200910

HFS-800
Office of Nutrition, Labeling, and Dietary Supplements
HFS-800
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
301-436-2373

www.fda.gov/FoodLabelingGuide

1.

2.
3.

4.

4
4

5.

14

FDA

6.

17

7.

FDA

FDA

FDA

25

8.

72

9.

87

10.

91

11.

95

12.

104

13.

EFDA

123

14.

F1

124

15.

G4

125

1
16.

HFDA

126

FDAFDA
Food Labeling and Standards Staff
(HFS-820), Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835
(301) 436-2371

2
FDA

FD&CFDA

FDA

FD&CNLEA

FR
21CFR
1

19949

a
PDP
bPDP
PDP

21 CFR 101.1, 21 CFR 101.2, 21 CFR 101.3, 21 CFR 101.4, 21 CFR 101.9
21 CFR 101.105
2PDPPDP?
PDP

PDP
PDP2
PDP21
CFR 101.1
3PDP

PDPPDP

IVV21 CFR 101.3(a)

21 CFR 101.105(a)
4

PDP

21 CFR 101.2(a)

6
PDP

PDP

21 CFR 101.2(b)

(d)FDA403 (w)
6

o1611/16
3
PDP

21 CFR 101.2(c)(f)

7
45

21 CFR 101.2(c)21 CFR 101.9(d)(1)(2)

7

FDA
UPCFDA
21 CFR 101.2(e)
8

c
d

e
21 CFR 101.5

PDPPDP21 CFR
101.3
2

PDP1
21
21 CFR 101.3(d)

21 CFR 101.3(b)(d)
4

PDP
21 CFR 101.3(d)
5

21 CFR 101.3(b)(3)
6

21 CFR 101.3(b)(2)

21 CFR 101.3(c)
8

21 CFR 101.3(e)

10

21 CFR 101.3(e
10

21 CFR 1.21(a) (1), 21 CFR 101.3(a), 21 CFR 101.105(h)

11

FDA/CBP

19 CFR 134)
12

21 CFR 101.15(c)(2)

J1

()

()

100
21 CFR
101.30(a)
J2

11

100
PDP
21 CFR 101.30(e)21 CFR 101.30(g)

12

J3

aflavorFlavored
b
c
21 CFR 101.30(c)
J4

10021 CFR 101.30(h)(1)

21 CFR 101.30(j), 21 CFR 101.30(h)
J5

100()100

21 CFR 102.33(a)
J6

21 CFR 102.33(g)
J7

2
1
5

13

101538
21 CFR 102.33(b), 21 CFR 102.33(c), 21 CFR 102.33(d)

14

J8

21
5
21PDP516
1PDP581
21 CFR 102.5(b)(2), 21 CFR 102.33(d), 21 CFR 102.33(g)
J9

21 CFR 101.30(a)

100

J1021 CFR 101.30

?

21
CFR 101.30(a)

J11

J12

J13

15

J14

FDA

21 CFR 101.30(h),100

J15

21 CFR 101.30(h)(1)

J16

J17

J18

100

21 CFR 101.30(h)(1)

J19

16

J2011
?3

21
21 CFR 102.33

17

J21

FDA
FDA

100

238
58 FR 2897 at 2921
J22

21 CFR 156.3(b) (c)

J23100100

100
10021 CFR
101..30(b)(3)101.54(e)
J24C

100
101.22(j)

J25

102.33(g)1

18

19

J26

J27

J2821 CFR 102.33100

J29753
2

3
2

23
1

J30

21 CFR 102.33(g)

J31

FDA

20

21 CFR 101.22

J32100

21

5.

21 CFR
101.105(a)(b)(c)
2

30%

30
21 CFR 101.105(e); 21
CFR 101.105(f)

1 lb 8 oz680g

1 lb 8 oz 680 g

500 ml1 pt 0.9 fl oz

1 gal3.79 L

P.L. 102-329199283; 21 CFR 101.105

4PDP

PDP

PDP

10 X 2 = 20
PDP = 20 X 40%
= 8
2

PDP40
21 CFR 101.1
5

22

PDP
o

23

1/161.6 mm

532 cm2

1/83.2 mm

532 cm2
25161 cm2

3/164.8 mm

25161 cm2
100645 cm2

1/46.4 mm

1/212.7 mm
21 CFR 101.105(h)(i)

100645 cm2
4002580 cm2
4002580 cm2

21 CFR 101.105 101.15

7

18

15425 g

21 CFR 101.105(g)
8

24

1_

14396 g

21 CFR 101.105(a)

11.95

.05_______

12 (340 g)

21 CFR 101.105(g)
10

21 CFR 101.105(o)

= L 2 [5g]
= 2 [5g]

25

6
1

21 CFR 101.4(a)
2

321 CFR 101.4(a)

3

PDP

21 CFR 101.4
37

161o

33
21 CFR 101.2(c)
5

21 CFR 101.4(a)21 CFR 101.4(c)555.875

6

26

4321 CFR 101.4(a)

10 ppm21 CFR
101.100(a)(3)
8

.1

21 CFR 101.4(b)(14)
9

27


21 CFR 101.22(j)
10

FD&C 403(i)(2)21 CFR 101.22(h)(1)

11

21 CFR 101.4(a)
12

28

13

28242824

2416
21 CFR 155.191(a)(3)(iv)
14

3.1109

21 CFR
155.191(a)(3)(i), 21 CFR 155.194(a)(3)(ii)(b)
15

21 CFR 101.4(b)(2)
16

21 CFR 101.22(i)21 CFR 169

17

21 CFR 101.22(h)(7)

29


C1

21 CFR
101.22(h)(3)
C2

21 CFR 101.22(a)(2)
C3

FD&C4040

Li

21 CFR 101.22(k)(1) (2), 21 CFR 74

C4

21 CFR 101.22 (k)(1)

F12004
2004FALCPA108-282II
20048FALCPAFDA
USDA
USDA
FALCPA

http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/default.htm
F2

30

FALCPA8
11
a
b
c

31

d
e
f
g
h
160
90
FALCPA
F3FALCPA

FD&CFDA200611
FALCPA
F4FALCPA

FALCPA

F5FALCPA

FALCPA
FALCPA

FALCPA
F6. FALCPA

FALCPA
81
FALCPAFALCPA

FALCPA203
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInfor
mation/ucm106187.htm
F7FALCPA

FALCPA

32


F8FALCPA3

FALCPA

F9FD&C403(w)(1)
FD&C
403(w)(2)
403(w)(2)
?

