Research on Stevia/Steviosides and
Information on Steviosides
This is a supplementary page for information on steviosides given by UK Food Standards Agency and other sources
Stevia and Stevioside
by UK Food Standards Agency (c)
Stevioside is a high intensity sweetener, 250-300 times sweeter than sucrose.
It is isolated and purified from the leaves of the Stevia plant (Stevia rebaudiana Bertoni), where it is present at levels up to 13%, and has been used for a number of years as a sweetener in South America, Asia, Japan and China.
As a result of the outcome of safety assessments which have been carried out Stevia and stevioside now permitted for sale as food and food ingredients in the UK and elsewhere within the EU.
Sweeteners and other food additives are tightly regulated within the European Union (EU) and may only be used once their safety has been rigorously assessed.
The EC Scientific Committee on Food (SCF) is an independent committee that advises the European Commission on questions concerning consumer health and food safety, in particular relating to toxicology and food hygiene.
The SCF identified safety problems with stevioside and recently rejected applications to market the plant and its products as sweeteners and as novel foods within the European Union.
Stevioside was first considered by the SCF for approval for use as a sweetener within the EU in 1985 and the review was updated in 1989.
On both occasions the Committee raised several questions of concern and concluded that, based on the submitted documentation, it could not accept its use. Extracts from Stevia rebaudiana leaves were also considered as toxicologically not acceptable.
A further application for approval of stevioside was received by the European Commission in 1998 and again referred to the SCF.
The data considered by the Committee indicated that the extract has the potential to produce adverse effects in the male reproductive system that could affect fertility and that a metabolite produced by the human gut microflora, steviol, is genotoxic (ie. damages DNA).
The Committee concluded that stevioside was not acceptable as a sweetener.
In 1998 a request was made for Stevia (the plants and dried leaves of Stevia rebaudiana Bertoni) to be marketed as a novel food under the EU novel foods legislation (Regulation 258/97(EC)).
The application was initially evaluated by the Belgian Authorities who recommended that the product should not be approved.
The product was then considered in the UK by the Advisory Committee on Novel Foods and Processes (ACNFP) as part of the approval process for novel foods.
The ACNFP agreed with the opinion of the Belgian Authorities and recommended that the product should not be approved due to lack of information supporting its safety, a view that was shared by a number of other Member States. The application was subsequently referred to the SCF.
The SCF concluded in June 1999 that the information submitted on the plant products was insufficient with regard to specification and standardisation of the commercial product and contained no safety studies.
There was no satisfactory data to support the safe use of these products as ingredients in food or as sucrose substitutes.
In December 1999 the Joint MAFF/DH Food Safety and Standards Group wrote to various companies known to be trading in Stevia products, informing them of the SCF’s opinion and stating that Stevia should not be offered for sale as a food or food ingredient in the UK.
Food Standards Agency
Chemical Safety and Toxicology Division,
London WC2B 6NH
– – – – – – – – –
Conclusion by Alan Hopking: Despite the submission of Stevia for commercial use in EU Member States the evaluation agencies found there was “no satisfactory data to support the safe use” (1999) of Stevia/steviosides despite up to a thousand research studies available in China, Japan and India clearly providing this evidence and supporting its safe use. Stevia and stevioside has been used safely in those countries for over 20 years. Literally hundreds of tests on Stevia over the last 50 years have proved that Stevia is safe in acute, sub-acute, carcinogenic evaluation and mutagenicity studies. See below for further contradictory evidence.
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From FSA web site:
Advisory Committee on Novel Foods and Processes
Evaluation of Stevia rebaudiana Bertoni as a novel food
Dr F Campoli
Rue de la Loi
19 October 1998[conclusion]i) the specification and analytical data are still not adequate to provide reassurance that this is a consistent product;
ii) many of the studies quoted on page 12 of the revised document are conducted on “Stevia extract” but the composition of this extract is not described;
iii) the subacute and chronic toxicity studies are conducted on stevioside rather than the dried plant material and there is still a lack of evidence on the extent to which stevioside present in the dried plant material might be metabolised by human gut flora and the toxicological consequences of this in terms of the formation of steviol.
