In December of 2008, the US Food and Drug Administration (FDA) informed 2 large food companies that the agency would not object to their use of preparations made from the herb stevia (Stevia rebaudiana, Asteraceae) as food substances that are generally recognized as safe (GRAS).1,2 This decision from the FDA came about after Cargill and Coca-Cola, PepsiCo and Merisant, and Wisdom Natural Brands released the results of scientific reviews self-affirming GRAS status of their specific food grade, high purity extracts from stevia as natural, no-calorie sweeteners last year.
FDA issued “no objection” letters to Cargill (Minneapolis, MN) and Whole Earth Sweetener Co. (Chicago, IL, a subsidiary of Merisant) in December regarding the use of those companies’ stevia extracts.3,4 In those letters, the FDA noted that both companies’ stevia extracts are highly purified components of the stevia plant. Therefore, the FDA’s responses to Cargill and Whole Earth Sweetener Co. do not necessarily apply to the uses of other stevia products.
Cargill has partnered with Coca-Cola in developing the zero-calorie, stevia-based sweetener TruviaTM (also referred to as rebiana). Cargill and Coca-Cola published the results of studies indicating the safety of Truvia (their trade name for the stevia constituent rebaudioside A) for rebiana’s GRAS status in May 2008.5 PepsiCo has been partnering with Merisant, the maker of the aspartame sweetener Equal®, on its steviabased sweetener PureViaTM, through Whole Earth Sweetener Co. Whole Earth Sweetener Co. submitted a GRAS affirmation notification and supporting scientific data to the FDA for review in early May 2008,2 a week prior to Cargill/ Coca-Cola’s filing. Wisdom Natural Brands, the first company to market stevia in the United States, starting in the early 1980s, completed its GRAS review of the company’s SweetLeaf® stevia sweetener in March 2008.5 Wisdom’s review was performed by 2 different groups of independent GRAS scientists. In accordance with the FDA regulations established in 1997, Wisdom Natural Brands initially chose not to file a notification of its self-GRAS affirmation with FDA; however, Wisdom reportedly is preparing to submit a formal FDA GRAS notification similar to those filed by Cargill and Whole Earth Sweetener Co. as a courtesy to FDA (S. Weinberger, e-mail, December 30, 2008).
According to Leslie Curry, director of regulatory and scientific affairs at Cargill, “We’re very pleased to see FDA’s concurrence on the GRAS status of the safety of high purity, food grade rebaudioside A (Truvia rebiana). FDA’s conclusion is consistent with United Nations and the World Health Organization’s assessment from earlier  that rebaudioside A is safe for use as a general purpose sweetener” (personal communication to M. Blumenthal, December 19, 2008). Curry continued, “There is significant consumer demand for a natural, zero-calorie sweetener— our leadership and work to ensure the safety and regulatory acceptance of Truvia rebiana is important toward introducing this great-tasting sweetener to consumers around the globe.”
Kathryn Wood, a spokesperson for Whole Earth Sweetener Co., said, “The FDA’s response gives Whole Earth Sweetener Co. the green light to complete distribution discussions with all retailers, including Wal-Mart, Kroger, Walgreens, and others that would not stock PureVia before the FDA responded to our filing. PureVia is now poised to redefine the sweetener category and has significant potential in other food products, such as beverages and cereals, through our partnership with PepsiCo” (e-mail, December 23, 2008).
