Watson Inc. - Label Changes Rev. 2019

Updated for
Label
2019!
Changes
Your Comprehensive Guide to the New Nutrition
and Supplement Facts Panels
Nutrition Facts
8 servings per container
Serving size 2/3 cup (55g)
230
Amount per serving
Calories
% Daily Value*
Total Fat 8g 10%
Saturated fat 1g 5%
Trans Fat 0g
Cholesterol 0mg 0%
Sodium 160mg 7%
Total Carbohydrate 37g 13%
Dietary Fiber 4g 14%
Total Sugars 12g
Includes 10g Added Sugars 20%
Protein 3g
Vitamin D 2mcg 10%

Calcium 260mg 20%
Iron 8mg 45%
Potassium 235mg 6%
*The % Daily Value (DV) 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.
Contents
Part 1
Introduction 2
Part 2
2015–2020 Dietary Guidelines for Americans 6
Part 3
Daily Value Changes 10
Part 4:
The Food Nutrition Label 14
Part 5
The Supplement Facts Panel 17
Part 6
What Food and Beverage Manufacturers Need to Know 18
Part 7
Other Topics 20
Part 8
Summary of Nutrition Label Changes 21
Part 9
Conclusion 21
Part 1:
Introduction
The Food and Drug Administration (FDA) has changed A draft guidance published in January of 2017 answers
the regulations for the nutrition and supplement twenty questions about compliance dates, added
facts panels in order to combat some of the health sugars, and the declaration of quantitative amounts of
problems in the country and provide people with better vitamins and minerals. Other regulations will need to
nutrition information. Its goal is “to assist consumers in be updated based on the final ruling, “Food Labeling:
maintaining healthy dietary practices.” Revision of the Nutrition and Supplement Facts Labels.”
FDA has said that these other regulations will be
In addition to material covered in the regulation itself, updated at a later date.
FDA has also responded to questions and comments
from the public. The federal register publication is This guide covers the 2015–2020 Dietary Guidelines
over 200 pages long, and much of the regulation for Americans that the nutrition label changes are
interpretation can be found in FDA responses to based on. It then details the changes in daily values for
comments. nutrients and describes the changes to the Nutrition
Facts and Supplement Facts label regulations.
While the media has focused mostly on the sweeping
changes to sugars and fibers in the nutrition facts
panels, there are also significant changes to the
recommended daily intakes for vitamins and minerals.
2 Label Changes - Your Comprehensive Guide to the New Nutrition and Supplement Facts Panels
The National Academy of Medicine
The National Academy of Medicine (NAM) collects data on the dietary patterns of consumers and combines
this data with scientific evidence to create Dietary Reference Intake reports (DRI). There are four categories of
these reports.
Estimated Average Requirement (EAR) Recommended Dietary Allowance (RDA)

The EAR is the median nutritional requirement for an The RDA is the intake estimated to meet the needs for
individual. This is estimated to meet the requirements 97-98% of the population, and is calculated statistically
of half of the population. Statistically, the EAR is the from the EAR plus twice the standard deviation.
center of the bell curve of the nutrient needs for all
individuals in a population, and is used to calculate Tolerable Upper Intake Level (UL)
statistical probabilities.
The UL is the highest average daily intake where an
individual is expected to see no adverse effects.
Adequate Intake Levels (AI)
The AI is a less formal and complete EAR. When the
NAM does not have enough data to calculate a full
EAR, it uses the available information to calculate an AI.
EAR (AI when less certain)
Risk of Adverse Effects

1.0 1.0
Risk of Inadequacy
RDA UL
0.5 0.5
Intake Level
Figure 1. Dietary Reference Intakes. Adapted from DRI Dietary Reference Intakes for Vitamin C, Vitamin E,
Selenium,and Carotenoids (p.5), by the National Academy of Sciences, 2000, National Academy Press.
Label Changes - Your Comprehensive Guide to the New Nutrition and Supplement Facts Panels 3
Dietary Guidelines for Daily Values
Americans FDA daily values are based on the recommendations
made by the DGA and information from the NAM.
The Dietary Guidelines for Americans (DGA) are Nutrients appear on the nutrition facts panel in
developed jointly by the United States Department percent daily values based on a 2,000 or 1,000 calorie
of Agriculture and the U.S. Department of Health diet. Daily values are not precise requirements for
and Human Services. The DGA recommends dietary individuals, but are to be used as a general guide.
patterns and quantitative intake for macro- and
micronutrients to the US population. The last DGA is There are two categories of daily values: Reference
based on the 2010 NAM data; the label changes are Daily Intakes (RDIs) and Daily Reference Values
based off that report. The DGA also released an interim (DRVs). RDIs are the daily values for small components
report in 2015, from which FDA took information about like vitamins and minerals. DRVs are either for
added sugars for use in planning the label changes. The nutrients to limit, like sodium and cholesterol, or they
next full DGA is scheduled to come out in 2020. are for nutrients with recommended levels based on
specific calorie intakes such as fat, carbohydrates,
protein, and fiber – the macronutrients.
DVs vs. RDAs
Many different terms are used to refer to either the The DVs were established by the U.S. Food and Drug
amount of a nutrient you should consume or the Administration (FDA). They were designed to be used
amount of a nutrient in a food or dietary supplement. on food and dietary supplement labels. Unlike RDAs,
Two of the most common are there is one DV for each
the Recommended Dietary
Allowance (RDA) and the
DVs are shown on food nutrient for all people ages
4 years and older. DVs are
Daily Value (DV).
and supplement label not recommended intakes.
DVs indicate how much of a
RDAs are recommended
daily intakes of a nutrient for as a percentage. This nutrient is in a serving of food
or a dietary supplement in the
healthy people. This is the context of a total daily diet.
amount of a nutrient such allows consumers to DVs often match or exceed the
as a vitamin or mineral that RDAs for most people, but not
you need to consume each
day to maintain health. The
easily compare one in all cases.
RDAs were developed by the

