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M E M O RA N D UM
V iaE lectronic M ail
TO:
Clients and Interested Parties
DATE:
June 2, 2016
RE:
FDA Issues Final Rule Revising the Nutrition and Supplement Facts Labels
On May 27, 2016, the Food and Drug Administration (FDA) issued its final rule on Food
Labeling: Revision of the Nutrition and Supplement Facts Labels.1 The final rule amends
existing regulations under 21 CFR 101.9 (“Nutrition labeling of food”) and 101.36 (“Nutrition
labeling of dietary supplements”). FDA issued a proposed rule on March 3, 2014 and a
supplemental rule on July 27, 2015.2 The final rule largely tracks the proposed rule, as modified
by the supplemental rule. The final rule: (1) updates the list of nutrients that are required or
permitted to be declared; (2) provides updated Daily Reference Values and Reference Daily
Intakes; (3) amends requirements for foods represented or purported to be specifically for
children under the age of 4 years, pregnant and lactating women and establishes nutrient
reference values specifically for these population subgroups; and (4) revises the format and
appearance of the Nutrition and Supplement Facts labels.
The final rule is intended to assist consumers in maintaining healthy dietary practices by
providing updated information on nutrition and supplement facts label and improving how the
nutrition information is presented to consumers. This final rule has been issued in conjunction
with FDA’s Final Rule on Serving Sizes of Foods That Can Reasonably Be Consumed at One
Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain
1
Final Rule: 81 Fed. Reg. 33741 (May 27, 2016), available at https://www.gpo.gov/fdsys/pkg/FR2016-05-27/pdf/2016-11867.pdf.
2
Proposed Rule: 79 Fed. Reg. 11880 (Mar. 3, 2014), available at
http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04387.pdf; Supplemental Rule: 80 Fed. Reg.
44303 (July 27, 2015), available at https://www.gpo.gov/fdsys/pkg/FR-2015-07-27/pdf/2015-17928.pdf.
Washington, D.C.
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Reference Amounts Customarily Consumed,3 which (1) changes Reference Amounts
Customarily Consumed (RACCs) for certain foods; (2) creates new reference amount categories
and reference amounts; (3) amends the definition of a single-serving container; and (4) requires
dual column nutrition labeling for certain food containers.
Although the final rule is effective on July 26, 2016, companies generally have until
July 26, 2018 to comply, except that manufacturers with less than $10 million in annual food
sales have until July 26, 2019.
I.
S u m maryof FinalRu le
As noted above, the final rule addressed (1) the list of nutrients that are required or
permitted to be declared; (2) Daily Reference Values and Reference Daily Intakes; (3) labeling
requirements for foods represented or purported to be specifically for children under the age of 4
years and pregnant and lactating women and nutrient reference values specifically for these
population subgroups; and (4) the format and appearance of the Nutrition and Supplement Facts
labels. A summary of each of these changes is provided below.
A.
N u trients Requ ired orP ermitted to be D eclared
1.
A d d ed S u gar
Consistent with the supplemental proposed rule, FDA will require a declaration of the
amount of added sugars and percentage daily value if a product contains 1 gram or more of
added sugars in a serving, or if claims are made about sweeteners, sugars, or sugar alcohol
content.
a.
Definition of Added Sugar
The final rule revises the proposed definition of added sugars in response to issues raised
in the comments. The final rule defines “added sugars” to mean “sugars [that] are either added
during the processing of foods, or are packaged as such.” The term includes:
 sugars (free, mono- and disaccharides);
 sugars from syrups and honey; and
3
See Final Rule on Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating
Occasion; Dual-Column Labeling; and Updating, Modifying, and Establishing Certain Reference
Amounts Customarily Consumed, 81 Fed. Reg. 34000 (May 27, 2016), available at
https://www.federalregister.gov/articles/2016/05/27/2016-11865/food-labeling-serving-sizes-of-foodsthat-can-reasonably-be-consumed-at-one-eating-occasion.
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 sugars from concentrated fruit or vegetable juices that are in excess of what would
be expected from the same volume of 100% fruit or vegetable juice of the same
type.
The following are explicitly excluded from the definition of added sugars:
 fruit or vegetable juice concentrated from 100% juices sold to consumers;
 fruit or vegetable juice concentrates used towards the total juice
percentage label declaration under 21 CFR 101.30 or for Brix
standardization under 21 CFR 102.33(g)(2);
 fruit juice concentrates which are used to formulate the fruit component of
jellies, jams, or preserves in accordance with the standard of identities set
forth in 21 CFR 150.140 and 150.160; and
 the fruit component of fruit spreads.
