CLA One Step Closer to EFSA Approval


As the global regulatory environment grows more stringent for functional ingredients, conjugated linoleic acid (CLA) appears to be weathering the storm in Europe. The European Food Safety Authority (EFSA) gave two companies—Cognis and Lipid Nutrition—cause for optimism with their respective CLA products. Both companies will need final approval, however, from the Standing Committee on the Food Chain and Animal Health before going to market.

EFSA issued favorable safety opinions about Cognis’s Tonalin and Lipid Nutrition’s Clarinol as food and beverage additives taken over a six-month period, but excluded type-2 diabetics and longer periods of consumption from its report. Tonalin studies focused on milk, yogurt and fruit applications at a daily intake of 4.5 grams. The Clarinol studies focused on beverage, milk and cereal applications, as well as CLA in dietary supplement form, at a daily intake of 3.75 grams. These amounts increase levels of CLA approximately tenfold over current average intakes from real foods.

Clinical studies continue to link CLA to fat reduction and the building of lean muscle. The fatty acid is commonly present in meats and dairy, but not in low-fat varieties that typically strip out the ingredient in production. It is worth noting from the study that, at proposed levels of intake, CLA had no effect on LDL cholesterol or LDL-HDL ratios. EFSA did note possible increases in subclinical inflammation that could raise flags for long-term consumption and atherosclerosis.

NBJ Bottom Line

The EFSA opinions were unusually positive about CLA, after dozens and dozens of negative reports and rejections for functional supplements in recent months. Passage of the Nutrition & Health Claims Regulation in November 2009 continues to make marketable health claims a rare commodity in Europe, so Cognis and Lipid Nutrition appear to have their science in better stead than many competitors. Both CLA products achieved GRAS status in the United States in 2008.

More importantly, regulatory approval for a product like Tonalin—well-regarded throughout the industry for its scientific pedigree—further points out the difficult environment facing functional suppliers dependent on health claims. Europe has effectively shut down that marketing channel, and there are growing calls for tougher rules governing health-claims substantiation in the United States as well. The bottom line for companies might be this: Find some more budget for R&D, and increase the scientific rigor of your clinical studies now—before you have to by law. You might also hire a few good lawyers while you’re at it.

Related NBJ links:

Cognis Achieves NSF International GMP Registration for Natural Vitamin E, Phytosterols and CLA – Complies with New FDA Regulations

2009 Raw Material & Ingredient Supply Report

Sports Nutrition & Weight Loss V

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