FDA awaits stevia petition
sweetener stevia into the spotlight, prompting the regulatory
agency to say it soon expects to be petitioned to approve the
ingredient for use in foods and beverages.
The agency sent a written request to natural and organic foods firm Hain Celestial Group, asking it to immediately re-label its Celestial Zingers To Go tea and drink mixes, which contain the sweetener. According to FDA, the products were "adulterated", as they were conventional food items marketed as dietary supplements, in an attempt to sidestep current regulations prohibiting the use of stevia in food but permitting it in dietary supplements. Stevia, derived from the South American plant stevia rebaudiana, is said to have up to 300 times the sweetness of sugar. As a sweetener, stevia's taste has 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. The potential use of the ingredient as a sweetener is gathering increasing attention as more and more consumers seek a more 'natural' sweetener alternative in an attempt to avoid what they consider 'artificial' products. Indeed, the ingredient has even grabbed the interest of big industry players, with Coca-Cola and Cargill teaming up to market a stevia sweetener product. Coca-Cola has filed 24 patent applications for the ingredient in the US, and media reports claim that the firms are gathering information to petition FDA for approval. Indeed, the regulatory agency yesterday told FoodNavigator-USA.com that "we're waiting for a petition", although it did not specify from where. It added, however, that the current information available on stevia is insufficient to allow for its safe use as a food ingredient. In its letter to Hain Celestial Group, FDA noted that it has received petitions and inquiries in the past related to the use of stevia or stevia extracts in food, but that "data and information necessary to support the safe use have been lacking". "In fact, literature reports have raised safety concerns about the use of stevia, including concerns about control of blood sugar, and the effects of reproductive, cardiovascular and renal systems," it wrote. Hain Celestial Group last month responded to FDA, announcing that it had made full changes to its labels to make the 'herbal supplement' claim more prominent, while removing the term 'iced tea mix'. Although the ingredient is not approved as a food additive in the US or Europe, around a dozen other countries currently approve stevia for use in foods and beverages, including Japan, Brazil and China. According to Mintel's Global New Products Database (GNPD), there have been 180 new food and beverage products containing stevia launched globally in the past year. These include teas, potato snacks, dressings and beverages. In order to seek approval for the use of stevia in foods in the US, food manufacturers have two options: they can either take the necessary steps to classify the ingredient as generally recognized as safe (GRAS), and be prepared to provide FDA with the necessary scientific backing if necessary; or they can petition FDA to approve the ingredient as a food additive. Achieving GRAS status is a much quicker process, with FDA generally responding to GRAS notices within 180 days of reception. To access an FDA article on how its GRAS notification program works, click here. To access FDA's GRAS FAQ, click here. To access FDA's guidance for industry on the petition process, click here.