“This is historic news,” said ABC Founder and Executive Director Mark Blumenthal. “Given the FDA’s earlier attempts to keep stevia from the market in the early 1990s, the agency’s approval of stevia as a safe food ingredient is good news for millions of American consumers who are seeking a safe, natural, non-caloric sweetener.” Blumenthal had recently called for the FDA to rescind its out-dated Import Alert on stevia in his “Dear Reader” column for HerbalGram issue 80.6
Not all responses to the FDA’s decision, however, have been positive. The Center for Science in the Public Interest (CSPI) released a statement claiming that it is too soon for stevia to be allowed in products for mass consumption,7 particularly since scientists at the University of California in Los Angeles previously concluded in an unpublished toxicological review of the scientific literature that rebaudioside A is inadequately tested in terms of cancer and has caused mutations in some laboratory tests.8 (The paper was co-authored by doctoral candidate Sarah Kobylewski, in the Department of Molecular Toxicology, and Curtis D. Eckhert, professor of environmental health sciences and molecular toxicology at the University of California, Los Angeles.) According to CSPI, “Congress and the Obama Administration should strengthen the law that allows companies to simply declare on their own that new additives are ‘generally recognized as safe’ and just start marketing them, even without notifying the FDA and public.”7
In response to CSPI’s statement, ABC’s Blumenthal has pointed out that the Joint Expert Committee on Food Additives of the United Nations and World Health Organization, after 5 years of research into the safety of stevia, recently concluded not only that stevia is safe (i.e., preparations consisting of 95% steviol glycosides) but that the previously contemplated recommendable daily intake of stevia could be doubled from 2 mg/kg body weight to 4 mg/kg body weight.9 “In view of the increasingly compelling body of toxicological and clinical data supporting the safety of various stevia preparations, CSPI’s position appears to be based on less than compelling data, particularly since the UCLA review does not appear to have been peer reviewed nor published—a key aspect of the scientific process,” said Blumenthal.
Shortly before the FDA’s decision regarding stevia, the governments of Australia and New Zealand approved stevia as a food additive in October 2008.10
The latest issue of the Food Chemical Codex (FCC) Forum, which was released December 31, 2008, by the United States Pharmacopeia (USP), includes a proposed monograph for rebaudioside A.11 The proposed monograph contains analytical test procedures with an associated level of specifications to assure the quality, identity, and purity of rebaudioside A. The monograph is open for public comment until March 31, 2009, after which a committee of the USP’s Council of Experts will review all comments and finalize the monograph for the next edition of the FCC. The FCC is a compendium of internationally recognized standards for purity and identity of food ingredients.
- Cargill receives official notification from FDA supporting the safety of TruviaTM Rebiana [press release]. Wayzata, MN: Cargill; December 17, 2008.
- US Food and Drug Administration issues no objection letter to GRAS status of Rebaudioside A [press release]. Chicago and Purchase, NY: Whole Earth Sweetener Co.; December 17, 2008.
- Tarantino LM. Agency response letter GRAS notice no. GRN 000253. December 17, 2008. Available at: http://www.cfsan.fda.gov/~rdb/opa-g253.html. Accessed December 23, 2008
- Tarantino LM. Agency response letter GRAS notice no. GRN 000252. December 17, 2008. Available at: http://www.cfsan.fda.gov/~rdb/opa-g252.html. Accessed December 23, 2008.
- Cavaliere C, Saxton KE. Wisdom Natural Brands begins marketing SweetLeaf® stevia as a sweetener. HerbalGram. 2008;79;20-21.
- Blumenthal M. FDA should rescind outdated import alert on stevia. HerbalGram. 2008;80:6.
- FDA issues midnight go-ahead for potentially harmful stevia sweetener [press release]. Washington DC: Center for Science in the Public Interest; December 18, 2008.
- Kobylewski S, Eckhert CD. Toxicology of rebaudioside A: A review. 2008. (unpublished).
- Joint FAO/WHO Expert Committee On Food Additives, Sixty-ninth meeting Rome, Italy, 17-26 June 2008. Summary and Conclusions issued 4 July 2008. Available at: http://www.fao.org/ag/agn/agns/ files/jecfa69_final.pdf.
- FSANZ Gazette Notices. Amendment No. 103 (FSC 45). Available at: http://www.foodstandards. gov.au/standardsdevelopment/gazettenotices/amendment1039october4070.cfm.
- Important alert: FCC Forum includes standard for rebaudioside A. FCC e-Newsletter. December 19, 2008.