403(w)(2)FDA

F10FD&C201(qq)
201(qq)3

201(qq)
403(w)(2)

Prunus dulcis (Rosaceae)

Fagus spp. (Fagaceae)

Bertholletia excelsa (Lecythidaceae)

Juglans cinerea (Juglandaceae)

Anacardium occidentale (Anacardiaceae)

Castanea spp. (Fagaceae)

Castanea pumila (Fagaceae)

Cocos nucifera L. (Arecaceae (alt. Palmae)

Corylus spp. (Betulaceae)

33

Ginkgo biloba L. (Ginkgoaceae)

Carya spp. (Juglandaceae)

Litchi chinensis Sonn. (Sapindaceae)

Macadamia spp. (Proteaceae)

34

Carya illinoensis (Juglandaceae)

Pinus spp. (Pineaceae)

Pistacia vera L. (Anacardiaceae)

Vitellaria paradoxa C.F. Gaertn. (Sapotaceae)

Juglans spp. (Juglandaceae)

201(qq)
FDA

FDA21 CFR 10.115

FDA
F11FD&C201(qq)
201(qq)?

1.

201(qq)Triticum

201(qq)Triticum

aestivum L.Triticum durum Desf.Triticum

compactum Host.Triticum spelta L.Triticum
durum Desf.Triticum monococcum L. subsp.
MonococcumTriticum turgidumL. subsp. dicoccon (Schrank)

2.

Thell.Triticum polonicum L.x Triticosecale

ssp. Wittm.

F12FALCPA(peanuts)
(soybeans)
almondpecan
walnut

FALCPApeanut
soybean
almondpecanwalnut

FDAsoybeansoysoya
soybeans
3soybeans

35

soybeans
1

soybeans
waterwheatsoybeanssalt

FALCPA
F13FALCPA
?

FALCPA1

F14FALCPA?

403(w)(1)

FDA

PDP
F15FALCPA

F162

36

CContains

Contains

walnutwalnutssoybeans
soysoyaFALCPA

37

G1

PDP
3PDP

PDP

21 CFR 101.2(b)(e)101.9(i)
G2

21 CFR 101.9(d)(1)(i)
G3

PDP

21 CFR 101.9(c)(d)

G4

FDA

G5

(1)21 CFR 101.9(d)(11)(2)

21 CFR
101.9(d)(11)

N1

38

7 L2

FDA
21 CFR 101.9(d)

39

(1)
(2) 8
13
(3) 3
21 CFR 101.9(a) and 21 CFR 101.9(a)(1)

21 CFR 101.9(j)(1)
101.9(j)(18)

21 CFR 101.9(j)(2)

21 CFR 101.9(j)(3)

21 CFR 101.9(j)(4)

21 CFR 101.9(j)(5)101.9(j)(7)

21 CFR 101.36

21 CFR 101.9(j)(6)

21 CFR 101.9(j)(8)

21 CFR 101.9(j)(9)

21 CFR 101.9(j)(10)

101.45

40

21 CFR 101.9(j)(11)

21 CFR 101.9(j)(14)

21 CFR 101.9(j)(15)

21 CFR 101.9(a)(2)

101.9(j)(16)

21 CFR 101.9(a)
21 CFR 101.9(a)(2)

21 CFR 101.9(j)(12)

N2

NCCFDA
NCC
AB21 CFR 101.13(c)
N3

L21RDI

A21 CFR 101.9(c)

N4

FDA
21 CFR 101.9(c)
N5

41

FDA

NCC

21 CFR 101.9(a), 21 CFR 101.9(c), 21 CFR 101.9(c)(8)(ii)

N6

FDAAC

21 CFR 101.9(c)(8)(ii)(A)-(B)

21 CFR 101.9(c)(8)(iv)

42

N715

55
55
(calorie free)
21 CFR 101.9(c)(1)
N8475045

50--5
4745
5010
96100
21 CFR 101.9(c)(1)H
N9

21 CFR 101.9(c)(1)(i)(A)
USDANo. 741
7.07
N10

=
+ 3121 CFR 101.9(c)(2)
N11

N1210.1 g

0.5 g0 g0
21 CFR 101.9(c)(1)(i), 21 CFR 101.9(c)(2)
N13

43

10.500.55
0.51/2
0.5 g1 g1.5 g2 g2.5 g3 g3.5 g4 g4.5 g5 g
5115

5 g6 g7 g
21 CFR 101.9(c)(2)H

44

N141

F1DVG4
121 CFR
101.9(c)(8)(iv) & (c)(9)
N150.51
DV10.2

%DV

101.9(d)(7)(ii)
1
DRV21 CFR
101.9(c)(7)(ii)
1
N16

21 CFR 101.9(c)(6)
N17

21 CFR 101.9(c)(6)
N18

21 CFR
101.9(c)21 CFR 101.9(c)(6)(ii)
N1910.81 g
1 g

111
1

1 g11
The <
21 CFR 101.9(d)(7)(i)21 CFR 101.9(c)(6)(i)21 CFR 101.9(c)(7)

45

N20

21 CFR 101.9(c)(6)(iii).

46

N211DVDRV
RDI

4DRV504
RDI1614
606521 CFR 101.9(c)(7)(iii)
N22DRV

DRV
4
4
Protein Digestibility Corrected Amino Acid ScorePDCAAS
FDADRV

N234DV

50DRVDV
DV1
50
21 CFR 101.9(c)(7)(ii)
N24DV4
DRV

DRV
DRV102,000
502,5006562.565

DRV2,0002,5003,50021 CFR 101.9(d)(9)

N25

21 CFR 101.9(c)
H
N26

AC
21 CFR 101.9 9c)(8)(iv)

47

21 CFR 101.9(c)(5)21 CFR

101.9(d)(8)

48

N271400

1
N28-3RDI/DRV

3300 mg
-3
21 CFR 101.13(i)(3)
N29

21 CFR 101.9(h)(4)
21 CFR
101.9(e)
N30

FDA
FDA

FDA
FDAFDA Nutrition
Labeling ManualA Guide for Developing and Using Databases
N31

FDA

FDAFDAFDA
Nutrition Labeling ManualA Guide for Developing and Using Databases
FDA1221 CFR
101.9(g)
N32

49

FDA

50

N33FDA

FDAFDA

FDA

N34FDA

FDA

N35FDA

FDA

FDAAOAC
182005Official Methods of Analysis of the AOAC International, 18th edition (2005)
Association of Analytical ChemistsAOAC

N36

N37

FDA

(21 CFR 101.9(h))

P1

51

101.9(h)(1)1

52

P2

101.9(h)(1)

P3

21 CFR 101.9(h)(3)
1
2RACC1
31varied
4

21 CFR 101.9(d)(13) (ii)

1
varied

7
TTB
TTB
P4
(1) 21 CFR 101.9(2)
12

53

2
12

(21 CFR 101.9(h)(3)(v)).