The SCF [the European Union’s Scientific Committee on Food] concluded in June 1999 that the information submitted on the plant products [Stevia] was insufficient with regard to specification and standardisation of the commercial product and contained no safety studies.
I hope all this hasn’t bamboozeled you but there are many questions and much confusion about the use and legality of Stevia so I thought I’d put it here from the horse’s mouth. In a nutshell: there is insufficient evidence concerning the safe use of the concentrated isolated constituent called stevioside, therefore its inclusion has been prohibited in EU food and drink manufacture, just in case…. PS In 2009 the EU allowed unrestricted use of stevia in all its forms (at last!!)
Now let’s give Alan our herbal practitioner the final word:
Alan Hopking MA writes:
The above conclusions by FSA and the Belgium Commission were done in 1998, 1999 and 2002, resulting in ‘lack of evidence’ regarding Steviosides and absolutely no conclusion about whole Stevia leaf. Respectfully speaking their conclusions are non-conclusive and bordering on shambolic in nature. Stevia is used in huge quantities by many manufacturers in many countries outside the EU. These countries are using Stevia following a huge number (over one thousand) of safety studies over the last 20 years but which are disregarded by the SFC and the EU. I reiterate, the Stevia I supply is whole leaf and whole leaf tincture for medicinal purposes for sugar addiction, blood sugar swings, hypoglycemia, diabetes, candida, dermatitis and pancreatic malfunction. Stevia is a safe and legal herbal medicine for herbal practitioners to dispense. There is no evidence of its toxicity because it is a non-toxic safe herb when used as it should be used in herbal medicine and as it has been used for centuries by Brazilians, that is, as a whole leaf.
PS In 2009 the EU allowed unrestricted use of stevia in all its forms (at last!!)
You can now confidently and guiltlessly consult me about ordering Stevia for your needs.
HERBACTIVE STEVIA COMES FROM PARAQUAY AS THE COUNTRY OF ORIGIN
The following research notes and researcher quotes are generously supplied by Donna Gates of Canadian Body Ecology.
Selected examples from the hundreds of studies attesting to the safety of
stevia leaf and its extracts.
Contraceptive concerns? : The FDA frequently cites a 32-year-old study about stevia and fertility. Read about the study at issue and what its author has to say.
Stevioside and two generations of hamsters
In 1991 a study was done by researchers at the Chulalongkorn University Primate Research Center in Bangkok , Thailand (Yodyingyuad, 1991). The researchers’ objective was to study the consequences of daily ingestion of stevioside — the main active sweetening agent in the stevia plant — in hamsters and its effects on two subsequent generations.
This study involved four groups of 20 hamsters (10 males and 10 females) who were one month old. The first group was fed a daily stevioside dosage of 500 mg/kg; the second group received a higher dose at 1,000 mg/kg; and the third group dosage was the highest at 2,500 mg/kg. The fourth group, which served as the control, received no stevioside. (Chinese researchers have estimated that the daily human consumption of stevioside is about 2 mg/kg; Xili, 1992).
The study showed no significant difference in the average growth of the first generation of hamsters in the groups receiving stevioside — no matter what dosage they were given. Even the third generation of hamsters, at 120 days of age, showed no significant differences in body weight — no matter which group they were in.
As to the mating performance, all three generations performed the same, no matter which dose of stevioside they received. Their performance was equal to the controls.
In summary, no growth or fertility abnormalities were found in hamsters of either sex. Mating was efficient and successful.
The researchers agreed, “The results of this study are astonishing. Stevioside at a dose as high as 2,500 mg/kg did not do any harm to these animals. We conclude that stevioside at a dose as high as 2.5 grams per kilogram of body weight affects neither the growth nor reproduction in hamsters.”
“Assessment of the carcinogenicity of stevioside in rats”
published in: Food and Chemical Toxicology 1997
This study was performed by Dr. K. Toyoda and colleagues, from the Division of Pathology, National Institute of Health Sciences in Tokyo , Japan . For a period of 104 weeks (two years), three groups of lab rats — 50 males and 50 females — were tested. One group received stevioside in a concentration that constituted 2.5 percent of its daily diet; the second group received a concentration that constituted 5 percent of its diet. The third group, which served as the control, received no stevoiside.
