Download March 25, 1998 : Mr. Macit Gurol .’

Food and Drug Admlnlstrati&
Washington DC 20204
March 25, 1998
Mr. Macit Gurol
President
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Tamer Inlernational,:Ltd.
1723012th Avenue N.E,
P.O. Box 65260
Seattle,WA 98155
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Dear Mr:Guroi:
’Q/
This is in. responseto your ietter of March 11, 199&,~on~er~in~.your “TAMER”
products, which are used to temper the acidic content of foods aiid beverages,,You &ted
severalactive and in&&e ingredientsthat you believeare gener@lyrecognizedas safe
(GRAS), You asked;for FRA approval.of theseproducts.
Under the Federal Fdod, ]Drug~and Costietic Act, FDA does not approve food products.
It i&he responsibility of the manufachureror distributor to nake~certain that the product
being mzkketedis safe within the meaningofthe Atit an&regulations prbmulgated
thereunder. Ingredietits that are usedns componentsof food must be either generalfy .
recognizedas safe (GRAS) or approvedas food addEves. Direct food additivesthat have
beenapprovedby FDA are codified in 21 C!FRPart 172. GRAS substances,on the other
hand, are Iisted in 21 CFR Parts 182 and 184.
The following ingredientsthat you listed are coveredby the FDA regulations indicated
beIow:
Ca,Jciurn$rhonate
Magnesiumhydroxide
Pdtassiumhydroxide
Potassiumchloride \
SodiumcarboxymethylcellulosePolyethyiene glyc@ (tiean molecular weight 200-9500)4
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..--- 23 CPR 184.1191
---- 21’CFR 184.1428
-21 CFR 184.1631
-21 CFR 184.1622
a--- 21 CFR 182.1745
w---- 2%CFR 172.820
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In ‘addition,microcr);staIIineceI1uIos~ is consideredto Ire GRAS, although it is not listed
in FDA regulations~ Sea salt can be
S if it Is preparedunder conditians of good
manufacturingpractice. Instant coffee’andd~st~~~~d
.wa&r &e of,courge accepta& &-i&;
If you have further questjoas,,pleasefeel free.to confactus.
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Sincerely.yours,
LawrenceJ, Lin, Ph.D.
Division of Petition Controf , HFS-215 ’
Cknter for Food Safety ‘
and Appf‘iednutrition
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