[This presentation article was written before the FDA banned importation of Stevia for use in foods (reportedly at Monsanto/ NutraSweet's request). It has a sales slant to it, but it has some very useful information in it.] STEVIOSIDE, "NATURALLY"! A Special Presentation To: The Calorie Control Council 23rd Annual Meeting Tucson, Arizona November 4-7, 1990 Prepared By: Dr. R. Elton Johnson, Jr. P.O. Box 1356 Fayetteville, Georgia 30214 TeL. / FAX - (404) 719-2134 Introduction ------------ We are living at a time when consumers, and consequently food processors, are being drawn magnetically by four words that make up two key descriptive expressions: 1) "all-natural" and 2) "low calorie." Our product, Stevioside, is exactly that and more! This exciting "new" product has actually been around for centuries. Man does not produce it, synthesize it in a laboratory or manufacture it. Man simply *extracts* it, just like nature produced it from the tiny leaf of a beautiful little South American plant. Thus Stevioside is not "artificial" or "synthetic" or even "nature-identical"...it is truly an ALL_NATURAL product.! Stevioside is also a "low-calorie" product. In fact, it is better than that...Stevioside has absolutely NO CALORIES! History ------- Modern scientific interest in the Stevia plant dates to the turn of this century. But long before Spanish and Portuguese colonial intrusions into South America in the sixteenth century, the local Guarani and Mato Grosso Indians already knew, appreciated and used its leaves to sweeten their medicines and teas, or just to chew as a sweet treat. They called the plant CAA-HEE (Honey Leaf). Later the early white settlers of the region learned from the local indigenous population about the sweetening quality of the Stevia plant. They began using the leaves to sweeten their teas, foods and drinks. They called it Yerba Dulce (Sweet Herb). The Gauchos of the region later used Stevia leaves to sweeten their Mate tea. The plant is native to the area of the Amabai Mountains of the Cordilleras Range along the Brazil-Paraguay border. Stevia rebaudiana (Bert.) Bertoni was first botanically described by the Paraguayan botanist M.S. Bertoni. In 1899 he originally classified the plant as of the genus Eupatorium, then in 1904 he reclassified it into the genus Stevia, a perennial herb belonging to the Compositae family. The property of the species which called attention to the plant was the intense sweet taste of the leave and aqueous extracts. In 1908 Rasenack reported the presence of various sweeteners in Stevia and in 1931 Briedel and Lavieille were able to crystallize Stevioside. In 1941, during World War II, the British seriously studied the possibility of commercially extracting Stevioside as an alternative to their threatened sugar supplies. It was a good idea that was ahead of its time since there was no industrial-scale production of the raw material and the necessary technology was lacking. It was not then a viable, cost-effective option. Around 1970 Japan began to prohibit (limit) the use of artificial sweeteners such as sodium cyclamate and dulcine, and as the questions arose about the safety of saccharine, this intensified the already ongoing Japanese studies as to the potential for commericial production and applications of Stevioside. By 1977 the Maruzen Kasei Co., Ltd. started extracting Stevioside on a commercial basis in Japan. For more than a decade Stevioside has been approved and widely used in Japan. It is also approved and used in Brazil, and in some ten countries altogether. We know of applications as a table top sweetener, in soft drinks, baked goods, pickles, fruit juices, tobacco products, confectionery uses, jams and jellies, candies, yogurts, pastries, chewing gum, sherberts, etc. Stevioside is of special interest to diabetics, persons with hyperglycemia and the diet conscious. Toxicology ---------- Of very special significance is the fact that numerous toxicological studies have consistently demonstrated the safety of Stevioside for human use. As early as 1900 there were studies performed by Rebaudi that affirmed its safety. Studies in 1915 by Kober, and in 1935 by Pomaret and Lavieille reaffirmed Stevioside's safety. In their 1975 study Akashi and Yamamoto reported an LD50 of 15g/kg in oral administration, and in 1976 Mitsuhashi reported an LD50 of 8.2 g/kg in subcutaneous administration. [LD50 is the dose required to kill 50% of the lab animals. 15g/kg means 15 grams of Stevioside for every 1 kg (2.2 lbs.) of body weight.] The 1982 study by Kurahashi et al reported results very similar to the results reported by Akashi and Yokoyama (1975) and Mitsuhashi (1976). Thus, considering that the annual per capita sucrose consumption as reported by the U.S. Department of Agriculture for 1985 was 130 pounds, the daily consumption for the average individual is 2.5 g/kg of weight. Since the LD50 for Stevioside was reported as 15 g/kg., and considering that Stevioside is some 300 times sweeter than sucrose, this would mean that the LD is some 1,800 times greater than the amount that an average person would need to ingest daily to satisfy his sweetening needs. Perhaps one of the most revealing indicators as to the safety of Stevioside for human use appears, ironically, in John M. Pezzuto's 1984 study on metabolically activated steviol, a study which some have wrongfully used to create a mutagenicity concern. In his closing remarks Pezzuto clearly acknowledges, "Finally, it should be emphasized that no reports have thus far appeared indicating that adverse effects have resulted from human use of Stevia products. Other substances found in the diet are known to mediate mutagenic responses with no apparent impact on health." The Production -------------- The Stevioside described and specified in this presentation