[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.108]
[Page 160-169]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 101_FOOD LABELING--Table of Contents
Subpart G_Exemptions From Food Labeling Requirements
Sec. 101.108 Temporary exemptions for purposes of conducting authorized
food labeling experiments.
(a) The food industry is encouraged to experiment voluntarily, under
controlled conditions and in collaboration with the Food and Drug
Administration, with and other formats for presenting nutrition and
other related food labeling information that is consistent with the
current quantitative system in Sec. Sec. 101.9 and 105.66 of this
chapter.
(b) Any firm that intends to undertake a labeling experiment that
requires exemptions from certain requirements of Sec. Sec. 101.9 and
105.66 of this chapter should submit a written proposal containing a
thorough discussion of each of the following information items that
apply to the particular experiment:
(1) A description of the labeling format to be tested;
(2) A statement of the criteria to be used in the experiment for
assigning foods to categories, e.g., nutrient or other values defining
``low'' and ``reduced'';
(3) A draft of the material to be used in the store, e.g., shelf
tags, booklets, posters, etc.;
(4) The dates on which the experiment will begin and end and on
which a written report of analysis of the experimental data will be
submitted to FDA, together with a commitment not to continue the
experiment beyond the proposed ending date without FDA approval;
(5) The geographic area or areas in which the experiment is to be
conducted;
(6) The mechanism to measure the effectiveness of the experiment;
(7) The method for conveying to consumers the required nutrition and
other labeling information that is exempted from the label during the
experiment;
(8) The method that will be or has been used to determine the actual
nutritional characteristics of foods for which a claim is made; and
(9) A statement of the sections of the regulations for which an
exemption is sought.
(c) The written proposal should be sent to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. The proposal should be clearly identified
as a request for a temporary exemption for purposes of conducting
authorized food labeling experiments and submitted as a citizen petition
under Sec. 10.30 of this chapter.
(d) Approval for food labeling experiments will be given by FDA in
writing. Foods labeled in violation of existing regulations will be
subject to regulatory action unless an FDA-approved exemption to the
specific regulation has been granted for that specific product.
(e) Reporting requirements contained in Sec. 101.108(b) have been
approved by this Office of Management and Budget and assigned number
0910-0151.
[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62
FR 15343, Mar. 31, 1997]
[[Page 161]]
Appendix A to Part 101--Monier-Williams Procedure (With Modifications)
for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food
and Drug Administration (November 1985)
The AOAC official method for sulfites (Official Methods of Analysis,
14th Edition, 20.123-20.125, AOAC INTERNATIONAL) has been modified, in
FDA laboratories, to facilitate the determination of sulfites at or near
10 ppm in food. Method instructions, including modifications, are
described below.
Apparatus--The apparatus shown diagrammatically (Figure 1) is
designed to accomplish the selective transfer of sulfur dioxide from the
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen
peroxide. This apparatus is easier to assemble than the official
apparatus and the back pressure inside the apparatus is limited to the
unavoidable pressure due to the height of the 3%
H2O2 solution above the tip of the bubbler (F).
Keeping the backpressure as low as possible reduces the likelihood that
sulfur dioxide will be lost through leaks.
The apparatus should be assembled as shown in Fig. 1 with a thin
film of stopcock grease on the sealing surfaces of all the joints except
the joint between the separatory funnel and the flask. Each joint should
be clamped together to ensure a complete seal throughout the analysis.
The separatory funnel, B, should have a capacity of 100 ml or greater.
An inlet adapter, A, with a hose connector (Kontes K-183000 or
equivalent) is required to provide a means of applying a head of
pressure above the solution. (A pressure equalizing dropping funnel is
not recommended because condensate, perhaps with sulfur dioxide, is
deposited in the funnel and the side arm.) The round bottom flask, C, is
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D,
(Kontes K-179000 or equivalent) should be of sufficient length to permit
introduction of the nitrogen within 2.5 cm of the bottom of the flask.
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a
jacket length of 300 mm. The bubbler, F, was fabricated from glass
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm and
a depth of 18 cm.
Buret--A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with
overflow tube and hose connections for an Ascarite tube or equivalent
air scrubbing apparatus. This will permit the maintenance of a carbon
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
Chilled Water Circulator--The condensor must be chilled with a
coolant, such as 20% methanol-water, maintained at 5 [deg]C. A
circulating pump equivalent to the Neslab Coolflow 33 is suitable.
