The legal status of stevia as a food additive or dietary supplement varies from country to country. In the United States, high-purity stevia glycoside extracts have been generally recognized as safe (GRAS) since 2008, and are allowed in food products, but stevia leaf and crude extracts do not have GRAS or Food and Drug Administration (FDA) approval for use in food. The European Union approved stevia additives in 2011, while in Japan stevia has been widely used as a sweetener for decades.
The plant Stevia rebaudiana has been used for more than 1,500 years by the Guaraní peoples of South America, who called it ka'a he'ê ("sweet herb"). The leaves have been used traditionally for hundreds of years in both Brazil and Paraguay to sweeten local teas and medicines, and as a "sweet treat". The genus was named for Spanish botanist and physician Petrus Jacobus Stevus (Pedro Jaime Esteve 1500–1556), a professor of botany at the University of Valencia.
In 1899, Swiss botanist Moisés Santiago Bertoni, while conducting research in eastern Paraguay, first described the plant and the sweet taste in detail. Only limited research was conducted on the topic until, in 1931, two French chemists isolated the glycosides that give stevia its sweet taste.
During the 1990s, the United States Food and Drug Administration (FDA) received two petitions requesting that stevia be classified as generally recognized as safe (GRAS), but the FDA "disagreed with [the] conclusions [detailed in the petitions]". Stevia remained banned for all uses until the Dietary Supplement Health and Education Act of 1994, after which the FDA revised its stance and permitted stevia to be used as a dietary supplement, although still not as a food additive. In 1999, prompted by early studies, the European Commission banned stevia's use in food products within the European Union pending further research. In 2006, research data compiled in the safety evaluation released by the World Health Organization found no adverse effects.
In December 2008, the FDA gave a "no objection" approval for GRAS status to Truvia (developed by Cargill and the Coca-Cola Company) and PureVia (developed by PepsiCo and the Whole Earth Sweetener Company, a subsidiary of Merisant), both of which use rebaudioside A derived from the stevia plant. However, the FDA said that these products are not stevia, but a highly purified product. In 2015, the FDA still regarded stevia as "not an approved food additive", and stated that it "has not been affirmed as GRAS in the United States due to inadequate toxicological information". In June 2016, the U.S. Customs and Border Protection issued an order of detention for stevia products made in China based on information that the products were made using prison labor. As of 2017, high-purity stevia glycosides are considered safe and allowable as ingredients in food products sold in the United States.
In the early 1970s, sweeteners such as cyclamate and saccharin were gradually decreased or removed from a variant formulation of Coca-Cola. Consequently, use of stevia as an alternative began in Japan, with the aqueous extract of the leaves yielding purified steviosides developed as sweeteners. The first commercial stevia sweetener in Japan was produced by the Japanese firm Morita Kagaku Kogyo Co., Ltd. in 1971. The Japanese have been using stevia in food products and soft drinks, (including Coca-Cola), and for table use. In 2006, Japan consumed more stevia than any other country, with stevia accounting for 40% of the sweetener market.
As of 2006, China was the world's largest exporter of stevioside products. In the mid-1980s, stevia became popular in U.S. natural foods and health food industries, as a noncaloric natural sweetener for teas and weight-loss blends. The makers of the synthetic sweetener NutraSweet (at the time Monsanto) asked the FDA to require testing of the herb. As of 2006, China was the world's largest exporter of stevioside products. In 2007, the Coca-Cola Company announced plans to obtain approval for its stevia-derived sweetener, Rebiana, for use as a food additive within the United States by 2009, as well as plans to market Rebiana-sweetened products in 12 countries that allow stevia's use as a food additive. In May 2008, Coca-Cola and Cargill announced the availability of Truvia, a consumer brand stevia sweetener containing erythritol and Rebiana, which the FDA permitted as a food additive in December 2008. Coca-Cola announced intentions to release stevia-sweetened beverages in late December 2008. From 2013 onwards, Coca-Cola Life, containing stevia as a sweetener, was launched in various countries around the world.
