F.D.A. stays alert on stevia in foods

by Jeff Gelski
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WASHINGTON — The Food and Drug Administration recently took action on the use of the natural sweetener stevia in food and beverage products. One instance involved a warning letter and the other a revision on an import alert. The F.D.A. allows the use of stevia (Stevia rebaudiuna) in supplements but not in foods or beverages.

The F.D.A. on Aug. 17 issued a warning letter to The Hain Celestial Group, Inc. for using stevia in an iced tea mix, although Hain Celestial reports the matter has been resolved. Hain Celestial, Boulder, Colo., had listed its Celestial Seasonings Zingers to Go Tangerine Orange Wave Herb Tea as a herbal supplement, but the F.D.A. disagreed. Stevia was on the ingredient list.

In a letter dated Aug. 17, Joseph R. Baca, director of the F.D.A.’s Office of Compliance Center for Food Safety and Applied Nutrition, said, "Notwithstanding your use of the term ‘herbal supplement’ to identify the product and your use of a supplement facts label for nutrition labeling, your Zingers Tangerine Orange Tea is subject to regulation as a conventional food and not a dietary supplement."

The F.D.A. added, "Any substance intentionally added to a conventional food, such as a powdered drink mix product, must be in accordance with a food additive regulation approving the substance for that use, unless the substance is generally recognized as safe (GRAS) . . ."

Celestial Seasonings worked directly with the F.D.A. to modify its packaging, said Dr. Gerry Amantea, Ph.D., vice-president, technical services for Hain Celestial.

"The F.D.A. asked that Zingers to Go packaging more prominently display the word ‘supplement,’" Dr. Amantea said. "Celestial Seasonings is making the requested label change and has been advised by the F.D.A. that the matter has been resolved."

On Sept. 12, the F.D.A. revised an import alert on the automatic detention of stevia leaves, extract of stevia leaves and food containing stevia. The Sept. 12 revision listed specific companies and products identified for automatic detention. They included the Japanese companies of JA Beverage Saga Co., Ltd. for its alfalfa drink; Kuroda Shokuhin Co., Inc.. (pickled relish); Miyazaki Nosan K.K. (pickled radish); Nozaki Tsukemo Co., Ltd. (salted radish); and Shinshin Shokuryo Kogyo Co., Ltd. (salted radish): Also on the list were the Republic of Korea’s Mammos Confectionary Co. (biscuits) and Brazil’s Natural Corporation Do Brazil Industria & Comercio, Ltd. (fruit and vegetable concentrate).

Extracted from the leaves of the stevia plant, stevia has been used in foods and beverages in Asia and South America for years. It has no calories and is 250 to 300 times as sweet as sugar.

Cargill, Minneapolis, and The Coca-Cola Co., Atlanta, earlier this year announced they will work together to develop and market rebiana, a sweetener produced from stevia extract, worldwide. They hope to meet regulatory requirements to make rebiana GRAS in foods and beverages in the United States.

In its letter to Hain Celestial, the F.D.A. said, "While F.D.A. has received inquiries and petitions for the use of stevia or stevia extracts in food, 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 effects on the reproductive, cardiovascular and renal systems."

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