This definition differs from FDA’s proposal in that the final rule provides more
detail on what would and would not be considered added sugar, and removes portions of
the definition that would have inadvertently captured ingredients that FDA does not
consider to be added sugars, such as dairy ingredients.
b.
Daily Value for Added Sugar
Consistent with the supplemental proposed rule, FDA is establishing a daily
recommended value for added sugars of 50 grams for children and adults 4 years of age and
older. This figure is based on the Agency’s finding that limiting consumption of added sugars to
10% of daily calories would assist consumers in choosing and maintaining a healthful dietary
pattern.4
In response to comments arguing that FDA does not have a scientific basis to establish a
DRV for added sugars, the Agency stated that the underlying evidence used to support the
S cientific Reportof the 2
0 1 5D ietary Gu id elines A d visory C ommittee (2015 DGAC Report)
provides a basis for FDA to establish a DRV for added sugars. The 2015 DGAC Report
recommended that Americans limit their consumption of added sugars to a maximum of 10% of
total calories based on modeling of dietary patterns, current added sugars consumption data, and
a published meta-analysis on sugars intake and body weight.
c.
4
Requirements for Added Sugar Declaration
The DRV of 50 grams was determined by first multiplying the 2,000 reference calorie intake by
10 percent (2,000 × 0.1 = 200 calories) and then by dividing the resulting 200 calories by 4 calories per
gram for carbohydrates (200 ÷ 4 = 50 grams).
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To address concerns regarding consumer understanding of an “Added Sugars”
declaration, FDA is requiring that the term “Total Sugars” be used instead of “Sugars”, and that
the declaration of added sugars, indented under “Total Sugars”, be prefaced by the word
“Includes” (i.e., “Includes __ g Added Sugars”). This wording is intended to provide a clearer
distinction between total and added sugars and to prevent consumers from confusing the “Added
Sugars” and “Sugars” declarations.
If a serving contains 1 gram or more of added sugars, the added sugars content must be
expressed to the nearest gram. As noted above, a statement of added sugars content is not
required for products that contain less than 1 gram of added sugars in a serving if no claims are
made about sweeteners, sugars, or sugar alcohol content. If the added sugars content is not
declared, the phrase “Not a significant source of added sugars” must be placed at the bottom of
the table of nutrient values. As an alternative, if a serving contains less than 1 gram, the
statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving
contains less than 0.5 gram, the content may be expressed as zero.
d.
Responses to Added Sugar Comments
FDA received numerous comments on the controversial proposal to require declaration of
added sugars content and to establish a daily value for added sugars. Principal objections, and
the Agency’s responses, include the following:
 FDA rejected arguments that the Agency does not have authority to require
declaration of added sugars, principally on the basis of its determination that “there is
adequate evidence to demonstrate that consumption of added sugars is a public health
concern.”
 The Agency disagreed with the argument that an added sugars declaration would be
false and misleading because it would convey to the reasonable consumer that added
sugars are chemically different than naturally-occurring sugars; the Agency stated
that the rationale for requiring an added sugars declaration was not based on a
physiological or chemical distinction between added and naturally-occurring sugars,
but rather its finding that consumption of too much added sugars can hinder
consumers’ ability to meet nutrient needs within calorie limits.
 FDA disagreed that it failed to demonstrate a public health significance exists for
added sugars labeling through well-established scientific evidence, arguing that
evidence shows that heathy dietary patterns associated with a decreased risk of
chronic disease are lower in sugar-sweetened foods and beverages, consumption of
too much added sugars can impact the nutrient density of the diet, and consumption
of sugar-sweetened foods and beverages is associated with increased adiposity in
children.
 The Agency rejected the contention that there is insufficient scientific evidence to
support a daily recommended value (DRV) for added sugars and that the Institute of
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Medicine (IOM) is the appropriate body to establish a Dietary Reference Intake
(DRI) upon which a DRV could be based. Although the Agency acknowledged that
a DRV derived primarily from food pattern modeling is different from a DRI
determined by the IOM, the Agency maintained that food pattern modeling is a valid
basis for deriving a DV for nutrient for which there is not a direct relationship
between consumption and disease risk.
 FDA also rejected comments arguing that certain nutrient-dense foods containing
added sugars (e.g., cranberries) should be exempted from the added sugars
declaration requirement, stating that if such an exempt were granted, consumers may
assume incorrectly that exempted products contain no added sugars. The Agency did
acknowledge that education and outreach will be needed to educate consumers that
the amount of added sugars in a serving of a product should be considered along with
other information on the label when constructing a healthy dietary pattern.
