After many years of regulatory hurdles and setbacks, stevia (Stevia rebaudiana, Asteraceae) has finally begun to enter the mainstream sweetener market. The company Wisdom Natural Brands (Phoenix, Arizona) announced in June 2008 that its stevia product SweetLeaf® has been self-affirmed as being generally recognized as safe (GRAS), allowing the company to immediately begin marketing SweetLeaf as a sweetener rather than as a dietary supplement.¹ Several other companies, including Cargill (Minneapolis, Minnesota) and Corn Products International (Westchester, Illinois), have also recently announced plans for marketing their own stevia-based sweeteners and products in the near future.^2,3

The leaves of the South American plant stevia have an extremely sweet taste that is far more potent than sucrose (table sugar).⁴ In addition to being a naturally-derived sweetening agent, stevia is non-caloric, making it particularly appealing to food and beverage companies catering to health-conscious consumers. Stevia was declared an “unapproved food additive” by the US Food and Drug Administration (FDA) in 1991. Since 1995 it has only been marketed in the United States as a dietary supplement, an exception allowed under the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which specifically exempts dietary supplements from the type of regulation—including pre-market approval—required for food additives. There has been speculation by some people in the natural products industry and beyond that producers of synthetic sweeteners may have initially pressured the FDA into designating stevia as an illegal food additive in order to keep stevia off the market as a competitor.⁵

Although Wisdom Natural Brands first introduced stevia into the US market in the form of ground or whole leaves in 1982, SweetLeaf has been sold as a dietary supplement for over a decade due to the marketing restrictions placed on stevia by the FDA. “My dream and my vision has always been to have SweetLeaf as a sweetener,” said James May, president and CEO of Wisdom (oral communication to C. Cavaliere, June 12, 2008).

Wisdom decided to utilize the GRAS self-affirmation process, which the FDA made available to companies in 1997 and involves having an independent group of qualified scientists review the available data on an ingredient’s safety and determine whether that ingredient is considered safe for its intended use and meets strict FDA requirements. The company ultimately hired 2 groups of independent scientists to review the available worldwide data on stevia, both groups containing former FDA officials familiar with the GRAS process. Both groups determined that SweetLeaf stevia meets safety and production requirements necessary for GRAS status, and this status was officially given to Wisdom on March 5, 2008.

SweetLeaf is 98% pure stevia glycosides (the sweet components of the stevia leaf). In its efforts to ensure that SweetLeaf would obtain GRAS status, Wisdom developed a new method for extracting glycosides from stevia leaves that involves a water-membrane filtration system. “We’ve really met heightened or superior standards for the manufacturing of the product,” May stressed.

“We’re on absolutely solid ground in this self-affirmation of GRAS,” he said. May explained that the FDA is not required to review or approve the decision made by the independent scientists who provided the GRAS status. However, the only way for the FDA to reverse the scientists’ GRAS determination would be to take the company to court and prove that stevia is harmful to the human body. According to May, over 1200 studies have now been published verifying the safety of stevia for human consumption.

Although Wisdom has become the first company to market a stevia-based sweetener, several other companies have announced plans for introducing their own stevia sweeteners in the near future. Cargill announced in May that it plans to release its steviabased sweetener Truvia^TM by the end of 2008.⁶ Cargill funded studies exploring the safety of rebiana (the common name for the stevia constituent rebaudioside A, from which Truvia is composed), which were published electronically in the journal Food and Chemical Toxicology in May 2008.² According to Ann Tucker, a spokesperson for Cargill, Cargill has notified the FDA that research data concerning the safety of rebiana have been completed and are available, which is one step of a multistage process in obtaining US regulatory approval (A. Tucker, oral communication to C. Cavaliere, June 10, 2008).

Tucker claimed that Truvia is distinguished from other stevia products in that it is a fully-characterized product that promises consistency and high-quality. She added that such consistency is what food companies typically look for in a sweetener, since these companies also want their finished products to be consistent. “All stevia isn’t the same,” said Tucker. “Unlocking the taste and getting it to be consistent was the hard part.”

Cargill has been collaborating with Coca-Cola Co. (Atlanta, Georgia) in developing its stevia-based sweetener, which Coca-Cola intends to use in beverages and Cargill plans to use in various food products, in addition to marketing the table-top sweetener Truvia.⁷ Coca-Cola filed 24 patent applications in May of 2007 to give the company exclusive rights to develop and sell beverages containing the stevia-based sweetener it has developed with Cargill.