Food and Nutrition Board
product to another in DVs are shown on food
and supplement label as
at the Institute of Medicine
of the National Academies. terms of nutrient values. a percentage. This allows
consumers to easily compare
They vary by age and gender. There are also specific one product to another in terms of nutrient values. For
RDAs for women that are pregnant or breastfeeding. example, the DV for Iodine is 150 mcg. If a product
Therefore there are several different RDAs for each label says it contains 10% of the DV for Iodine it would
nutrient. contain 15 mcg. If another products said it contained
20% of the DV for Iodine, it is easy to see that the
second product contains twice as much Iodine(30 mcg.)
Part 2:
2015–2020 Dietary Guidelines for Americans
5 Principle Guidelines
The DGA gives Americans five guiding principles to follow in their food choices:
The DGA has shifted the

focus back to counting
1 FOLLOW
a healthy eating
pattern. All food and
It is difficult to stay within
calorie levels while meeting
calories and keeping
beverage choices matter – you the nutrient requirements that
appropriate calorie levels.
can’t make healthy choices one day FDA has set, so consumers
This principle also implies
and not the next. Americans should really will have to focus on
that one’s diet affects one’s
choose a healthy eating pattern at eating nutrient-dense foods.
health, which is a notable
an appropriate calorie level to help
development.
achieve and maintain a healthy
body weight, support nutrient
5 2
adequacy, and reduce the
risk of chronic disease.
SUPPORT
healthy eating
patterns for all. Everyone
has a role in helping to create FOCUS
and support healthy eating on variety, nutrient density, and
patterns in homes, schools, work, amount. To meet one’s nutrient
and communities nationwide. It takes needs within calorie limits, Americans
healthy eating and information in all should choose a variety of nutrient-
areas of the community for people dense foods across all food groups
to be healthy – at school, at in recommended amounts.
home, at the doctor’s office,
and in the community
at large.
4 3
LIMIT
SHIFT
calories from added sugars and
to healthier food and beverage
saturated fats, and reduce sodium
choices.
intake.
Key Recommendations
The DGA recommends healthy eating patterns that account for all foods and beverages within an appropriate
calorie level. A healthy eating pattern includes:
A variety of vegetables from all Fruits, especially whole fruits Grains, at least half of which are
of the subgroups – dark green, whole grains
red and orange, legumes, and
starchy
Fat-free or low-fat dairy, A variety of proteins, including Oils, including olive oil and
including milk, yogurt, cheese, seafood, lean meats and poultry, soybean oil
and/or fortified soy beverages eggs, legumes, nuts, seeds, and
soy products
Dietary Components to Limit

Following a healthy eating pattern also means limiting certain dietary components:
Added Sugars Saturated Fats Sodium

Consume less than 2,300
Consume less than 10 Consume less than 10
milligrams (mg) per day
percent of calories per day percent of calories per day
of sodium (reduced from
from added sugars from saturated fats
2,400 mg)
While “less than 10 percent of calories per day” is a concise way for the DGA to release these guidelines, it is
not how added sugars and saturated fats are being measured on the label. Instead, sugar and saturated fats are
to be labeled in quantitative amount and percent daily value. The DGA also emphasizes that individuals should
meet their nutrition needs primarily from foods; however, they acknowledge that fortified foods, beverages, and
supplements can help meet unachievable nutrient levels.
Underconsumed Nutrients
The DGA identifies nutrients that are underconsumed by Americans. It also specifies that iron is underconsumed
by adolescent girls and women ages 19 to 50. Calcium, potassium, dietary fiber, and vitamin D are now considered
nutrients of public health concern and are required on labeling.
Choline
Potassium Dietary
Fiber
Vitamin
Calcium
A
Magnesium
Vitamin Vitamin
E D Vitamin
C
Iron is
Iron underconsumed by = Required
adolescent girls on Labeling
and women ages
19 to 50
Dietary Principles
The DGA claims that there are many ways to meet one’s nutrient needs through foods.
The DGA suggests three dietary principles to follow in order to meet their Key Recommendations:
1. An eating pattern represents the totality of all foods and beverages consumed
2. Nutritional needs should be met primarily from foods
3. Healthy eating patterns are adaptable
Healthy Eating Patterns
The DGA defines three healthy eating patterns to accommodate cultural and personal preferences; the healthy
U.S.-Style eating pattern, a healthy Mediterranean eating pattern, and a healthy vegetarian eating pattern.
The Healthy U.S.- The Healthy

