Download The Serving Size Proposed Rule

The Serving Size Proposed Rule
Cherisa Henderson
Nutrition Programs Staff
Office of Nutrition, Labeling
and Dietary Supplements
FDA:CFSAN
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Poll Question
The current serving size on the nutrition facts
label is based on…
A. A recommended amount of a food product
that consumers should aim to eat during a
meal.
B. The average amount of a food product that
people usually eat during a meal.
Serving (or Serving Size)
§ 101.9(b)(1)
• An amount of food
customarily (or usually)
consumed per eating
occasion by persons 4 years
of age or older, which is
expressed in a common
household measure that is
appropriate to the food.
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Serving Size Vs. RACC
• The Reference Amount Customarily Consumed or RACC is a
number developed by FDA that manufacturers use to
determine the serving size you see on the label.
• The serving size is the actual number that you see on a
product package.
FDA determines the RACC.
Manufacturers determines the serving size.
Serving Size is critical!
• It provides the basis upon which the number
of calories and the levels of nutrients are
determined.
• It is not the same as portion sizes
recommended in dietary guidance.
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Check Serving Information
Entire
1 Serving % DV Package % DV
Serving Size
Calories
Calories from
Fat
Total Fat
Trans Fat
Saturated Fat
Cholesterol
Sodium
Total
Carbohydrate
Dietary Fiber
Sugars
Protein
Vitamin A
Vitamin C
Calcium
Iron
1 cup
(228 g)
250
2 cups
(456 g)
500
110
12 g
1.5 g
3g
30 mg
470 mg
220
24 g
3g
6g
60 mg
940 mg
31 g
0g
5g
5g
18%
15%
10%
20%
10%
0%
4%
2%
20%
4%
62 g
0g
10 g
10 g
36%
30%
20%
40%
20%
0%
8%
4%
40%
8%
Why do Manufacturers Care
about Serving Size?
If a manufacturer wants to make a label
claim on their product, such as saying that
the product is “low in fat” or “high in
calcium” the information used to calculate
serving size is used as the basis to
determine if the product meets the
standards for the claim.
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Nutrition Labeling and
Education Act of 1990 (NLEA)
• Gave FDA the explicit authority to provide for nutrition
labeling on packaged foods based on a serving size
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Reference Amounts Customarily
Consumed (RACCs) and Serving Sizes
• In 1993 FDA established RACCs based on national
consumption data
• Provided manufacturers with rules to determine
the serving size of their product from the
appropriate RACC
Why Update Serving Size Regulations?
• Availability of newer consumption data
• Research showing that consumption patterns of
Americans have changed
• Availability of recent consumer research on the use
and understanding of the Nutrition Facts label
• Numerous requests from food manufacturers
requesting changes
Advance Notice of Proposed Rulemaking
(ANPRM)
• 2005 – FDA issued a ANPRM that, among other things,
requested comment on the following topics:
– Single-serving Containers
– Dual-column Labeling
– Updating the RACCs
• Comments to the ANPRM were considered during this
proposed rulemaking
Key Proposed Changes
• Amend the definition of a single-serving container
• Require dual-column labeling for certain packages
• Update, modify and establish reference amounts
customarily consumed
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Current Definition of a Single Single-Serving Container
A Package that can reasonably be consumed in a single-eating occasion
• A product that is packaged and sold individually and contains less
than 200 percent of the RACC. Except, that if a product has a large
RACC (i.e., 100 grams or 100 milliliters or more) and contains more
than 150 percent and less than 200 percent of the RACC, it may be
labeled as one or two servings
• A product is packaged and sold individually and contains 200 percent
or more the RACC may be labeled as a single-serving container if the
package can reasonably be consumed at a single-eating occasion
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Basis for Allowing Large RACC Products to be
Labeled as 1 or 2 servings
FDA Analysis has determined that
• It is less likely that an individual would consume about twice the
amount of a product with a large RACC, than he or she would
consume about twice the amount of a product with a small RACC
• It is just as likely that an individual would consume about twice the
RACC of a food with a large RACC as it is that he or she would
consume twice the RACC of a food with a small RACC
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Proposal for a Single-Serving Container
A Package that can reasonably be consumed in a single-eating occasion
• A product that is packaged and sold individually and that
contains less than 200 percent of the RACC must be labeled as
a single-serving container regardless of the RACC
• Eliminate the provision that packaged foods sold individually
