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TIWMASJEFFREY
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J. 8ASINOWSKl
lMANEs.MccoLL
A. MS
SIEGNER
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ALAN M. KIRSCHENBAUM
DOIBUS
R FARouHAFl
.lOHN A. C1LBERT. JR
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MARCH.SHAPlRO
FRANCESKWU
790
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WASHINCITON.
ROSERT T. ANGAR0l.A
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:TREET.
N.W.
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0. C. 20005-5929
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
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SHAWN M. BROWN-
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&
YQUhim 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’s a-cyclodextrin may be marketed immediately for use in fii&.
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’s a-cyclodextrin for use in foods. After a critical review of the scientific
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’s a-cyclodextrin is GRAS under the conditions of its
intended use in foods.
Accordingly, based on its GRAS status, Wacker’s u-cyclodextrin may be legally
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
J-
it&k&
Diane B. McCall
DBM/hfin