Although a recent spat with one manufacturer has led industry experts to conclude the U.S. Food and Drug Administration won't sweeten its attitude toward stevia anytime soon, two other manufacturers are banking their research dollars on the hope that those experts are wrong.
On Aug. 17, the FDA sent a warning letter to Melville, N.Y.-based The Hain Celestial Group, advising that its Zingers To Go Tangerine Orange Wave Herb Tea was an "adulterated" food product "because it bears or contains stevia, which is an unsafe food additive." The agency emphasized that to be included in a food, an ingredient must be generally recognized as safe. Currently, stevia is allowed only as a dietary supplement in the United States.
"Literature reports have raised safety concerns about the use of stevia, including concerns about control of blood sugar, and effects on the reproductive, cardiovascular and renal systems," the FDA wrote in its letter. "In light of these safety concerns, the use of stevia in your Zingers Tangerine Orange Tea product does not satisfy the criteria for GRAS status."
"Those were studies in animals that have never been repeated in humans," said Mark Blumenthal, executive director of the American Botanical Council. Indeed, 10 of the 12 studies an FDA spokesman cited were performed on rats, mice or dogs. The two human studies were conducted in 1981 and 1991.
Nevertheless, Hain immediately changed the packaging so it no longer represents the product as a food, said spokeswoman Mary Anthes, so the stevia may remain.
The interaction brought speculation that Hain or another company—perhaps Coca-Cola, which announced May 31 that it would partner with Cargill to develop products that are sweetened with stevia—would petition the FDA to use stevia as a food additive, a move that goes a step beyond attaining GRAS status.
Anthes said Hain has no plans to petition the FDA. "We've been using [stevia] as a supplement thusly labeled," she said, noting that the company would watch Coca-Cola's progress "with interest." In Japan, where stevia is permitted as a food ingredient, Coca-Cola has used stevia to sweeten its Diet Coke.
ABC's Blumenthal said it's presumed by many in the industry that Coke and Cargill have already self-affirmed stevia as GRAS, with FDA notification. That means they would have financed research on the safety of stevia for use in food, and submitted that research to the FDA.
"Notification with a positive assent is as good as a petition," Blumenthal said, noting that the advantage to manufacturer-funded research is that it allows the companies to maintain control. If they petitioned the agency, "It could be 10 years before FDA even responds," because the FDA would have to conduct safety research on its own timeline and out of its own budget, Blumenthal said. However, an FDA spokesman said the agency has not received a notification yet from either Coke or Cargill.
Blumenthal predicted that Coke and Cargill would eventually seek a full-on petition. "They're not going to self-affirm and start selling in the U.S. in the current climate," he said, noting that the risk would be too great if the companies funneled research, development and marketing dollars into the products, and the FDA later challenged their GRAS status. An FDA spokesman said, "A company can self-affirm GRAS status but … we may question that particular affirmation," noting, "We haven't seen any evidence that demonstrates that there is a consensus of expert opinion about the safe use of stevia in food."
Even if Coke/Cargill has self-affirmed stevia as GRAS with FDA notification, it's unlikely that a slew of stevia-sweetened products will be released, Blumenthal said. "To what extent is Coke's stevia preparation different from others', and to what extent are they going to be able to express or represent a proprietary preparation?" he asked. "The affirmation is specific for their preparation as they intend to use it."
Natural Foods Merchandiser volume XXVIII/number 11/p. 1,14