and containing 200 percent or more the RACC may be labeled
as a single-serving container if the package can reasonably be
consumed at a single-eating occasion
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Dual-Column Labeling
Pancake Mix
Currently manufacturers can
voluntarily provide dual-column
labeling by listing nutrition
information for two or more
forms of the same food (e.g.,
both as “purchased” and
“prepared”)
Dual-Column Labeling (continued)
CEREAL BOX
Nutrition information can also
be presented for foods
commonly combined with other
ingredients or otherwise
prepared before eating
Consumer Studies on Dual-Column Labeling
• FDA conducted consumer research to help enhance our understanding of
whether and how much modifications to the label format may help
consumers use the label1
• The study compared participants’ ability to perform various tasks, such as
evaluating product healthfulness and calculating the number of calories
and other nutrients per serving and per container, when using the current
label versus modified versions of the current label, and compared
participants’ overall attitudes toward these labels
1Lando,
A. M., S. C. Lo. "Single-Larger-Portion-Size and Dual-Column Nutrition Labeling May Help Consumers
Make More Healthful Food Choices," Journal of the Academy of Nutrition and Dietetics, 113:241-50, 2013
Consumer Studies on Dual-Column Labeling
Results
Among other findings this research shows that dualcolumn labels resulted in more participants correctly
identifying the number of calories per container and
the amount of other nutrients per container and per
serving
Consumer Studies on Dual-Column Labeling
Second Study
• In another study, participants were given a snack food product and either
a single-column nutrition label or dual-column nutrition label (i.e., labeling
indicating the nutrition information per serving and per container)1
• Findings from the study suggested that dual-column labeling led
consumers who are not dieting to reduce the amount of food they
consumed
• The authors of this study speculated that a dual-column label works as a
contextual cue that raises awareness of the amount of food consumed in a
package among certain consumers
1Antonuk,
B., L. Block. "The Effect of Single Serving Versus Entire Package Nutritional Information on
Consumption Norms and Actual Consumption of a Snack Food," Journal of Nutrition Education and Behavior,
38:365-70, 2006.
Proposal for Dual-Column Labeling
Packages likely to be consumed as one or multiple servings
• Intended for products that can be consumed as one serving or as
multiple servings
• Dual-column labeling that would present nutrition information per
serving and per container would generally be required for products
in packages that contain at least 200% of the RACC and up to and
including 400%
Example: A 90 g bag of chips would now have to list nutrition information
serving (30 g) and per package (90 g)
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Proposal for Dual-Column Labeling
(Continued)
• Dual-column labeling for products with 400 percent or less of the
RACC would capture the most frequent consumption habits for all
product categories
• Dual-column labeling would provide nutrition information for those
who consume the entire container in one-eating occasion as well as
those consumers who share the container with others and
consumers who would consume the container over multiple-eating
occasions
Proposed Exempted Products
•
Products that meet the requirement to use the small tabular format in 21 CFR
101.9(j)(13)(ii)(A)(1) or the linear format in 21 CFR 101.9(j)(13)(ii)(A)(2)
•
Bulk products that are used primarily as ingredients (e.g., flour, sweeteners,
shortenings, oils)
•
Bulk products traditionally used for multi-purposes (e.g., eggs, butter, margarine)
•
Multipurpose baking mixes
•
Food products that require further preparation and voluntarily contain two columns of
nutrition information on the “as purchased” and “as prepared” forms of the food per
serving
•
Food products that are commonly consumed in combination with other foods and
voluntarily include another column with information regarding the combined food per
serving (e.g., cereal and skim milk)
It is helpful to consumers to include nutrition information based on the food in the
prepared form or the combination of the foods
Proposal for Dual-Column Labeling
Alternate Formats
• FDA also requested comments on other options for requiring
certain nutrition information per serving and per container
- Calories only
- Calories, saturated fat and sodium
• In these options the information listed per serving and per
container would be beneath the serving size information and the
remaining nutrients would be listed on a per serving basis in a
single column
Current 1993 RACCs
• The 1993 RACCs represent the amount of a food product customarily
consumed per eating occasion and are based primarily on 1977–1978 and
1987–1988 nationwide food consumption surveys conducted by the U.S.
