Blue California nears self-affirmed GRAS stevia launch
self-affirmed generally regarded as safe (GRAS) approval for its
stevia-derived sweetener compound by next month.
The company claims that the independent GRAS review, which began in February of this year, had recently completed its preliminary findings on the available science, and the final paper work should now be completed during August.
Rival launch Blue California's announcement follows on from similar claims by a rival ingredient maker that it is near to launching a stevia-based sweetener product for general food use onto the US market for the first time.
The product has only been previously available in the US as a dietary supplement.
The manufacturer claims that its Rebaudioside A 99 per cent, derived from the South American plant stevia rebaudiana, can be up to 400 times sweeter than sugar and at its intended levels, should not cause any harm.
Steiva, as a sweetener, has been found to offer taste with a slower onset and longer duration than that of sugar, although some of its extracts may have a bitter or liquorice-like aftertaste at high concentrations.
Safety criteria However, Blue California executive vice president Cecilia McCollum claimed that she was extremely confident that Rebaudioside A, which the company has been producing since December 2007, will now pass all requirements for its self-affirmation.
"Blue California was extremely confident from the very beginning that a product of this level of purity would easily meet the safety requirements for GRAS self-affirmation and the level of scientific data necessary to meet FDA's required criteria for safety," she stated.
"[The FDA's safety criteria is a] reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use."
Despite the company's confidence over the issue, acceptance for the use of Stevia in food formulation from EU and US regulators has remained elusive.
Currently, stevia is authorized for general food use Japan, South Korea, Brazil, Argentina, and Paraguay.
By contrast, in the US, China and some Western European countries, it is allowed for sale as a dietary supplement.
Blue California has not been alone in trying to push stevia products towards being accepted as a food and beverage ingredient.
Just last month, Arizona-based Wisdom Natural Brands announced to had self-affirmed its version of stevia - Sweet Leaf - as being GRAS and said the ingredient would be available in a soda or food product by year's end.
Further pressure has been put onto ingredients groups with the recent publication of science provided by Coca-Cola and Cargill backing their ingredient Truvia, which they have yet to bring to market.
Self-affirmed concerns The potential emergence of a preference for going ahead with pushing self-affirmed GRAS products onto the market is not without its dangers though for stevia manufacturers.
Following Wisdom Natural Brands announcement back in June, Daniel Fabricant, PhD, science and regulatory affairs vice president at the Washington DC-based Natural Products Association (NPA), said the group were pursuing a risky strategy by pursuing incorporation into the "food matrix" without FDA GRAS approval.
May said Wisdom Natural Brands had given up waiting for such approval after first submitting a GRAS application in 1995 that included 900 studies demonstrating stevia's safety.
"Of course a company can go ahead and incorporate the ingredient into different foods without FDA approval but if the FDA cracks down on them it can be a public relations disaster," Fabricant said.
Frank Jaksch, the chief executive officer of analytical standard supplier ChromaDex, shared similar reservations over the possible launch of stevia products with self-affirmed GRAS.
"They're announcing a self-affirmed GRAS at a point when Cargill is still being quite defensive about it...
I'm not quite sure how they're going about it.
The devil's in the details really," he told FoodNavigator-USA.com.