Style Pattern Mediterranean Style
The Healthy U.S.-Style Pattern Pattern
is the same as the primary USDA This pattern is really a version of
Food Pattern from the 2010 DGA, the Healthy U.S.-Style Pattern, but it
and is similar to the old DASH emphasizes seafood and fruits, and
diet. It is based on proportions of suggests less dairy. This pattern yields
food that Americans typically eat, lower levels of calcium and vitamin
and promotes the consumption of D because of the reduction in dairy
nutrient dense foods. consumption.
The Healthy
Vegetarian Pattern
The vegetarian pattern is also adapted
from the Healthy U.S.-Style Pattern. Meat,
poultry, and seafood are eliminated. Dairy
and eggs are included because they are still
consumed by most vegetarians. It would
likely be very difficult to balance a vegan diet
with the guidelines that they have released.
Comparatively, the vegetarian approach
is higher in calcium and fiber but lower
in vitamin D than the Healthy U.S.-Style
Pattern.
Part 3:
Daily Value Changes
Changes for All Vitamins and Minerals Rounding Rules
All vitamins and minerals will now be declared in both Since manufacturers can choose to declare a nutrient
quantitative amount and percent daily value. The which is present in quantities as low as 2% of the daily
rounding laws are therefore a bit confusing because the value, it is important that they have enough decimal
rounded values for quantity and percentage could be places to declare quantitative amounts accurately. It is
different. Any vitamin or mineral present at 2% or less equally as important to avoid such amounts appearing
of the daily value can be called 0%. This does need to to be more accurately measured than they are.
Nutrition Facts
align with the quantitative amount – if the percent daily
value is written as zero, then the quantitative amount
must also be written as zero.
Therefore, FDA has created recommendations for how
to round quantitative amounts of nutrients with RDIs,
to be used on both the Nutrition Facts and Supplement
8 servings per container
Facts labels.
Required Nutrients
Reference Daily Rounding Rule
230
Vitamin D and Potassium
Amount per serving will now be required on
Calories
labels, as deficiencies of these vitamins represent
public health concerns: vitamin D is essential for bone
Intake (RDI)
Less than 25 mg or mcg Declare to the nearest 0.1
health. Potassium is a challenging nutrient to fortify mg or mcg per serving.
% Daily Value*
with: it has flavor notes and a large daily value.
Total Fat 8g 10%
However, the quantitative
and C willfatno1glonger be required on 5%
Vitamin ASaturated the amount may be declared
nutrition Trans
panel, Fat
although
0g manufacturers will still be to the nearest 0.01 or
allowed to voluntarily label them. NAM data has shown 0.001 mg or mcg if that
Cholesterol
that Americans 0mg lack vitamins A and0%
no longer C in their many decimal places are
diets. Sodium 160mg 7% needed to get a value
Total Carbohydrate 37g 13% that is at least 2% DV.
FDA has said that it does
Dietary Fiber 4g
not expect manufacturers
14%
to stop fortifying with A and C, nor does it expect Between 25 and 250 mg Declare to the nearest
Total Sugars
manufacturers to start12g
fortifying with vitamin D and or mcg mg or mcg per serving.
potassium. Includes 10g Added Sugars 20% Between 250 and 500 Round to the nearest 5
Protein 3g mg or mcg mg or mcg per serving.
Greater than 500 mg or Round to the nearest 10
Vitamin D 2mcg 10% mcg mg or mcg per serving.
Calcium 260mg 20%
Iron 8mg 45%
Potassium 235mg 6%
Table of Daily Value Changes
Nutrients are listed in the order in which they appear on the supplement facts panel.
Increase / Recommended
Previous
Nutrient New Daily Value Rounding
Decrease Daily Value
Increment
Vitamin A - 40%  5000 IU 900 mcg RAE* Nearest 10 mcg
Vitamin C (ascorbic acid) + 50%   60 mg 90 mg Nearest mg
Vitamin D + 100%   400 IU 20 mcg † Nearest 0.1 mcg
Vitamin E - 25.5%  30 IU 15 mg alpha-tocopherol* Nearest 0.1 mg
Vitamin K + 50%   80 mcg 120 mcg ‡ Nearest mcg
Thiamin (Vitamin B1) - 20%  1.5 mg 1.2 mg Nearest 0.1 mg
Riboflavin (Vitamin B2) - 23.53%  1.7 mg 1.3 mg Nearest 0.1 mg
Niacin (Vitamin B3) - 20%  20 mg 16 mg* Nearest 0.1 mg
Vitamin B6 - 15%  2 mg 1.7 mg Nearest 0.1 mg
Folate & Folic Acid - 40.03%  400 mcg 400 mcg DFE* Nearest 5 mcg
Vitamin B12 - 60%   6 mcg 2.4 mcg Nearest 0.1 mcg
Biotin - 90%   300 mcg 30 mcg Nearest mcg
Pantothenic Acid - 50%  10 mg 5 mg Nearest 0.1 mg
Choline N/A N/A 550 mg Nearest 10 mg
Calcium + 30%  1000 mg 1300 mg Nearest 10 mg
Iron No Change 18 mg 18 mg Nearest 0.1 mg
Phosphorus + 25%  1000 mg 1250 mg Nearest 10 mg
Iodine No Change 150 mcg 150 mcg Nearest mcg
Magnesium + 5%  400 mg 420 mg Nearest 5 mg
Zinc - 26.67%  15 mg 11 mg Nearest .1 mg
Selenium - 21.43%  70 mcg 55 mcg Nearest mcg
Copper - 55%   2 mg 0.9 mg Nearest 0.1 mg
Manganese + 15%  2 mg 2.3 mg Nearest 0.1 mg
Chromium - 70.83%   120 mcg 35 mcg Nearest mcg
Molybdenum - 40%  75 mcg 45 mcg Nearest mcg
Chloride - 32.35%  3400 mg 2300 mg Nearest 10 mg
Sodium - 4.17%  2400 mg 2300 mg N/A
Potassium + 34.29%  3500 mg 4700 mg Nearest 10 mg
Fluoride N/A N/A N/A N/A
* See Unit Conversions † Can voluntarily declare in International Units ‡ See Further Nutrient Discussion
New Unit Conversions
Vitamin A Niacin
The daily value for vitamin A Niacin (B3)
used to be in international units. Vitamin B3 is now measured
The new daily value is in Retinol in Niacin equivalents. Sixty
Activity Equivalents (RAE). FDA gives milligrams of tryptophan is
specific conversion factors from different forms of equivalent to one milligram of niacin, so any
vitamin A to RAE. product with protein in it that contributes more
than 19 milligrams of tryptophan will also have to
Old DV = 5000 IU declare niacin, because the niacin equivalent will
New DV = 900 mcg RAE (equivalent to ~3000 IU) be greater than the 2% threshold for declaring as
zero.
1 mcg of RAE (Retinol Activity Equivalents)
= 1 mcg retinol Old DV = 20 mg Niacin
= 2 mcg supplemental Beta Carotene New DV = 16 mg NE (niacin equivalents)
= 12 mcg naturally occurring Beta Carotene
= 24 mcg Alpha Carotene 1 mg NE
= 24 mcg Beta Cryptoxanthin = 1 mg Niacin
= 60 mg Tryptophan
Vitamin E Folate and Folic Acid