Reagents
(a) Aqueous hydrochloric acid, 4N.--For each analysis prepare 90 ml
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid
(12N) to 60 ml of distilled water.
(b) Methyl red indicator--Dissolve 250 mg of methyl red in 100 ml
ethanol.
(c) Hydrogen peroxide solution, 3%--Dilute ACS reagent grade 30%
hydrogen peroxide to 3% with distilled water. Just prior to use, add
three drops of methyl red indicator and titrate to a yellow end-point
using 0.01N sodium hydroxide. If the end-point is exceeded discard the
solution and prepare another 3% H2O2 solution.
(d) Standardized titrant, 0.01N NaOH--Certified reagent may be used
(Fisher SO-5-284). It should be standardized with reference standard
potassium hydrogen phthalate.
(e) Nitrogen--A source of high purity nitrogen is required with a
flow regulator that will maintain a flow of 200 cc per minute. To guard
against the presence of oxygen in the nitrogen, an oxygen scrubbing
solution such as an alkaline pyrogallol trap may be used. Prepare
pyrogallol trap as follows:
1. Add 4.5 g pyrogallol to the trap.
2. Purge trap with nitrogen for 2 to 3 minutes.
3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml
distilled water (caution: heat).
4. Add the KOH solution to the trap while maintaining an atmosphere
of nitrogen in the trap.
Determination
Assemble the apparatus as shown in Fig. 1. The flask C must be
positioned in a heating mantle that is controlled by a power regulating
device such as Variac or equivalent. Add 400 ml of distilled water to
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of 4N
hydrochloric acid to the separatory funnel. Begin the flow of nitrogen
at a rate of 20010 cc/min. The condenser coolant
flow must be initiated at this time. Add 30 ml of 3% hydrogen peroxide,
which has been titrated to a yellow end-point with 0.01N NaOH, to
container G. After fifteen minutes the apparatus and the distilled water
will be thoroughly de-oxygenated and the apparatus is ready for sample
introduction.
Sample preparation (solids)--Transfer 50 g of food, or a quantity of
food with a convenient quantity of SO2 (500 to 1500 mcg
SO2), to a food processor or blender. Add 100 ml of 5%
ethanol in water and briefly grind the mixture. Grinding or blending
should be continued only until the food is chopped into pieces small
enough to pass through the 24/40 point of flask C.
[[Page 162]]
Sample preparation (liquids)--Mix 50 g of the sample, or a quantity
with a convenient quantity of SO2 (500 to 1500 mcg
SO2), with 100 ml of 5% ethanol in water.
Sample introduction and distillation--Remove the separatory funnel
B, and quantitatively transfer the food sample in aqueous ethanol to
flask C. Wipe the tapered joint clean with a laboratory tissue, apply
stopcock grease to the outer joint of the separatory funnel, and return
the separatory funnel, B, to tapered joint flask C. The nitrogen flow
through the 3% hydrogen peroxide solution should resume as soon as the
funnel, B, is re-inserted into the appropriate joint in flask C. Examine
each joint to ensure that it is sealed.
Apply a head pressure above the hydrochloric acid solution in B with
a rubber bulb equipped with a valve. Open the stopcock in B and permit
the hydrochloric acid solution to flow into flask C. Continue to
maintain sufficient pressure above the acid solution to force the
solution into the flask C. The stopcock may be closed, if necessary, to
pump up the pressure above the acid and then opened again. Close the
stopcock before the last few milliliters drain out of the separatory
funnel, B, to guard against the escape of sulfur dioxide into the
separatory funnel.
Apply the power to the heating mantle. Use a power setting which
will cause 80 to 90 drops per minute of condensate to return to the
flask from condenser, E. After 1.75 hours of boiling the contents of the
1000 ml flask and remove trap G.
Titration.--Titrate the contents with 0.01N sodium hydroxide.
Titrate with 0.01N NaOH to a yellow end-point that persists for at least
twenty seconds. Compute the sulfite content, expressed as micrograms
sulfur dioxide per gram of food (ppm) as follows:
ppm=(32.03xVB xNx1000)/Wt
where 32.03=milliequivalent weight of sulfur dioxide;
VB=volume of sodium hydroxide titrant of normality, N,
required to reach endpoint; the factor, 1000, converts milliequivalents
to microequivalents and Wt=weight (g) of food sample introduced into the
1000 ml flask.
