The British company recently passed the US Food & Drug Administration's New Dietary Ingredient hurdle, allowing it to market the ingredient with novel food echium .
Echium oil comes from the same family as the borage plant and contains the omega-3 fatty acid stearidonic acid, which is readily converted to EPA (eicasapentaenoic acid) in the body.
The main obstacle in getting the same benefits of omega-3 fatty acids to vegetarian consumers is plant-derived sources have tended to contain the shorter chain ALA.
As such, Incromega V3 has the potential to break into new waters in the category.
"The biggest selling point of this is the omega-3 EPA for those people who don't want to take fish supplements," David Shannon, sales director for Croda Health Care told NutraIngredients-USA. EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) are derived from marine sources such as oily fish, and DHA can also be derived from microalgae.
ALA (alpha-linolenic acid) is derived from plant sources such as flaxseed.
While all products containing EPH, DHA or ALA can claim to be sources of "omega-3" , EPA and DHA are significantly more bioavailable than ALA.
The shorter long-chain omega-3 fatty acid ALA is a precursor to DHA and has to be converted by the body before it can be used.
"We've done some studies at the University of Guelph in Canada, that show about four times more ready conversion from stearidonic acid to EPA than from ALA to EPA," said Shannon.
Croda claims the stearidonic acid in Incromega V3 allows for a more bioavailable conversion to EPA, thereby giving the ingredient anti-inflammatory and cardiovascular benefits.
The European company has been developing the ingredient for over seven years and faced a stumbling block with the lengthy EU novel foods approval process.
As such, it decided to first launch Incromega V3 in the US as a New Dietary Ingredient while compiling the paperwork for novel food status in the EU.
"The EU has a very different process that's independent from others," said Shannon, who doubts the US launch will have significant impact on regulatory status for the ingredient the other side of the Atlantic.
Under DSHEA (the 1994 Dietary Supplement Health and Education Act) any dietary ingredient not marketed in the US before October 15 1994 must be notified as a New Dietary Ingredient (NDI) 75 days before entering the market - a process that involves submission of scientific data to the FDA.
Apart from Incromega V3's stearidonic acid content (C18:4 n-3), there are also significant levels of the omega 6 fatty acids (linoleic acid C18:2 n-6 and gamma-linolenic acid C18:3 n-6), as well as oleic acid (C18:1 n-9).
Croda is marketing its new ingredient as the first truly sustainable vegetarian long chain omega 3 and plans to advertise in industry trade publications.
The company says that in terms of regulation, its NDI approval has paved the way for other products containing echium to make their way on the market.
"I see this going into the vegetarian market, as well as the 'beauty from within' market," said Shannon.
According to Shannon, echium oil is currently used in creams for anti-inflammatory purposes.