The old daily value for vitamin Folate will now be measured
E was in international units. The in micrograms of Dietary Folate
new daily value is in milligrams of Equivalents (DFE). One mcg of
alpha-tocopherol. FDA has recognized natural food folate is equivalent to one
that there are eight different isomers of vitamin E. mcg DFE, while one mcg of synthetic folic acid
These isomers have been split into two categories: is equivalent to 1.7 mcg DFE. As of yet there are
RRR or d-alpha-tocopherol, and all-racemic or no conversions for other forms of folate such as
d,l-alpha-tocopherol. RRR is generally recognized quatrefolic acid. FDA has said that the conversion
as natural, while all-racemic is usually synthetic. factor for other forms of folate can go as high as
In the new conversion factors, natural alpha- 1.7, but cannot exceed 1.7. FDA still does not permit
tocopherol will be worth twice the amount of the addition of any folate form other than synthetic
vitamin E as synthetic alpha-tocopherol. FDA will folic acid to standard food products; quatrefolic
be relying on manufacturing records to tell the acid can only be used in supplements.
difference between the two types.
Old DV = 400 mcg Folic Acid (equivalent to 667
Old DV = 30 IU mcg DFE)
New DV = 15 mg alpha-tocopherol (22.35 IU) New DV = 400 mcg DFE (Dietary Folate
Equivalents)
1 mg alpha-tocopherol
= 1 mg RRR-alpha-tocopherol (natural) 1 mcg naturally occuring folate = 1 mcg DFE
= 2 mg all-racemic alpha-tocopherol (synthetic) 1 mcg synthetic folic acid = 1.7 mcg DFE
Further Nutrient Discussion
Vitamin K Fluoride
Vitamin K is the only nutrient set from an Adequate Previous FDA regulations did not require or permit
Intake Level rather than an Estimated Average fluoride to be listed on the nutrition facts panel.
Requirement. The National Academy of Medicine only Fluoride has now been added as a voluntary
had data on vitamin K1, so the only vitamin K that FDA declaration. It is considered a non-essential nutrient,
will allow standard foods to be fortified with is vitamin but FDA has acknowledged the importance of fluoride
K1 – vitamins K2 and K3 can continue to be used in in preventing dental caries. FDA does not expect
supplements. people to fortify their products with fluoride: if a
manufacturer wanted to add additional fluoride to a
Potassium food product, they would have to petition the FDA for
a food additive regulation. FDA only expects people to
Potassium is now required on nutritional labels, and label the fluoride that’s naturally occurring in products,
the daily value for potassium increased from 3500 mostly from public water sources.
mg to 4700 mg. FDA has said that it does not expect
people to start fortifying their products with potassium. Fluoride does not have a daily value, and should be
Fortifying with potassium is a challenge: it contributes declared as follows:
excessive weight which can have an effect on serving <0.1 mg = 0
size. The most active source available is potassium Declare in 0.1 mg increments up to 0.8 mg
chloride, which has a metallic aftertaste. Potassium Declare in 0.2 mg increments for amounts greater than
chloride is also problematic because the daily value 0.8 mg
for chloride has been reduced from 3400 mg to
2300 mg. Potassium phosphate is also available, but
unfortunately also has taste concerns and can change
the buffering within a finished product.
Part 4:
The Food Nutrition Label
Reasons for the label changes as described by the FDA: • If more people read the label, Americans will
• A large proportion of US population is at risk for make more informed choices
chronic disease • Americans will make healthier food and beverage
• The new label will be easier to understand choices
• The new label design will increase use of the label
There are nine basic areas of the label where changes

have been made:
Serving Size
Nutrition Facts Odd Size
8 servings per container Packages
Total
230
Amount per serving
Calories
Calories Calories from
Fat
% Daily Value*
Total Fat 8g 10%
Saturated fat 1g 5%
Trans Fat 0g
Multi-Serving Cholesterol 0mg 0%
Products Sodium 160mg 7%
Dietary
Fiber
Total Sugars 12g
Added Protein 3g
Sugars Vitamin D 2mcg 10%