Shortly afterward, PepsiCo and Pure Circle announced PureVia, their brand of stevia-based sweetener, but withheld release of beverages sweetened with rebaudioside A until receipt of FDA confirmation. Since the FDA permitted Truvia and PureVia, both Coca-Cola and PepsiCo have introduced products that contain their new sweeteners.
Rebaudioside A has the least bitterness of all the steviol glycosides in the Stevia rebaudiana plant. To produce rebaudioside A commercially, stevia plants are dried and subjected to a water extraction process. This crude extract contains about 50% rebaudioside A. The various glycosides are separated and purified via crystallization techniques, typically using ethanol or methanol as solvent.
Stevia extracts and derivatives are produced industrially and marketed under different trade names.
- Rebiana is an abbreviated name for the stevia extract, rebaudioside A.
- Truvia is the brand for an erythritol and rebiana sweetener concoction manufactured by Cargill and developed jointly with the Coca-Cola Company.
- PureVia is PepsiCo's brand of rebiana.
Mechanism of action
Glycosides are molecules that contain glucose residues bound to other non-sugar substances called aglycones (molecules with other sugars are polysaccharides). Preliminary experiments deduce that the tongue's taste receptors react to the glycosides and transduce the sweet taste sensation and the lingering bitter aftertaste by direct activation of sweet and bitter receptors.
According to basic research, steviol glycosides and steviol interact with a protein channel called TRPM5, potentiating the signal from the sweet or bitter receptors, amplifying the taste of other sweet, bitter and umami tastants. The synergetic effect of the glycosides on the sweet receptor and TRPM5 explains the sweetness sensation. Some steviol glycosides (rebaudioside A) are perceived sweeter than others (stevioside).
Safety and regulations
Although both steviol and rebaudioside A have been found to be mutagenic in laboratory in vitro testing, these effects have not been demonstrated for the doses and routes of administration to which humans are exposed. Two 2010 review studies found no health concerns with stevia or its sweetening extracts.
The WHO's Joint Experts Committee on Food Additives has approved, based on long-term studies, an acceptable daily intake of steviol glycoside of up to 4 mg/kg of body weight. In 2010, The European Food Safety Authority established an acceptable daily intake of 4 mg/kg/day of steviol, in the form of steviol glycosides. Meanwhile, the Memorial Sloan Kettering Cancer Center warns that "steviol at high dosages may have weak mutagenic activity," and a review "conducted for" the Center for Science in the Public Interest notes that there are no published carcinogenicity results for rebaudioside A (or stevioside).
Availability and legal status by country or area
The plant may be grown legally in most countries, although some countries restrict its use as a sweetener. The legally allowed uses and maximum dosage of the extracts and derived products vary widely from country to country.
- Argentina: available as of 2008, regulatory status uncertain
- All steviol glycoside extracts were approved in 2008.
- Brazil: stevioside extract approved as food additive since 2005.
- Canada (as of November 2012)
- Steviol glycosides became available as a food additive on 30 November 2012.
- Stevia rebaudiana leaf and extracts are available as dietary supplements.
- Chile: available as of 2008, regulatory status uncertain
- China: available since 1984, regulatory status uncertain
- Colombia: available as of 2008, regulatory status uncertain
- European Union: Steviol glycosides were approved and regulated as food additives by the European Commission on 11 November 2011.
- Hong Kong: steviol glycosides approved as food additives since January 2010
- India: In a notification dated 13 Nov 2015 FSSAI has permitted its use in a range of products. This includes carbonated water, dairy-based desserts and flavoured drinks, yoghurts, ready-to-eat cereals, fruit nectars and jams. Madhu-Tulsi (Sweeteners in Food Regulations; Public Health and Municipal Services Ordinance).
- Indonesia: (2012)
- Steviol glycosides are available as food additives since 2012.
- Stevia leaf is available as a dietary supplement.
