The legal status of stevia as a food additive or dietary supplement varies from country to country. In the United States, certain high-purity stevia glycoside extracts have been generally recognized as safe (GRAS) and may be lawfully marketed and added to food products, but stevia leaf and crude extracts do not have GRAS or Food and Drug Administration (FDA) approval for use in food.[9] The European Union approved Stevia rebaudiana additives in 2011.[10] In Japan, stevia has been widely used as a sweetener for decades.[11]
The plant Stevia rebaudiana has been used for centuries by the Guaraní peoples of South America, who called it ka'a he'ê ("sweet herb").[12] The leaves have been used traditionally for hundreds of years in both Paraguay and Brazil to sweeten local teas, and as a "sweet treat".[12] The genus was named for the Spanish botanist and physician Pedro Jaime Esteve (Petrus James Stevus, 1500–1556) a professor of botany at the University of Valencia.[13]
History
In 1899, Swiss botanist Moisés Santiago Bertoni, while conducting research in eastern Paraguay, first described the plant and the sweet taste in detail.[14] Only limited research was conducted on the topic until, in 1931, two French chemists isolated the glycosides that give stevia its sweet taste.[15]
Early regulation
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]".[16] 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.[17] In 1999, prompted by early studies, the European Commission banned stevia's use in food products within the European Union pending further research.[18] In 2006 and 2016, research data compiled in the safety evaluations released by the World Health Organization found no adverse effects.[19][6]: 60
In December 2008, the FDA gave a "no objection" approval for GRAS status to Truvia[a] and PureVia,[b] both of which use rebaudioside A derived from the Stevia rebaudiana plant.[20] However, the FDA said that these products are not stevia, but a highly purified Stevia rebaudiana-extract product.[21] 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".[22] 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.[23] Certain high-purity stevia glycoside extracts have been generally recognized as safe (GRAS) and may be lawfully marketed and added to food products.[9]
Commercial use
Use of stevia as a sweetener began in Japan,[non-primary source needed] with the aqueousextract of the leaves yielding purified steviosides developed as sweeteners. Japanese firm Morita Kagaku Kogyo claims they were the first, in 1971, to commercialize stevia sweetener production.[24]
In the mid-1980s, stevia was commonly used in U.S. natural foods and health food industries, as a noncaloric natural sweetener for teas and weight-loss blends.[25][26] The makers of the synthetic sweetener NutraSweet (at the time Monsanto) asked the FDA to require testing of stevia extracts.[26]
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.[27][28]
In May 2008, Coca-Cola and Cargill announced the availability of Truvia, a consumer-brand Stevia sweetener containing erythritol and Rebiana,[29] which the FDA permitted as a food additive in December 2008.[30] Coca-Cola announced intentions to release stevia-sweetened beverages in late December 2008.[31] From 2013 onwards, Coca-Cola Life, containing stevia as a sweetener, was launched in various countries around the world.[32]
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 the Coca-Cola Company and PepsiCo have introduced products that contain their new sweeteners.[33]
Industrial extracts
Rebaudioside A has the least bitterness of all the steviol glycosides in the Stevia rebaudiana plant. To produce steviol glycosides commercially, Stevia rebaudiana plants are dried and subjected to a hot water extraction process.[6]: 56 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.[34] The dried extract contains no less than 95% steviol glycosides.[6]: 56 [35]
Stevia rebaudiana extracts and derivatives are produced industrially and marketed under different trade names.
Rebiana is an abbreviated name for the Stevia extract, rebaudioside A.[36]
Truvia is the brand for an erythritol and rebiana sweetener concoction manufactured by Cargill and developed jointly with the Coca-Cola Company.[37]
EverSweet, discovered and developed by Evolva,[38] and manufactured jointly by Cargill and DSM.[39][40]
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.[41]
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.[42] 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).[43]
Steviol is processed by intestinal microflora and is also taken up into the bloodstream, further metabolised by the liver to steviol glucuronide and several other metabolites, and excreted in the urine.[44][6]: 56–57
A three-dimensional map of the proteins produced by the stevia plant, showing the crystalline structures that produce both the sensation of sweetness and bitter aftertaste in the sweetener, was reported in 2019.[45]
Safety and regulations
A 2010 review found that the use of Stevia rebaudiana sweeteners as replacements for sugar might benefit children, people with diabetes, and those wishing to lower their intake of calories.[46]
Although both steviol and rebaudioside A have been found to be mutagenic in laboratory in vitro testing,[47] these effects have not been demonstrated for the doses and routes of administration to which humans are exposed.[19][48][49] Two 2010 review studies found no health concerns with Stevia rebaudiana or its sweetening extracts.[46][50]
Used as an extract, stevia leaves have been used traditionally in Paraguay as a women's contraceptive, administered as a daily drink. The effect has been tested in rats, finding a 57–79 percent reduction in fertility compared with the control group, the lowered fertility continuing after withdrawal of the drug for up to two months.[51][52]
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 mass.[19][6]: 60 [35] In 2010, The European Food Safety Authority established an acceptable daily intake of 4 mg/kg 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,"[53] 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).[47]
In August 2019, the US FDA placed an import alert on Stevia leaves and crude extracts – which do not have GRAS status – and on foods or dietary supplements containing them due to concerns about safety and potential for toxicity.[54]
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[55]
Australia:
All steviol glycoside extracts were approved in 2008.[56]
Brazil: stevioside extract approved as food additive since 2005.[57]
Canada (as of November 2012)
Steviol glycosides became available as a food additive on 30 November 2012.[58]
Stevia rebaudiana leaf and extracts are available as dietary supplements.