3

P5

P6

2
1

P7

21 CFR 101.45

P8

54


101.9(h)(3)(i)

55

L1

(21 CFR 101.9(d)(2))6

8(21 CFR 101.9(d)(1)(iii))
(21 CFR 101.9(d)(1)(ii)(C))
L2

FDA
21 CFR 101.9(d)

13

8
1
7

3
8

1/4

4
8
4 10

6
1

56


16/
4

2%8

4181

516
6 (1)8
4
784
10
86
1

17
3
21/4
2

3
L37L2

21 CFR 101.9(d)7L2

57

2
813
33
L4. 86

68

58

L5

21 CFR 101.9(j)(13)(ii)(D)40
40
PDP21 CFR 101.2

21 CFR 101.9(j)(17)
L6

FDA21 CFR 101.9(d)(1)(iii)

L7

40

59

21 CFR 101.9(d)(11)

60

L8

L9

21 CFR 101.9(g)(9)
Office of Nutrition, Labeling,
and Dietary Supplements HFS-800 5100 Paint Branch Parkway College Park, MD 20740
L1010

AC

ABC

(21 CFR 101.9(c))

21 CFR 101.9(c)(1)(ii)

0.5 g

21 CFR101.9(c)(2)(i)

0.5 g

21 CFR 101.9(c)(2)(ii)

0.5 g

21 CFR 101.9(c)(3)

2 mg

21 CFR 101.9(c)(6)(i)

1g

61


21 CFR 101.9(c)(6)(ii)

0.5 g

AC

RDI2%

21 CFR 101.9(c)(8)(iii)

62

L11

101.9(d)(1)(i)

FDA

21 CFR 101.9(d)(1)(iv)

L12944

21 CFR 101.9(d)(10)
L1321 CFR 101.9(d)(7)(ii)

L14

L15

L16

63

L17

21 CFR 101.9(d)(14)

64

L18Frijoles Pintos

21 CFR 101.15(c)

L19

21 CFR 101.9(d)(13)(i)(ii)

65

L206

1
2
1131

21 CFR 101.9(h), 21 CFR

101.9(d)(13)
L21
1

PDP

PDP

L22

L23

2
DV
/

200 mg265 mg21 CFR 101.9(e)

L24211

66

1RACC11
112
21 CFR 101.9(b)(9) and 21 CFR 101.9(e)

67

L25
1RACC250%

101.9(b)(11)RACC200%
FDA
21 CFR
101.9(b)(11)

2
L261
240 mLRACC1/21/4

1/2
1/4_____2
21 CFR 101.9(e)
L27____

21 CFR 101.9(e)
L28

1RACC
200%RACC200%

21 CFR 101.9(b)(11)
L29

21

114g
121 CFR 101.9(b)(7)(v), 21 CFR 101.9(e)(5)

68

L30

69


AC2
5

21 CFR 101.9(f)101.9(f)(1)101.9(c)

L31

5
0
1g21 CFR 101.9(c)
L32_____________

1
23

21 CFR 101.9(f)(4)
L33

_____________21 CFR 101.9(f)

21 CFR 101.9(f)(4)
L34

_____________

21 CFR 101.9(f)(4)

70

L35

71

AC
21 CFR 101.9(f)(4)
L36

21 CFR 101.9(d)(9)
L37_____________

_____________

L38_____________

6
L39

21 CFR 101.9(f)
L40

21 CFR
101.9(f)(5)
L4120002500DV
40

2000
11
DVDV1
1
DV200021 CFR 101.9(f)(5)

72


L42FDA

FDA
LDL-C
()

73

LDL-C
IOM/NAS

FDA
(68 FR 414342003711)
L43

FDA

(68 FR 41434414612003711)
L44

21 CFR 101.9(c), (c)(2)(ii), (c)(2)(iii)(c)(2)(iv)

L45

Trans Fat
Trans
Trans
15
0.5510.5
0(21 CFR
101.9(c)(2)(ii))
L4610.5

0.51

74

021 CFR
101.9(c)(2)(ii)

75

L47%DV

%DV
FDADV
DV%DV
21 CFR 101.9(d)(7)(ii)
L48
0g

0.51/2g0()
0

10.5g

L49

FDA
NCC

L50FDA

FDAAdvanced Notice of Proposed

RulemakingANPRM
68 FR 415072003711
NCC
NCC

FDA

76


L51FDA

FDA

L52

L53

21 CFR 101.9(g)(9)FDA

Office of Nutrition, Labeling, and Dietary Supplements, HFS-800, 5100 Paint Branch Pkwy., College
Park, MD 20740121 CFR 101.9(g)(9)
2
3
4

L54

L55

L56FDA

1
1(RACC)
L5711

77

11RACC101.12(b)
22

78

FDA139RACC1
RACC
RACC21 CFR 101.12(c)
def2
RACC
111
1
21 CFR 101.9(b)(6)
121 CFR 101.9(b)(6)1

22RACC1(21
CFR 101.9(b)(2),(3), (4)).
1
1/2112
21 CFR 101.9(b)(5)
21 CFR 101.9(b)(7

3321 CFR
101.9(b)(8)
L58RACC50154
RACC50

RACC
541RACC
1

L59RACC2
RACC

RACC1
RACC14021 CFR 101.12(c)
L60

RACC3021
CFR 101.12(b)

79

L61RACC

21 CFR 101.12(h)

80

FDARACC
RACC
RACC
FDA
21 CFR 101.12(h)RACCFDA

L62RACC

RACC1

15 g

15 mL

4
5g

2
2

10 g

60 g

1
0.5 g

1/3
10 g

3g

2
10 g

L631

12
(g)

81

(mL)

128 g128 g/1 oz

8 fl oz240 mL1240 mL
11

15 g 15 g/0.2 oz

21 CFR 101.9(b)(2), 21 CFR 101.9(b)(5), 21 CFR 101.9(b)(7), 21 CFR 101.12(b)

L64RACC1

RACC1
RACC16 oz454g1
11RACC (21 CFR 101.12(b))RACC140g

22140gRACC
(16oz/454g)
1/3 X 454g = 151g
1/4 X 454g = 113g
151g113gRACC140g
331RACC

111/3(151g)
11/3151gRACC140g
101.9(b)(2)(i)21 CFR 101.9.(b)(2)(ii)
)21 CFR 101.9(b)(2)(iii)RACC1
21 CFR 101.12(b)
L65RACC
1

FDA1RACC

82

21 CFR 101.12(b)
L66RACC

21
(21 CFR 101.9(b)(5)(ix))RACC30 g12 g
1224 g336 g
2.530 g1
3 (36 g)
L671

1RACC(21 CFR 101.12(b))RACC

55g

83

255g

32

413
1
1__(__ g)
21 CFR 101.12(b)(c)
L681RACC30g

RACC
28 35 RACC
11
(28g)4(28g/1 oz)21 CFR 101.12(b)
L691

1/3
1/22/33/4111/41
(4 fl oz5 fl oz6 fl oz)
111/311/212/323
1/81/41/23/412
21 CFR 101.9(b)(5)(i)
L701