Calcium 260mg 20% Vitamins and
Iron 8mg 45% Minerals
Potassium 235mg 6%
Daily Value Footnote

Serving Size Notes on New Manufacturing Records
Serving size will now be changed to reflect what The industry will have to keep additional manufacturing
people typically consume, rather than what they are records for any nutrient that requires distinguishing
suggested to consume. For example, a can of soup between multiple sources where the sources cannot
used to be labeled as two servings, but most people be verified through analytical testing. This will include
eat a whole can. As a result, a can of soup will now be dietary fibers (soluble and insoluble), sugars (added
labeled as one serving. This isn’t meant to encourage and inherent), Vitamin E (natural and synthetic),
people to eat more; instead, FDA wants people to be Vitamin A (when using natural and synthetic beta
aware of the calories that they’re actually consuming. carotene), and folate (folate and folic acid). These
Similarly, packages between one and two servings will records will need to be maintained for two years past
now be labeled as one serving. The serving size is now the last date of introduction into interstate commerce.
written in household measurements to make it resonate The record retention period is a change from the
Nutrition Facts
more with the consumer and emphasize the calories current industry standards as it requires additional
consumed. focus on the date of shipment as opposed to the date
8 servings per container of manufacture and the date of expiration.
Multi-Serving Products
230
Amount per serving
Calories
Total Calories If a package can be consumed in single or multiple
The totalNutrition Facts sittings, there will now be multiple columns on the label
calorie count is now highlighted. The number to show the percent and quantitative daily values,
% Daily Value*
8 servings
of calories is writtenper
in acontainer
much larger font to make it calories, and macrocomponents for each possible
Total
ServingFat 8g
size
more noticeable to the consumer.2/3 cup 10%
(55g)
Saturated fat 1g 5%
serving size. For example, if a package could be
consumed in one or two sittings then it would have two
230
Amount per0gserving
Trans Fat
columns on the nutrition facts panel with two different
Calories
Cholesterol 0mg
Sodium 160mg
0%
7%
sets of nutritional information.
Total Carbohydrate 37g % Daily Value* 13%
Total Fat 8g 10%
14%
Added SugarsDietary Fiber 4g
Saturated fat 1g 5%
Total Sugars 12g
The “AddedTrans
Sugars”
Fat category has been added to
0g
the nutritional label, and is measured in both
Cholesterol
Protein 3g 0mg 0%grams
and percentages. FDA
Sodium 160mg
hopes that this category
7% will
encourage people
Vitamin to
D 2mcg cut down on their sugar
10%intake.
The DGACalcium
has told consumers that it is very difficult to
Nutrition Facts
Dietary260mg
Fiber 4g 20%
14%
meet nutrient
Iron 8mgneeds while staying within 45% calorie limits
Total Sugars 12g
if you consume more
Potassium 235mg than 10% of your daily6%calories
8 servings
Includes per
10g container
Added Sugars
from added sugars. Added sugars will be labeled in a 20%
Serving
Protein
quantitative
*The 3gValue
amount
% Daily size
(DV) tells you2/3
(grams) and cup
percent
how much (55g)daily
a nutrient in
value.
230
Vitamin
Amount D 2mcg
per serving 10%
Calories
This change requires manufacturers to keep
Calcium 260mg 20%
additional records. Because there is no way to
Iron 8mg 45%
differentiate analytically between%added sugars
Daily Value* and
Potassium
naturally Total
occurring 235mg
sugars, FDA will be 6% on
relying
Fat 8g 10%
manufacturing records
*The % Daily Value (DV)to
Saturated fat 1g
tell
tells youthe difference.
how much a nutrient in These
5%
records will not
a dayTrans
only
is used Fat
have to take into account sugars
0g nutrition advice.
for general
that were added, but also any ways in which those
Cholesterol 0mg 0%
added sugars might have been reduced: for example,
Sodium 160mg 7%
through non-enzymatic browning or fermentation in
the product.
Total Sugars 12g
Protein 3g
Vitamin D 2mcg 10%

