Dear Ms. Bonvie:

This is in response to your request of May 8, 1997, through Brad Stone of the FDA press office, for a "list of all studies FDA is aware of alleging a detrimental effect from stevia or steviosides" with an indication of whether FDA had reviewed the study. FDA does not have any lists responsive to this request.

The agency does have in its files a number of published articles on stevia and stevia-derived sweeteners which have raised questions about their safe use. These include:

Akashi and Yokoyama, Safety of Extract of Dried Stevia Leaves - Results of Toxicity Tests, Shokuhin Kogya, 10B, 34-43, 1975.

Alvarez et al., Effect of Aqueous Extract of Stevia rebaudiana Bertone on Biochemical Parameters of Normal Adult Persons, Brazilian J. Med. Biol. Res., 19, 771-774, 1986.

Hubler et al., Influence of Stevioside on Hepatic Glycogen Levels in Fasted Rats, Research Communications in Clinical Pathology and pharmacology, 84(1), 111-118, 1994.

Ishii et al., Inhibition of Monosaccharide Transport in the Intact Rat Liver by Stevioside, Biochem, Pharmacology, 36(9), 1417-1433, 1987.

Kelmer-Bracht et al., Effects of Stevia rebaudiana Natural Products on Rat Liver Mitochondria, Biochem, Pharmacology, 34(6), 873-882.1985.

Melis et al., Effects of Two Concentrations of Stevioside on Renal Function and Mean Arterial Pressure in Rats, IRCS Medical Science, 14, 973, 1986.

Nakayama et al., Absorption, Distribution, Metabolism and Excretion of Stevioside in Rates, J. Food hygiene Soc. Japan, 27(1), 1-8, 1986.

Nunes et al., The Effect of Stevia rebaudiana on the Fertility of Experimental Animals, Revista Brasileira de Farmacia, 69, 46-50, 1988.

Oviedo et al., Hypoglycaemic Action of Stevia rebaudiana Bertoni (Kaa-he-e), Exerpta Medica (International Congress Series), 208-92-1971.

Pezzuto et al., Metabolically Activated Steviol, the Aglycone of Stevioside is Mutagenic, Proc. Natl. Acad. Sci. USA, 82, 2478-2482, 1985.

Planas and Kuc, Contraceptive Properties of Stevia rebaudiana, Science, p. 1007, 29 Nov. 1968.

Suttajit et al., Mutagenicity and Human Chromosomal Effect of Stevioside, a Sweetener from Stevia rebaudiana Bertoni, Eviron, Health Perspectives Supplements, 101 (Suppl. 3), 53-56, 1993.

Suzuki et al., Influence of Oral Administration of Stevioside on Levels of Blood Glucose and Liver Glycogen in Intact Rats, Nippon Nogei Kagaku, 51(3), 171-173, 1977.

Toskulkao et al., Nephrotoxic Effects of Stevioside and Steviol in Rat Renal Cortical Slices, J. Clin. Biochem. Nutr., 16(2). 123-131, 1994.

Toskulkao and Sutheerawattananon, Effects of Stevioside, A Natural Sweetener, on Intestinal Glucose Absorption in Hamsters, Nutrition Research, 14(11), 1711-1720, 1994. 

von Schmeling et al., Stevia rebaudiana Bertoni; Evaluation of the Hypoglycemic Effect on Alloxanized Rabbits, Ciencia e Cultura, 29(5), 599-601, 1977.

Wingard et al., Intestinal Degradation and Absorption of the Glycosidic Sweeteners Stevioside and Rebaudoside A, Experientia, 36, 519-520, 1980.

Yamamoto et al., Effect of Steviol and its Structural Analogues on Glucose Production and Oxygen Uptake in Rat Renal Tubules, Experientia, 41, 55-57, 1985.

You may already have obtained copies of these articles from FDA.

Sincerely yours,

Martha Peiperl
Division of Petition Control, HFS-215
Center for Food Safety and Applied Nutrition 

January 19, 1998

To:
Ms. Linda Bonvie
Bonvie Comanor Associates
Fax: 001 609 660 1571
Barnegar, NJ - USA

From:
Mauro Alvarez
Parque Tecnologico Agro-Industrial do Oeste
Fone/Fax: (045) 227 1220
Cascavel-Pr. - Brasil -

Dear Ms. Bonvie;

Recently I obtained a copy of a letter from the United States Food and Drug Administration's Center for Food Safety and Applied Nutrition Addressed to you which I felt compelled to answer to get the facts straight. FDA's letter to you is regarding a request you made from that agency to list studies that allege Stevia or Steviosides are detrimental to the health of consumers.

FDA have included in the list some of the studies in which I was the primary researcher and studies in which I participated as collaborator, and 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.

The first misunderstanding is the confusion between Stevia tea (grounded leaves) and the purified sweeteners as stevioside or rebaudiosides. Effects attributed to concentrated Stevia tea or impure extracts cannot be extended to pure sweeteners stevioside and rebaudioside.

The other equivocation found in their reply to your request is the admission that FDA's scientists have not reviewed these studies why do they keep on reporting to the American Public that the results of the studies show a detrimental effect?

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.

Sincerely yours,

Prof. Mauro Alvarez, Ph.D

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