- Israel: approved as food additive since January 2012.
- Japan: widely available since the 1970s and regulated as an existing additive since 1995.
- Korea: available as of 2008, regulatory status uncertain.
- Malaysia: available as of 2008, regulatory status uncertain.
- Mexico: mixed steviol glycoside extract (not separate extracts) approved since 2009.:[third-party source needed]
- New Zealand:
- All steviol glycoside extracts were approved in 2008.
- Steviol glycoside approved as food additive (E 960) since June 2012.
- The plant itself has not been approved as of September 2012.
- Paraguay: available as of 2008, regulatory status uncertain.
- Peru: available as of 2008, regulatory status uncertain.
- Philippines: available as of 2008, regulatory status uncertain.
- Russian Federation: stevioside approved as food additive since 2008, in the "minimal dosage required" to achieve the goal.
- Saudi Arabia: available as of 2008, regulatory status uncertain.
- Singapore: steviol glycosides approved as food additive in certain foods, since 2005 Previously it was banned.
- South Africa: approved since September 2012 and widely available.
- Taiwan: available as of 2008, regulatory status uncertain.
- Thailand: available as of 2008, regulatory status uncertain.
- Turkey: available as of 2008, regulatory status uncertain.
- United Arab Emirates: available as of 2008, regulatory status uncertain.
- Uruguay: available as of 2008, regulatory status uncertain.
- United States (as of April 2017):
- Purified rebaudioside A has been allowed since December 2008 as a food additive (sweetener), sold under various trade names, and classified as "generally recognized as safe" ("GRAS").
- Stevia rebaudiana leaf and extracts have been available as dietary supplements since 1995, but the 2008 FDA authorization does not extend to them, and they do not have GRAS status.
- Vietnam: available as of 2008, regulatory status uncertain.
- Asteraceae, botanical family containing Stevia
- Steviol glycosides, chemicals responsible for the sweetness
- Sugar substitute, primary usage of stevia
- Thaumatin, a natural sweetener, derived from an African fruit
- Miraculin, a substance that modifies the perception of sour foods into sweet
- "Stevia". British & World English. Oxforddictionaries.com. 7 February 2013. Archived from the original on 12 February 2013. Retrieved 13 February 2013.
- "Stevia". US English. Oxforddictionaries.com. 7 February 2013. Archived from the original on 9 May 2013. Retrieved 13 February 2013.
- Cardello, H.M.A.B.; Da Silva, M.A.P.A.; Damasio, M.H. (1999). "Measurement of the relative sweetness of stevia extract, aspartame and cyclamate/saccharin blend as compared to sucrose at different concentrations". Plant Foods for Human Nutrition. 54 (2): 119–129. doi:10.1023/A:1008134420339.
- Brandle, Jim (Aug. 19, 2004). "FAQ—Stevia, Nature's Natural Low Calorie Sweetener". Agriculture and Agri-Food Canada. Retrieved Aug. 11, 2006.
- "Has Stevia been approved by FDA to be used as a sweetener?". US Food and Drug Administration. 28 April 2017. Archived from the original on 29 July 2017. Retrieved 27 July 2017.
- Stones, Mike (2011). "Stevia wins final EU approval". foodmanufacture.co.uk. Archived from the original on 18 November 2011. Retrieved 22 November 2011.
- "Stevia herb shakes up global sweetener market". The Independent. 28 March 2010. Archived from the original on 28 July 2017. Retrieved 13 July 2017.
- Misra, H.; Soni, M.; Silawat, N.; Mehta, D.; Mehta, B. K.; Jain, D. C. (April 2011). "Antidiabetic activity of medium-polar extract from the leaves of Stevia rebaudiana Bert. (Bertoni) on alloxan-induced diabetic rats". J Pharm Bioallied Sci. 3 (2): 242–8. doi:10.4103/0975-7406.80779. PMC 3103919. PMID 21687353.
