Health Canada issues CLA monograph
Lipid Nutrition worked with some of its clients to provide information for the monograph that can be used for their own proprietary dietary supplement applications to have products approved on the Canadian market.
Other suppliers such as Cognis also contributed data to the monograph.
The Health Canada-issued monograph may assist the development of monographs and CLA-based product approvals in other markets such as the US and Europe.
Jaap Kluifhooft, the director of regulatory affairs at Dutch-based Lipid Nutrition, said the monograph came at an opportune time as the derogation period for hundreds of unresolved NHPD applications expired at the beginning of this year.
It is expected that Lipid Nutrition’s NHPD license application, and those of some of its business partners, may be processed within 60 days.
“This monograph is very important for our B2C customers and for ourselves,” Kluifhooft told NutraIngredients-USA.com. “It should significantly boost CLA-based NHPD applications. I think this monograph is also testimony to what can be achieved by working with other partners as we coordinated with our customers to order the information so that Health Canada could understand it.”
“With an ingredient like CLA (conjugated linoleic acid) where there is so much science both for and against it is vital to do this kind of work. You need to do more than just present the science to the regulator. You need to explain it as well. That’s what we did and why we are so pleased that Health Canada has recognized our work.”
CLA is marketed on its potential to assist weight management. The market is dominated globally by Lipid Nutrition with its version, Clarinol, and Cognis which markets Tonalin.
Lipid Nutrition’s CLA ingredient is derived from safflowers. It has two CLA isomers – known as trans-10 cis-12 and cis-9 trans-11 – which are respectively responsible for the effects of reducing body fat and increasing lean muscle.
This article has been amended to reflect the fact suppliers other than Lipid Nutrition contributed to development of the monograph.