11/2
1/31/41/51/61/81/91/101/122
321 CFR 101.9(b)(2)(ii)
L71RACC1

1RACC67%
200%11RACC200%
1
50%67%112

84

1RACC50%RACC1
21 CFR 101.9(b)(2)(i) 21 CFR 101.12
L722

250.52
2.533.544.55

85

51
567
21 CFR 101.9(b)(8)

1
L73RACC111
1

RACC11

1
1
1
21 CFR 101.9(b)(9)
L7411

11
RACC
21 CFR
101.9(b)(10)(iii)

1
L751/81

(21 CFR 101.9(b)(5)(v))

1/12(40 g/ 1/3 )

(21 CFR 101.9(b)(5)(iii)). 1 lb (16 oz)2 oz (56 g/ 1/8 )

L76

1
(21 CFR 101.9(b)(5)(iv))360 mL

86

2(38 g)
(21 CFR 101.9(b)(5)(iv))222 g145 g

87

L77

1a
b
(21 CFR
101.9(b) (5)(i)-(iii), CFR 21 101.9(b)(2)(i)(H)):(160 g)
2 (110 g)(50
g)250 g50 g2
(21 CFR 101.9(b)(5)(vii))4
112 g/ 2/3 2
384 g/ 2/31(28 g/
2)
L781

RACC301
301
1
(30 g/ 1 )
L791

1
1
21 CFR 101.9(b)(8)(ii), 21 CFR 101.9(b)(9)
1

L80100
100 mL

21 CFR 101.9(b)(10)
100100 mL
11

L81

88

2
11
2
21 CFR 101.9(b)(11), 21 CFR 101.9(e)

89

L82RACC
30RACC130

1
11
RACC302RACC
21 CFR 101.9(b)(11); 21 CFR 101.9(e)

11
L831

111
1
11
1
111
1
(1(__g)) 21 CFR
101.9(b)(5)(iv), 21 CFR 101.9(b)(7)(i) 21 CFR 101.9(d)(3)(ii)
L841

21 CFR 101.9(b)(6)
RACC200%1RACC
200%
RACC
40 g80 g1
80 g
1

L85RACC1

RACC100 g 100 mL
RACC150%1
RACC150%200%
12
RACC140 g
210 g1210 g280 g
122

90

11/2
21 CFR 101.9(b)(6)

91

L861

1
(21 CFR 101.9(b)(5)(i)-(iii))1
(21 CFR 101.9(b)(5)(iv))

11

1360 mL
1(360 mL)
11000 mL8 fl oz240
mL1(240 mL)4
L871
1

111
8 fl oz12 fl
oz16 fl ozRACC 240 mL1
11(240 mL)8 fl oz (240 mL)
L88RACC551130
1

130RACC236%RACC200%
1
12
1(130 g)1/2(65 g)21 CFR 101.9(b)(6)
L891

21 CFR 101.12RACC200%
1RACC200%
11
21 CFR 101.9(b)(6)
L902

RACCRACC100g
100mL2RACC200%
RACC100g 100mLRACC
150%200%12
21 CFR 101.9(b)(6) and 21 CFR 101.12(b)

92

93

1
L9111.51.5

150.5
212
RACC140 gRACC100 gRACC150%200%
12
225 g375 g13
(225 g)1
12150 g1
1.52
21 CFR 101.9(b)(8)
1(21 CFR 101.9(b)(2)(i))
L921

121 CFR 101.9(b)(2)(i)

1RACC

1RACC50%1RACC

RACC15 gRACC 50% 7.5 g

4 g (7.5 g)14
(16 g)

1RACC50%67%12

1 2RACC30 g
RACC 50%15 gRACC 67%20.1 g
17 g15 g < 17 g < 20.1 g11(17 g)
2(34 g)

1RACC67% 200%11

RACC50 gRACC67%33.5 g
200%100 g11145
gRACC100 g100 mL
RACC150%200% 1
21

1RACC200%21

94

RACC40 gRACC200%80 g
90 g11(90 g)
(45 g)

95

FDA121 CFR 101.9(b)(8)(ii)

22
21 CFR 101.9(b)(5)(vii);31
21 CFR 101.9(b)(5)(iv)
L93RACC240 mL8 fl oz6 fl oz
18 fl oz240 mL

RACC100 mLRACC67%150%
11160.8 mL360 mL
6 fl oz (180 mL)11

L94RACC125
551

55
g1RACC50%125g 50% = 62.5 g
1RACC2110 g3165
g12(110 g)21 CFR 101.9(b)(2)(i)(A)

1 (21 CFR 101.9(b)(2)(ii))

L95.1
1
21 CFR 101.9(b)(2)(ii)1
RACC1
RACC
RACC140 g16 oz454 g1= 227 g1
= 151 g1= 113 g1/3; 1
1/3151 g
1/2 1/31/41/51/623
1/8
1/4 21/71/111/131/14

96

1(21 CFR 101.9(b)(2)(iii))

L961

1
21 CFR
101.9(b)(2)(iii)1RACC
1RACC
RACC30 g123 g
1 28.75 g1 1/330.7 g
1 1/311 1/3(31 g)
a1/41/31/22/33/4
11 1 1/3b 11 1/31 1 2/32 3c
1/81/41/23/41221
CFR 101.9(b)(5)
L97

(21 CFR 101.9(b)(5)(vii))

RACC112 9
3 3
14 oz112 g/ 2/3 2

13 (84 g/2/3
)1(28 g/2)
L981

1
RACCRACC
RACC
RACC80 480900
1/1275 gRACC80
RACC480 g1/1240 g
11/12 (40 g/ 1/3)

97

1
(21 CFR 101.9(b)(5))

L991

21 CFR 101.9(b)(5)
1
(21 CFR 101.9(b)(5)(i))2

(21 CFR 101.9(b)(5)(ii))

(21 CFR 101.9(b)(5)(iii))

____ g

__
__ g/1/81 1/4
(21 CFR 101.9(j))

L100

21 CFR 101.9(j)

L1011

L102

FDA
FDA
FDA

98

L103

21
CFR 101.9(j)

99

L10421 CFR 101.9(j) L104. 21 CFR 101.9(j)

21 CFR 101.9(j)

(21 CFR 101.9(j)(1) and 101.9(j)(18))

L105 $51,000
$490,000

$501,000$49,000NLEA
$500,000
$50,000
21 CFR 101.9(j)(1)(i)

()

$50,000

$500,000

$50,000

$500,001

$50,001

$500,000

$50,001

$500,001

L106X
X

L107
FDA

FDA
L108

100

101

L109

21 CFR 101.9(j)(1) (18)

L110

21 CFR 101.9(j)(1) ()

21
CFR 101.9(j)(18)

L111

FTE

L112FDA

FTE10 10,000
FDA

FD&C Act 403(q)(5)(E)(iii); 21 U.S.C. 343(q)(5)(E))iii); 21 CFR 101.9(j)(1) & (j)(18)

L113

(21 CFR 101.9(j)(2))