- Parsons, WT; Cuthbertson, EG (2001). Noxious Weeds of Australia, 2nd ed. Collingswood, Australia: CSIRO Publishing. ISBN 978-0-643-06514-7., page 309.This reference refers specifically to Stevia eupatoria, a related weed having the same nomenclature origin.
- Bertoni, Moisés Santiago (1899). Revista de Agronomia de l'Assomption. 1: 35. Missing or empty
- Bridel, M.; Lavielle, R. (1931). "Sur le principe sucre des feuilles de kaa-he-e (stevia rebaundiana B)". Comptes Rendus de l'Académie des Sciences (Parts 192): 1123–5.
- Drake, Laurie (7 March 2001). "So Sweet, So Natural, So L.A". The New York Times. Archived from the original on 6 September 2017. Retrieved 15 September 2017.
- McCaleb, Rob (1997). "Controversial Products in the Natural Foods Market". Herb Research Foundation. Archived from the original on 18 October 2006. Retrieved 8 November 2006.
- European Commission Scientific Committee on Food (June 1999). Opinion on Stevioside as a Sweetener Archived 23 October 2006 at the Wayback Machine
- Benford, D. J.; DiNovi, M.; Schlatter, J. (2006). "Safety Evaluation of Certain Food Additives: Steviol Glycosides" (PDF). WHO Food Additives Series. 54: 140. Archived (PDF) from the original on 10 September 2008. Retrieved 12 July 2006.
- Newmarker, Chris (18 December 2008). "Federal regulators give OK for Cargill's Truvia sweetener". Minneapolis / St. Paul Business Journal. Archived from the original on 1 January 2009. Retrieved 18 December 2008.
- "What refined Stevia preparations have been evaluated by FDA to be used as a sweetener?". fda.gov. U.S. Food and Drug Administration. Archived from the original on 23 April 2014. Retrieved 22 March 2014.
- Food and Drug Administration (1995, rev 1996, 2005). Import Alert #45-06 Archived 30 October 2015 at the Wayback Machine: "Automatic Detention of Stevia Leaves, Extract of Stevia Leaves, and Food Containing Stevia"
- "CBP Commissioner Issues Detention Order on Stevia Produced in China with Forced Labor". 1 June 2016. Archived from the original on 8 May 2017. Retrieved 14 April 2017.
- "Stevia". Morita Kagaku Kogyuo Co., Ltd. 2004. Archived from the original on 26 October 2007. Retrieved 6 November 2007.
- Jones, Georgia (February 2014). "Stevia". NebGuide: University of Nebraska–Lincoln Institute of Agriculture and Natural Resources. Archived from the original on 13 January 2017. Retrieved 12 January 2017.
- Zeavin, Edna. "The Outlaw Herbal Sweetener". East West Journal. February 1988. p. 28. "Stevia, also called sweet leaf or sweet herb, is making inroads into the health food and natural foods markets."
- Keville, Kathi. "Exploring South America's Medicinal Plants". Vegetarian Times. April 1987. p. 47.
- Stanford, Duane D. (31 May 2007). "Coke and Cargill teaming on new drink sweetener". Atlanta Journal-Constitution. Archived from the original on 3 June 2007. Retrieved 31 May 2007.
- Etter, Lauren & McKay, Betsy (31 May 2007). "Coke, Cargill Aim For a Shake-Up in Sweeteners". Wall Street Journal. Archived from the original on 24 January 2018. Retrieved 1 June 2007.
- "Truvia ingredients". Archived from the original on 7 August 2009. Retrieved 15 May 2008.
- "Stevia sweetener gets US FDA go-ahead". Decision News Media SAS. 18 December 2008. Archived from the original on 18 June 2009. Retrieved 11 May 2009.
- "Coke to sell drinks with stevia; Pepsi holds off". The Seattle Times. Associated Press. 15 December 2008. Archived from the original on 19 December 2008. Retrieved 16 December 2008.