Department of Agriculture
• Currently, there are 11 product categories for infants and children 1 to 3
years of age and 129 product categories for individuals 4 years or older
• The RACCs are organized so that foods that have similar dietary usage and
product characteristics are grouped together in product categories
• Uniform RACCs help consumers to make nutritional comparisons of similar
products in the marketplace.
Current 1993 RACCs (continued)
• Other factors considered:
– Consistency between product categories within a product
category
– Dietary guidance documents
– Canadian serving size
– Commonly used serving size
– Industry practice
– Public comments
Reasons for Updating, Modifying and
Establish RAACs
• Newer consumption data to update RACCs
• Requests from industry and agency initiative to
modify RACCs
• Establish RACCs for products not currently in the
Tables in 21 CFR 101.12 based on requests and
agency initiative
Scenarios for Updating, Modifying and
Establishing the RACCs
• Update the 1993 RACCs
- When intake data significantly increases or decreases from the 1993
RACCs
• Modify existing RACCs
- When intake data does not significantly increase or decrease from the
1993 RACCs but instead are based on requests from manufactures and
agency initiative
• Establishing RACCs
- For products that do not have RACCs
Data Sources Used to Update, Modify and
Establish the RACCs
• What We Eat in America (WWEIA), National Health and
Nutrition Examination Survey (NHANES)
• The WWEIA provides gram amounts of each food reported
consumed in the past 24-hours from each survey participant
• Combined 2003-2004, 2005-2006, and 2007-2008 from the
NHANES because starting in 2003 2 days of consumption data
have been available
• Include reliable intake data
• Populations: infants through 3 years of age and 4+
Methods
• Analyze each product within product category
– Calculate minimum sample size
– Estimate the median
– Determine if there was a significant increase or
decrease in consumption levels from the 1993 RACCs
Other Factors Considered when Updating the
1993 RACCs
•
•
•
•
Consistent RACCs for products in a product category
Consistent RACCs for products that have similar dietary
usage, product characteristics and are used interchangeably
If the median estimates varied for products in a product
category, greater consideration was given for the product
with the largest sample size
The reasonable consumption amount suggested in the Food
and Nutrient Database for Dietary Studies
Summary of RACCs to be Updated for General
Food Supply
Food Product
Current RACC
Proposed RACC
Bakery products:
Bagels
55 g
110 g
Toaster Pastries
55 g
110 g
Muffins (excluding
English muffins)
55 g
110 g
Updated RACCs
Beverages Product Categories
Food Product
Beverages:
Carbonated and noncarbonated beverages
Wine Coolers
Water
Coffee flavored and
sweetened
Tea flavored and
sweetened
Current RACC
Proposed RACC
240 mL (8 fl oz.)
360 mL (12 fl oz.)
240 mL (8 fl oz.)
240 mL (8 fl oz.)
360 mL (12 fl oz.)
360 mL (12 fl oz.)
240 mL (8 fl oz.)
360 mL (12 fl oz.)
240 mL (8 fl oz.)
360 mL (12 fl oz.)
Updated RACCs
Fish and Fruit Product Categories
Food Product
Current RACC
Proposed RACC
Fish, Shellfish, Game Meats, and
Meat or Poultry Substitutes:
Canned fish, shell fish, or game
meat
Fruits and Fruit Juices:
55 g
85 g
Fruits used primarily as ingredients,
avocado
30 g
50 g
Updated RACCs
Sugars and Sweets
Food Product
Current RACC
Proposed RACC
Sugars and Sweets:
All other candies
Syrups
Sugar
40 g
30 g
30 mL for syrups
used primarily as an
ingredient (e.g.,
light or dark corn
syrup); 60 mL for all
others
30 mL
4g
8g
Modifying the 1993 RACCs
• When intake data does not significantly increase or
decrease from the 1993 RACCs
- Based on requests from manufactures
- Comments to the 2005 ANPRM
- Agency initiatives
Modified RACCs
Dairy and Dessert Product Categories
Food Product
Dairy Products and
Substitutes:
Yogurt
Current RACC
Proposed RACC
225 g
170 g
Ice cream, ice milk, frozen
yogurt, sherbet, bulk
½ cup
1 cup
frozen flavored and
sweetened ice, frozen fruit
juices, bulk
85 g
1 cup
frozen flavored and
sweetened ice, frozen fruit
juices: novelties
85 g
½ cup
Desserts:
Modified RACCs
Fruits and Miscellaneous Product Categories
Food Product
Current RACC
Proposed RACC
Fruits and Fruit Juices:
Fruits used primarily as
ingredients, others
(cranberries, lemon, lime)
Miscellaneous:
Drink Mixes (without
alcohol): all other types
(e.g., flavored syrups, and
powdered drink mixes)
55 g
50 g
Amount to make 240 mL
(without ice)
Amount to make 360 mL
(without ice)
Establishing New RACCs
• Factors considered
- USDA Guidance document
- Guidance for Industry: A Food Labeling Guide
- Industry practices (e.g., Mintel, Gladson databases)
- Recipe calculation
- National Nutrient Database for Standard Reference
-Determine main dietary usage (e.g., Food Lover’s Companion,
allrecipes.com, etc.)
