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 are generally recognized as safe (GRAS) since 2008 and allowed as ingredients 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 the people of Japan have widely used stevia 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.
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. 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.
As of 2006, China was the world's largest exporter of stevioside products.
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.
Mechanism of actionEdit
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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 regulationsEdit
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 areaEdit
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
- Australia and New Zealand:
- 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]
- 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.
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