LAW
OFFICES
HYMAN,PHELPS%MCNAMARA,PC
JAMK.6 R. . PHRP@ . . .-- . . . . Pan. H HYMN RoBERTADoRMER S-nRoGEl?c.n4lEs TIWMASJEFFREY N. ClBB.6 BRlANJ.DoNATo FRMK J. 8ASINOWSKl lMANEs.MccoLL A. MS SIEGNER JR ALAN M. KIRSCHENBAUM DOIBUS R FARouHAFl .lOHN A. C1LBERT. JR JoMNRFLaa3 MARCH.SHAPlRO FRANCESKWU ROSERT T. ANGAR0l.A IIWS-lOS6.l 790 Tt!:BTEEb!TY SUITE WASHINCITON. :TREET. I200 DAVID 8. cLl5soLD CASSANDRA A. SOLTIS JOSEPHlNEMTUV?ENTE MlCtELlELBUlLEFl ANN MARIE LIURPHY PAUL L. FERRUIl SFIXY NWASERSTEIN MICHAEL 0. RERNSrnN LARRY K. HOlAX DARA 6. KAlCl-ER. KUZTRKARST MOLLY c. ANIREsml SHAWN M. BROWNN.W. 0. C. 20005-5929 1202l737-5500 FACSIMILE l202l737-9329 -.hpm.axn
DIIWSFDIAL (202) 7374291
June 22,2004
Bv Facsimile/Confirmation bv Mail M r. Christian Gimber Wacker Chemical Corporation 3301 SuttonRoad Adrian, M ichigan 49221-9397 Dear M r. Gimbe&
YQU him Iiskedwhaherthe c~y&xIeti m imddmd by Wacker Chemical Corporation (Wackcr) may be legally marketed in.the United States for food use. The answer is yes, Wacker’ a-cyclodextrin may be marketed immediately for use in fii&. s
As you know, many substancesadded to foods are not food additive and do not require approwd by the Food ad Dru% Admix&&&n @DA) p&r to use. These substances,popularly known as “GRAS” substances,are considered to’be ‘ generally recognized as safe.” As @atedin the Federal Food, I)ru& and Cosmetic Act (FDC Act), a GRAS substanceis generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or in the case of a substanceused in food prior to January 1,1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
26o3uAlNsTRcTr. 6urrE 760
IRVINE CAUFOKNli (D40( 556-7400 F”(D401563-7433 62614
46l6~6DuL2vAND
WRHAM slllTE400 NORTN CAROLINA Dla 319-4750 FAX; ma 9(3-475, 27703
.
0
h&. Christian Gimber June 22,2004 Pig+2 21 U.S.C. 6 321(s). If a substance is 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 amendment [to the PDC Act], a substanoe that is GRAS s i 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). A specially-convened independent panel of qualified scientific experts recently evaluated Wacker’ a-cyclodextrin for use in foods. After a critical review of the scientific s evidence, including, e.g., physical and chemical identity information, Wacker’ s manuf&uing process, publicly available safety data, corroborating unpublished safety data, the intended uses and consu~~ption e&&es, the Expert Panel concluded that, based on scientific procedures, Wacker’ a-cyclodextrin is GRAS under the conditions of its s intended use in foods. Accordingly, based on its GRAS status, Wacker’ u-cyclodextrin may be legally s marketed for the conditions of use in foods that were evaluated by the w Pzel, We trust that these comments are responsive to your inquiry. If you have any further questions, please do not hesitate to contact us. , Sincerely, )&&CL Jit&k&
Diane B. McCall
DBM/hfin