The company announced on Friday that a panel of four independent experts based at US institutes had declared that Clarinol CLA can be 'generally recognized as safe', giving it the self-affirmed 'GRAS' status required before US food manufacturers begin using an ingredient.
A voluntary notification of this GRAS determination has been submitted to the US Food and Drug Administration, in accordance with FDA's procedures.
GRAS will give Lipid Nutrition access to a new market - the world's biggest weight management foods market, seeing rapid growth as a result of the obesity problem in the US. The ingredient is already used in supplements but functional foods present a much larger sales opportunity - Loders expects food use to more than triple current demand for CLA.
The news also confirms the safety of the ingredient for European supplement makers, many of which are still hesitating to use CLA unlike their US counterparts. Among the data provided to the panel, Lipid Nutrition submitted results of a safety study on 60 people who took 7.5 grams of Clarinol for one year, without side effects.
The panel concluded that Clarinol can safely be used in yoghurt products, milk-based meal replacements, nutritional bars, low-calorie salad dressings, and frozen or shelf-stable plate meals with meat, fish or poultry.
Katinka Abbenbroek, marketing director at Lipid Nutrition, told NutraIngredients.com: "We are very happy to be the first company able to begin serious partnerships for CLA with American food companies. This brings us into contact with multinational food companies, who will not talk to an ingredient supplier if it does not have GRAS."
The firm has beaten German competitor Cognis, which markets CLA under the Tonalin brand. Cognis marketing manager Nina Likins told us that they are expecting self affirmation of GRAS status for Tonalin in the second quarter this year.
Gaining access to the European functional food market will however be much tougher. CLA is currently in a regulatory grey area - it is considered a 'new' ingredient by food makers yet has been available in foods before the European Union's 1997 novel foods regulation, suggesting that it should not require safety approval.
"There is no consensus in Europe on the status of this ingredient so although marketers are eager to start using CLA, the legal issue presents a significant barrier," said Abbenbroek.
The dossier for GRAS, developed over a three-year period, will however be a good basis for novel foods approval, if eventually required.
Evidence of efficacy is less substantial, however. Loders has invested more in the research and marketing of Clarinol than any of its other products.
Both Loders and Cognis stress that the product can reduce body fat, rather than targeting actual weight. But in a review on CLA in this month's American Journal of Clinical Nutrition, Antonius Terpstra from Utrecht University in the Netherlands writes that most of the human studies have been done in free-living subjects and were not strictly controlled for nutrient and energy intakes.
He notes that only two studies have showed a significant but relatively small body fat-lowering effect. And although there are indications from animal studies that CLA may have effects on plasma lipids, only one study in humans has showed a significant HDL-cholesterol-lowering effect.
Loders has shown CLA to reduce the side effects normally seen during dieting, and although weight loss in this research could be attributed to the effects of the low-calorie diet, CLA may help dieters to stick with the regime, improving efficacy in a secondary way.
"Compared to other supplements, CLA currently has the best research to demonstrate its effects on weight management," added Abbenbroek.
The company will publish new results on Clarinol's efficacy from its latest research in May.