Poster Topical Area: Policy

Location: Hall D

Poster Board Number: 851

P24-010 - FDA Review of Stevia as a Generally Recognized as Safe Food Ingredient

Monday, Jun 11
8:00 AM – 3:00 PM

Stevia rebaudiana (Bertoni) Bertoni, known as Stevia, is a plant native to South America that has been cultivated for hundreds of years and used traditionally to sweeten local teas and medicines. Since 1995, stevia that was imported and sold as a dietary supplement became popular in the U.S. as a non-caloric sweetener for teas and weight-loss blends. As of 2008, when FDA did not object to the use of highly purified steviol glycosides obtained from stevia leaves after the review of Generally Recognized as Safe (GRAS) notifications, these substances have been widely used as a general purpose sweetener in a variety of foods. Subsequently, FDA has reviewed more than 50 GRAS notices and has not objected to the use of various high-purity steviol glycosides as sweeteners and flavor modifier in food. The constituents of stevia leaves responsible for its sweet taste are steviol glycosides, a group of highly sweet diterpene glycosides, each of which has its own unique taste profile and sweetness potency that is 200 times or more sweet than sucrose. Stevia leaves contain a complex mixture of steviol glycosides including stevioside, rebaudioside A, rebaudioside B,rebaudioside C, rebaudioside D, rebaudioside E, rebaudioside F, rebaudioside M, steviolbioside, dulcoside A, and rubusoside that canbe extracted and processed to high-purity ingredients. All steviol glycosides are glycosylated derivatives of the aglycone steviol anddiffer from each other by the number of glycoside moieties and bonding order. The safety of stevia-derived sweeteners has been extensively studied and reported in the scientific literature. Results from several toxicological studies in animals along with clinical studies in humans support the safety of high-purity (> 95%) steviol glycosides. The Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives, in its review of steviol glycosides at the 69th meeting in 2008, established an acceptable daily intake for steviol glycosides as 4 mg/kg body weight per day expressed as steviol equivalents. FDA does not consider whole-leaf stevia to be GRAS for sweetener use in food due to inadequate toxicological information. As such, whole-leaf and crude stevia extracts are the subject of an Import Alert in the U.S. and are not permitted for sweetener use in U.S. commerce.

*This abstract reflects the views of the author and should not be considered to represent FDA's views or policies.

Funding Source:


Judy Perrier

College Park, Maryland