:
 2007 
( 2 )
 
,: 
,: 
College ParkPaint Branch Parkway 5100(:20740), 
, 
,HFS-005 
()301-436-1500 
http://www.fda.gov/FoodGuidances 
 
(21 CFR 10.115(g)(5)),
FDA,
60
Fishers Lane 56301061
(20852),(HFA-305)
:http://www.regulations.gov(
) 
,(CFSAN), 
:301-436-1500 
(CVM),:240-276-9200 
 
 
 
(CFSAN) 
(CVM) 
(ORA) 
2010 5   
 
 
I.    
II.    
III.    
A.    
B.   
C.   
D.   
E.   
F.   
G.   
H.   
I.   
J.   
K.   
L.   
M.   
N.   
 
 
1 
 2007  
( 2 ) 
(FDA)
,FDA
,
,FDA
FDA, 
I.   2007(Pub.L.110-085)
,
1005(f),FDA20099
,
,,200998
,FDA/

,
(:)
,
, 
FDA,,,
FDA,,
FDA(), 
II.  
2007927,2007
(FDAAA)417,,
(FD & C)417
()(FDA)
,
FDA(Pub.L.110-085,1005
(a)(4))FD & C(417)
,FD & C417FDA
,FDA,
,FDA
,,FDA
, 
FD&C417,(1),
FDA;(2)FDA;(3)
FDA;(4) 
III.  
A. 
A.1 [20105] FDA FDAAA?  FDA
20105,FDA-
(NIH)()
FDANIH,
NIH 
 
 
A.2? 
200998FDA.GOV 
 
A.3 [20105] ? 
FDA
,FDA
FDA,Internet 
ExplorerFirefox 
A.4 ? 
FDA.GOV(http://www.fda.gov)
,2010517,URL,
:  http://www.safetyreporting.hhs.gov. 
,, 
 
A.5 [20105] ,
,? 
: 
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(:) 
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16) 
   
A.6 [20105] ,? 

A,A,
A
 
A.7 ,? 
,
 
 
A.8 ,FDA
? 
: 
.pdf -  
.jpg, .jpeg -  
.bmp -  
.png - () 
.gif - () 
.tif.tiff -  
.rtf -  
.txt -  
.xls.xlsx -  
.doc.docx - Word 
.wpd - Word  A.9 [20105] ? 
FDAhttp://www.fda.gov,,
http://www.fda.gov,FDA
FDAFDA
,1-888-SAFEFOOD(,
8:004:00) 1-888-INFO-FDA 
A.10 [20105] 
,? 
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:
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A.11 [20105] ? 
,

(http://www.fda.gov/reportablefoodregistry),
 
 
A.12 [20105] 
,? 
FDA,
http://www.fda.gov/reportablefoodregistry
RFRSupport@_fda.hhs.gov, 
 
A.13 [20105] FDA/
? 
FDA,
,()
,FDA 
 
B.  
B.1 (FD & C417)?  FDAAA1005(e),FD & C(21 U.S.C. 350f(d))417
(d)2008927,FDAAAFDAAA107
,200710120085
27,FDA,
FDA 
200998,FDA(FD & C417),FD & C
FD & C(21 U.S.C. 331(mm))
(301(mm)),FDA 2009128
90,:FDA
FD & C417, 
 
C.  
C.1 FDA
? 
FD & C(21 U.S.C. 350d)415(a),415(a)
FD 
& C415,
FD & C201
(e)(21 U.S.C.321(e))
 
FD & C 201(e)417(a)(1) 
C.2 FD & C415(a),
? 
FD & C415(a)
(FD & C415(a)(2)),
,,FDA
,
 
(FD & C415(a)(2)) 
C.3 
?  
FDA
(21 CFR 1.225(c))
FDA
,
 
C.4 [20105] 
? 
 