The rats who received the stevioside weighed less than those in the control group. Considering stevioside has no calories, this makes sense. When the organs and tissues of the rats were examined under a microscope, there was almost no difference between those who were given stevia and those who were not. One interesting difference, however, was that the females who took stevioside had a decreased incidence of breast tumors, while the males displayed a lesser incidence of kidney damage. The researchers state, “It is concluded that stevioside is not carcinogenic in rats under the experimental conditions described.”
Excerpted from: “The Stevia Cookbook,” copyright 1999 by Ray Sahelian, MD and Donna Gates
Quotes and comments
“According to the Herb Research Foundation, numerous scientists, and tens of millions of consumers throughout the world, especially in Japan , the herb is safe and intensely sweet, which could make it a popular noncaloric sweetener.”
Rob McCaleb, president, Herb Research Foundation, Boulder, Colo., USA
“…as a scientist with over 15 years researching the safety of stevia and of many other plants used as food or food ingredients, I can assure that our conclusions in these various studies indicate that stevia is safe for human consumption as per intended usage, that is, as a sweetener.”
Mauro Alvarez, Ph.D., Brazil
“The petition cites over 120 articles about stevia written before 1958, and over 900 articles published to date. In this well-chronicled history of stevia, no author has ever reported any adverse human health consequences associated with consumption of stevia leaf.”
Supplement to GRAS affirmation petition no. 4G0406, submitted by the Thomas J. Lipton Company February 3, 1995
“Stevia leaf is a natural product that has been used for at least 400 years as a food product, principally as a sweetener or other flavoring agent. None of this common usage in foods has indicated any evidence of a safety problem. There are no reports of any government agency in any of the above countries indicating any public health concern whatsoever in connection with the use of stevia in foods.”
Gras affirmation petition submitted on behalf of the American Herbal Products Association, April 23, 1992
“…various extract forms of stevia have been extensively studied and tested. These tests include acute, sub-acute, carcinogenic evaluation and mutagenicity studies. These scientific data, while not directly relevant or required for exemption under the common use in food proviso, nevertheless demonstrate cumulatively that there is no safety problem associated with the use of an extract of stevia. It appears to be extraordinarily safe.”
Introduction to GRAS affirmation petition submitted by the American Herbal Products Association, April 23, 1992
Additional studies and citations More quotes and comments
A. Yamada, S. Ohgaki, T. Noda, and M. Shimizu. 1985. Chronic toxicity study of dietary stevia extracts in F344 rats. J ournal of the Food Science and Hygiene Society of Japan 26, 169-183. (in English).
1. “As a result of this protracted and extensive investigation, it was concluded that no significant dose-related changes were found in the growth, general appearance, hematological and blood biochemical findings, organ weights, and macroscopic or microscopic observations, as a result of feeding male and female F344 rats with S. rebaudiana extracts at levels up to 1% of their feed for about two years. This…study…(involved) nearly 500 test animals that were treated for up to two years..the highest dose level administered to the animals represented some 100 times the estimated daily intake of this sweet material in the human diet. The results obtained are supportive of the safety of S. rebaudiana extracts, stevioside and rebaudioside A when consumed as sucrose substitutes by human populations.”
1. Food Ingredient Safety Review: Stevia rebaudiana leaves by A. Douglas Kinghorn, Ph.D.
2 . “Crude and purified extracts of Stevia rebaudiana have been subjected to acute toxicity tests in rats and mice, the results of which endorse the use of these materials for human consumption.
In a study performed in the United States, no evidence of acute toxicity was observed when separate 2 g/kg doses of the S. rebaudiana sweet glycoside constituents, stevioside, rebaudiosides A-C, dulcoside A, and steviolbioside were administered to mice…The results of these acute toxicity studies in rodents do not predict any potential risk for human populations by the ingestion of S. rebaudiana extracts and constituents.”
2. Ibid. at 1.
3. “Acute toxicity was not demonstrated when separate 2 g/kg doses were administered to mice by oral intubation, indicating that a concentrated extract of stevia is less than 1/10 as toxic (acute) as caffeine.”