2.
D ietaryFiber
a.
Definition of Dietary Fiber
The final rule defines dietary fiber as:
 non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units)
and lignin that are intrinsic and intact in plants; and
 isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units)
determined by FDA to have physiological effects that are beneficial to human health.
FDA explains that “intrinsic and intact” includes “non-digestible carbohydrates that are created
during normal food processing (e.g., cooking, rolling, or milling)”, such as non-digestible
(resistant) starch in flaked corn cereal. However, resistant starch that has been extracted and
isolated from the flaked corn cereal is not intrinsic (part of the food matrix) and intact; these
fibers would be considered “isolated” non-digestible carbohydrates. “Synthetic non-digestible
carbohydrates” refers to fiber that is not isolated from plant sources but that is chemically
synthesized. This definition of dietary fiber is equivalent to the IOM’s definition of “total
fiber”.
b.
List of Approved “Isolated or Synthetic” Dietary Fibers
In the final rule, FDA identifies the following as isolated or synthetic non-digestible
carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological
effects that are beneficial to human health:
 [beta]-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)(A));
 psyllium husk (as described in 21 CFR 101.81(c)(2)(ii)(A)(6));
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




cellulose;
guar gum;
pectin;
locust bean gum; and
hydroxypropylmethylcellulose (HPMC).
In the preamble, FDA also states that they intend to publish a separate notice seeking
comments on the available scientific data on other non-digestible carbohydrates to determine if
they should be added to the list. In this notice, FDA will identify and summarize publically
available clinical trial data for the following non-digestible carbohydrates: inulin, bamboo fiber,
soy fiber, pea fiber, wheat fiber, cotton seed fiber, sugar cane fiber, sugar beet fiber, and oat
fiber.
c.
Procedure to Amend List of Approved “Isolated or Synthetic”
Dietary Fibers
Any interested person may seek to amend the listing of added fibers through the existing
citizen petition process in 21 CFR 10.30. In the preamble, the Agency indicates it intends to
issue a guidance document identifying the information FDA recommends be provided to
demonstrate that an isolated or synthetic non-digestible carbohydrate (with 3 or more monomeric
units) has physiological effects that are beneficial to human health. This guidance document will
also identify the approach FDA intends to use to evaluate the studies, including the approach for
evaluating the strength of the scientific evidence. The preamble states that the Agency does not
consider animal or in vitro data to be sufficient.
FDA states that “beneficial physiological effects” include (but are not limited to)
lowering total/LDL levels, lowering post-prandial glucose levels, reducing gut transit time and
improving laxation (fecal output), reduced blood pressure, and increased satiety associated with
reduced energy intake and with possible associated outcomes on body weight to be physiological
endpoints. The Agency indicated that it considers colonic fermentation and short chain fatty acid
production and modulation of the colonic microflora to be processes associated witha
physiological endpoint, rather than physiological endpoints themselves.
FDA indicated that, although it considers an isolated or synthetic fiber that is the subject
of an authorized health claim to meet the definition of dietary fiber, it is not able to make the
same determination for such a fiber that is the subject of a health claim notification submitted
under section 403(r)(3)(C) of the FD&C Act (typically referred to as a Food and Drug
Administration Modernization Act or “FDAMA” health claim). While the agency has 540 days
to publish a final rule to authorize a health claim, it has only 120 days to review FDAMA health
claims. Thus, the Agency’s position is that it may not have adequate time during a FDAMA
health claim review period to address whether the scientific evidence for a fiber that is the
subject of a FDAMA health claim notification is sufficient to amend the list of dietary fibers in
the dietary fiber definition for nutrient declaration. Accordingly, the Agency intends to consider
this issue on a case-by-case basis.
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d.
Compliance
Dietary fiber content may be determined by subtracting the amount of non-digestible
carbohydrates added during processing that do not meet the definition of dietary fiber (in
§ 101.9(c)(6)(i)) from the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent
AOAC method of analysis as given in the “Official Methods of Analysis of the AOAC
International” 19th Edition. To verify the quantity of dietary fiber when both dietary fiber that
meets the definition and other non-digestible carbohydrates are present, FDA is requiring that
manufacturers establish and maintain written records to verify the correct amount of dietary fiber
that is present in the product pursuant to the definition.
3.
C alories from Fat
Consistent with the proposed rule, FDA will no longer require and will not permit the
declaration of “Calories from fat” on the label. FDA indicated that it reviewed current scientific
evidence and consensus reports to evaluate whether information on calories from fat is necessary
to assist consumers in maintaining healthy dietary practices. The Agency determined that,
because current dietary recommendations emphasize that the intake of total calories and the type
of fat consumed are more important than information on calories from fat in maintaining healthy
dietary practices, the extra emphasis of “Calories from fat” in addition to the Total Fat
declaration is not necessary.