102

L114

21 CFR 101.9(j)(2)(iii) and 21 CFR 101.9(j)(2)(iv)(B)

L115

1
21 CFR 101.9(j)(2)(i)
L116

L117

L118FDA

1)2)
3)(
)
(
)

103

 21 CFR 101.9(j)(2)

21 CFR 101.9(j)(3)

104

(1 lb2 lb1 lb
5)
21 CFR
101.9(j)(3)(iv)
L119
$500,000

21 CFR 101.9(j)(3)

(21 CFR 101.9(j)(4))

L120

21 CFR 101.9(j)(4)

L1211

L122

105

FDA

106

L123FDA

RDI DRV

(21 CFR 101.9(j)(5))

L124

421 CFR 101.9(d)(9)

%DV2

21 CFR 101.9(j) (5) (i)

%DV

24

(21 CFR 101.9(j)(13))

L125

40
()
DV2000
21 CFR 101.9(d)(9)

21 CFR 101.9(j) (5) (iI)

21 CFR 101.9(j)(13)(ii)(A)(1)
L126

40

107

21 CFR 101.9(j)(13)(ii)(A)(2)

108

L127

40

Serving size

Serv size

Cholesterol

Cholest

Servings

Total carbohydrate

Total card

Fat cal

Dietary fiber

Fiber

Sat fat cal

Soluble fiber

Sol fiber

Sat fat

Insoluble fiber

Inso fiber

Monunsat fat

Sugar alcohol

Sugar alc

Polyunsat fat

Other carbohydrate

Other carb

1
Servings per container
1
Calories from fat

Calories from saturated fat

Saturated fat

Monounsaturated fat

Polyunsaturated fat

21 CFR 101.9(j)(13)(ii)(B)
L128

12

21 CFR 101.9(j)(13)(i)

L129

12
6161
21 CFR 101.9(j)(13)(i)(B)
L130

21 CFR 101.9(d)

109

L131

21 CFR 101.1(c)21 CFR 101.2(a)(1)

110

L132

L13312

101.9(j)(13)(i)

L134UPC

21 CFR 101.9(j)(17)
L135

12

21 CFR 101.9(13)(i)

(21 CFR 101.9(j)(16))

L136

101.9(j)(16)

L13721 CFR 101.9(d)

111

112

L138

L139

L140

FDA

L141

L142

(21 CFR 101.9(j)(10)21

CFR 101.42- 101.45)
L14320

200672571 FR 420312006817 (71 FR 47439)FDA20

2021 CFR 101.44

20

20

113

20

114

L14420

FDA
(21 CFR
101.45(c)(1)). FDA21 CFR 101.9(g)

L145
(21 CFR 101.45)
21 CFR 101.9

21
CFR 101.9(d)
L146FDA

NLEA
FD&C

21 CFR 101.45

21 CFR 101.9
L147

115

116

L148

L149

21 CFR 101.9(h)(1)

L150

L151

21 CFR 101.45
L152

117

118

L153

21 CFR 101.9(j)(3)

119

8.

N1. NCC

10021 CFR
101.13(b), 21 CFR 101.13(a)
N2NCC

NCCAB
N3NCCFDA

21 CFR 101.13(b)
N4NCC

21 CFR 101.13101D10510721
CFR 101.13(b).
N5NCC

NCC2
2

21 CFR 101.13(f)
N6

21 CFR 101.13(n)
N7

120


21 CFR 101.13(h)(1)-(3)
N8

NCC1
RACC150

121


8 N18)

13.0

4.0

60

480

21 CFR 101.13(h)(1)
N91

RACC30 g2
21 CFR 101.13(h)(1)
N10

21 CFR 101.13(h)(4)(i)-(ii)
N11

403(r)(2)(A)(iii)-(v)
21 CFR 101.13(h)(4)(ii)
N12

N13

21 CFR 101.105(i)
PDP5
161PDP525
81PDP25100163

122

PDP10041400
2121 CFR 101.13(h)(4)(i)

N14

2
161
21 CFR 101.13(h)(4)(i).
N15

3
1321
21 CFR 101.13(h)(4)(i)
N161

11

21 CFR 101.13(h)(4)(iii)
N1712

N18

21 CFR 101.13(l)1

26 g
8 g
120 mg
960 mg
21 CFR 101.13(h)(2)

123

21 CFR 101.13(m)1

19.5 g
6.0 g
90 mg
720 mg
21 CFR 101.13(h)(3)
N19

RDIDRVDV1019
DV20
21 CFR 101.54(b)-(c)
N201

DV

124

DV
21 CFR 101.54(a)
N21DV-3

1
1
-3
21
CFR 101.13(i)(3)
N22DV-3

DV
-3-3

-3-3

1
21 CFR 101.54(c)
N23RDI
NCC

21 CFR
101.13(q)(3)(i), 21 CFR 101.13(n),21 CFR 101.13(h)
N24

21 CFR 101.13(e)(1)-(2)
N25

125

()
21 CFR 101.13(e)(1)

126

N26

FDA

N271001

RACC0.5
100
FD&C403(a)(1)201(n)100
100
FDA

N28

1RACC
139

N298 N28

A2

N30

11

127

N31

N32

21 CFR 101.13(j)(1)(i)(B)

21 CFR 101.13(j)(1)(ii)(A)

21 CFR
101.13(j)(1)(ii)(A)
N33

21 CFR 101.13(j)(1)(i)(A)

N34

21 CFR 101.13(j)(2)(i)

128


21 CFR 101.13(j)(1)(ii)(A)

129

N35

50

21 CFR 101.13(j)(2)(i).
N36

N371

N38

2
12

N39

N40

N41

130

N42

N43

31501
2004g3008g
21 CFR 101.56(b)(3)(i)-(ii)21 CFR 101.13(j)(2)
N44

21 CFR 101.13(j)(2)(ii)

21 CFR 101.13(j)(2)(iv)(B)
N45NCC

21 CFR
101.13(d)
N46

131

1. (1)

PDP

2. (2)

PDP

3. (3)

4. (4)

21 CFR 101.13(j)(2)(iii)

132

N47

161

1232
121 CFR 101.2(c)
N48NCCFDA

21 CFR 101.6521 CFR 101.69(o)

N49Healthy

Healthy
B

NCC
21 CFR 101.65(d)(2)
N50Fresh

21 CFR 179.2621 CFR 101.95(a)21 CFR 101.95(c)1

N51Fresh

FDAFresh

21
CFR 101.95(b)

133


H1.