3. Gras Affirmation Petition, Stevia leaves, presented on behalf of the American Herbal Products Association, April 23, 1992
4. “It has been concluded by Akashi and Yokoyama (H. Asaki and Y. Yokoyama. 1975. Dried-leaf extracts of stevia. Toxicological tests. Shokuhin Kogyo 18(20), 34-43. In Japanese, partial English translation provided), that laboratory chow containing up to 7.0% w/w stevioside produced no untoward toxic effects, when fed to male and female rats for nearly two months.”
4. Ibid. at 1.
5. “A subacute toxicity study was carried out on rats using an aqueous extract of S. rebaudiana containing about 50% w/w stevioside. Two levels of extract were mixed with laboratory chow for feeding studies, allowing each animal to receive either 0.25 g or 0.5 g stevioside in 15 g of feed per day. Animals were fed the experimental diets for 56 days…There were no abnormalities relative to controls reported that were dose-related, except for a significant decrease in serum lactic dehydrogenase levels.
Neither of these two subacute toxicity studies would predict any potential harm on ingestion of S. rebaudiana extracts by humans.”
5. Ibid. at 1.
“My government is trying to cause the farms of my country to cease growing marijuana and replace these crops with stevia. This idea is strongly supported by the Drug Enforcement Agency because stevia is an excellent cash crop, grows well in Paraguay …finally and most important, stevia is a completely safe health-promoting herb. This has been well-demonstrated by its extensive use in Paraguay and Japan , where its refined product known as stevioside, enjoys 41% of the sweetener market.”
Juan Esteban Aguirre, Paraguayan Ambassador to the United States, in a letter to the U.S. Food and Drug Administration, September 23, 1993
“There are more than 2,000 folders in my office, each with a collection of facts and fables about various medicinal plants. In one of these folders there’s an old wrinkled envelope dated 5/19/45. In it are old leaves of Paraguay ‘s…”sweet herb,” Stevia rebaudiana. More than 40 years old, one leaf of the Stevia will still sweeten a cup of coffee or tea enough to satisfy my sweet tooth….I predict rough sailing with our FDA for this non-nutritive sweetener. I hope it will make it.”
James A. Duke, former chief of Medicinal Plant Research of the USDA; The Business of Herbs, November/December, 1986
“(The FDA action on stevia is) a restraint of trade to benefit the artificial sweetener industry.”
J on Kyl (R), AZ in a 1993 letter to former FDA Commissioner David Kessler about the 1991 stevia “import alert.”
“Stevia has a political problem.”
Rob McCaleb, president Herb Research Foundation
“I had one guy from the FDA tell me ‘if we wanted to make carrots (be) against the law, we could do it.'”
Kerry Nielson, former director of operations at Sunrider International, discussing the 1985 FDA seizure of his company’s stevia.
“Even if they have reviewed these studies, the only possible way to report that the results showed detrimental effects is by taking information out of context. If this is the case, one concludes that these FDA scientists are incompetent and irresponsible, or if not, they must belong to some sort of conspiracy group to carry on a sinister agenda against this plant with the objective to keep it away from American consumers by attributing to it safety issues that do not exist.” Mauro Alvarez, Ph.D., responding in a 1998 letter to the fact that the FDA cited stevia studies he conducted as evidence that stevia is unsafe.
In 1968 Professor Joseph Kuc, then a member of Purdue University ‘s department of biochemistry, performed a study on rats to see if stevia had any contraceptive effect. Undertaken with a faculty member at the University of the Republic in Montevideo , the study was prompted by a rumor that Indian women in South America used the herb for contraceptive purposes. It should be noted that researchers have been unable to duplicate the conclusions of this study.
While the results of the Kuc study might appear at first glance to bear out such rumors, closer examination raises doubts about the methods that were used, and how they apply to the typical way in which stevia is consumed. In fact, Kuc himself, although still standing by his findings of marked, relatively long-term reductions in the numbers of offspring born to female rats administered his stevia solution, acknowledges that those results aren’t necessarily applicable to human consumption.
The Kuc study involved a very high concentration — ten milliliters of a dosage administered in about 20 minutes — of a concoction derived by drying to a powder and boiling not just the leaves, but material from the stevia plant that would not ordinarily be consumed. This liquid replaced the animals’ drinking water, and was given at such a rate as to equate with a person drinking 2.5 quarts of liquid in less than half an hour.
