FDA Proposed Changes to Nutrition Labeling Regulations
Summary by: Elizabeth Pelofske
On March 3, 2014, FDA proposed regulations to amend the Nutrition Facts and Supplement
Facts labels. The proposals include changes to serving sizes and labeling requirements.
Serving Size
Reference Amounts Customarily Consumed (RACCs) or standard serving sizes, were updated
from their 1970s and 1980s data, to reflect consumption in a typical eating occasion today.
Serving sizes are required by law to be based on typical consumption rather than recommended
consumption. See charts below for comparison of select current and proposed RACCs.
Larger Individual Units - food units weighing at least 200 percent and up to and including 400
percent of the RACC, would require an additional column on Nutrition Facts panel, listing the
amount and percent Daily Value for the entire individual unit, as well as the original column
listing the same for the RACC serving size.
Single serving containers - containing less than 200 percent of the RACC must be considered as
a single-serving container, and the entire content of the product must be labeled as one serving.
Servings per Container - to be rounded to the nearest whole number except if between 2 and 5
servings and random weight products, number of servings must be rounded to the nearest 0.5
serving. Rounding should be indicated by the term “about” (e.g., about 2 servings, about 3.5
servings). For containers with more than 5 servings, if the number of servings falls exactly
halfway between two allowable declarations, the manufacturer must round the number of
servings up.
For random weight products, manufacturers may declare “varied” for the number of servings per
container, if the nutrition information is based on the RACC and expressed in the appropriate
household measure. Random weight products are for example cheeses sold in weights that vary
in size. The manufacturer may provide the typical number of servings in parenthesis following
the “varied” statement.
1 Serving Size: Proposed Changes to RACCs
Food category
Appetizers, hor d’oeuvres,
Mini Mixed Dishes, e.g.
mini bagel pizzas, breaded
mozzarella sticks, egg rolls,
dumplings, potstickers,
wontons, mini quesadillas,
mini quiches, mini
sandwiches, mini pizza rolls,
potato skins
Bakery Products
Bagel
Crepes
Muffin
Toaster Pastries – see
bagels, toaster pastries,
muffins (excluding English
muffins)
Scones, Crumpets
Cakes, heavy weight
Fruit Cake
Pie Shell, Pastry Sheets
Beverages
Beverages – soft drinks
Beverages – water
Beverages – all other
Dairy Products and
Substitutes:
Milk-Substitute Beverages,
Soy Beverage
Yogurt
Desserts
Ice cream, ice milk, frozen
yogurt, sherbet, frozen
flavored and sweetened ice,
frozen fruit juices: all types
bulk
Ice cream, ice milk, frozen
yogurt, sherbet, frozen
flavored and sweetened ice
and pops, frozen fruit juices,
all types novelties (e.g. bars,
sandwiches, cones, cups)
Custards, Gelatin or Pudding
Current RACC
N/A
Proposed RACC
85g, add 35g for
products with gravy or
sauce topping
55 g
N/A
55 g
55g
110g
110g
110g
110g
N/A
125g
N/A
N/A
55g
1 ½ oz
the allowable
declaration closest to
an 8 square inch
surface area
240 mL
240 mL
240 mL
360 mL
360 mL
360 mL
N/A
240 mL
225g
170g
½ cup
1 cup
85g
½ cup
½ cup
½ cup prepared;
amount to make ½
2 prepared when dry
Dessert Toppings and
Fillings
Cake Frostings or Icings
Egg and Egg Substitutes
Egg White, Sugared Egg,
and Sugared Egg Yolk
Eggroll, Dumpling, Wonton,
or Potsticker Wrappers”
Fish, Shellfish, Game Meats,
and Meat or Poultry
Substitutes
Fish, shellfish, or game
meat, canned
Seafood Substitutes
Fruit and Fruit Juices
Fruits used primarily as
ingredients, avocado
Fruits used primarily as
ingredients, other
(cranberries, lemon, lime)
Miscellaneous Category
Cocoa Powder, Carob
Powder, Unsweetened
Drink Mixers (without
alcohol)
Drink Mixes (without
alcohol): all other types (e.g.
flavored syrups and
powdered drink mixes)
Mixed Dishes:
Not Measurable with cup,
e.g. burritos, enchiladas,
pizza, pizza rolls, quiche,
sandwiches
Sauces, Dips, Gravies,
Condiments
Barbecue sauce, hollandaise
sauce, tartar sauce, tomato
chili sauce, other sauces for
dipping (e.g. mustard sauce,
sweet and sour sauce), all
dips (e.g. bean dips, dairybased dips, salsa)
Minor main entrée sauces
(i.e. pizza sauce, pesto
sauce, Alfredo sauce), other
sauces used as toppings (e.g.