134

21 CFR 101.14(a)(1)

FDA

3
12
H2

FDA
FD&C403(r)(3)(c)
FDA
C
21 CFR101.9(k)(1)101.14(c)-(d)21 CFR 101.70
H3

SSA
QHC
21 CFR 101.14S/F

S/F
S/FS/F
FDA
[21 U.S.C. 343(r)(6); 21 CFR 101.93]
H4

SSAQHC
21 CFR
101.1412)

135

3
12
25

136

13
1

1
H5

FDA
FDA
(21
CFR 101.93)
FDA

H61993QHC

21 CFR 101.14
FDA1990
SSA
SSA
QHC

QHC
QHC

Q1FDAQHC

FDA
QHC

Significant Scientific AgreementSSA

137

FDA20039
1QHC
Q2QHC

FDAQHC

Advanced Notice of Proposed RulemakingANPRM

138

FDA

Q3

FDAFDA
QHC
FDA

QHC

Q4QHC

CFR 101.14
SSAQHC
SSAH7

Q5QHC

15FDA45FDA

21 CFR 101.70
FDA60
FDA
270FDAQHC

FDA270

Q6SSASSAQHC
FDA

SSA
QHC
FDAQHC270

139

FDASSAQHC

Q7

21 CFR 101.70
121 CFR 101.70(f)(A)21 CFR 101.14(b)

140

 Re
21 CFR 170.3(o)

(21 CFR 101.14(b)(3)(ii))

221 CFR 101.70(f)(B)
321 CFR 101.70(f)(C)
421 CFR 101.70(f)(D)
521 CFR 101.70(f)(E)




621 CFR 101.70(f)(F)
FDAQHC
SSA
Q8

Food and Drug Administration

Office of Nutrition, Labeling and Dietary Supplements (HFS-800)
5100 Paint Branch Parkway
College Park, MD 20740
Q9FDA

Q10FDAQHC?

QHCD

S1

1994DSHEAFD&C403(r)(6)

141


101.93(f)FD&C403(r)(6)
101.93(f)

142

(f) (a)(e)

(g)
(21 CFR 101.93)
(g)

FD&C403(r)(6)

http://www.fda.gov/Food/LabelingNutrition/LabelClaims/StructureFunctionClaims/default.htm
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.
S2

403(r)(6)C

S3
?

31

230FDA
3
FD&C403(r)(6)
S4

W
1997923(62 FR

4985949883)21 CFR 101.93(b)

(e)21 CFR 101.93(a)
S5

143

144

2FDA

FDA
1010
S7
S6

101.93(g)

S7

(65 FR 1000-1050)
20001610
10
These 10 criteria can be found in theStructure/Function
Claims Small Entity Compliance Guide
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupple
ments/ucm103340.

145

9. A:

FreeLowReduced/Less
Free

Low

Reduced/Less

Free

Low

Reduced/Less

FreeVery

ZeroNo

Little

Low

WithoutTrivial

Few

Lower

Low

source of

Contains a Small Amount of

Negligible source of

Low Source of

Dietarily Insignificant

Fewer

Source of

Free

Modified

100

Free

Low

RACC

RACC40

21 CFR
101.60(b)

5(b)(1)

RACC
50
g(b)(2)

100 g120
(b)(3)

Reduced/Less

LightLite

RACC25

50

100 g

RACC50

25

50

RACC

50
1/321
CFR 101.56(b)
LightLite

Less

Fewer

(b)(4) & (5)

21 CFR 101.56(d)

146

40
21 CFR 101.60(a)(4)

147

Free

Low

Reduced/Less

RACC 3 g

__ Fat Free

21 CFR 101.62(b)

RACC 0.5 g

RACC

RACC

Low Fat

50 g

25

)(b)(2)

21 CFR
101.62(b)(6)

1 0.5 g
(b)(1)

100 g 3 g

(*)

30
(b)(3)

100 g
25
(b)(4) & (5)

100 Fat Free100

(b)(6)(iii)
Light

1 40

21 CFR
101.62(a)(4)

RACC 1

RACC 1 g

21 CFR 101.62(c)

0.5

RACC

RACC 2 mg

15

25

RACC 3

0.5 g

(c)(2)

100 g

25

RACC

(c)(4) & (5)

0.5 g

0.5 g
0.5 g
(c)(1)

100 g 1 g

10

(c)(3)

1
21 CFR 101.62(c)
1 40

(*)

21 CFR
101.62(a)(4)

148

Free

Low

Reduced/Less

RACC

RACC 20 mg

21 CFR 101.62(d)

2 mg

RACC

RACC

RACC 2 g

50 g

25

)
(d)(2)

Free100 g

100 g

Low

25

Reduced/Less

(d)(4) & (5))

1 2 mg
)

100 g 20 mg

(d)(3)

(d)(1)

RACC
RACC 50 g
) 13 g
1
19.5 g 26 g

1 40

RACC

RACC 140 mg

Light

21 CFR 101.61

5 mg

RACC

RACC

21CFR

50 g

)(b)(4)

25

5021
CFR 101.56(c)(1)

1 5 mg
(b)(1)

100 g 140 mg

100 g

(b)(5)

25

Very Low

SodiumRACC

35 mg

RACC

(b)(6) & (7)

50 g

Salt Free
Sodium
Free

(c)(1)

100 g 35mg
(b)(2)
& (3)

RACC 50
21 CFR 101.56(c)(2)

21 CFR 101.56(d)(2)

21 CFR
101.61(c)(2)

149

Lightly Salted
50

21 CFR 101.56(g)

150

Free

Low

Reduced/Less

Sugar Free

No Added Sugars

21 CFR 101.60

RACC

RACC

Without Added Sugars

25

100

0.5 g (c)(1)

25

(c)(2)

(*)

(c)(5) & (6)

0.5
g

Unsweetened
No Added Sweeteners

(c)(3)

Sugar Free
No Added Sugar
2

*
*

RACC =

RACC = 30 g 2 RACC
21 CFR 101.9(f)(1)
50 g

RACC 1 RACC
50 g 13 g 4 g 60 mg
480 mg

151

light

lightlight21 CFR 101.56(e)

light corn syrup

light brown sugar21 CFR 101.56(f)

10. B:

(21 CFR 101.13(j)(1))

Light

(1) 3
(2)

Reduced
Added
Extra
Plus
Fortified
Enriched

(1)
(2)

More
Less
Fewer

(1)
(2)

21 CFR
101.13(j)(2)(i)21 CFR 101.13(j)(2)(ii)
1
21 CFR 101.13(j)(2)(iv)(A)

3 g
21 CFR 101.13(j)(3)

152

HighRich

Excellent Source Of

RACCDV20

21 CFR 101.54(b)

Good Source
Contains
Provides
()

RACC1019DV

21 CFR101.54(e)

153

More Fortified,
Enriched, Added,
Extra, or Plus

RACC10DV

21 CFR 101.54(e)

Lean

RACC100g10
4.5g95mg
100
1RACC8
3.5g80 mg
21 CFR 101.12(b)
2RACC83.5g
80mg21 CFR 101.62(e)(1)-(3)

Extra Lean
()

RACC100g5
2g95mg
100
121 CFR 101.62(e)(4) & (5)

High Potency

RACCRDI100
RDI2RDI
32RDI100

21 CFR
101.54(f)

Modified

35
21 CFR 101.13(k)

1
21 CFR 101.54(d)(1)

1. RDI

2.