- Geller, Martinne (26 June 2013). "Coke to sell 'natural' mid-calorie cola in Argentina". Reuters. Archived from the original on 27 June 2013. Retrieved 27 June 2013.
- "FDA Approves 2 New Sweeteners". The New York Times. Associated Press. 17 December 2008. Retrieved 11 May 2009.
- Purkayastha, S. ""A Guide to Reb-A", Food Product Design". Archived from the original on 26 March 2009. Retrieved 28 March 2009.
- Prakash I, Dubois GE, Clos JF, Wilkens KL, Fosdick LE (July 2008). "Development of rebiana, a natural, non-caloric sweetener". Food Chem. Toxicol. 46 Suppl 7 (7): S75–82. doi:10.1016/j.fct.2008.05.004. PMID 18554769.
- Mike Hughlett (10 August 2013). "New Cargill sweetener aims at the giant worldwide cola market". Star Tribune Media Company LLC, Minneapolis, MN. Archived from the original on 6 March 2017. Retrieved 5 March 2017.
- Hellfritsch, C; Brockhoff, A; Stähler, F; Meyerhof, W; Hofmann, T (11 July 2012). "Human psychometric and taste receptor responses to steviol glycosides". Journal of Agricultural and Food Chemistry. 60 (27): 6782–93. doi:10.1021/jf301297n. PMID 22616809.
- Philippaert, K; Pironet, A; Mesuere, M; Sones, W; Vermeiren, L; Kerselaers, S; Pinto, S; Segal, A; Antoine, N; Gysemans, C; Laureys, J; Lemaire, K; Gilon, P; Cuypers, E; Tytgat, J; Mathieu, C; Schuit, F; Rorsman, P; Talavera, K; Voets, T; Vennekens, R (31 March 2017). "Steviol glycosides enhance pancreatic beta-cell function and taste sensation by potentiation of TRPM5 channel activity". Nature Communications. 8: 14733. doi:10.1038/ncomms14733. PMC 5380970. PMID 28361903.
- Well, C; Frank, O; Hofmann, T (2013). "Quantitation of sweet steviol glycosides by means of a HILIC-MS/MS-SIDA approach". Journal of Agricultural and Food Chemistry. 61 (47): 11312–20. doi:10.1021/jf404018g. PMID 24206531.
- Geuns, JM; Buyse, J; Vankeirsbilck, A; Temme, EH; Compernolle, F; Toppet, S (5 April 2006). "Identification of steviol glucuronide in human urine". Journal of Agricultural and Food Chemistry. 54 (7): 2794–8. doi:10.1021/jf052693e. PMID 16569078.
- "This enzyme is what makes stevia so sweet". Chemical & Engineering News. Retrieved 22 August 2019.
- Goyal, S. K.; Samsher; Goyal, R. K. (February 2010). "Stevia (Stevia rebaudiana) a bio-sweetener: a review". Int J Food Sci Nutr. 61 (1): 1–10. doi:10.3109/09637480903193049. PMID 19961353.
- Kobylewski, Sarah; Eckhert, Curtis. "Toxicology of Rebaudioside A: A Review" (PDF). Archived (PDF) from the original on 10 September 2015. Retrieved 19 August 2015.
- Geuns JM (2003). "Stevioside". Phytochemistry. 64 (5): 913–21. doi:10.1016/S0031-9422(03)00426-6. PMID 14561506.
- Brusick DJ (2008). "A critical review of the genetic toxicity of steviol and steviol glycosides". Food Chem Toxicol. 46 (7): S83–S91. doi:10.1016/j.fct.2008.05.002. PMID 18556105.
- Ulbricht, C.; Isaac, R.; Milkin, T.; Poole, E. A.; Rusie, E.; et al. (April 2010). "An evidence-based systematic review of stevia by the Natural Standard Research Collaboration". Cardiovasc Hematol Agents Med Chem. 8 (2): 113–27. PMID 20370653.