[[Page 163]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.362
Figure 1. The optimized Monier-Williams apparatus. Component
identification is given in text.
[[Page 164]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.363
Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in mm.
[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]
Appendix B to Part 101--Graphic Enhancements Used by the FDA
[[Page 165]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.364
[[Page 166]]
[GRAPHIC] [TIFF OMITTED] TR11JY03.006
[58 FR 17332, Apr. 2, 1993, as amended at 70 FR 41506, July 11, 2005]
[[Page 167]]
Appendix C to Part 101--Nutrition Facts for Raw Fruits and Vegetables
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total fat Saturated Cholesterol Sodium Potassium Total Dietary Sugars Protein Vitamin Vitamin Calcium Iron
Nutrition facts \1\ for raw fruits and vegetables edible Calories --------------- fat ------------------------------------------ Carbohydrate Fiber ----------------- A C ---------------
portion Calories from fat -------------- ---------------------------- ------------------
(g) (%) (g) (%) (mg) (%) (mg) (%) (mg) (%) (g) (%) (g) (%) (g) (g) (%) (%) (%) (%)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Banana, 1 medium (126 g/4.5 oz)............................... 110 0 0 0 0 0 0 0 0 0 400 11 29 10 4 16 21 1 0 15 0 2
Apple, 1 medium (154 g/5.5 oz)................................ 80 0 0 0 0 0 0 0 0 0 170 5 22 7 5 20 16 0 2 8 0 2
Watermelon, \1/18\ medium melon; 2 cups diced pieces (280 g/ 80 0 0 0 0 0 0 0 10 0 230 7 27 9 2 8 25 1 20 25 2 4
10.0 oz).....................................................
Orange, 1 medium (154 g/5.5 oz)............................... 70 0 0 0 0 0 0 0 0 0 260 7 21 7 7 28 14 1 2 130 6 2
Cantaloupe, \1/4\ medium (134 g/4.8 oz)....................... 50 0 0 0 0 0 0 0 25 1 280 8 12 4 1 4 11 1 100 80 2 2
Grapes, 1\1/2\ cups (138 g/4.9 oz)............................ 90 10 1 2 0 0 0 0 0 0 270 8 24 8 1 4 23 1 2 25 2 2
Grapefruit, \1/2\ medium (154 g/5.3 oz)....................... 60 0 0 0 0 0 0 0 0 0 230 7 16 5 6 24 10 1 15 110 2 0
Strawberries, 8 medium (147 g/5.3 oz)......................... 45 0 0 0 0 0 0 0 0 0 270 8 12 4 4 16 8 1 0 160 2 4
Peach, 1 medium (98 g/3.5 oz)................................. 40 0 0 0 0 0 0 0 0 0 190 5 10 3 2 8 9 1 2 10 0 0
Pear, 1 medium (166 g/5.9 oz)................................. 100 10 1 2 0 0 0 0 0 0 210 6 25 8 4 16 17 1 0 10 2 0
Nectarine, 1 medium (140 g/5.0 oz)............................ 70 0 0.5 1 0 0 0 0 0 0 300 9 16 5 2 8 12 1 4 15 0 2
Honeydew Melon, \1/10\ medium melon (134 g/4.8 oz)............ 50 0 0 0 0 0 0 0 35 1 310 9 13 4 1 4 12 1 2 45 0 2
Plums, 2 medium (132 g/4.7 oz)................................ 80 10 1 2 0 0 0 0 0 0 220 6 19 6 2 8 10 1 6 20 0 0
Avocado, California, \1/5\ medium (30 g/1.1 oz)............... 55 45 5 8 1 5 0 0 0 0 170 5 3 1 3 12 0 1 0 4 0 0
Lemon, 1 medium (58 g/2.1 oz)................................. 15 0 0 0 0 0 0 0 5 0 90 3 5 2 1 4 1 0 0 40 2 0