,,
(A),
,(B)
,A,
AICSR 
(A), 16,
,ABA
,FDA,
 
C.5 [20105]  FD & C415(a),
24? 
,(FD & C417
(e)(1)): 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoo
dFacilities/OnlineRegistration/default.htm 
 
D. 
D.1 ? 

() 
(FD & C201(ff)417(a)(2)) 
D.2 [20105] ?  FD & C(D.3) 
(FD & C201(f)417(a)(2)) 
D.3 [20105] FD & C? 
:(1),(2),
(3)
(FD & C417) 
(FD & C201(f)201(ff)) 
D.4 [20105] 
? 
/,
,FD & C761(21 U.S.C. 379aa-1),
FDA,
21 CFR 107.240
 
: 
http://www.fda.gov/Food/DietarySupplements/Alerts/ucm111110.htm 
: 
http://www.fda.gov/Food/FoodSafety/Product-
SpecificInformation/InfantFormula/default.htm 
D.5 I? 
FDAII

(21 CFR 7.3(m)(1)) 
(FD & C417(a)(2)) 
D.6 ? 
FDA
FDA,,I
I
FDA
, :
http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm 
I: 
o   
o   
o  (Lm) 
o   
o   
o   
o   
o   
o   
D.7 [20105] 
? 
(FALCPA)
(D.6)
,FALCPA
: 
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/default.htm 
D.8 USDA? 
(21 U.S.C. 601)(21 
U.S.C. 451)(21 U.S.C. 1031),
(USDA),
USDA 
D.9 [20105] ,
,,
,
? 
,
,,,
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  D.10 [20105] ,
,
,? 
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FD & C415(a)FDA,417
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(FD & C417(a)(1)) 
D.11 [20105] FD & C415(a)FDA

,
FDA? 
C.1,
,,
,FD & C417(d)(2)
(E.3)
(
),FD & C415(a)

,FD & C415(a)
,FD & C417
 
(FD & C417(a)415(a)) 
 
E.? 
E.1 FDA? 
FDA,
24 
(FD & C417(d)(1)) 
E.2 ?  ,,,
 
(FD & C417(d)(1)(B)417(e)(5)) 
E.3 ,,FDA
? 
,: 
  ;  
  ;  
    
o  ;  
o   
(FD & C417(d)(2)(A)-(C)) 
E.4 FD & C417(d)(2)(B),? 
,FD & C201(e)
 
FDA,
:A,
/ 
(FD & C417(d)(2)(B)201(e)) 
 
E.5 ,
,? 
,FD & C201(e)
(21 U.S.C.321(e))
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(FD & C417(d)(2)(B)201(e)) 
E.6 24?:,
,24,
?  FDA,
24

;,
,,
FDA
;;
 
 
E.7 [20105] ,
,,? 
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417(d)(2)(A)-(C)(E.3) 
E.8 FDA? 
FDA 
(FD & C417(d)(4)) 
E.9 [20105FDA2010319
:2007
] ,
,
? 
,(
/)
,

 
,
,,
, 
A.8 
,FDA(*)
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,
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,,
417(d)(2)(E.3) 
(FD & C417(a)(1)(d)(2)(B)) 
F. 
F.1 FDA? 
: 
(1) FD & C415(a)(3),; 
(2) ; 
(3) ,; 
(4) ; 
(5) (); 
(6) (); 
(7) ,
 
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(ICSR)
  (FD & C417(d)(1)(A)417(d)(4)417(e)
) 
F.2 F.1(1)-(7)
? 
24
7(:(5)(6)
)FDA
,FDA
FDA 
(FD & C417(d)(1)(A)417(e)) 
F.3 ? 
(*) 
G. 
G.1 FDA? 
,FDA(
FDA): 
  FDA,
/;  
  /,
:  
(1) ; 
(2) ,; 
(3) ; 
(4) (); 
(5) (); 
(6) ,
; 
(7) ; 
(8) ; 
(9) ; 
(10) FDA(:FDA, //); 
(11) FDA 
(FD & C417(d)(6)417(e)) 
 
G.2 [20105] ? 
(),
 
(FD & C417(d)(4)) 
G.3 [20105] ? 
,,
,
, 
,,
16
,,
, 
(FD & C417(d)(4)417(d)(6)(A)417(d)
(8)) 
G.4 ? 
,FDAFDA
,
,FDA FDA 
(FD & C417(d)(1)(A)417(d)(6)417(d)
(7)417(e)) 
 
H. 
H.1 
/,
?  ()
,,
A.8FDA 
H.2 FD & C417
? 
,,
FDA FD & C417 
(FD & C417(d)(6)(B)(i)-(ii) 417(d)(7)(C)
(i)-(ii)417(e)(9)) 
 