Calcium 260mg 20%
Label Changes - Your Comprehensive Guide to the
Iron 8mg 45%
New Nutrition and Supplement Facts Panels 15
Potassium 235mg 6%
Total Fat 8g 10% 8 servings per container
Saturated fat 1g 5% Serving size 2/3 cup (55g)
Trans Fat 0g
230
Amount per serving
Calories
Cholesterol 0mg 0%
Sodium 160mg 7%
• polydextrose
• resistant maltodextrin/dextrin
The footnote that defines daily
Total Carbohydrate 37g values has been
13% % Daily Value*
changed to be more streamlined.
Dietary Fiber 4g 14% Manufacturers will8g
Total Fat also have to keep additional
10%
Total Sugars 12g manufacturing records for
Saturated fat 1g dietary fibers, analytically
5%
Old Footnote: “Percent Daily Values are based on a
there is no way to Fat
distinguish these fibers from the
2,000 calorie Includes 10gdaily
diet. Your Added may be20%
Sugars
value higher or Trans 0g
Protein 3g
other carbohydrates that have traditionally been
Cholesterol 0mg 0% called
lower depending on your calorie needs.”
dietary fibers.
Sodium 160mg 7%
Vitamin“The
New Footnote: D 2mcg 10%
% Daily Value (DV) tells you Total Carbohydrate 37g 13%
Calcium 260mg 20%
how much a nutrient in a serving of food contributes Dietary Fiber 4g 14%
to a dailyIron
diet.8mg
2,000 calories a day is used 45%
for general Total Sugars 12g
nutrition Potassium
advice.” 235mg 6% Includes 10g Added Sugars 20%
Protein 3g
a serving of food contributes to a daily diet. 2,000 calories Calories from Fat
a day is used for general nutrition advice. Vitamin D 2mcg 10%
FDA has removed the “Calories from Fat” line in
Calcium 260mg
response to research which shows that the 20% type of fat
Iron
is more important8mg than the amount of fat consumed. 45%
Space hadPotassium
to be made 235mg
for some of the other 6% label
changes. This
*The %could give
Daily Value (DV)conflicting
tells you how muchmessages
a nutrient in to
consumers: the
a serving DGA says that
of food contributes to a consumers should get
daily diet. 2,000 calories
less than 10% of their calories per day from saturated
fats, but those calories will not be indicated on the
label.
Nutrients Less Than 2% DV

