Has stevia broken US dietary supplement shackles?

Arizona-based Wisdom Natural Brands has self-affirmed its version of stevia - Sweet Leaf - as being generally regarded as safe (GRAS) and said the ingredient would be available in a soda or food product by year's end.

Wisdom Natural Brands chief executive officer and founder, Jim May, told FoodNavigator-USA.com, at least one major beverage manufacturer had shown strong interest in Sweet Leaf.

In the meantime it would be available at retail level as a table-top sweetener that would be labeled as a sweetener not a dietary supplement as has been the case in the past.

This was significant because for the first time stevia would be sold alongside other sweeteners and not among dietary supplements on store shelves.

"We have produced 40,000-50,000 units that will be on the shelf across the US in a week," May said.

The US market is estimated to be worth about $60m, a figure analysts say could triple if FDA GRAS was granted, as the industry has resolved many of the taste and formulation issues that plagued the ingredient in the past.

Supply problems have also been eased as channels have opened up and been developed in places like China for stevia, which is between 250 and 400 times sweeter than regular sugar.

Building science Wisdom Natural Brands had completed a review of available science on March 5, which had prompted it to make the self-affirmed GRAS announcement.

"We had third-party, former-FDA analysts assess the science and so feel confident about the is GRAS affirmation," he said.

"We would have liked to delay the announcement but there is a war of attention happening right now with Coke and Cargill's announcement so we felt we should go ahead with this now."

Coca-Cola and Cargill recently published science backing their ingredient Truvia but have yet to bring it to market although a launch looks imminent.

May said Sweet Leaf-branded, table-top sweetener products would be on shelves next week, and all existing Wisdom Brands sweeteners marketed as dietary supplements would be phased out except in export markets.

But Daniel Fabricant, PhD, science and regulatory affairs vice president at the Washington DC-based Natural Products Association (NPA), said Wisdom Brands was 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.

This happened in 2007 with a tea product called Celestial Seasonings the FDA determined was not labeled clearly enough as a dietary supplement, and which required re-labeling with the words 'dietary supplement' appearing more prominently.

But the fact the product remained on market in the form of a tea, highlights a regulatory grey area that allows products containing stevia to be labeled as dietary supplements when they are clearly being consumed in the manner of foods.

Although Coke/Cargill's science relates only to their own proprietary version of stevia, the science around the ingredient's safety is growing to the point where it is going to be increasingly difficult for FDA to refuse it, especially as consumer demand for natural low-calorie sweeteners grows.

But Fabricant suggested GRAS approval may still be some time off.

"There have been so many different studies on various chemical stevia entities that FDA has had little trouble throwing it out, so it will be interesting to see how much of an impression this new science makes," he said.

The biggest markets for stevia are Japan and Korea, where stevia has been used to sweeten diet drinks for around 20 years and is commonly used as an 'at-home' sweetener.

Stevia is derived from the South American plant stevia rebaudiana .