On December 15, Cargill issued a press release in which it announced a “broad-based national integrated marketing campaign” to promote its sweetener Truvia™ (Truvia™ is Cargill’s preparation of rebiana, or rebaudioside A, one of the sweetening components that can be extracted from Stevia rebaudiana). According to Cargill, “the tabletop version of Truvia™ natural sweetener is now available nationwide, wherever groceries are sold.” Previously, Cargill had filed a voluntary GRAS notification with FDA (GRN #253) setting out Cargill’s determination that its rebiana is safe for use as a general purpose sweetener. FDA has yet to respond to that notification.
Under § 201(s) of the Federal Food, Drug, and Cosmetic Act ("FDC Act"), many food ingredients are not subject to approval and regulation by FDA as food additives if the use of those ingredients in foods is generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures or common use in foods, to be safe under the conditions of their intended use. Self-determination that the use of an ingredient is GRAS can be made independent of FDA, and requires neither FDA approval nor FDA notification. Use of a self-determined GRAS ingredient carries with it the risk that FDA will disagree with the self-determination of GRAS status and take action against the substance as an unapproved food additive. For this reason, potential users often demand that ingredient developers voluntarily notify FDA of their GRAS self-determinations. If FDA has no questions about the notifier’s GRAS determination, FDA issues a letter stating so (a so-called “no questions” letter). A notifier can accept the risk that FDA will disagree with its notified GRAS determination, and proceed to market without first receiving a “no questions” response letter from the agency.
In the case of Stevia-derived sweeteners, proceeding to market without a GRAS notice “no questions” letter from FDA may carry some added risks. As recently as August 2007, FDA issued a warning letter to the manufacturer of a tea product in which the agency took the view that Stevia rebaudiana is an unapproved food additive that renders a food adulterated under FDC Act § 402(a)(2)(C). Additionally, the Center for Science in the Public Interest ("CSPI") issued its own press release on December 15, the same day as the Cargill press release, in which it contends that additional tests are needed to demonstrate the safety of Stevia and rebaudioside A, and that “FDA should immediately order those products off the market until all the safety testing has been done.” Also, there is pending before the agency a citizen petition contending that the addition of steviol glycosides (the sweetening components that can be extracted from Stevia) to food is prohibited by FDCA § 301(ll) (see Docket No. FDA-2008-P-0542).