Any vitamin or mineral present at 2% or less of the
Dietary Fiber daily value is not required to be declared on the label.
The daily value for dietary fiber has increased from 25 g However, a manufacturer may choose to declare such
to 28 g. Interestingly, FDA has limited what qualifies as a vitamin or mineral using a zero or an asterisk. The
dietary fiber. Only fibers which have been determined asterisk must refer to one of the following statements,
by FDA to have physiological effects beneficial to located below the table of nutrient values:
human health may be called dietary fibers. FDA gives a
short list of the qualifying fibers: beta glucan, psyllium “Contains less than 2 percent of the Daily Value of this
husk, cellulose, guar gum, pectin, locust bean gum, (these) nutrient (nutrients).”
and HPMC. This list leaves out many of the fibers that “Contains <2 percent of the Daily Value of this (these)
manufacturers have traditionally used. nutrient (nutrients).”
To date, manufacturers have already filed petitions for Vitamin D, calcium, iron, and potassium are usually
26 other fibers. Some of these petitions were made by required on the nutrition facts label. However, if any of
individual companies for specific fibers, while others them are present in amounts less than 2% of the daily
were made by groups of companies working together. value, then one may choose instead to write below the
In June 2018 the FDA issued guidance approving eight table of nutrient values:
additional Dietary Fibers.
“Not a significant source of _____ (listing the vitamins
The additional dietary fibers include: or minerals omitted).”
• mixed plant cell wall fibers (a broad category that
includes fibers like sugar cane fiber and apple
fiber, among many others)
• arabinoxylan (derived from cereal grains)
• alginate (derived from seaweed)
• inulin and inulin-type fructans (derived from
chicory root)
• high amylose starch
• galactooligosaccharide (derived from milk sugar)
Part 5:
The Supplement Facts Panel
Calories product for purposes of supplementation, or when a
claim is made about them.
Manufacturers can choose whether to declare calories
on the label, depending on whether or not they believe
calories to be a significant contributor. FDA has said Ingredient Listing
that since supplements aren’t typically a significant Quantitative amounts must now be listed on the
contributor of calories, it is acceptable to either list or supplement facts panel in addition to percent
not list calories. FDA originally stated that total calories daily value. The supplement facts panel allows
should be listed in the new larger font on both the food manufacturers to label their ingredients inside the
and supplement panels, but this was an error. FDA has panel if they have enough space. If an ingredient is
said that it will correct this in a future amendment. labeled in the panel, then it does not have to be labeled
The larger font is only to be used on the nutrition facts in the list below the panel. Ingredients can be labeled
panel. in one location or the other, or both. This will make
some nutrients clearer and more understandable for
Dietary Ingredients to be Declared consumers. For example vitamin D2, which has the
intimidating name ergocalciferol, can be labeled on the
The dietary ingredients that are required to be declared
panel.
on the supplement panel are the same ones required
on the nutrition facts panel for foods. FDA has also
stated that protein cannot be declared in addition to Other Units of Measure
individual amino acids. Daily values are specifically measured in micrograms
and milligrams, but there are many ingredients that
Dietary Ingredients to Declare: are not measured in these units. For example, the
quantity of bacteria in a probiotic is often measured in
• Total Calories • Total Sugar CFUs/g. FDA has declined to permit these other units
• Total Fat • Added Sugar of measure on the supplement facts panel. However,
• Trans Fat • Protein it has also recognized that this is a problem, and that
• Cholesterol • Vitamin D it will need to issue more information at a later date.
• Sodium • Calcium Therefore, manufacturers may have some leeway while
• Total Carbohydrate • Iron FDA makes decisions on this issue.
• Dietary Fiber • Potassium
Order of Vitamins and Minerals on Label When a manufacturer claims Daily Reference Values
(total fat, saturated fat, carbohydrates, dietary fibers,
The order of vitamins and minerals on the label has
protein, and added sugars) on the supplement facts
changed. FDA has added choline after pantothenic
panel, the daily value footnote must be included
acid, and it has added the voluntary nutrient fluoride
on the panel. If no DRVs are claimed, then the daily
near the end of the list. (See the Table of Daily Value
value footnote is not required. Manufacturers should
Changes for the full order.)
choose the appropriate footnote depending on who the
product is intended for.
Declaring Vitamins and Minerals
Vitamins and minerals should be declared in For most products:
accordance with the same rules as on the Nutrition Percent Daily Values are based on a 2,000 calorie diet.
Facts label. In supplements, vitamins and minerals
with an RDI are not declared when they are present in If the product is for children 1 to 3 years of age:
amounts less than 2% of the daily value. Vitamins and Percent Daily Values are based on a 1,000 calorie diet.
minerals must be declared when they are added to the
Part 6:
What Food and Beverage Manufacturers Need to Know
On May 20, 2016, the FDA announced new used in large quantities. The challenge for those who
requirements for the Nutrition Facts label that appears fortify foods is to reformulate their products so that
on packaged foods. The new labeling requirements are the levels of these key nutrients are significant to their
meant to reflect new information from the scientific overall diet, but still acceptable to the palate.
community, especially
highlighting the link
between diet and chronic “These changes are The purpose of the new
label changes is to provide
diseases such as obesity better information for
and heart disease. especially significant to consumers to make
informed choices about the
As part of the changes,
some nutrients that were
food manufacturers when food they eat, and ultimately
to help consumers make
previously required to be
listed on the nutrition label
it comes to calcium and food choices that will better
support their health.
have been dropped. Since
deficiencies in vitamins A potassium.” Public Perception
and C have become much
less prevalent recently, these nutrients no longer must The new DVs for nutrients will also be changing the
be listed on the label. Iron and calcium amounts must public’s perception of the level of a nutrient that is
still be included in the nutrition facts panel, and vitamin in food, even if that level of the nutrient remains the
D and potassium have been added to the required same. On the next page is an example of a specification
list. In addition to including the percent daily value, for a premix used for a children’s nutrition bar.
manufacturers must now declare the actual amount of
these nutrients, as well. Let’s look at calcium, for example. This premix delivers
300 mg of calcium per serving, per nutrition bar. Each
At the same time that the listed nutrients have nutrition bar will contain 300 mg of calcium.
changed, some of the Daily Values (DV) of various
nutrients have changed as well. The DV of dietary The old DV for calcium was 1000 mg; therefore 300
fiber, for example, has gone from 25 grams per day mg of calcium per serving was 30% of the old DV. The
to 28 grams per day. Calcium previously had a DV new DV for calcium is now 1,300 mg, so the same
of 1,000 milligrams per day. The new rules raise that 300 mg of calcium per bar would now be reflected on
requirement to 1,300 milligrams per day. The DV of the label as 23% of the DV. Due to this, a consumer’s
potassium has also gone up significantly—from 3,500 perception may be that calcium was reduced in this
milligrams per day to 4,700. product, even though the formula itself did not change.
These changes are especially significant to food Manufacturers will need to determine if they want to
manufacturers when it comes to calcium and reformulate their premixes to keep the percentages
potassium. With the new DVs, the amount of each of the daily values constant, or to alter their labels to
nutrient in a food may remain the same but the label reflect the percentage of the new daily value, which
will different as the percentages will change. This poses may also impact the front-of-package claims. For
a challenge for food fortification in that quantities of example, to qualify for the claim “an excellent source
both calcium and potassium will have to be increased of calcium” a product must contain at least 20% of the
to keep those percentages as they are today. DV for calcium. Our example premix would still qualify
for this claim with the new DVs, but depending on the
Both of these minerals are challenging since they were formulation, some products could fail to make the 20%
already significant contributors to a food’s makeup. DV claim with the new label.
In the case of potassium, the increase is made even
more challenging by the fact that potassium has flavor
issues—it can give a metallic or overly salty taste when
Nutrient Minimum Activity %DV
per 2300 mg
Calcium (Dicalcium Phosphate) 300 mg 30%
Iron (Ferrous Sulfate) 3.6 mg 20%
Zinc (Zinc Oxide) 3 mg 20%
Magnesium (Dimagnesium Phosphate) 120mg 30%
Phosphorus (Dicalcium Phosphate, Dimagnesium Phosphate) 350 mg 35%
Vitamin A (Beta Carotene) 5000 IU 100%
Vitamin C (Ascorbic Acid) 60 mg 100%
Vitamin D (Cholecalciferol) 80 IU 20%
Vitamin E (d,l Alpha Tocopheryl Acetate) 30 IU 100%
Thiamin (Thiamin Mononitrate) 0.3mg 20%
Riboflavin 0.34 mg 20%
Niacin (Niacinamide) 4 mg 20%
Pantothenic Acid (d-Calcium Pantothenate) 2 mg 20%
Pyridoxine (Pyridoxine Hydrochloride) 0.4 mg 20%
Vitamin B-12 (Cyanocobalamin) 1.2 mg 20%
Folic Acid 80 mg 20%
Biotin 60 mg 20%
Nutrition Bar with Old DV Nutrition Bar with New DV