- "Joint FAO/WHO Expert Committee on food additives, Sixty-ninth Meeting". World Health Organization. 4 July 2008. Archived from the original on 4 March 2016. Retrieved 23 August 2018. Cite journal requires
- "Stevia". Memorial Sloan Kettering Cancer Center. Archived from the original on 12 September 2015. Retrieved 19 August 2015.
- "Olam and Wilmar in 50:50 JV to Acquire 20% Stake in PureCircle, a Leading Producer of Natural High-Intensity Sweeteners for USD 106.2 Mln". flex-news-food.com. 1 July 2008. Archived from the original on 13 March 2012. Retrieved 5 April 2012.
- "Stevia gets Australian approval for food and beverages". Foodnavigator.com. Retrieved 13 February 2013.
- "Consulta Pública nº 86, de 7 de dezembro de 2005. D.O.U de 08/12/2005" [Public Consultation nº 86, 7 december of 2005.] (PDF). ANVISA - Agência Nacional de Vigilância Sanitária. Retrieved 2 February 2019.
- "Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Steviol Glycosides as a Table-Top Sweetener and as a Sweetener in Certain Food Categories – Document Reference Number NOM/ADM-0002". Health Canada. 2012. Archived from the original on 2 October 2013. Retrieved 26 November 2013.
- "Commission Regulation (EU) No 1131/2011" (PDF). Official Journal of the European Union: 205. 11 November 2011. Archived from the original on 20 November 2011. Retrieved 15 November 2011.
The CE regulation establishes steviol glycosides as food additive, and establishes maximum content levels in foodstuff and beverages.
- Halliday, Jess (8 September 2009). "France approves high Reb A stevia sweeteners". foodnavigator.com. Archived from the original on 27 February 2010. Retrieved 23 January 2010.
- "Cap 132U Schedule (Sweeteners in Food Regulations; Public Health and Municipal Services Ordinance) |". legislation.gov.hk. 2011. Retrieved 22 June 2011.
- Pinto, Viveat Susan (24 November 2015). "Sweetener Stevia clears FSSAI hurdle | Business Standard News". Business Standard India. Business-standard.com. Archived from the original on 25 November 2015. Retrieved 22 September 2016.
- Indonesia's Minister of Health (2012), Regulation of No. 033 on Food Additives Archived 30 May 2013 at the Wayback Machine
- "Stevia Sweeteners Now Approved in Israel". greenprophet.com. 2012. Archived from the original on 6 May 2012. Retrieved 5 April 2012.
- "The Act for Partial Provisions of the Food Sanitation Act and the Nutrition Improvement Act, Supplementary Provisions Article 2". houko.com. 1995. Archived from the original on 6 June 2016. Retrieved 11 January 2018.
- "Norwegian Stevia fact sheet Norwegian Institute of Public Health". EFSA Journal. 8 (4): 1537. 17 June 1999. doi:10.2903/j.efsa.2010.1537. Archived from the original on 8 January 2013. Retrieved 13 February 2013.
- "Technical regulations for juice products from fruits and vegetables" (PDF). Russian Federation Federal Law. 27 October 2008. p. Table 5. Archived (PDF) from the original on 3 November 2012. Retrieved 15 April 2011.
- "Sale of Food Act, Chapter 283, Section 56(1): Food Regulations" (PDF). Agri-Food & Veterinary Authority of Singapore. 2005. Archived from the original (PDF) on 8 March 2012.
- Li, Simon (27 March 2002). Fact Sheet: Stevioside (PDF). Hong Kong Legislative Council Secretariat Research and Library Services Division. Archived (PDF) from the original on 10 December 2004. Retrieved 8 September 2003.
- "Stevia approved for use in South Africa". Foodstuffsa.co.za. 10 September 2012. Archived from the original on 23 September 2016. Retrieved 22 September 2016.
- Curry, Leslie Lake. "Agency Response Letter GRAS Notice No. GRN 000287". Archived from the original on 29 March 2011. Retrieved 28 August 2010.
- Media related to Stevia sugar at Wikimedia Commons