Pineapple, 2 slices, 3'' diameter, \3/4\'' thick (112 g/4 oz). 60 0 0 0 0 0 0 0 10 0 115 3 16 5 1 4 13 1 0 25 2 2
Tangerine, 1 medium (109 g/3.9 oz)............................ 50 0 0.5 1 0 0 0 0 0 0 180 5 15 5 3 12 12 1 0 50 4 0
Sweet cherries, 21 cherries; 1 cup (140 g/5.0 oz)............. 90 0 0.5 1 0 0 0 0 0 0 300 9 22 7 3 12 19 2 2 15 2 2
Kiwifruit, 2 medium (148 g/5.3 oz)............................ 100 10 1 2 0 0 0 0 0 0 480 14 24 8 4 16 16 2 2 240 6 4
Lime, 1 medium (67 g/2.4 oz).................................. 20 0 0 0 0 0 0 0 0 0 75 2 7 2 2 8 0 0 0 35 0 0
Potato, 1 medium (148 g/5.3 oz)............................... 100 0 0 0 0 0 0 0 0 0 720 21 26 9 3 12 3 4 0 45 2 6
Iceberg lettuce, \1/6\ medium head (89 g/3.2 oz).............. 15 0 0 0 0 0 0 0 10 0 120 3 3 1 1 4 2 1 4 6 2 2
Tomato, 1 medium (148 g/5.3 oz)............................... 35 0 0.5 1 0 0 0 0 5 0 360 10 7 2 1 4 4 1 20 40 2 2
Onion, 1 medium (148 g/5.3 oz)................................ 60 0 0 0 0 0 0 0 5 0 240 7 14 5 3 12 9 2 0 20 4 2
Carrot, 7'' long, 1\1/4\'' diameter (78 g/2.8 oz)............. 35 0 0 0 0 0 0 0 40 2 280 8 8 3 2 8 5 1 270 10 2 0
Celery, 2 medium stalks (110 g/3.9 oz)........................ 20 0 0 0 0 0 0 0 100 4 350 10 5 2 2 8 0 1 2 15 4 2
Sweet corn, kernels from 1 medium ear (90 g/3.2 oz)........... 80 10 1 2 0 0 0 0 0 0 240 7 18 6 3 12 5 3 2 10 0 2
Broccoli, 1 medium stalk (148 g/5.3 oz)....................... 45 0 0.5 1 0 0 0 0 55 2 540 15 8 3 5 20 3 5 15 220 6 6
Green cabbage, \1/12\ medium head (84 g/3.0 oz)............... 25 0 0 0 0 0 0 0 20 1 190 5 5 2 2 8 3 1 0 70 4 2
Cucumber, \1/3\ medium (99 g/3.5 oz).......................... 15 0 0 0 0 0 0 0 0 0 170 5 3 1 1 4 2 1 4 10 2 2
Bell pepper, 1 medium (148 g/5.3 oz).......................... 30 0 0 0 0 0 0 0 0 0 270 8 7 2 2 8 4 1 8 190 2 2
Cauliflower, \1/6\ medium head (99 g/3.5 oz).................. 25 0 0 0 0 0 0 0 30 1 270 8 5 2 2 8 2 2 0 100 2 2
[[Page 168]]
Leaf lettuce, 1\1/2\ cups shredded (85 g/3.0 oz).............. 15 0 0 0 0 0 0 0 30 1 230 7 4 1 2 8 2 1 40 6 4 0
Sweet Potato, medium, 5'' long, 2'' diameter (130 g/4.6 oz)... 130 0 0 0 0 0 0 0 45 2 350 10 33 11 4 16 7 2 440 30 2 2
Mushrooms, 5 medium (84 g/3.0 oz)............................. 20 0 0 0 0 0 0 0 0 0 300 9 3 1 1 4 0 3 0 2 0 2
Green onion, \1/4\ cup chopped (25 g/0.9 oz).................. 10 0 0 0 0 0 0 0 5 0 70 2 2 1 1 4 1 0 2 8 0 0
Green (snap) beans, \3/4\ cup cut (83 g/3.0 oz)............... 25 0 0 0 0 0 0 0 0 0 200 6 5 2 3 12 2 1 4 10 4 2
Radishes, 7 radishes (85 g/3.0 oz)............................ 15 0 0 0 0 0 0 0 25 1 230 7 3 1 0 0 2 1 0 30 2 0
Summer squash, \1/2\ medium (98 g/3.5 oz)..................... 20 0 0 0 0 0 0 0 0 0 260 7 4 1 2 8 2 1 6 30 2 2
Asparagus, 5 spears (93 g/3.3 oz)............................. 25 0 0 0 0 0 0 0 0 0 230 7 4 1 2 8 2 2 10 15 2 2
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Raw, edible weight portion. Percent (%) Daily Values are based on a 2,000 calorie diet.