4.
V itamins and M inerals
FDA has finalized changes to its regulations regarding the vitamins and minerals “of
public health significance,” based on the agency’s analysis of nutrient inadequacy. Under the
final rule, manufacturers will need to declare the absolute amount (e.g., mg) and % DV of
vitamin D, calcium, iron, and potassium. Declaration of vitamins A and C will become
voluntary.
5.
Record keeping& A ccess Requ irements
Consistent with the proposed rule, manufacturers must establish and maintain written
records to support the declarations of certain nutrients under specified circumstances as follows:
 when a food contains dietary fiber (whether soluble, insoluble, or a combination
of both) and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, records to verify the amount of added non-digestible
carbohydrate that does not meet the definition of dietary fiber;
 when vitamin E is present in a food as a mixture of allrac-α-tocopherol acetate
and RRR-α-tocopherol, records to verify the amount of allrac-α-tocopherol
acetate added to the food and RRR-α-tocopherol in the finished food;
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 when a mixture of folate and folic acid is present in a food, records to verify the
amount of folic acid added to the food and folate in the finished food; and
 when added sugars as well as naturally occurring sugars are present in a food,
records to verify the declared amount of added sugars in the food.
Finally, manufacturers must make and keep records to verify the declared amount of
added sugars in specific foods, alone or in combination with naturally occurring sugars, where
the added sugars are subject to non-enzymatic browning and/or fermentation. However, for
manufacturers of such foods who are unable to reasonably approximate the amount of added
sugars in a serving of food to which the records requirements apply, the final rule allows
manufacturers to submit a petition (under 21 CFR 10.30) to request an alternative means of
compliance.
6.
O therP rovisions
In addition to the major provisions noted above, FDA also addressed a number of other
topics. Despite comments to the contrary, the final rule:
 continues to require the declaration of trans fat;
 retains the terms “soluble” and “insoluble” dietary fiber and keeps these
declarations voluntary; and
 does not adopt use of household measure or ounces to express the amount of total
fat, carbohydrate, sugars, added sugars, protein, and sodium in a product. FDA
indicated that grams are more accurate than household measures, such as
teaspoons, which are volumetric and are more precise than ounces or pounds,
because, if declarations were in terms of ounces or pounds, fractions would have
to be declared.
The Agency also finalized the following changes:
 The Agency will no longer permit the previously voluntary “other carbohydrate”
declaration;
 FDA will now permit the declaration of a product’s fluoride level; the fluoride
level may be declared as 0 if the product that contains less than 0.1 mg, to the
nearest 0.1 mg if the product contains no more than 0.8 mg, and to the nearest 0.2
mg if the product contains more than 0.8 mg; and
 The following caloric conversion are adopted:
o C arbohyd rate: 4.0 kcal/g of total carbohydrate less the amount of nondigestible carbohydrates
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o S olu ble non-d igestible carbohyd rates: 2.0 kcal/g
o Insolu ble non-d igestible carbohyd rates: not included in calorie calculation
o S u garalcohols:Isomalt—2.0 kcal/g, lactitol—2.0 kcal/g, xylitol—2.4 kcal/g,
maltitol—2.1 kcal/g, sorbitol—2.6 kcal/g, hydrogenated starch hydrolysates—
3.0 kcal/g, mannitol—1.6 kcal/g, and erythritol—0 kcal/g.
The final rule requires records to be kept for at least 2 years after introduction or delivery
for introduction of the food into interstate commerce. These record requirements are designed to
ensure that the nutrient declarations are accurate, truthful, and not misleading, based on
information known only to the manufacturer.
B .
Revisions to D ailyReference V alu es and Reference D ailyIntakes
FDA finalized its proposal to revise the DVs for certain nutrients, including fat, dietary
fiber, sodium, calcium, and vitamin D. Specifically, FDA is:
 increasing the DRV for total fat from 30% of calories to 35% of calories, which
results in a DRV of 78 grams;
 decreasing the DV for total carbohydrate from 60% of calories to 55% of calories,
which results in a DRV of 275 grams (so that the percentage of calories
contributed by total fat, total carbohydrate, and protein continues to add up to
100% on the label without reducing the DRV for protein to fall below the RDA
for protein)
 increasing the DV for dietary fiber from 25 g to 28 g;
 decreasing the DRV for sodium from 2,400 mg to 2,300 mg; and
 as discussed in Section I.A.1.b of this memorandum, establishing a DRV for
added sugars of 50 g.