Another company, Corn Products International (CPI), has also indicated that it plans to add a stevia-based ingredient to its list of sweeteners.³ CPI announced in April 2008 that it has entered into an agreement with the Japanese company Morita Kagaku Kogyo Company Ltd., which has been producing stevia sweeteners since 1971, to market that company’s patented stevia strain. CPI has announced that it will also make a $20 million investment to build a stevia extraction factory in Brazil. CPI plans to initially market the stevia-based ingredient, called Enliten^TM, in select Latin American and Asian countries, where the sweetener is already approved for use in foods. The company reportedly will also file for regulatory approval of Enliten in the United States and Europe.

Oscar Rodes of Stevita Co. Inc. (Arlington, Texas), a distributor of stevia products manufactured by Steviafarma of Brazil, is also developing, in conjunction with the Brazilian manufacturer, a table-top sweetener to be released in 2009. Rodes expects that Steviafarma will have had its steviosides reviewed and affirmed as GRAS by that time. Rodes has intended to market stevia as a sweetener and food additive for the last 20 years, but when he met with the FDA in 1989, he learned that there were concerns about the product’s widespread use as a table-top sweetener without having first undergone some rigorous safety studies. Conducting such studies would have totaled an estimated $10 million; Rodes decided this was too high a cost for his small company at that time. However, now Stevita and Steviafarma are working with a large US-based food manufacturer (name undisclosed), which has reportedly spent over $6 million testing the safety of the product and will spend an additional $40 million in a project to launch its own stevia-based table-top sweetener.

“Ten million doesn’t seem like so much now,” said Rodes (oral communication to K. Saxton, June 16, 2008). According to Rodes, this product is going to be at least 95% pure glycosides extracted from special stevia cultivars with a particularly high concentration of rebaudioside A. The company’s extraction process uses water filtration and natural resins instead of solvents or chemicals.

Although various stevia sweeteners may therefore enter US stores in the near future, Wisdom’s May argued that not all of these sweeteners are prepared in the same fashion and can promise the same health benefits. May explained that a blending agent must be used (to bulk up the product to enable packaging in sachets for single servings) when manufacturing stevia products, and many companies utilize a carbohydrate-based compound such as maltodextrin, sorbitol, dextrose, erithrytol, lactose, etc. Some of these blending agents could prevent the stevia products from providing zero carbohydrates or a zero score on the glycemic index. Wisdom’s SweetLeaf stevia is blended with inulin, a prebiotic carbohydrate that is beneficial for gastrointestinal flora and can help improve immune system function. “We’ve blended our stevia with something that also is extraordinarily good for the human body,” said May. He stated that consumers should be careful to read labels and learn the facts about various stevia products.

Consumer interest in stevia sweeteners is expected to be rather high. Tucker stated that Cargill has received very few questions from industry members or the public concerning the science behind stevia. “The majority of questions have been ‘Where can I get it?’ ‘When can I taste it?’—which has been very interesting!” she said.

May stated that the new designation of “sweetener” could possibly raise SweetLeaf’s sales substantially, particularly since the product can now be sold in the baking aisle rather than the herbal dietary supplements aisle.

—Courtney Cavaliere and Kelly E. Saxton

References

1. Starling S. Has stevia broken US dietary supplement shackles? NutraIngredients.com. June 4, 2008. Available at: http://www.nutraingredients-usa.com/news/ng.asp?id=85710. Accessed June 5, 2008.
2. Cargill introduces Truvia natural sweetener brand, the first natural, zero-calorie, great tasting sweetener [press release]. Wayzata, MN: Cargill; May 15, 2008.
3. Corn Products International adds stevia-based, high-intensity sweetener to its ingredient portfolio [press release]. Westchester, IL: Corn Products International; April 22, 2008.
4. Cavaliere C, Blumenthal M. Coca-Cola and Cargill developing new natural sweetener from stevia. HerbalEGram. October 2007;4(9). Available at: http://abc.herbalgram.org/site/ PageServer?pagename=04_10_Stevia_Coke&autologin=true. Accessed June 5, 2008.
5. Bonvie L, Bovie B. Sinfully sweet? New Age Journal. Jan/Feb 1996.
6. Cargill sees Truvia on US market by year end. Reuters. May 15, 2008. Available at: http://uk.reuters.com/article/governmentFilingsNews/idUKN1527123920080515. Accessed May 23, 2008.
7. Etter L, McKay B. Coke, Cargill aim for shake-up in sweeteners. Wall Street Journal. May 31, 2007; A1.