[61 FR 42761, Aug. 16, 1996]
Appendix D to Part 101--Nutrition Facts for Cooked Fish
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total fat Saturated fat Cholesterol Sodium Potassium Total Dietary
Calories ------------------------------------------------------------------------ carbohydrate fiber Sugars Protein Vitamin Vitamin Calcium Iron
Nutrition facts\1\ fish (84 g/3 oz) Calories from fat ---------------------------- (g) (g) A (%) C (%) (%) (%)
(g) (%) (g) (%) (mg) (%) (mg) (%) (mg) (%) (g) (%) (g) (%)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shrimp....................................................... 80 10 1 2 0 0 165 55 190 8 140 4 0 0 0 0 0 18 0 0 2 15
Cod.......................................................... 90 0 0.5 1 0 0 45 15 60 3 450 13 0 0 0 0 0 20 0 0 2 2
Pollock...................................................... 90 10 1 2 0 0 80 27 110 5 360 10 0 0 0 0 0 20 0 0 0 2
Catfish...................................................... 140 80 9 14 2 10 50 17 40 2 230 7 0 0 0 0 0 17 0 0 0 0
Scallops, about 6 large or 14 small.......................... 120 10 1 2 0 0 55 18 260 11 280 8 2 1 0 0 0 22 0 0 2 2
Salmon, Atlantic/Coho........................................ 160 60 7 11 1 5 50 17 50 2 490 14 0 0 0 0 0 22 0 0 0 4
Salmon, Chum/Pink............................................ 130 35 4 6 1 5 70 23 65 3 410 12 0 0 0 0 0 22 2 0 0 2
Salmon, Sockeye.............................................. 180 80 9 14 1.5 8 75 25 55 2 320 9 0 0 0 0 0 23 4 0 0 2
Flounder/sole................................................ 100 14 1.5 2 0.5 3 60 20 90 4 290 8 0 0 0 0 0 21 0 0 2 2
Oysters, about 12 medium..................................... 100 35 3.5 5 1 5 115 38 190 8 390 11 4 1 0 0 0 10 0 0 6 45
Orange roughy................................................ 80 10 1 2 0 0 20 7 70 3 330 9 0 0 0 0 0 16 0 0 0 0
Mackerel, Atlantic/Pacific................................... 210 120 13 20 1.5 8 60 20 100 4 400 11 0 0 0 0 0 21 0 0 0 5
Ocean perch.................................................. 110 20 2 3 0 0 50 17 95 4 290 8 0 0 0 0 0 21 0 0 10 6
Rockfish..................................................... 100 20 2 3 0 0 40 13 70 3 430 12 0 0 0 0 0 21 4 0 0 2
Whiting...................................................... 110 25 3 5 0.5 3 70 23 95 4 320 9 0 0 0 0 0 19 2 0 6 0
Clams, about 12 small........................................ 100 15 1.5 2 0 0 55 18 95 4 530 15 0 0 0 0 0 22 10 0 6 60
Haddock...................................................... 100 10 1 2 0 0 80 27 85 4 340 10 0 0 0 0 0 21 0 0 2 6
Blue crab.................................................... 100 10 1 2 0 0 90 30 320 13 360 10 0 0 0 0 0 20 0 0 8 4
Rainbow trout................................................ 140 50 6 9 2 10 60 20 35 1 370 11 0 0 0 0 0 21 4 4 6 2
Halibut...................................................... 110 20 2 3 0 0 35 12 60 3 490 14 0 0 0 0 0 23 2 0 4 4
[[Page 169]]
Lobster...................................................... 80 0 0.5 1 0 0 60 20 320 13 300 9 1 0 0 0 0 17 0 0 4 2
Swordfish.................................................... 130 35 4.5 7 1 5 40 13 100 4 310 9 0 0 0 0 0 22 2 2 0 4
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Cooked, edible weight portion. Percent (%) Daily Values are based on a 2,000 calorie diet.
[61 FR 42761, Aug. 16, 1996]
[[Page 170]]