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0 21 U.S.C. 5 321(s). If a substanceis found to be GRAS under the intended conditions of use, FDA approval or notification is not required prior to such use. FDA acknowledges that “under the 1958 aunendment[to the FDC Act], a substancethat is GRAS f$f c particular use may be marketed for that use without agency review and approval.” 62 Fed. Reg. 18938,18939 (April 17,1997). FDA also recognizes that companies “have the right to make independent GRAS determinations on food substances.”53 Fed. Reg. 16544, 16545 (May 10,1988). Aspecially-convened independent panel of qualified scientific experts recently evaluated Wacker’ a-cyclodextrin for use in foods. After a critical rev& of the scientific s evidence, includin& e.g., physical and chemical identity information, Wacker’ s manticturing process,publicly available safety data, corroborating unpublished saf&y data, the intended uses and c~w$tion m ixx&s, the Expert Panel ccmhdd that, based on scientific procedures, Wacker’ a-cyclodexirin is GRAS upder the conditions of its s intended use in foods. Accordingly, based on its GRAS status,Wacker’ a-cyclodcx& may be legally s marketed for the conditions of use in foods that were evaluated by the m j$.&, We trust that these comments are responsive to your inquiry. If you have any f&ther questions, please do not hesitate to contact us. ,
Diane B. M&o11
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