gravy, white sauce, cheese
35g
2 tbsp
N/A
N/A
An amount to make 1
large (50g) egg
20g
55g
85g
N/A
55g
30g
50g
55g
50g
N/A
1 tbsp
Amount to make
240 mL drink
(without ice)
N/A
N/A
Amount to make 360
mL drink (without ice)
140g (+55 g for
prod w/sauce)
2 tbsp
N/A
¼ cup
N/A
3 sauce), cocktail sauce
Minor Condiments, e.g.
horseradish, hot sauces,
Worcestershire sauce
Seasonings Oils and
Seasoning Sauces (e.g.
coconut concentrate, sesame
oil, almond oil, chili oil,
coconut oil, walnut oil)
Seasoning Pastes (e.g. garlic
paste, ginger paste, chili
paste, miso paste, fresh or
frozen)
Soups:
Dry Soup Mixes, Bouillon
Snacks
All varieties, chips, pretzels,
popcorn, extruded snacks,
fruit and/or vegetable-based
snacks (e.g. fruit chips),
grain-based snack mixes
Sugars and Sweets
After-dinner Confectionaries
Hard Canies, breath mints
Hard Candies, other;
Powdered Candies; Liquid
Candies
All other candies
Honey, jams, jellies, fruit
butters, molasses, fruit paste,
fruit chutney
Sugar
Syrups (all others)
Vegetables
Dried Vegetables, Dried
Tomatoes, Sun-dried
Tomatoes, Dried
Mushrooms, Dried Seaweed
Dried Seaweed Sheets
Fresh or Canned Chili
Peppers, Jalapeño Peppers,
Other Hot Peppers, Green
Onion
Pickles and Pickled
Vegetables, All Types
Sprouts, all types: fresh or
1 tbsp
N/A
N/A
1 tbsp
N/A
1 tsp
N/A
Amount to make 245g
30g
N/A
N/A
2g
15g
10g
N/A
15g for all others; 15
mL for liquid candies
40g
1 tbsp
30g
N/A
4g
60 mL
8g
30 mL
N/A
5g, add 5g for product
packaged in oil
N/A
30g
3g
N/A
30g
N/A
N/A
¼ cup
4 canned
Vegetables Primarily Used
for Garnish or Flavor (e.g.
pimento, parsley, fresh or
dried)
4g
N/A
Changes to Nutrient Declarations
Calories from fat - proposed to be removed from Nutrition Facts.
Calories from saturated fat - remains a voluntary nutrient.
Total fat - an expanded definition proposed but no change to the current analytical method,
DRV or rounding of total fat on nutrition facts
Saturated fat – no change
Trans fat - no change, however FDA asked for comments on whether trans fat labeling will be
necessary at all if Partially Hydrogenated Oils are not GRAS. Considering that trans fat labeling
was instigated due to PHOs and that naturally occurring trans fat is exempt from New York
City’s health code and USDA School Lunch Guidelines’ 0 grams trans requirements, it would
seem to make sense to drop trans fat labeling in that case.
Polyunsaturated fat and monounsaturated fat - no changes
Cholesterol - no change
Sodium - no change to rounding and reporting of sodium but Daily Recommended Value (DRV)
to be decreased to 2300 mg (from 2400 mg).
Fluoride – becomes a voluntary nutrient to be listed underneath sodium on the nutrition facts.
Milligrams of fluoride may be declared voluntarily, unless a fluoride claim is made in
which case fluoride becomes mandatory to list. Fluoride content would be expressed as
zero when the serving contains less than 0.1 milligram, or to the nearest 0.1 milligram
increment when the serving contains less than or equal to 0.8 milligrams of fluoride, and
the nearest 0.2 milligram-increment when a serving contains more than 0.8 milligrams of
fluoride.
Potassium – mandatory declaration of potassium is proposed, but its position would be moved
from declaration following sodium to the section of the nutrition label governing the declaration
of other vitamins and minerals. Further detail shown below.
Total Carbohydrate - no changes
5 Dietary Fiber - a new definition of Dietary Fiber is proposed. No change to rounding or
declaration, but the DRV increases from 25 grams per day to 28 grams per day. The proposed
definition:
1) non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and
lignin that are intrinsic and intact in plants; 2) isolated and synthetic non-digestible
carbohydrates (with 3 or more monomeric units) that FDA has granted be included in the
definition of dietary fiber, that such carbohydrates have a physiological effect(s) that is beneficial
to human health; or 3) isolated and synthetic non-digestible carbohydrates (with 3 or more
monomeric units) that are the subject of an authorized health claim. β-glucan soluble fiber and
barley β-fiber are the only fiber ingredients included in the proposed definition at this time.
Dietary fiber content may be determined by subtracting the amount of non-digestible
carbohydrates contained in a formula that do not meet the definition of dietary fiber from
the value obtained using AOAC 2009.01, AOAC 2011.25, or an equivalent method of
analysis as given in the "Official Methods of Analysis of the AOAC International," 19th
Ed. (2012), which is incorporated in rules by reference.
Records and maintenance would be required to be kept in manufacturing facilities to
show FDA for compliance if necessary, as there is not a current testing method that
isolates only the approved dietary fibers. See further detail below.