New RACCs
Bakery and Egg Product Categories
Food Product
Proposed RACC
Bakery products:
Eggroll, Dumpling, Pot sticker, Wonton wrappers
20 g
Crepes
110 g
Scones and Crumpets
55 g
Pie Shells and Pastry Sheets
The allowable declaration
closest to an 8 square inch
surface area
Egg and Egg Substitutes:
Sugared eggs, and Sugared egg yolk
Amount to make 1 large (50 g)
egg
New RACCs
Fish and Miscellaneous Product Categories
Food Product
Fish, Shellfish, Game Meats, and Meat or Poultry
Substitutes:
Seafood substitutes
Proposed RACC
55 g
Miscellaneous:
Cocoa powder, carob powder, unsweetened
Milk, milk substitutes and fruit based drink mixers
(without alcohol) e.g., drink mixers, fruit flavored
powdered drink mixes, sweetened coca powder
Seasoning oils and seasoning sauces (e.g., coconut
concentrate, sesame oil, almond oil, chili oil, coconut
oil, walnut oil)
1 tbsp.
Amount to make 240 ml drink
(without ice)
1 tbsp.
New RACCs
Miscellaneous, Mixed Dishes and Sauces Product Category
Food Product
Proposed RACC
Miscellaneous:
Seasoning pastes (e.g. garlic paste, ginger paste, curry
paste, chili paste, miso paste), fresh or frozen
Mixed Dishes:
1 tsp.
Appetizers, hors d’oeuvres, mini mixed dishes, e.g.,
mini bagel pizzas, breaded mozzarella sticks, egg rolls,
85 g add 35 g for gravy or topping
dumplings, pot stickers, wontons, mini quesadillas,
sauce
mini quiches, mini sandwiches, mini pizza rolls, potato
skins
Sauces, Dips, Gravies and Condiments:
Alfredo sauce
¼ cup
New RACCs
Soups and Sugars Product Category
Food Product
Proposed RACC
Soups:
Dry soup mixes and bouillons
Amount to make 245 g
Sugars and Sweets:
After dinner confectionaries
10 g
Powdered candies
15 g
Liquid candies
Fruit pastes and fruit chutney
15 mL
1 tbsp.
New RACCs
Vegetables Product Category
Food Product
Proposed RACC
Vegetables:
Dried vegetables, dried tomatoes, sun-dried
tomatoes, dried mushrooms, dried seaweed
Dried Seaweed sheets
5 g, add 5 g for products
packaged in oil
3g
Jalapeno and other hot peppers
30 g
Pickled vegetables
30 g
Vegetables:
Dried vegetables, dried tomatoes, sun-dried
tomatoes, dried mushrooms, dried seaweed
Sprouts, all types: fresh or canned
5 g, add 5 g for products
packaged in oil
¼ cup
Impact of Changes in RACCs on Claims
• The agency recognizes that changes in RACCs and the Daily
Values will affect the eligibility of foods to bear nutrient
content claims and health claims
• Changes in the ability to make claims may be appropriate in
light of the change in the amounts of foods customarily
consumed
• The agency requested comments related to changes to
current claims that will be affected if the RACCs are finalized
as proposed
To begin shortly…
Label Claims
Vincent de Jesus
Office of Nutrition, Labeling, and Dietary
Supplements
FDA:CFSAN
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