3. highgood source
more

4.
CE
21 CFR 101.54(g).

154


21 CFR 101.65

3

Low
Good Source

1
[][]
81
C21 CFR 101.65(c)(2)

1)
1002)
3)
4)
5) 105
healthyhealth
healthfulhealthfullyhealthfulness
healthierhealthiest
healthilyhealthiness
21 CFR 101.65(d)(2)

RACC100g

5 g

RACC100g

2 g
RACCl.s.

RACC50 g

RACCl.s.

480 mg

RACC50 g

l.s.600 mg

155

480 mg

RA100 g
95 mg

RACC 10DV
AC

l.s.90 mg

RACC
10DV
AC

l.s.
10DV
AC

21CFR136, 137, or 139

21 CFR 104.20

21 CFR 104.20

21 CFR 104.20

l.s. = 1RACC =
1 RACC = 30 g 2

2
2

1. 1
21 CFR 101.13(q)(3)(i)
2. 10721
CFR 101.13(b)

156

3. Unsweetened
Unsalted21 CFR 101.60(c)(3)
4. Sugar FreeNo
Added Sugar
21 CFR 101.60(c)(4)

157

11. C:

(21 CFR 101.72)

D
D D

(21 CFR 101.73)

Extra lean

158

(21 CFR 101.74)

(21 CFR 101.75)

LDL

LDL

(21 CFR 101.76)

159

(21 CFR 101.77)

RACC
0.6

160

LDL

LDL

(21 CFR 101.78)

1

A
C

A C

A C

A
C

A C
1

40 mcg

Folatefolic acid

(21 CFR 101.79)

B 1
Folate B
1 folic acid

B 1

161

 A
D
RDI100

USP

Sugar free

(21 CFR 101.80)

pH 5.7

162

[]

D-

1)
: D-

D-

2)

D-

3)

15

163

(21 CFR 101.81)

1 1)

2)3)
4)

RACC

0.75 g CHD

RACC 0.75 g

RACC 1.7 g

1)

2)

3)

4)

5)
6)
7)
95
RACC

164

(21 CFR 101.17(f))

[] 1 [
]
[
1
]

RACC

(1)

6.25 g

1 25

(21 CFR 101.82)

[
] 1

(2)

1 25

[] 1

165

RACC

(1)

1 1

1.3

1 2 0.65

0.65
g

(21 CFR 101.83)

RACC




1.7 g

50 g 13 g

1
1

166

(2)

3.4

10DV

[]

167

FDAMAFDA

RACC 51

(
1999P-2209)

55 g RACC 3.0 g

50 g RACC 2.8 g
45 g RACC 2.5 g
35 g RACC 1.7 g

(
2000Q-1582)

21 CFR 165.110

21 CFR 101.14)

2006Q-0418)

(21 CFR 101.14(e)(6)),

[
]

0.61.0 mg/L

RACC 0.5 g

2006Q-0458)

168

 6.5 g

169

12. D:

FDA 21CFR 101.14

FDA

0.8 mg

FDA

0.8 mg

0.8 mg

FDA

1991N-100H

10/10/2000

04/03/2001

21 CFR 101.79

170

1 0.4mg

B B6B12 FDA

B6 B12

1999P-3029

FDA

11/28/2000

05/15/2001

1 DV 100

400

DV 1
1
1,000
1 mg

B6B12

USP
USP

171

(1)

FDA

2002P-0457
02/21/2003

04/28/2003

1 1
400

(2)

101.14(d)(2)(vii)

101.14(d)(2)(vii)

FDA

RACC 1
DV 20 20DV
14

E (1)

FDA

1991N-0101

04/01/2003

1 C1

(2)

2000 mg E1

172

1000 mg 1

 101.14(d)(2)(vii) FDA

RACC 1

(2)

DV 20 C

20%DV 12 mg E 20%DV

6 IU
FDA

(1)

2002P-0413

FDA

02/24/2003

05/13/2003

11/24/2004

(2)

FDA

173

(1)

21 CFR

101.14(a)(4) 1.5

2002P-0505

07/14/2003

RACC

10
1

A
C

101.14(e)(6)

21
CFR 101.9(f)(1)

(2)

174

.
21 CFR

101.14(a)(4)50 g

4 g

RACC 11 g

(3)

21

CFR 101.14(a)(4)RACC 13 g

4 g 60 mg

480 mg

21 CFR 101.14(a)(4)
50 g
4 g

21
CFR101.62(c)(2)
50 g

21 CFR101.62(d)(2)

4 g

RACC 10 1
A C
21
CFR 101.14(e)(6)

175

21 CFR 101.14(a)(4)

RACC 10 1

2002P-029

A C

03/09/2004

101.14(e)(6)

11.5

FDA

FDA

176

-3

EPADHA

-3

2003Q-0401
09/08/2004

09/08/2004
Martek

EPADHA

EPADHA-3

RACC5 g
RACC1
RACC5 g
50 g
13.0 g

RACC5 g

RACC30 g2

[]1[

]EPA

DHA-3
[

1EPADHA

RACC50 g13.0 g

-3
-3

RACC16.0 g
RACC13.0 g

21 CFR 101 9(f)(1)

177

RACC30 g
2
RACC50 g13.0 g
1
26.0 g119.5 g

RACC1 g

15

RACC4.0 gRACC30 g
2RACC50 g4.0
g

RACC1 g

15100 g1 g

10

(21 CFR 101.62(c)(2))

CFR
(21 CFR 101.62(c)(3))

RACC5 g
50 g60 mg
RACC5 g

RACC5 g

50 g20 mg

178

RACC100 g
95 mg
RACC60 mg

(21 CFR
101.62(d)(2))

21 CFR101.62(d)(2)

RACC30 g
2RACC
50 g480 mg1
960 mg1720 mg

10
10

RACCA 500 IUC 6 mg

1.8 mg100 mg5
g10
(21 CFR 101.14(e)(6))

179

1223

21 CFR 101.14(a)(4)

2003Q-0559
11/01/2004

50
(21

RACC6 g CFR 101.14(e)(3))

(21CFR
101.62(d)(2))50 g
4 g

RACC6 g

(21
CFR 101.62(d)
(2))50 g4 g

1
[x]

RACC
101RACC
AC
(21 CFR 101.14(e)(6))

RACC6 g
(21CFR 101.62(c)(2))

1
[x]

*(1)

(21CFR 101.62(d)

(2))10

A
C

(2)
(21 CFR 166.110)

(3)

(4)

180

(5)

181

RACC30 g

RACC4 g

RACC
30 g
50 g4
g

RACC6 g

(21 CFR
101.62
(d)(2))RACC4 g

(21 CFR
101.13 (l))
(21 CFR
101.13(m))