is extracted by INGA'STEVIA INDUSTRIAL, S.A., of Maringa', Parana', Brazil. On May 7, 1990 contracts were signed at the corporate offices of ----------------------------------- giving ------- the exclusive rights to import and market the natural sweeteners extracted by INGA'. Stevioside is only produced on a commercial scale by Japan and Brazil. Japan's production is so limited by climatic and soil conditions that they cannot meet the growing demands of their own internal market. Consequently, Japan is now importing Stevioside from INGA' STEVIA INDUSTRIAL, S.A., which is the only source for Stevioside in the Western Hemisphere. INGA' has the important advantage of being located where the plant is native thus having all the ideal soil and climatic conditions for abundant production. In addition to the company's own plant development and study farm, INGA' has an area of 100 hectars (about 250 acres) that are fully irrigated and in cultivation. Currently there are also some 250 other growers in the region under contract to produce Stevia leaves for the company, under INGA's strict technical supervision. INGA's production facility was built with the capacity to expand to five times the market demands. INGA's extraction facilities, technology and equipment were all locally financed and developed and are justifiably, the object of great pride and support in the community and area. I recently visited the company with a consultant who for many years worked for the FDA. He was under contract to us checking on the G.M.P. (Good Manufacturing Practices) of the plant, to see how they would fare in an FDA inspection. After a detailed, thorough and exhaustive inspection and report, he stated in his concluding remarks: "This firm is being operated by a highly qualified staff who is intent on producing a quality product. The facility is relatively new and in an excellent state of repair. Based on my physical examination of the operation of this facility, the operation is essentially in compliance with the United States Code with respect to a food product production." The Product ----------- Stevioside is a white, crystalline powder extracted from the leaves of the Stevia rebaudiana (Bert.) Bertoni plant, an herbal shrub native to the Brazil-Paraguay border. Its chemical identification and quantitative compositions are attached for those with a more scientific interest in the product. Of special importance to this Council and to consumers in the general are Stevioside's very special characteristics, which include: - 100% NATURAL - NO CALORIES - 250-300 times sweeter than sugar - Heat stable to 198-200 Celsius - Non-fermentable - Flavor enhancer - Anti-plaque - Anti-caries - Recommended for diabetics - Non-toxic - Extensively tested in animals - Extensively used by humans with no adverse effects Stevioside has not yet been approved by the FDA for use in the U.S. I have met several times with the FDA officials and we are working with a world-renowned laboratory in preparation for the necessary testing. The interest in Stevioside, however, is already running high. "Food Processing" magazine did a feature editorial story about us and our product in their August 1990 issue in the "Foods of Tomorrow" insert (attached). We have received approximately 200 inquires as a result, from practically everybody who is anybody in the food industry. Research and development people are working with our samples of Stevioside and we are beginning to get reports. We have sample experimental products such as chewing gum (excellent), toothpaste and mouthwash (outstanding) and even an anti-smoking lozenge. A major bakery chain experimented with various products and wrote that Stevioside is an important "breakthrough" for the baking industry. I have been meeting with corporate representatives and R&D people of companies that make up a significant list that would look like a veritable "who's Who" of American businesses. Aside from Stevioside's intense sweetness the primary interest seems to be that it is: 1) NATURAL, 2) NON-CALORIC, 3) Heat Stable, and 4) Anti-Plaque/Anti-Caries. Under contract to us Purdue University's Dental Science Research Group has done three special studies. The first demonstrated that Stevioside is 100% compatible with fluoride. The second showed that Stevioside "significantly" inhibits plaque growth. The third, now being written, indicates close to a 20% reduction in cavities (attached). The researchers called this "statistically significant." We agree! The Conclusion -------------- We are staring at what I sincerely consider to be the next generation of sweeteners. One scientist with whom I have discussed it has been researching Stevioside for four years and just concluded his post-doctoral studies in England researching the Stevioside molecule. He was so totally caught up by the product that he declared that he saw Stevioside as "a noble molecule" with tremendous potentials, some of them so great he said that someday we will look back and feel we have "insulted" the Stevioside molecule by thinking of it merely as a sweetener! My personal conviction is that even if none of his lofty anticipations ever come true, and all that Stevioside is ever used and valued for is as a non-caloric sweetener, flavor enhancer and anti-plaque/anti-caries agent, that could weel be enough to make Stevioside one of the most significant breakthroughs in the food industry in this generation! Directing the Stevioside Project has been one of the great challenges and privileges of my life. Should anyone desire to pursue the subject further with me, please feel free to contact me. Thank you for the opportunity of meeting with you and presenting Stevioside to you at this important conference. Respectfully presented November 6, 1990. Dr. R. Elton Johnson, Jr. Tel. / FAX: (404) 719-2134