The rule also finalizes a number of proposed changes to the RDIs for vitamins and
minerals, summarized below.
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V itamins:
M inerals:
N u trient
Biotin
Choline
Folate
Niacin
Pantothenic acid
Riboflavin
Thiamin
Vitamin A
Vitamin B 6
Vitamin B 12
Vitamin C
Vitamin D
Vitamin E
Vitamin K
Calcium
Chloride
Chromium
Copper
Iodine
Iron
Magnesium
Manganese
Molybdenum
Phosphorus
Potassium9
Selenium
Zinc
P reviou s RD Is
300 micrograms
550 milligrams5
400 micrograms
20 milligrams
10 milligrams
1.7 milligrams
1.5 milligrams
5,000 International Units
2.0 milligrams
6 micrograms
60 milligrams
400 International Units
30 International Units
80 micrograms
1,000 milligrams
3,400 milligrams
120 micrograms
2.0 milligrams
150 micrograms
18 milligrams
400 milligrams
2.0 milligrams
75 micrograms
1,000 milligrams
3,500 milligrams
70 micrograms
15 milligrams
Revised RD Is
30 micrograms.
550 milligrams.
400 micrograms DFE.6
16 milligrams NE.7
5 milligrams.
1.3 milligrams.
1.2 milligrams.
900 micrograms RAE.8
1.7 milligrams.
2.4 micrograms.
90 milligrams.
20 micrograms.
15 milligrams.
120 micrograms.
1,300 milligrams.
2,300 milligrams.
35 micrograms.
0.9 milligrams.
150 micrograms.
18 milligrams.
420 milligrams.
2.3 milligrams.
45 micrograms.
1,250 milligrams.
4,700 milligrams.
55 micrograms.
11 milligrams.
5
A notification was submitted in 2001 for the use of certain nutrient content claims for choline,
identifying the daily value for choline as 550 mg. This value is based on the AI set by the IOM of the
NAS in 1998.
Retinol activity equivalents (described in further detail below); 1 RAE = 1 mcg retinol, 12 mcg βcarotene, or 24 mcg α- carotene, or 24 mcg β-cryptoxanthin.
6
7
Niacin equivalents, 1 mg niacin = 60 mg of tryptophan.
8
Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food
or as a supplement consumed with food.
9
This mineral previously had a DRV and the final rule establishes an RDI.
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FDA acknowledges that some foods that are currently able to bear claims may no longer
be able to bear such claims due to these changes. FDA intends to consider in future rulemaking
whether changes to criteria for claims would assist consumers in maintaining a healthy diet and
whether such criteria should change.
C .
L abelingRequ irements forFood s forC hild ren u nd erthe A ge of 4 Y ears and
P regnantand L actatingW om en
N u trients,V itamins and M inerals Requ ired to be D eclared and P ermitted to be
D eclared :Consistent with the proposed rule and the supplemental proposed rule, the final rule:
 requires the declaration of saturated fat, trans fat, and cholesterol on food for
infants 7 through 12 months and children 1 through 3 years;
 requires the declaration of percent DV for protein on food for infants 7 through 12
months and children 1 through 3 years;
 permits the declaration of calories from saturated fat, polyunsaturated fat, and
monounsaturated fat on foods for infants 7 through 12 months and children 1
through 3 years.
 requires the declaration of added sugars on the labels of foods for infants 7
through 12 months, young children 1 through 3 years, and pregnant and lactating
women and requires declaration of percent DV for added sugars on the labels of
foods for children 1 through 3 years and pregnant and lactating women;
 permits the voluntary declaration of fluoride on foods for infants 7 through 12
months, for children 1 through 3 years, and for pregnant and lactating women;
and
 requires declaration of calcium, iron, vitamin D, and potassium on foods for
infants 7 through 12 months, for children 1 through 3 years, and for pregnant and
lactating women. Vitamin A, vitamin C and other essential vitamins and minerals
that do not have public health significance for these subpopulations may be
declared on a voluntary basis, unless they are added to foods as a nutrient
supplement or if the labeling makes a claim about them, in which case declaration
would be required.
D ailyRecom m end ed V alu es and Recom m end ed D ailyIntakes: The final rule
establishes a number of DRVs and RDIs for infants 7 through 12 months, for children 1 through
3 years, and for pregnant and lactating women and requires foods for these populations include
declarations of percent DV for those nutrients.
