as you will be spending your days re-staffing your team over and over again. Leaders also need to be tenacious, compassionate, quick-thinking, and empathic as you convince people with families and mortgages to trust in you and follow you into battle.
Sheldon Baker is CEO of the Baker Dillon Group LLC and has created numerous nutraceutical brand marketing communications and public relations campaigns for many well-known supplement and food industry companies. For interview consideration or brand marketing consulting, contact him at Contact@The420AreaCode.com.