Soluble Fiber – remains a voluntary nutrient, except in the case of a claim where it becomes
mandatory to list.
Insoluble fiber – remains a voluntary nutrient, except in the case of a claim where it becomes
mandatory.
FDA proposes changes to the definitions of soluble and insoluble fibers by use of specific
analytical methods, and recordkeeping maintenance to provide FDA for compliance if necessary.
Sugars, total – no change
Added sugars - proposed to require listing of added sugars, on the line following total sugars.
Added sugars would not be required for products containing less than 1 gram of added sugars in
a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol. FDA
also proposes the following definition of “added sugars” for nutrition labeling purposes:
Added sugars shall be defined as sugars that are either added during the processing of
foods, or are packaged as such, and include sugars (free, mono- and disaccharides),
syrups, naturally occurring sugars that are isolated from a whole food and concentrated so
that sugar is the primary component (e.g., fruit juice concentrates), and other caloric
sweeteners.
6 FDA proposes recordkeeping maintenance in facilities for FDA’s determination of compliance if
necessary, due to the fact that no analytical methods differentiate between total sugar and added
sugar.
Sugar alcohols - declaration to follow total sugars if sugar alcohols are present
Other carbohydrates – removed from voluntary declaration.
Protein - the DRV for the general population remains at 50 grams. New reference values (RDI
or DRV) were proposed for specific population subgroups:
Infants 7 through 12 months -- 11 grams
Children 1 through 3 years – 13 grams
Pregnant and lactating women -- 71 grams
Vitamins and Minerals – proposal includes declaration of both weight and percent Daily Value.
Vitamin D, calcium, iron, and potassium – proposed as mandatory in that order, by both
weight and percent Daily Value, for the general population ages 4 up. Changes to the RDIs for
these and other vitamins and minerals are shown below. For example the RDI for vitamin D
doubles to 20 mcg and changes units, from the previous 400 IU. Calcium DRV increases to 1300
mg per day. Potassium increases from 3500 mg to 4700 mg per day.
Vitamins A & C - proposed to be removed from mandatory labeling and with other vitamins and
minerals, could be voluntarily declared, except when a claim is made they are mandatory
Some clarification remains to be seen in the rounding and declaration of some vitamins and
minerals.
Folate – is the proposed term to be used in Nutrition Facts labels (for conventional foods), while
“Folic acid” would be the term on dietary supplements. When a mixture of folate and folic acid
is present in a food, manufacturers must make and keep written records of the amount of folic
acid added to the food and folate in the finished food.
Vitamin E - when a mixture of all rac-α-tocopherol acetate and RRR-α-tocopherol is present in a
food, manufacturers must make and keep written records of the amount of all rac-α-tocopherol
acetate added to the food and RRR-α-tocopherol in the finished food.
The tables below show the proposed RDIs for vitamins and minerals, followed by DRVs for
macronutrients:
Nutrient
Vitamins:
Biotin
Choline
Folate
Current RDIs
Proposed RDIs
300 micrograms
5501 milligrams
400 micrograms
30 micrograms
550 milligrams
400 micrograms DFE
7 Niacin
Pantothenic acid
Riboflavin
Thiamin
Vitamin A
Vitamin B6
Vitamin B12
Vitamin C
Vitamin D
Vitamin E
Vitamin K
Minerals:
Calcium
Chloride
Chromium
Copper
Iodine
Iron
Magnesium
Manganese
Molybdenum
Phosphorus
Potassium2
Selenium
Sodium
Zinc
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
16 milligrams NE
5 milligrams
1.3 milligrams
1.2 milligrams
900 micrograms RAE
1.7 milligrams
2.4 micrograms
90 milligrams
20 micrograms
15 milligrams
120 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
2,400 milligrams
15 milligrams
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
2,300 milligrams
11 milligrams
RAE=Retinol activity equivalents; 1 RAE=1 mcg retinol, 12 mcg �-carotene, or 24
mcg a- carotene, or 24 mcg �-cryptoxanthin.
NE=Niacin equivalents, 1 mg niacin=60 mg of tryptophan.
DFE=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.
1
A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for
the use of certain nutrient content claims for choline. These statements identify the
daily value for choline as 550 mg. This value is based on the AI set by the IOM of the
NAS in 1998 (Refs. 138 and 137).
2
These minerals currently have a DRV and we are proposing to establish an RDI.
Macronutrients
Total Fat
Saturated Fat
Cholesterol
Carbohydrates
Dietary Fiber
Protein
Current DV
65 g
20 g
300 mg
300 g
25 g
50 g
Proposed DV
65 g
20 g
300 mg
300 g
28 g
50 g
8 Nutrition Label Format
The format of the nutrition label changes with calories and serving size to be more prominent
with larger font. Amounts are to be listed on the left side with nutrient names to follow, %DV on
the far right. See examples below:
Proposed Columnar Format
Current Columnar Format
9