KSM-66, an ashwagandha root-only extract from Ixoreal BioMed, has been approved in Canada for health claims that include stress reduction, sports nutrition benefits and support for healthy testosterone levels. The approval of the claims, which go beyond the more generic claims that can be made by referencing the approved monograph for the ingredient, is a testament to Ixoreal’s strong data, said the company’s Canadian collaborator.
“The Canadian regulatory environment is very challenging, but it rewards good science,” Michael Chernyak, president of Toronto-based raw material supplier CK Ingredients told NutraIngredients-USA.
“If you have a unique product in a category with some unique clinical data then enhanced claims are possible,” he said.
Strong science backing
Canada has a regulatory structure botanical ingredients that relies on a series of monographs that cover the specifications of hundreds of different ingredients, Chernyak said. These monographs also cover what claims can be made without additional data. So purveyors of less-researched ashwagandha extracts can by referencing the approved ashwagandha monograph market their ingredients in Canada for their traditional uses as sleep aids, general tonics and as memory enhancers.
Chernyak said in particular the stress reduction claims and testosterone support claims would not have been possible without truly convincing data, which Ixoreal was able to supply. CK Ingredients only took the ingredient on after an internal review of the quality of Ixoreal’s studies, he said.
“The breadth of science is just so impressive. They have five clinical trials, two already published, and another 10 going on. We see this as a well-rounded ingredient,” he said.
“Ixoreal and CK share a strong belief and deep commitment to the philosophy of discovering and bringing to market the best science-based ingredients that nature has to offer,” said Kartikeya Baldwa, director of Ixoreal Biomed.
Streamlined regulatory approval
Among the services that CK Ingredients provides is a streamlined regulatory approval process, Chernyak said. After the present process of health claims approval product licenses was put into place, a huge backlog developed. While Health Canada has worked through that, the process lately has seemed to slow some.
When taking on a new ingredient like KSM 66 the company adjusts its process to the nature of claims being made. While licensing a compendia product, one making claims based only on what’s allowed in a monograph takes 30 days or so, a unique formulation with unique claims can take 180 days. So the company files preliminary product license applications that can be making their way through the system while it drums up customers for a new ingredient.
“It’s going to take us four or five months to go through the sales cycle and garner interest in the ingredient,” Chernyak said. “Then if someone wants to go market immediately with KSM 66 we can annex them to our application.”
Chernyak said the complex regulatory environment proves to be an opportunity for companies like his. “Companies want financial outcomes in Canada, but they don’t necessarily want to be here,” Chernyak said. “Because we make our living in Canada and are specialists in science-based ingredients we can take that over for companies.”
And while that regulatory complexity does add cost, it provides certain advantages to ingredients that have strong science backing like KSM 66, he said. Among them is peace of mind for consumers. The finished formulation will be safe, and will contain efficacious dosages.
“One of the good things about our regulatory environment is that it’s safety first, with efficacy a very close second,” Chernyak said.