I.  
(A)FDA/
(B),BFDA B/
? 
,B,BFDA,
24FDAB
FDA,FDA,/ B
/I.5
(FD & C417(d)(6)417(d)(7)) 
I.2 (A)FD & C417(d)(1)FDA
,(B)AFDA,A
FDA/
? 
AFDA/
,AFDA,B
B,FDA
(FD & C417(d)(8)) 
I.3 [20105] ,
,FD & C415(a),
? 
,,
,FD & C 417,
,FDA,
24:415(a)
,FDAICSR
,FDAFD & C417(d)(7)
(FD & C417(d)(1)417(d)(7)) 
I.4  FDA,
,FDA? 
FDA/
,/
(FD & C417(d)(6)(B)(i)-(ii) 417
(d)(7)(C)(i)-(ii)) 
I.5 FDA
? 
FDA(FDA
): 
  FDA,G.1
FDA 
  () 
  /,G.1
(FD & C417(d)(7)(A)-(C)
) 
I.6 /? 
/

,FDA/
 
,FDA/
? UPC
; /
; ; ; 
; ; ; FDA
(ICSR)(FD & C417(d)(6)(B)
417(d)(7)(C))  I.7 (A),FDA
ICSR
(FDA), ICSR
AICSR, AFDA
ICSR? 
,A
ICSRICSR FDA
 
I.8 [20105] ,
ICSRICSR,? 
,ICSR,
ICSR,
FDA ICSR,11(00000000000) 
 
J.  
J.1 , FDA,
? 
,FDAFDA,
FDA
,,
24(FD & C417(d)(1)) 
J.2  FDA/
? 
FDA
,24(FD & C417(d)(1)
(A))FDA/
 
J.3  24,FDA
,FDA,
?  FDA,FDA,
(FD & C
417(d)(6)(A)) 
K.  
K.1 ? 
FD & C417
FDA, 2(FD & C417(g)) 
K.2 FDA/ FD & C
417FDA? 
FDAFD & C
417FDA,FD & C414,
(FD & C414417(g)) 
K.3 FDA,
? 
FDA,
FD & C756(21 U.S.C. 379v)
,
,(),
(FD & C417(i)
417(j)) 
K.4 ? 
FD & C417(h),
(FOIA)(5 U.S.C. 552),FD & C415(a)(4),
,FDA
,FOIA, 552(b)(5 U.S.C. 552( b)),
FDA20(21 CFR part 20),,
,(FD & C415(a)(4)417
(h)) 
K.5 [20105] FDA
,FDA?  ,FDA,

,,
FDA 
L.  
L.1 [20105] FDA
? 
FDA,
L.2L.3 
L.2 ? 

FDAFDA
http://www.fda.gov/iceci/inspections/iom/ucm124008.htm 
L.3 FDA? 
agency'sFDA7126.20,
,FDA:
http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074
694.htm 
M.  
M.1 [20105] 
FDA? 
FDA

FDA
(FD & C417(b)(1)(A)) 
M.2 
,? 
 
M.3 [20105] ?  FDAFDA
,24
301-443-1240FDA,FDA

http://www.fda.gov/safety/reportaproblem/consumercomplaintcoordinators/default.htm
()
,FDA
1-888-(1-888-723-3366)consumer@_fda.gov 
N. [2010 5]  
N.1 [20105] /
? 
2
FD&C415(a),
/(),(FD&C
415(b)(3)[21 U.S.C. 350d(b)(3)] 21 CFR 1.226(a))
FD & C415(a),FD & C417
,
24,
(http://rfr.fda.gov)(FD & C415(a)415(b)(3)
417(a)(1)) 
N.2 [20105] FDA,
? 
FDA,
FDA,,
 
N.3 [20105] FD & C415(a)

? 
C.3 
N.4 [20105] ? 
,
417(d)(3)
FDA FDA,FDA
FDAFDA
 
N.5 [20105] , FD 
& C415(a)/
? 
,,FDA
, 
N.6 [20105] FD & C415(a)
,? 
FD & C417(a)(1)
,,
24 
N.7 [20105] FD & C415(a)
/FDA
,
? 
FDA,FDA
 
 
1.
,
 
2.,FDA,
,,D.1
D.2