The study also only utilized one dosage level. Typically, a biological effect (such as what Kuc reported) would be demonstrated by using a variety of doses to establish what is known as a dose-response relationship.
Kuc acknowledges that the study “absolutely needs to be redone” (just as all research, in his view, needs to be “checked and rechecked” to determine whether it “stands the test of time”). He further concedes that this finding, in itself does not constitute an important reason for keeping stevia off the U.S. market.
Kuc also notes something else: that effects in rats aren’t necessarily experienced by people — as illustrated by the apparent lack of any correlation between the results of his rat research and birth rates among regular stevia consumers. As pointed out in the Lipton petition to the FDA, “…if this reproductive effect in rats is real and can be extrapolated to humans, then one might suspect that there would be very few children in some regions of Paraguay.”
Scraping the bottom of the research barrel
A second study dealing with stevia’s supposed contraceptive effect was performed on female mice and published in a Brazilian pharmacological journal in 1988. It was later informally translated by an FDA employee familiar with Portuguese. The only problem is that, outside of the FDA, no one in the scientific community gives it credence.
The research at issue, according to one authority who analyzed it (Professor Mauro Alvarez of Brazil ‘s State University of Maringa Foundation) “caused surprise with regard to the lack of information about the quantities that were administered and the preparation of the infusions, because mice, due to their low body weight, cannot receive high volumes intragastrically without suffering major stress.” What’s more, the study involved a small number of test animals and was “highly susceptible to external influences,” he observed.
The same study was characterized by Mark Blumenthal, editor of Herbalgram — a newsletter published jointly by the American Botanical Council and Herb Research Foundation — as “the kind of research which FDA would never accept if a petitioner was using it (as a basis for) his or her arguments.” In his opinion, “The FDA would laugh them out of the room.”
What’s perhaps most interesting about the FDA’s citation of these two studies, however, is that what it regards as a possibly harmful effect is just as apt to be viewed as a beneficial one. As the authors of the Lipton petition put it, “One would think that this effect would make stevia extract the perfect contraceptive agent — easy to consume… and effective long-term — and would be intensely pursued by pharmaceutical companies, the World Health Organization, etc. Obviously this has not happened (or if it has, then there was no effect), which casts further doubt on the validity of the data.”
Excerpted from “The Stevia Story: A tale of incredible sweetness & intrigue, copyright 2000, by Donna Gates
The following is a government warning about Stevioside from the website of the Scotland Government:.[comment by Alan Hopking. Note how this article is headlined, viz. Stevia. But read the article and it refers to Stevioside and Steviol. Again this vindicates the safe use of the whole leaf of Stevia as made by me at Herbactive.co.uk.]
PRODUCTS CONTAINING STEVIA REBAUDIANA BERTONI
Environmental Health Departments will wish to be aware that two dietary supplement products containing Stevia, the plants and dried leaves of Stevia rebaudiana Bertoni – a plant which is native to South America, are being withdrawn from sale.
The products in question are ‘Udo’s Choice Wholesome Fast Food Blend’ (227g and 454g packs) and ‘Udo’s Choice Beyond Greens’ (255g pack).
These products have been sold through specialist health shops throughout the UK and by mail order. Under the direction of West Yorkshire Trading Standards, the importer has contacted all retail stockists and recalled the products from sale. A notice will also be displayed in each of these retail outlets indicating that anyone who has purchased these products should return them to their retailer immediately.
Stevia rebaudiana Bertoni does not have clearance to be marketed in the European Community. A recent marketing application was rejected on the basis of potential toxicity problems of one of its components,Stevioside. Stevioside has been shown to decrease fertility in male rats. Additionally, Steviol, which is a metabolite of Stevioside, has been reported to cause cancer when fed at very high doses to rodents (up to 1000mg per kg of body weight – this is 1500 times greater than the average daily dose of these products consumed by a person weighing 60kg!!).
The level of Stevia in these preparations is very low and does not pose any immediate threat to health. However, as a precautionary measure, members of the public should dispose of any unused product they may have in their possession, or return it to their retailer immediately.
