FDA Issues “No Questions” Letters in Response to GRAS Notices for Stevia-Derived Sweeteners

By Diane B. McColl & Ricardo Carvajal –

FDA has issued “no questions” response letters to the GRAS notices submitted by Cargill and Whole Earth Sweeter Company for rebaudioside A, described as “a highly purified component of the stevia plant.”  The letters (available here and here) note that the GRAS notices are for “use of a specific purified component of stevia” and that the agency’s response does “not necessarily apply to the uses of other stevia products.”  The letters also include a § 301(ll) disclaimer, such that the response letters can not be construed as “a statement that foods that contain rebaudioside A, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).”

Cargill’s GRAS self-determination encompasses “use as a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by current good manufacturing practices.”  Whole Earth Sweetener Company’s GRAS self-determination encompasses “use as a sweetener in a variety of food categories [cereals (oatmeal, cold cereal, cereal bars), ready-to-drink teas, fruit juice drinks, diet soft drinks, energy drinks, and flavored waters], as well as use as a table top sweetener….”

Contrary to characterizations in the popular press, the issuance of a “no questions” response letter does not constitute an “approval.”  As noted in such response letters, FDA does not make its own determination regarding the GRAS status of the substance at issue, and places on the notifier the “continuing responsibility” of ensuring the safety of the substance and its compliance with all applicable legal requirements.