The Netherlands-based firm yesterday said it received a letter of no objection from the US Food and Drug Administration (FDA) confirming the ingredient’s status as GRAS (generally recognized as safe).
The determination means that Clarinol, a weight management ingredient, can be used in fluid and flavored milks, yoghurts, milk-based meal replacements, meal replacement bars, soy milk, and fruit juice applications.
CLA
Conjugated linolenic acid (CLA) is a fatty acid naturally present in ruminant meat and dairy products. Due to changes in the Western diet, average intake of CLA has fallen; if the fat is removed from a dairy product to make a low fat version that will be acceptable to consumers, CLA is removed along with it.
Lipid Nutrition submitted the voluntary GRAS notification to FDA together with the German firm Cognis, which also manufactures its own branded CLA ingredient. Cognis was unable to confirm in time for publication if the GRAS approval also related to its branded Tonalin CLA.
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, are respectively responsible for the effects of reducing body fat and increasing lean muscle.
Lipid Nutrition’s marketing manager for North America, Patrick Luchsinger, told NutraIngredients.com that the company had been working an achieving GRAS approval for around four years.
He said the firm has already discussed the development with a number of companies, and has seen interest from manufacturers of nutritional bars and dairy products, who have been waiting for the FDA GRAS approval before going any further.
The ingredient, which has until now been used in supplements, comes in oil form and powder form. Luchsinger said both forms have a clean flavour profile so would not affect the taste of products.
European approval
Clarinol still does not have Novel Foods approval, which is the European equivalent to GRAS.
In May this year, Lipid Nutrition said its CLA had won approval for use in foods and beverages within the European Union from the Food Safety Authority of Ireland (FSAI).
The FSAI handed down a positive opinion on Lipid Nutrition's "thick file" which was then passed to the European Commission for assessment by the EU's member states and finally, the European Food Safety Authority. The approval is a significant step in Dutch-based Lipid Nutrition's attempt to gain EU Novel Foods approval for Clarinol.
Clarinol has been on the European market for more than a decade but only in food supplement form and not long enough to be exempt from long-winded Novel Foods approval under the 1997 rule.
That rule states any products on-market in one or more EU member states before May 1997 do not require Novel Foods approval.
Cognis
Earlier this month, Cognis said it has also moved closer to Novel Foods approval for its Tonalin ingredient, after the Spanish food agency turned in its final assessment.
This has also been passed to the European Commission and will be sent to the other 26 member states for review in a process that has no deadline but is unlikely to be completed this year.
The firm said beverages and dairy products would be the first to come to market if and when the ingredient receives approval.