182

21 CFR 101.14(a)(4)

(1) 2

2004Q-0083

FDA

06/30/2005

FDA

FDA21 CFR 101.14(e)(6)10 (2) 1

FDA21 CFR 101.14(e)(6)

FDA

2004Q-0144

FDA

21 CFR101.54(b)

RACC24 mg FDA

08/25/2005

183

21 CFR101.54(b)

RACC200 mg

(21 CFR

2004Q-0097

101.72(c)(ii)(B))
U.S.P

10/12/2005

U.S.P

(21 CFR 101.72(c)(ii)(C))

FDA

FDA

21 CFR101.54(b)

RACC200 mg

2004Q-0098

(21 CFR

10/12/2005

101.72(c)(ii)(B))
U.S.P
U.S.P

(21 CFR 101.72(c)(ii)(C)

FDA

14

FDA

13

184

FDA

185

(1)

(2) 8.37

2004Q-0201

211

FDA

11/08/2005

112

11/08/2005

FDA

FDA

FDA

186

119

21 CFR 101.14(a)(4)
RACC4.75 g

2006Q-0091

10/06/2006

(21CFR 101.62(c)
(2))
(21CFR 101.62(d)
(2))

(21CFR 101.14(a)(4)).

.
RACC
101RACC
AC
(21 CFR 101.14(e)(6))

10

(21
CFR 101.14(e)(6))

1[x]

(1)

(2)

(21 CFR 166.110)

(3)

(4)

(5)

187

21 CFR101.14(a)(4) 16

RACC4 g

50

2006P-0243

(21 CFR 101.14(e)(3))

3/26/2007

21
CFR 101.62(d)

(2)

(21 CFR 101.14(a)(4))

RACC4 g

RACC
101RACC
AC
(21 CFR 101.14(e)(6))

(21 CFR 101.62(d)(2))

(21
CFR 101.14(a)(4))50 g

RACC4 g

1[x]

(21CFR 101.62(c)(2))

21

CFR 101.62(d)
(2)

4 g

(1)

FDA

RACC4 g

(2)
2

(3)
(21
CFR 166.110)

(4)

(5)

(6)

188

189

21 CFR 101.14(a)
(4)RACC
10
AC

4 g

RACC4 g

(21
CFR 101.62(d)
(2))

(21CFR 101.14(a)
(4))10
A
C

RACC30g

4g

RACC30g

50g4g

190

FDA-2008Q-0323
06/19/2009

101.14(d)(2)(vii)

RACC20

1
FDA

DV
20DV14 4
3

FDA

FDA

191

1 1000 mg

FDA-2008Q-0299
06/19/2009

C 1 670 mg 11
E C

101.14(d)(2)(vii)

RACC20
DV
20%DV12 mgE
20%DV6 IU

FDA
C

1
E

FDAE

21
E

FDAE
* 2000

E1500

IUE

2200IU

mg0.67

192

X RRR-a-tocopherolIU= 0.45 X

rac-a-tocopherol2000

IOM20006

13. E:

FDA

FDA
A Labeling Guide for Restaurants and Other Retail Establishments Selling Away From-Home Foods

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053455.htm
FDA Nutrition Labeling ManualA Guide for Developing and Using DatabasesFDA

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm063113.htm
Small Business Nutrition Labeling Exemption
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053857.htm

Food and Drug Administration Modernization Act of 1997, Public Law 105-1151997 105-115
GPO(869-033-00116-9)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstothe
FDCAct/FDAMA/FullTextofFDAMAlaw/default.htm
Compilation of Laws Enforced by the United States Food and Drug Administration and Related Statutes

V. 1 (1996)
GPO017-012-00378-81996

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm and
http://www.fda.gov/RegulatoryInformation/Legislation/ucm153119.htm
Title 21, Code of Federal Regulations 21 CFR GPOFDA

199
100169
170199
8001299

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Superintendent of Documents
Government Printing Office
Washington, DC. 20402
(202) 512-1800

193

 GPO
FDA

194

14. F:

1
2 1) 1
DRV 2) 1 RDI

DRV 4
RDI DRV

RDI 4

DRV RDI 1 1
DV%DV
4
DV
2000 4 DV

A
C

D
E
K

DV
65 grams (g)
20 g
300 milligrams (mg)
2,400 mg
3,500 mg
300 g
25 g
50 g
5,000 International Units (IU)
60 mg
1,000 mg
18 mg
400 IU
30 IU
80 micrograms (g)
1.5 mg
1.7 mg

DV
20 mg

B6

2 mg

400 g

B12

6 g

300 g

10 mg

1,000 mg

150 g

400 mg

15 mg

70 g

2 mg

2 mg

120 g

75 g

3,400 mg

DV 1 DV
()
DV

195


21
CFR 101.9(c)
21 CFR 101.9(c)(9) DRV 21 CFR 101.9(c)(8)(iv)
RDI

196

15. G:

4
1

58 FR 2206 at 2213;1993 1
6 IUmg
mcgg
4
mg
mcg 60 FR 67164 to 67174

1,500

2,500

8,000

IU

35

40

60

mg

600

800

1,300

mg

15

10

18

mg

400

400

400

IU

10

30

IU

0.5

0.7

1.7

mg

0.6

0.8

2.0

mg

20

mg

B6

0.4

0.7

2.5

mg

100

200

800

mcg

mcg

50

150

300

mcg

10

mg

500

800

1,300

mg

45

70

150

mcg

70

200

450

mg

15

mg

0.6

1.0

2.0

mg

B12

197

198

16. H:
FDA

(1)

5 0
50 5
50 10

0.5 g 0
5 g 0.5g
5 g 1 g

0.5 g

(3)

2 mg 0
25 mg5 mg
5 mg 5 mg

2 mg

(4)

5 mg 0
5 140 mg5 mg
140 mg 10 mg

5 mg

0.5 g 0
1 g 1 g 1 g
1 g 1 g

1 g

0.5 g 0
1 g 1 g 1 g
1 g 1 g

0.5 g

0.5 g 0
1 g 1 g 1 g
0.5 g 1 g 1 g
1 g 1 g

1 g

(1)(ii)
(1)(iii)
(2)
(2)(i)
(2)(ii)
(2)(iii)
(2)(iv)

(5)
(6)
(6)(i)
(6)(ii)

(6)(i)(A)&(B)&(6)(ii)
(6)(iii)
(6)(iv)
(7)

RDI DV 1%DV

1DV

(8)(iii)

199

RDI2
(1) 12%DV
(2) 0
(3)
1
2
(4) AC

()

RDI2

DV

RDI102%DV
RDI10505%DV
RDI5010%DV

DV

A RDI102%DV
A RDI10505%DV
A RDI5010%DV

1 g 2 2.52.99 g
3 g2 2.01 g2.49 g2 g
%DV when the %DV 2
2.52.99)32 2.012.49
2

200

201

200910

202