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A summary of the DRVs for infants 7 through 12 months, children 1 through 3 years, and
pregnant and lactating women is presented in the table below.10
N u trient
Unitof M easu re
Calories
Total Fat
Saturated Fat
Cholesterol
Carbohydrates
Sodium
Added Sugars
Dietary Fiber
Protein
Biotin
Calcium
Chloride
Choline
Chromium
Copper
Folate
Iodine
Iron
Magnesium
Manganese
Molybdenum
Niacin
Pantothenic acid
Phosphorous
Potassium
Riboflavin
Selenium
Thiamin
Vitamin A
Vitamin B 12
Vitamin B 6
Grams (g)
Grams (g)
Milligrams (mg)
Grams (g)
Milligrams (mg)
Grams (g)
Grams (g)
Grams (g)
Micrograms (mcg)
Milligrams (mg)
Milligrams (mg)
Milligrams (mg)
Micrograms (mcg)
Milligrams (mg)
Micrograms DFE (mcg)
Micrograms (mcg)
Milligrams (mg)
Milligrams (mg)
Milligrams (mg)
Micrograms (mcg)
Milligrams NE11(mg)
Milligrams (mg)
Milligrams (mg)
Milligrams (mg)
Milligrams (mg)
Micrograms (mcg)
Milligrams (mg)
Micrograms RAE (mcg)
Micrograms (mcg)
Milligrams (mg)
Infants to
12 months
N/A
30
N/A
N/A
95
N/A
N/A
N/A
11
6
260*
570
150
5.5
0.2
80
130
11*
75
0.6
3
4
1.8
275
700*
0.4
20
0.3
500
0.5
0.3
C hild ren
1 -3 years
1,000
39
10
300
150
1500
25
14
13
8
700*
1500
200
11
0.3
150
90
7*
80
1.2
17
6
2
460
3000*
0.5
20
0.5
300
0.9
0.5
P regnantW omen &
L actatingW omen
2,000
65
20
300
300
2300
50
28
71
35
1,300*
2300
550
45
1.3
600
290
27*
400
2.6
50
18
7
1,250
5100*
1.6
70
1.4
1,300
2.8
2.0
10
FDA considered but did not establish DRVs for saturated fat, trans fat, cholesterol, sodium,
dietary fiber, sugars, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, added
sugars, sugar alcohols and fluoride for infants 7 through 12 months. FDA considered but did not establish
DRVs for trans fat, polyunsatured fat, monounsaturated fat, sugars, added sugars, insoluble fiber, soluble
fiber, sugar alcohols and fluoride for children 1 through 3 years of age and for pregnant and lactating
women.
11
NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan.
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Vitamin C
Vitamin D
Vitamin E
Vitamin K
Zinc
D.
Milligrams (mg)
Micrograms (mcg)
Milligrams (mg)
Micrograms (mcg)
Milligrams (mg)
50
10*
5
2.5
3
15
15*
6
30
3
120
15*
19
90
13
N u trition L abeling
The final rule incorporates most, but not all, changes proposed in the proposed rule and
supplemental proposed rule.
O rd erof Information: Consistent with the proposed rule, the final rule reverses the
order of the servings per container and serving size declarations; inserts the declaration for
“Added Sugars” indented below the declaration for “Sugars”; inserts the declaration for Vitamin
D above Calcium; and inserts the declaration for Potassium below Iron ((§§ 101.9(c)(6)(iii) and
(c)(8)(ii)). Also, if only one sugar alcohol is used the specific name of the sugar alcohol can be
used in lieu of “sugar alcohols.”
P lacementof Information: Consistent with the proposed rule, quantitative amounts in
the “Serving size” declaration must be right-justified to emphasize information about serving
sizes.
C apitalization and W ord ing: Changes to capitalization and wording are as follows (§§
101.9(c)(6); (d)(3) – (6); (j)(13)(ii)(B)):
Form erD eclaration
Serving Size
Servings per Container
Revised D eclaration
Serving size
__ servings per container
(with the blank filled in with the appropriate number)
The final rule does not incorporate FDA’s proposal to rearrange the % DV information,
which the proposed rule would have required be placed in column to the left of the names of
nutrients and their qualitative amounts (§ 101.9(d)(12)); the proposal to use “Amount Per ___”
instead “Amount Per Serving”; nor the proposal to use “% DV” in place of “% Daily Value*” as
a column heading.
V itamins and M inerals (§§ 101.9(c)(8)(iii); (d)(7)(i)): The final rule implements FDA‘s
proposal to require a declaration of the absolute amounts for all mandatory vitamins and
minerals, as well as folic acid when added as a supplement or claims are made about the vitamin,
in addition to the requirement for percent DV declaration, but makes declaration of the absolute
amount optional for voluntary vitamins and minerals.