Nutritive and Nonnutritive Artificial Sweeteners in Your Diet
By Jane Kirby, RD and The American Dietetic Association
Two kinds of sweeteners are widely used to replace sugar in your diet. Some are classified as nutritive, because they provide calories and nutrients; others are nonnutritive, because they don’t.
When artificial sweeteners were introduced, everyone thought that people would eat less sugar. But evidence now suggests that people simply add the sweeteners to their diets. In reality, consumers are eating three times the amount of sweeteners that they were ten years ago.
Most nutritive sweeteners used as replacements for sugar have just as many calories as sugar. Refined sugars, high-fructose corn syrup, crystalline fructose, glucose, dextrose, corn sweetener, honey, lactose, maltose, invert sugar, and concentrated fruit juice are examples of nutritive sweeteners that are just as caloric as plain old sugar.
Saccharin, aspartame, acesulfame potassium (or acesulfame-K), sucralose, and cyclamates are the most commonly used nonnutritive sweeteners in North America. They help add sweetness to foods for people who need to limit their intake of sugar, such as those with diabetes, and they also aid in the prevention of dental cavities. Although these no-calorie sweeteners may seem like a dream come true, most come with some warnings.
* Acesulfame-K (Sunette) is 200 times sweeter than sugar. It is used as a tabletop sweetener, and in soft drinks, chewing gum, desserts, candies, sauces, and yogurt. It can be used in cooked and baked goods. However, it may not work well in some recipes due to its finer texture.
* Aspartame (Nutrasweet, Equal) is 160 to 220 times sweeter than sugar, and is added to more than 6,000 foods, personal care products, and pharmaceuticals. It is considered calorie free.
Aspartame is a combination of two amino acids: phenylalanine and aspartic acid. People who have phenylketonuria (PKU), which is only about 1 in 15,000 people, have adverse neurological reactions when they consume phenylalanine, because they can’t metabolize it. Therefore, foods that contain aspartame are required to carry a label warning consumers that the product contains phenylalanine. In the United States, all infants are screened for PKU at birth.
Aspartame isn’t heat stable and loses its sweetness in liquids over time. Look for it in puddings, gelatins, frozen desserts, hot cocoa mixes, soft drinks, chewing gum, and tabletop sweeteners.
* Cyclamate is 30 times sweeter than sucrose and is heat stable. Since 1970, however, it’s been banned in the United States based on a study suggesting that cyclamate may be related to the development of bladder tumors in rats. Although more than 75 subsequent studies have failed to show that cyclamate is carcinogenic, the sweetener has yet to be reapproved in the United States.
* Saccharin (Sweet’ N Low): is 300 times sweeter than sugar, and has been back on the market in the United States since 1991, after having been banned in 1977, because it was found to cause cancer in rats. Newer studies cleared saccharin of links to cancer. Saccharin is calorie free, because the body can’t break it down.
Saccharin is heat stable and, unlike aspartame, can be used in cooked and baked goods. However, it may not work well in some recipes as a substitute.
* Sucralose (Splenda) is 600 times sweeter than sugar and doesn’t contain calories. It’s the only low-calorie sweetener that’s made from sugar. Sucralose is heat stable in cooking and baking and can be used virtually anywhere sugar can without losing its sugar-like sweetness. Currently, sucralose is approved in more than 25 countries around the world for use in food and beverages. It’s mainly a tabletop sweetener, and you can find it in desserts and candy.
Amazingly Jane Kirby in this article doesn’t even mention Stevia green leaf powder or the white Steviaside powder, both becoming very popular in USA the former of which would greatly benefit the health of all diabetics.. The green Stevia is better as it has high health value whereas the white stevioside is industrialised isolation of the active chemical in stevia and has virtually no health value. – comment by Alan Hopking
HERBACTIVE STEVIA COMES FROM PARAQUAY AS THE COUNTRY OF ORIGIN
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“I am very happy with the results I’ve had from the Stevia tincture you sent me. My energy levels are much improved and I’m finding it very easy to use and to stay away from the foods that are harmful to me but to which before I was hopelessly addicted. Many, many thanks for making it possible for me to enjoy this freedom!” Anita Adamson, Herts. UK
For more citations about Herbactive Whole Stevia, click here