Chile: available as of 2008, regulatory status uncertain[55]
China: available since 1984, regulatory status uncertain
Colombia: available as of 2008, regulatory status uncertain[55]
Hong Kong: steviol glycosides approved as food additives since January 2010[61]
India: In a notification dated 13 November 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.[c][62]
Indonesia: (2012)
Steviol glycosides are available as food additives since 2012.[63]
Stevia leaf is available as a dietary supplement.
Israel: approved as food additive since January 2012.[64]
Japan: widely available since the 1970s and regulated as an existing additive since 1995.[65]
Korea: available as of 2008, regulatory status uncertain.[55]
Malaysia: available as of 2008, regulatory status uncertain.[55]
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.[56]
Norway:
Steviol glycoside approved as food additive (E 960) since June 2012.[66]
The plant itself has not been approved as of September 2012.
Paraguay: available as of 2008, regulatory status uncertain.[55]
Peru: available as of 2008, regulatory status uncertain.[55]
Philippines: available as of 2008, regulatory status uncertain.[55]
Russian Federation: stevioside approved as food additive since 2008, in the "minimal dosage required" to achieve the goal.[67] Stevia leaves powder, syrups and crude extracts derived form it, have been banned. The ban is enacted on 27 February 2024. E960 is still approved.[68]
Saudi Arabia: available as of 2008, regulatory status uncertain.[55]
Singapore: steviol glycosides approved as food additive in certain foods, since 2005[69] Previously it was banned.[70]
South Africa: approved since September 2012 and widely available.[71]
Taiwan: available as of 2008, regulatory status uncertain.[55]
Thailand: available as of 2008, regulatory status uncertain.[55]
Turkey: available as of 2008, regulatory status uncertain.[55]
United Arab Emirates: available as of 2008, regulatory status uncertain.[55]
Uruguay: available as of 2008, regulatory status uncertain.[55]
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").[9][72]
Stevia rebaudiana leaf and crude 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.[9] In 2019, leaves and crude extracts were included in an FDA import alert with concerns about their safety for use in foods or supplements and potential for toxicity.[54]
Vietnam: available as of 2008, regulatory status uncertain.[55]
See also
Thaumatin, a natural sweetener, derived from an African fruit
Miraculin, a substance that modifies the perception of sour foods into sweet
^Madhu-Tulsi (Sweeteners in Food Regulations; Public Health and Municipal Services Ordinance)
References
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^"Stevia". Oxforddictionaries.com. US English. 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. PMID10646559. S2CID38718610.
^"Stevia rebaudiana". Missouri Botanical Garden. 2024. Retrieved 30 October 2024.
^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): 1123–1125.
^ abcBend, J.R.; et al. (Food and Agriculture Organization of the United Nations, World Health Organization, International Program on Chemical Safety) (2006). Safety evaluation of certain food additives(PDF). Geneva: World Health Organization, International Program on Chemical Safety. p. 140. ISBN978-92-4-166054-9. OCLC70637287. Archived(PDF) from the original on 10 September 2008.
^"Stevia". Morita Kagaku Kogyo. 2007. Archived from the original on 27 October 2013. Retrieved 5 July 2023.
^Zeavin, Edna (February 1988). "The outlaw herbal sweetener". East West Journal. p. 28 – via Google Books. Stevia, also called sweet leaf or sweet herb, is making inroads into the health food and natural foods markets.
^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): 11312–11320. doi:10.1021/jf404018g. PMID24206531.
^Geuns, J.M.; Buyse, J.; Vankeirsbilck, A.; Temme, E.H.; Compernolle, F.; Toppet, S. (5 April 2006). "Identification of steviol glucuronide in human urine". Journal of Agricultural and Food Chemistry. 54 (7): 2794–2798. doi:10.1021/jf052693e. PMID16569078.
^Brusick, D.J. (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. PMID18556105.
^Ulbricht, C.; Isaac, R.; Milkin, T.; Poole, E.A.; Rusie, E.; et al. (Natural Standard Research Collaboration) (April 2010). "An evidence-based systematic review of stevia by the Natural Standard Research Collaboration". Cardiovasc Hematol Agents Med Chem. 8 (2): 113–127. doi:10.2174/187152510791170960. PMID20370653.
^Commission Regulation (EU) No 1131/2011. Official Journal of the European Union (Report). 11 November 2011. p. 205. 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.
^"Cap 132U Schedule". legislation.gov.hk. Sweeteners in Food Regulations; Ordinance. Hong Kong: Public Health and Municipal Services. 2011. Retrieved 22 June 2011.
^"Supplementary Provisions Article 2". houko.com. The Act for Partial Provisions of the Food Sanitation Act and the Nutrition Improvement Act. 1995. Archived from the original on 6 June 2016. Retrieved 11 January 2018.
^"Food Regulations"(PDF). Sale of Food Act. Singapore: Agri-Food & Veterinary Authority. 2005. Chapter 283, Section 56(1). Archived from the original(PDF) on 8 March 2012.
^Li, Simon (27 March 2002). Fact Sheet: Stevioside(PDF). Research and Library Services Division (Report). Hong Kong Legislative Council Secretariat. Archived(PDF) from the original on 10 December 2004. Retrieved 8 September 2003.
^Curry, Leslie Lake (28 August 2009). GRAS Notice No. GRN 000287 (Report). Agency Response Letter. U.S. Food and Drug Administration. Archived from the original on 29 March 2011. Retrieved 17 July 2020.
External links
Media related to Stevia sugar at Wikimedia Commons