Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 03/14/2025 updates the reason for alert, guidance section including agency contacts, and PAC. Changes to the import alert are bracketed by asterisks (***). The term stevia, as used in commerce, refers to the leaves of Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America. With regard to use in conventional foods, stevia leaf, or its crude extract, is not an approved food additive and is not considered GRAS due to inadequate toxicological information. With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations. Stevia leaf-derived products are approved for use as sweeteners in foods in Japan, Brazil, Australia, New Zealand, and other countries. Said products are used in a variety of foods, including teas, and are commonly used as table-top s

Quoted from the “Reason for Alert” section of the FDA page for 45-06, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.