Wisdom Natural Brands launches a natural sweetener formulation derived from the stevia leaf without FDA affirming the ingredient as safe, an approach industry stakeholders say is best for the firm's business.

Wisdom founder and CEO Jim May said he expects no regulatory warnings regarding the product being generally recognized as safe.

May said he had two independent research groups, including former FDA GRAS experts, certify SweetLeaf Sweetener , currently available through his company's Web site and in some retail locations, as GRAS. He added that a proprietary filtration process makes theproduct smoother and sweeter than previous stevia dietary supplements made by Gilbert, Ariz.-based Wisdom.

By moving ahead without FDA's blessing, May appears to be "taking a calculated risk, and I think he's doing it in a smart way," said Natural Products Association VP of Scientific and Regulatory Affairs Dan Fabricant.

With sizable competition on the horizon, Wisdom had little choice but to launch with self-certified GRAS.

Coca-Cola and Cargill are collaborating on Truvia , a calorie-free sweetener made from stevia-derived rebiana (¹ 'The Tan Sheet' May 19, 2008, In Brief).

In addition, Corn Products International - recently acquired by Bunge - reached a licensing agreement with Morita Kagaku Kogyo of Japan to market stevia-based Enliten in the U.S.

Fabricant said larger companies can afford to use more time to bring stevia sweeteners to market by cooperating with FDA on the rigorous food additive petition process and ultimately get the agency's go ahead for across-the-board use.

Despite the lack of regulatory approval for SweetLeaf Sweetener, Wisdom is "on absolutely solid ground, there is nothing the FDA could do to stop us," May said in an interview June 24. He added it would be "impossible" for FDA to prove stevia harmful, based on existing clinical data.

In an August 2007 warning letter to Celestial Seasonings about its stevia-containing Zingers to Go Tangerine Orange Wave Herb Tea, FDA noted "literature reports have raised safety concerns about the use of stevia," including effects on blood sugar and the cardiovascular, reproductive and renal systems (² 'The Tan Sheet' Sept. 24, 2007, In Brief).

The agency told Celestial Seasonings the product's use of stevia did not satisfy GRAS criteria, as its labels gave the impression it was a conventional food.

Since Congress passed the Dietary Supplement Health and Education Act in 1994, FDA has not allowed stevia's use as a food ingredient, but has generally not taken action against stevia formulations marketed as dietary supplements.

Food and drug attorney Jim Turner said he does not understand why FDA has historically been more permissive of artificial sweeteners with dubious safety data compared to stevia.

Turner, a principal of Washington-based Swankin & Turner, said any attempt by FDA to regulate SweetLeaf Sweetener would be "overreaching" since FDA regulations permit self-certification of GRAS, and he is not aware of the agency producing proof of stevia's danger.

FDA has associated stevia with "the word 'unsafe,' which is a tricky word because unsafe does not mean they have evidence that it will harm you," Turner said. He added that, as an herbal product, stevia should not have to undergo the battery of studies required by FDA to consider a substance safe.

A lack of uniformity in stevia formulations used in studies probably yielded inconsistent results that have led to uncertainty at FDA, according to Fabricant.

In affirming GRAS for SweetLeaf Sweetener, Wisdom likely concentrated on the "narrow range of an extract, versus what's been out there in the public domain, which was very diverse stevia products," he said.

May said he is confident that, if asked by FDA, he would be required only to submit signed GRAS certification statements from the researchers who tested his product, rather than being required to publicize Wisdom's proprietary data.

He said he is certain stevia-based products will comprise at least 20 percent of the U.S. sweetener market within five years, although his current concern is securing a sustainable supply of South American stevia rebaudiana leaves against growing competition.

- Dan Schiff (d.schiff@elsevier.com)

Wisdom’s Unconventional Launch: Stevia Sweetener Without FDA’s GRAS

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