Contains Watson Custom Nutrient premix WT-5882 Contains Watson Custom Nutrient premix WT-5882
Part 7:
Other Topics
Potassium in Supplements Overages
In light of the substantial increase to potassium’s The regulation implies that testing of products should
daily value, FDA has received several questions on its result in 100% of label claim without allowance
position about gastrointestinal injury and potassium. for being above that amount. There were several
In 1975, FDA made a statement that if any tablet comments asking what this means for overages:
or capsule containing more than 99 milligrams of manufacturers usually add overages so that at the
potassium is designed to be consumed without end of a product’s shelf life the product is at 100% of
being diluted in water to a suitable amount, then label compliance. FDA’s guidance for testing makes it
that tablet or capsule must bear a warning label for difficult for manufacturers to add these overages. FDA
gastrointestinal injury, specifically lesions. In response did comment that this warrants further consideration,
to the comments FDA maintained that it has “not but have given no ruling on the matter at this time.
established any limits on potency or recommended
uses for dietary supplements containing potassium
salts. … Under the FD&C act a manufacturer is Limits to the Regulation
responsible for ensuring that dietary supplements are
Many comments referenced other regulations including
safe.”
approved health and structure/function claims. FDA
responded that anything outside of the nutritional
It is possible, therefore, that if a manufacturer could
panel is completely outside the scope of this regulation.
prove the safety of their product, FDA might be
This ruling touches many other regulations which will
persuaded that the warning label is unnecessary.
need to be updated in the future.
However, this does put the burden of proof on
manufacturers. FDA has not said anything specifically
about soft gels, which had yet to be invented at the
time of the original 1975 statement. Synthetic and Natural
Nutrients
FDA indicated that a product would be misbranded if
its labeling implied that a natural vitamin was superior
to an added or synthetic vitamin.
Part 8:
Summary of Nutrition Label
Changes
As the compliance dates draw nearer, it’s important nutrients
that manufacturers reassess their readiness to • Changing “sugars” to “total sugars”
implement the new label requirements. R&D, • Declaring “added sugars” in grams and % DV
marketing, sales, operations, purchasing, and beneath total sugars
warehousing departments are all likely to be impacted • Using updated serving sizes for several product
by the changes. categories
• Labeling packages between one and two servings
The new changes to the nutrition label include: as one serving, and calculating calories and
nutrients accordingly
• Increasing the font size for “calories,” “servings • Providing dual column calorie and nutrient
per container,” and the serving size declaration information for certain products that contain
• Bolding the number of calories and the serving more than one serving but could be consumed in
size declaration one sitting
• Removing “calories from fat” from the label • Changing the footnote wording to read “The
• Replacing vitamins A and C on the label with % Daily Value tells you how much a nutrient
vitamin D and potassium in a serving of food contributes to a daily diet.
• Declaring the actual amount (in addition to % Two thousand calories a day is used for general
DV) of calcium, iron, vitamin D, and potassium nutrition advice.”
• Using updated DVs and units for a number of
Part 9:
Conclusion
We are all facing a year of change. The decision For most companies, product packaged on or after
to change what is added to a product or to make January 1, 2020 needs to comply with the new label
significant label changes is not a simple one: in either regulations. For companies which did less than 10
case, consumers may react unpredictably. If we change million dollars in total sales in one of the last three
our inputs to maintain label claims, the product may years, the date is extended to January 1, 2021.
change significantly. It isn’t easy to add an additional
thirty percent calcium to a product to maintain a We hope that this guide, and Watson, can be a
25% daily value claim. If we choose not to alter our resource to you in the label-changing process. In
products and instead alter the label, consumers may addition to this guide, Watson has released a lecture
be surprised: for example, a product that currently video on this subject, and will be releasing further
contains 20% DV of biotin would contain 200% DV on information as it becomes available from FDA.
a new label. We must consider consumer reactions as
we make our adjustments.
The FDA has recently made extensive changes to the
regulations for the nutrition facts and supplement facts
panels. The new regulation is difficult, and the clarifying
materials from the FDA are 260 pages long. This
guide distills the information from the regulation and
clarifying material and discusses the most important
topics and frequently asked questions. The guide also
covers the origins of the new label changes, including
the 2015–2020 Dietary Guidelines for Americans.
Watson hopes that this guide can be a resource to

companies as we all work to change our labels and recipes.
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West Haven, CT 06516
www.watson-inc.com
203-932-3000
v. 7.0 3-29-19

Watson Inc. - Label Changes Rev. 2019

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Updated for

Vitamin D 2mcg 10%

Estimated Average Requirement (EAR) Recommended Dietary Allowance (RDA)

EAR (AI when less certain)

Risk of Adverse Effects

RDAs were developed by the

The DGA has shifted the

Dietary Components to Limit

Added Sugars Saturated Fats Sodium

The Healthy U.S.- The Healthy

Vitamin E Folate and Folic Acid

There are nine basic areas of the label where changes

Sugars Vitamin D 2mcg 10%

Daily Value Footnote

Vitamin D 2mcg 10%

Nutrients Less Than 2% DV

Nutrition Bar with Old DV Nutrition Bar with New DV

Watson hopes that this guide can be a resource to

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