[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.
 

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.