title: Steviol glycoside safety: is the genotoxicity database sufficient?
abstract: The safety of steviol glycoside sweeteners has been extensively reviewed in the literature. National and international food safety agencies and approximately 20 expert panels have concluded that steviol glycosides, including the widely used sweeteners stevioside and rebaudioside A, are not genotoxic. However, concern has been expressed in recent publications that steviol glycosides may be mutagenic based on select studies representing a small fraction of the overall database, and it has been suggested that further in vivo genotoxicity studies are required to complete their safety profiles. To address the utility of conducting additional in vivo genotoxicity studies, this review evaluates the specific genotoxicity studies that are the sources of concern, and evaluates the adequacy of the database including more recent genotoxicity data not mentioned in those publications. The current database of in vitro and in vivo studies for steviol glycosides is robust and does not indicate that either stevioside or rebaudioside A are genotoxic. This, combined with a lack of evidence for neoplasm development in rat bioassays, establish the safety of all steviol glycosides with respect to their genotoxic/carcinogenic potential.
authors.affiliation: ToxStrategies, Inc., 9390 Research Blvd., Suite 250, Austin, TX 78717, United States. jurban@toxstrategies.com
authors.forename: J D
authors.initials: JD
authors.lastname: Urban
authors.forename: M C
authors.initials: MC
authors.lastname: Carakostas
authors.forename: D J
authors.initials: DJ
authors.lastname: Brusick
mesh_terms: D000818:Animals; D002273:Carcinogens / Q000633:toxicity; D016208:Databases, Factual; D045786:Diterpenes, Kaurane / Q000633:toxicity*; D005960:Glucosides / Q000633:toxicity; D006801:Humans; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity; D051381:Rats; D013549:Sweetening Agents / Q000633:toxicity
chemical_list: D002273:Carcinogens; D045786:Diterpenes, Kaurane; D005960:Glucosides; D009153:Mutagens; D013549:Sweetening Agents; C012043:stevioside; C012042:steviol