The two companies will collaborate with the National Institute of Standards and Technology (NIST) on ways cannabis testing labs can demonstrate and improve measurement capabilities and comparability. The tools developed through the program will support measurements establishing legal, commerce, and safety claims through the development of fit-for-purpose analytical methodologies, production of Reference Materials,
NIST is part of the US Department of Commerce. NIST does research on and develops validation standards for materials testing and measurements of all kinds. In the dietary supplement realm, NIST has in the past developed a multivitamin validation standard and more recently has worked on DNA identification techniques for botanical ingredients.
NIST is now administering a Cannabis Quality Assurance Program (CannaQAP). CV Sciences and Alkemist will assist in developing fit-for-purpose analytical tools and validated reference materials to support legal, commerce and safety claims on hemp/CBD raw material and finished products.
CV Sciences, Alkemist Labs to collaborate on distribution of validated materials
Under the program CV Sciences will produce reference materials to be distributed to participating laboratories. Alkemist Labs will do the initial validation testing on those reference standards, including verifying that their THC levels comply with the federal definition of industrial hemp, which is no more than 0.3% THC by dry weight.
The companies said hemp testing does not present any special challenges over and above those presented by any other botanical. But there’s more at stake, making the outcome of one test in particular something that can make or break a company.
“Cannabis analytical testing does not include any inherent technical challenges when compared to testing other botanical extracts or finished products. However, what is significantly different is that the accuracy of one specific test result, delta-9 tetrahydrocannabinol (THC), determines if the product is legal or illegal,” said Duffy MacKay, ND, CV Sciences’ senior vice president of scientific and regulatory affairs.
“There is a lot at stake, so analysis must be performed correctly,” said Elan Sudberg, CEO of Alkemist Labs.
“Having a single test result that is so impactful makes normal lab variables, like sample preparation or a known margin of error for a specific piece of lab equipment, a much bigger deal with cannabis testing than other botanicals. I predict there will be many (more) legal cases where the accuracy of a THC test will be at the center of the outcome of the case,” MacKay said.
Standards needed to sort out turbulent marketplace
Sudberg said the development of adequate standards has been complicated over the years by the listing of the Cannabis sativa plant as a schedule 1 federally controlled substance. This has required labs like Alkemist to obtain a license from the federal Drug Enforcement Administration to be able legally to even have the plant on the premises. Now, as the market for hemp and recreational marijuana products has opened up, it has opened a door for labs of all levels of ethics and expertise to participate.
“From the lab perspective, it's a new mess that makes the dietary supplement industry suddenly seem more mature and even docile, “ Sudberg said. “The more time we spend in the cannabis testing arena the more I am grateful for mature and established clients like CV Sciences. Together with NIST we are helping to improve all that.”
MacKay said validated methods are urgently needed in a marketplace full of all kinds of products. What should ‘full spectrum hemp extract’ mean? How about ‘broad spectrum?’ Are CBD isolate products with a few terpenes or a smidge of other cannabinoids sprinkled back in to mimic a straight broad spectrum extract fraudulent, or just not very transparently labeled? Who can say without a standard in place?
“We have tested hundreds of hemp extracts and CBD finished products. What we find is predictable. There are hundreds of opportunistic brands, mostly on the internet with terrible product that does not meet specifications. Our test results are consistent with several published studies including FDA’s that have tested product and found poor label compliance,” MacKay said.