The North American divisions of the world’s two leading CLA suppliers, Cognis Nutrition and Lipid Nutrition, both worked closely with their dietary supplement customers selling CLA products in Canada to provide information Health Canada has incorporated into the monograph.
The monograph follows letters that were sent to 106 dietary supplements manufacturers in July, 2009, after Health Canada decided to pursue concerns that had been raised in some quarters about the body shaping ingredient’s safety and efficacy.
The monograph affirms CLA’s safety but is selective in the kinds of weight management claims it supports.
Jaap Kluifhooft, the director of regulatory affairs at Dutch-based Lipid Nutrition, said the situation had become “very critical” in the summer as the letters were dispatched from Health Canada headquarters, but coordinated supplier-manufacturer efforts had demonstrated the fatty acid’s credentials.
“There was a certain amount of heavy weather in the summer but this monograph is testimony to the good science that exists for CLA,” he said.
Cognis Nutrition’s science and regulatory manager, David Cai, highlighted the fact the monograph reaffirmed the safety of CLA, whilst affirming its role in body shaping and body composition.
“It keeps the market open for dietary supplements and that is the main thing.,” he said. “You have to bear in mind that Health Canada is a very conservative regulator. In these matters you are never going to be completely happy with the result but we are gratified to see that several of our suggestions have been incorporated into the monograph. We have been fully supportive of this process.”
Cai and Kluifhooft both commented on the openness of the Health Canada process, with both companies able to view drafts of the monograph before it was published, and provide feedback along with the dietary supplements manufacturers contacted by the agency in the first place.
Kluifhooft observed that Health Canada’s actions were spurred by the diversity of scientific findings in regard to CLA, a menagerie of results he described as, “the good, the bad and the ugly” and which government agencies were not always best equipped to decipher.
The monograph in part stated:
- There is insufficient evidence to support the use of Conjugated linoleic acid (CLA) as a weight loss aid. Consumers wishing to achieve weight loss should consult a health care practitioner prior to taking CLA.
- The use of the term “may” in the use or purpose statements reflects the uncertainty of the evidence. For example, some reviews have concluded that CLA does not significantly affect body fat mass.
- The claim “May help to support a modest improvement to body composition” refers to evidence showing that CLA may modestly reduce body fat. Weak evidence also demonstrates that CLA may help to modestly increase lean muscle mass.
- The recommendations for decreased caloric intake and increased physical activity are included as components of the use or purpose statements in order to provide a health context.
- Though CLA has been administered to subjects for up to two years, there is insufficient evidence to support any benefits beyond six months. As such, a duration of use of six months has been included on the monograph.
- CLA does not exert positive effects on any health risk biomarkers (e.g. LDL-cholesterol, HDL-cholesterol, plasma glucose, plasma insulin, etc.) and there is some evidence to suggest that its use may be unsafe in particular subpopulations. As such, mandatory risk information is required on the Product License Applications and label to identify subpopulations at risk.