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 Truvia^TM (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 stevia-based sweetener PureVia^TM, 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 [2008] 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.”

“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.

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.

—Courtney Cavaliere