The joint program will vet the level of the psychoactive constitutent in products derived from cannabis. The US federally set level for products that qualify as industrial hemp and its derivatives is 0.3% THC. Europe sets a limit at 0.2%, which is the level the partners have chosen for their program so as to have products that qualify for as many jurisdictions as possible.
THC levels are a concern
The 0.3% THC level has proven problematic for some producers of CBD/hemp products. At the NOCO Hemp Expo in Denver CO earlier this year, there were frank dicussions about how in the extraction and concentation of CBD products the THC level could rise above the federal limit even when starting with raw material that had compliant (meaning low) levels of THC. Dilution with MCT oil or another carrier seemed to be one common strategy producers were taking to deal with this.
Alkemist, which is a contract analytical laboratory based in Garden Grove, CA, and Nutrasource, which is a Canadian contract research organization based in Guelph, ON, are calling the new program the International Cannabinoid Analysis Program (ICAP). It is a certification program for manufacturers and brands that is designed to provide consumers with freely available third-party verified testing results in order to increase confidence and improve decision making in the cannabis products market. ICAP tests cannabis, hemp and their extracts or derivative products with appropriate methods to ensure they contain less than 0.20% delta-9-tetrahydrocannabinol. The limit is in alignment with the European regulations, the most stringent global standards.
“Clearly accurate testing in this product category is a concern, as evidenced by several comments at the recent FDA meeting on CBD regulation,” said Elan Sudberg, Alkemist Labs CEO. “The expertise of our two companies working together brings a high level of credibility to this program.”
“I think we all know that the range of quality in these products is wide, and some are more committed to doing things correctly than others. Confirming that an herbal product is what the label says and nothing else is what we do every day for companies that want to do things right,” Sudberg added.
“Our program is suited for the premium brands who wish to showcase a lot to lot commitment to quality and label compliance. For finished product brands It also allows consumers to make informed decisions in terms of what they are feeding themselves and their families from a THC exposure perspective. For the ingredient and process companies in the supply chain, similar to our IFOS program, the ICAP certification may be used to QAQC inputs and outputs within the manufacturing flow for trusted and transparent sourcing,” said William Rowe, president and CEO of Nutrasource.
One issue with testing in this field has been the multiplicity of methods, with little consensus on which are best fit for purpose. Sudberg said this picture is starting to come into clearer focus.
“The cannabis industry is moving so fast, but fortunately important players like AOAC have published methods for THC level testing. At Alkemist Labs we have invested considerable resources towards in developing our own suite of methods to service this industry,” he said.
Beta test period
The program is set for a formal launch in September. In the meantime, the partners are now accepting samples for a beta-testing group. Successful beta participants will be the first companies to appear on Nutrasource’s certification website, with their testing results readily available for transparency-seeking consumers.
Both Sudberg and Rowe said there has been no formal communication with FDA yet on the testing program, but said the agency is closely monitoring market developments in the sector as it wrestles with what the ultimate regulatory solution for CBD will look like.
“We have not communicated with the FDA about this program, but it’s important to remember that FDA is watching, always. Accuracy in testing to confirm label claims in the cannabis sector is a concern many stakeholders have voiced,” Sudberg said.
“This program has not yet been formally communicated to the FDA or the USDA as we are in the process of launching the beta stage. The new seal will articulate the THC compliant cut point we have established for the program and will become a quality mark for the industry,” Rowe added.