Type S izes (§§ 101.9(d)(1)(iii); (d)(3)(i); (d)(3)( ii); (d)(4); (d)(5)) & H ighlighting(§§
101.9(d)(1)(iii); (d)(1)(iv); (d)(3)(i); (d)(4)): The final rule implements the following minimum
type size and highlighting requirements for the Nutrition Facts label:
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D eclaration
“Nutrition Facts” heading
__ servings per container
Serving Size
Amount per serving
“Calories” heading
Numeric amount of Calories
% Daily Value column heading
Names of all nutrients that are not indented
(i.e., “Calories,” “Total Fat,” “Cholesterol,”
“Sodium,” “Total Carbs” and “Protein”)
Names of all nutrients that are indented and vitamins
and minerals (except sodium)
Percentage amounts of DRVs for all nutrients
(but not the percentage symbol)
All other information
Footnote
Caloric conversion information (when provided)
M inim u m S ize
Larger than all other
type except numeric
amount of calories
10 pt
10 pt
6 pt
16 pt
22 pt
6 pt
8 pt
H ighlighting
Bold or Extra Bold
8 pt
Not highlighted
8 pt
Bold or Extra Bold
8 pt
6 pt
6 pt
Not highlighted
Not highlighted
Not highlighted
Not highlighted
Bold or Extra Bold
Bold or Extra Bold
Bold or Extra Bold
Bold or Extra Bold
Bold or Extra Bold
Bold or Extra Bold
Ru les (§§ 101.9(d)(1)(v); (d)(12); (d)(11)(iii); (j)(5)9i); (13)(ii)(A)(1); (j)(13)(ii)(A)(2)) –
The final rule adds a horizontal hairline rule (0.25 point) to separate “Nutrition Facts” from the
servings per container statement and removes the horizontal hairline rule above the Calories
declaration. The final rule also uses a 3 point rule in place of the hairline currently used to
separate the declaration of vitamins and minerals from the footnote.
L ead ing(§ 101.9(d)(ii)(C)) – The final rule does not include any changes to minimum
leading (i.e., space between two lines of text); thus, all information within the nutrition label
must utilize at least one point leading, except that at least four points leading is required between
declarations for nutrients, vitamins, and minerals.
Footnote (§ 101.9(d)(9)(i)): The preexisting regulations required a footnote statement
that reads: “*Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be
higher or lower depending on your calorie needs.” Below this footnote, a table that lists DRVs
for total fat, saturated fat, cholesterol, sodium, total carbohydrate, and dietary fiber based on
2,000 and 2,500 calorie diets must be provided.
In the final rule, FDA eliminates the requirement for the footnote table and instead
requires a footnote stating that, “* The % Daily Value tells you how much a nutrient in a serving
of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” For
food for children 1 through 3 years of age, “1,000 calories” should replace “2,000 calories” in
the footnote.
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The footnote will not be required on products that can use the terms “calorie free,” “free
of calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or
“dietary insignificant source of calories”, as these terms are defined in § 101.60(b).
FDA has provided the example below illustrating the new requirements:
A lternate Formats (101.9(e)(5); (e)(6)(i); (e)(6)(ii); (d)(13)(ii):
Simplified format
For consistency, changes to the standard format nutrition label also apply to the
simplified format, except that a full footnote is not required. Where % DV is not spelled out in
the heading, the following abbreviated footnote must be used: “*% DV = % Daily Value”.
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Currently, the declaration of nutrition information may be presented in the simplified
format when a food product contains insignificant amounts of eight or more of the following:
Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber,
sugars, protein, vitamin A, vitamin C, calcium, and iron (§ 101.9(f)). The final rule revises this
list by including added sugars and replacing vitamin A and vitamin C with vitamin D and
potassium.
Tabular Display
As is currently the case, under the final rule, if there is not sufficient continuous vertical
space (i.e., approximately 3 inches) to accommodate the required components of the nutrition
label up to and including the mandatory declaration of potassium, the nutrition label may be
presented in a tabular display as illustrated above (§ 101.9(d)(11)(iii)).
For consistency, FDA is requiring that all other changes to the standard format nutrition
label (e.g., type size, highlighting) also apply to the tabular display, except that the Calories
declaration may be no smaller than 10 point type size and the numeric calories information may
be no smaller than 14 point type size.
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Certain additional changes are permitted when the tabular display is used on small
packages, as described below.
