In June, the company submitted a voluntary notification to the FDA, and can now officially claim that Clarinol reduces weight gain, increases lean muscle mass, reduces the amount of body fat and maintains body weight level.
"The passage of 30 days after filing the structure/function claims means that the FDA believes we have substantial evidence to make such claims," said David Lewis, the business unit manager, North America, for Lipid Nutrition. "With this notification we expect to expand the marekting ativities of Clarinol CLA."
This development follows the introduction of Clarinol A95, which is said to offer the highest form of active CLA isomers at 95 percent.
Lipid Nutrition claims that Clarinol A95 offers distinct advantages over the conventional 80 percent active CLA concentration by allowing for a more highly concentrated 1-gram capsule, thereby enabling nutraceutical manufacturers to offer a smaller capsule to the consumer.
This could have cost advantages, said according to Ruud Peerbooms Lipid Nutrition sales director.
"The starting price for Clarinol is €45-50 per kg. Normally an increase of 10 per cent in concentration means a slightly higher price but the customer will make savings on encapsulation," he added.
Back in March, Lipid Nutrition became the first company to demonstrate the safety of its conjugated linoleic acid, announcing that a panel of independent experts had declared that Clarinol CLA could be 'generally recognized as safe', giving it the self-affirmed 'GRAS' status required before US food manufacturers begin using an ingredient.
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 yogurt products, milk-based meal replacements, nutritional bars, low-calorie salad dressings, and frozen or shelf-stable plate meals with meat, fish or poultry.
The firm pipped competitor Cognis - which markets CLA under the Tonalin brand - to the post in receiving GRAS status. The German firm was approved as safe for use in foods in April.
The US represents the world's biggest weight management foods market, seeing rapid growth as a result of the obesity problem.
The market for CLA, worth around €40 million according to an estimate earlier this year, is tightly controlled by a handful of companies that have licensed patents from US-based WARF, the technology transfer unit of the University of Wisconsin-Madison, to Norway's Natural, which carries out research on lipids. Natural has in turn licensed its patents for CLA in dietary supplements to Lipid Nutrition and Cognis, the biggest supplier of the product that currently holds about 70 per cent of the market.