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FDA Approves Stevia as a Safe Food Additive

© American Botanical Council

(Austin, TX) December 19, 2008. The US Food and Drug Administration (FDA) has approved the herb stevia (Stevia rebaudiana) as a safe food additive. Prior to this official approval from the FDA, several companies, including food giants Cargill and Coca-Cola, PepsiCo, and Wisdom Natural Brands, performed reviews self-affirming GRAS (generally recognized as safe) status of stevia as a natural, no-calorie sweetener.

Cargill, of Minneapolis, Minnesota, issued a press release Wednesday announcing that it has received a “no objection” notification from FDA, verifying that the stevia extract used in the company’s sweetener TruviaTM is “generally recognized as safe.”1

FDA also issued a “no objection” letter to PepsiCo for the stevia extract used in its sweetener PureViaTM.2 Pepsi has been partnering with Merisant, the maker of Equal®, on its stevia-based sweetener, through Merisant’s subsidiary Whole Earth Sweetener.

Wisdom Natural Brands, the first company to market stevia in the United States, starting in the 1980s, completed its GRAS review of the company’s SweetLeaf® stevia sweetener in March.3 PepsiCo and Merisant announced their GRAS review in early May,2 and Cargill and Coke published the results of studies indicating the safety of Rebiana (their trade name for the stevia constituent rebaudioside A) for Truvia’s GRAS status in May.3

Leslie Curry, director of regulatory & scientific affairs at Cargill, told ABC this morning, “We’re very pleased to see FDA’s concurrence on the GRAS status of the safety of high purity, food grade rebaudioside A. FDA’s conclusion is consistent with United Nations and the World Health Organization’s assessment from earlier this year that rebaudioside A is safe for use as a general sweetener” (personal communication to M. Blumenthal, December 19, 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.”

In related developments, the governments of Australia and New Zealand approved stevia as a food additive in October,4 following the approval of stevia by the United Nations and World Health Organization’s Joint Expert Committee on Food Additives (JECFA) in June,5 after an extensive multi-year review of the safety of the natural sweetener. The JECFA approval relates to stevia extract containing 95% stevia glycosides.

The American Botanical Council has published several recent stories on this subject in previous issues of HerbalGram and HerbalEGram. An article published in the October 2007 issue of ABC’s monthly e-newsletter HerbalEGram provided much background information on the regulatory hurdles that stevia has faced within the sweetener industry.6 Issue 79 of ABC’s quarterly peer-reviewed journal HerbalGram contained an article on the self-affirmation of GRAS status that Wisdom Natural Brands and other companies had recently announced in regards to their stevia-based sweeteners,3 and Mark Blumenthal’s “Dear Reader” article in HerbalGram issue 80 called for the FDA to rescind its out-dated Import Alert on stevia.7

For this morning’s audio coverage of this story on National Public Radio, click here.

References

1. Cargill receives official notification from FDA supporting the safety of TruviaTM Rebiana [press release]. Wayzata, MN: Cargill; December 17, 2008.

2. US Food and Drug Administration issues no objection letter to GRAS status of Rebaudioside A [press release]. Chicago and Purchase, NY: Whole Earth Sweetener Company; December 17, 2008. Available at: http://www.purevia.com/media/081217Pure.aspx.

3. Cavaliere C, Saxton KE. Wisdom Natural Brands begins marketing SweetLeaf® stevia as a sweetener. HerbalGram. 2008;79;20-21.

4. FSANZ Gazette Notices. Amendment No. 103 (FSC 45). Available at : http://www.foodstandards.gov.au/standardsdevelopment/gazettenotices/amendment1039october4070.cfm.

5. 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.

6. Cavaliere C, Blumenthal M. Coca-Cola and Cargill developing new natural sweetener from stevia. HerbalEGram. October 2007;4(9).

7. Blumenthal M. FDA should rescind outdated import alert on stevia. HerbalGram. 2008;80:6.

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