Tabular Display for Small Packages
Small packages are defined as those that have a total surface area available to bear
labeling of 40 or less square inches. As illustrated above, under revised § 101.9 (d)(1)(iii), in
addition to the modified type size requirements permitted for tabular displays generally, for the
tabular display for small packages, the “__servings per container” and serving size information
may be no smaller than 9 point type size. Consistent with the current regulations, the final rule
permits use of abbreviations listed in § 101.9(j)(13)(ii)(B) when the tabular display for small
packages is used. Additionally, FDA will not require the label to include the footnote or the
declaration of the absolute amount of vitamins and minerals on small packages; for these
packages, vitamins and minerals (other than sodium) need only be declared as percent DVs.
Linear display
In recognition that the proposed “linear” format would have occupied significantly more
space than the previous string format, and would not fit on many of the small packages for which
it was intended, FDA elected not to finalize the proposed changes but rather to retain the text
wrapping feature of the preexisting linear format, with updates to make it consistent with the
other format changes. As is currently the case, under the final rule, if the size of the package is
such that it will not accommodate a tabular display, the nutrition label may be presented in a
linear display as illustrated above (§ 101.9(j)(13)(ii)(A)).
The modified type size requirements for tabular display for small packages may be used
for the linear format. As with the tabular display for small packages, the final regulations permit
use of the abbreviations listed in § 101.9(j)(13)(ii)(B) when the linear display is used and,
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because of space limitations, do not require the inclusion of the absolute amount of vitamins and
minerals on packages nor the footnote.
Dual Column Labels
As illustrated in the examples that follow, the final rule adds a thin vertical line to dual
column labels (i.e., those displaying nutrition information per container and per unit, in addition
to per serving) to separate each of the dual columns and aggregate display columns from each
other.
A ggregate D isplay
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P erservingand percontainer
P erservingand peru nit
Tabu laraggregate format
II.
D ietaryS u pplements
FDA is finalizing several amendments to the regulations for dietary supplement nutrition
labeling that appear in § 101.36 so that the content and format of the Supplement Facts label
corresponds with that of the Nutrition Facts label. The changes include the following:
Requ ired D eclarations (§ 101.36(b)(2)(i)) – Declaration of vitamin A, vitamin C, or
Calories from fat is no longer required, while declaration of vitamin D, potassium, and added
sugars are required when present in amounts that cannot be declared as zero. Sugars must be
declared as “Total sugars”.
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C holine and Flu orid e (§ 101.36(b)(2)(i)(B)) – When declared, choline shall follow
pantothenic acid and calcium and iron shall be declared after choline. When declared, fluoride
shall follow potassium.
Folic acid (§ 101.36(b)(2)(i)(B)) – The Supplement Facts label must declare folate in
mcg Dietary Folate Equivalents (DFE), a percent DV based on mcg DFE, and that the mcg of
folic acid be stated in parenthesis when folic acid is added as a nutrient supplement to a dietary
supplement
V itamin A (§ 101.36(b)(2)(i)(B)(3)) – When β-carotene is stated in parentheses
following the percent statement for vitamin A, it should be declared using “mcg” (representing
mcg Retinol Activity Equivalents (RAE)).
Units of M easu re (§ 101.36(b)(2)(ii)(B)) – The units of measure for vitamin D, vitamin
E, and folate used in the Nutrition Facts label must also be used in the Supplement Facts label.
D ietaryS u pplements forS pecific S u bpopu lations – With respect to dietary
supplements that are represented or purported to be specifically for infants 7 through 12 months,
children 1 through 3 years, and pregnant and lactating women, FDA is:

Amending § 101.36(b)(2)(iii) to remove the statement that such dietary supplements
may not state the percent DV for total fat, saturated fat, cholesterol, total
carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium,
molybdenum, chloride, sodium, or potassium.

Requiring that when a product is represented or purported to be specifically for
children 1 through 3 years and contains a percent DV declaration for total fat, total
carbohydrate, dietary fiber, or protein, the footnote required under §
101.36(b)(2)(iii)(D) state “Percent Daily Values are based on a 1,000 calorie diet.”

Amending § 101.36(b)(2)(iii)(F) such that the requirement for an asterisk noting that
a DV has not been established would be applicable to foods for subpopulations only
when a DRV has not been established for a nutrient.
Footnote –The final rule requires that, if the percent DV is declared for total fat, total
carbohydrate, dietary fiber, protein, or added sugars, the label include a footnote stating “Percent
Daily Values are based on a 2,000 calorie diet” (or, if the supplement is for use by children 1
through 3 years of age, “a 1,000 calorie diet”).
*
*
*
Please do not hesitate to contact us with any questions or concerns.
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