# Presentation: 705731

## Nutrition Labeling – FSIS Regulated Foods

**The following is a comprehensive presentation on the essential requirements for nutrition labeling on meat, poultry, and egg products.**
**If at the end of the presentation, the reader has questions, he/she may contact the Labeling and Consumer Protection Staff at:**** **
- _[Labeling and Consumer Protection Staff](http://www.fsis.usda.gov/About_FSIS/labeling_&_consumer_protection/index.asp)_
**or**
- _[FSIS.labeling@fsis.usda.gov](mailto:FSIS.labeling@fsis.usda.gov)_

- USDA-FSIS

- June 15, 2006

## Nutrition Labeling – FSIS Regulated Foods

***Nutrition Labeling – FSIS Regulated Foods***

- USDA-FSIS

- June 15, 2006

## Nutrition Labeling and Education Act 

- Requires what nutrients are listed on label, and how they are to be listed
- Defines nutrients
- Establishes reference amounts for determining serving sizes
- Adopts standardized format
- Requires nutrition labeling on most foods that contain more than insignificant amounts of nutrients
- FSIS is not covered by NLEA

- USDA-FSIS

- June 15, 2006

**Notes:**
Some declarations were added; some declarations were deleted.

Format was standardized to facilitate finding and use.

Mandated for virtually all packaged consumer products; exemptions will be discussed later.

Established reference amount from which serving size could be calculated according to regulated procedures, but did not establish serving size.

## Nutrients Listed on Label

| Calories | Total carbohydrate |
| --- | --- |
| Calories from fat/calories from saturated fat | Dietary fiber (soluble and insoluble fiber) |
| Total fat | Sugars (sugar alcohols) |
| Saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, trans fat | Other Carbohydrates |
| Cholesterol | Protein |
| Sodium | Vitamins and minerals (for which RDI’s have been established) |
| Potassium
 |  |

- USDA-FSIS

- June 15, 2006

**Notes:**
Table is from 101.9(c)(9) and lists the vitamins and minerals that must or may be declared and the order in which they are to be declared.

If not listed, cannot be declared.

Table in CFR also includes the quantitative RDI for each vitamin or mineral.

## Definitions

_**Total fat**_**:** Total lipid fatty acids expressed as triglycerides [317.309(c)(2), 381.409(c)(2)]
_**Saturated fat**__:_ The sum of all fatty acids containing no double bonds [317.309(c)(2)(i)]
_**Polyunsaturated fat**_: *cis, cis*-methylene-interrupted polyunsaturated fatty acids [317.309(c)(2)(ii)]
_**Monounsaturated fat:**_ *cis*-monounsaturated fatty acids [317.309(c)(2)(iii)]

- USDA-FSIS

- June 15, 2006

**Notes:**
Understanding definitions very important.

Definition of mono- and polyunsaturated fat excludes trans fatty acids.

Make sure analytical methods are appropriate for material being declared.

Lack of definitions contributed to the “jungle” than developed in the marketplace in the mid to late 1980s.

## Definitions (contd.)

***Definitions ******(contd.)***

_**Total carbohydrate:**_ Amount calculated by subtraction of the sum of crude protein, total fat, moisture, and ash from the total weight of food [317.309(c)(6)]
_**Sugars**_: The sum of all free mono- and disaccharides [317.309(c)(6)(ii)]
_**Other carbohydrate**_: The difference between total carbohydrate and the sum of dietary fiber, sugars, and, when declared, sugar alcohol [317.309(c)(6)(iv)]

- USDA-FSIS

- June 15, 2006

**Notes:**
“Other carbohydrate” is what used to be called “complex carbohydrates.”

Sugar singular is sucrose or cane or beet sugar.

Sugars plural includes any sweetener from any source.

## Daily Values (DV)

- Two sets of label reference values
- reference daily intakes (RDIs)
- daily reference values (DRVs)
- Applicable to persons 4 or more years of age

- USDA-FSIS

- June 15, 2006

**Notes:**
Daily Value has replace U.S.RDA

RDIs for nutrients having a RDA.

DRVs for components not having RDA, but having recommended or suggested minimum or maxiumu daily intake levels.

## Reference Daily Intakes (RDIs)

- USDA-FSIS

- June 15, 2006

**Notes:**
Table is from 101.9(c)(9) and lists the vitamins and minerals that must or may be declared and the order in which they are to be declared.

If not listed, cannot be declared.

Table in CFR also includes the quantitative RDI for each vitamin or mineral.

## Daily Reference Values (DRVs)

- USDA-FSIS

- June 15, 2006

**Notes:**
Daily Reference Values - some good/some not so good!

Based on dietary recommendations:

	30% of calories from fat
	30% of 200 = 600
	600 calories = 66.67 g fat rounded to 65

## Reference Amount Customarily Consumed (RACC)

- Established for 27 red meat categories
**27 red meat (317.312) 26 poultry (381.412)**
- Basis for labeled serving size
- Basis for nutrient “claims”
- Derived from food consumption data
- Developed jointly with FDA
- Petition process to modify RACC

- USDA-FSIS

- June 15, 2006

**Notes:**
The petition process to modify RACC actually works as evidenced by some changes made in recent years.

## What’s Needed?

- Serving size
- household and metric measure

-  Servings per container

-  Mandatory nutrients

-  Established format

- USDA-FSIS

- June 15, 2006

## Serving Size

- As packaged
- In household measures
- cups, tablespoons, teaspoons: fl oz for beverages
- pieces, slices, fractions, etc.
- ounces (appropriate visual unit is optional)
- Based on Reference Amount

- USDA-FSIS

- June 15, 2006

**Notes:**
As packaged and if mix or base, the amount to give the RACC for the product as consumed (pancake mix; beverage base)

## Labeled Serving Size Designations

***Labeled Serving Size Designations***

- Required: household and metric measure
- 1 cup (___g)
- 1 slice (___g)
- 1 dinner (___g)
- 2 oz (___g)
- Options: ounce or fluid ounce
- 1 cup (___g/_fl oz)
- 1 slice (___g/_oz)

- USDA-FSIS

- June 15, 2006

**Notes:**
Common household measured followed by parenthetical metric equivalent.

If ounce used must provide visual reference (___inch slice).

## Examples of Acceptable Serving Size Designations

***Examples of Acceptable Serving Size Designations***

- Chili:			1 cup (___g)
- Meat pizza:		1/5 pie (___g)
- Sliced ham:		4 slices (___g)
- Gravy:  			1/4 cup (___g)

- USDA-FSIS

- June 15, 2006

**Notes:**
Common household measure that is appropriate for the food:
	cup
	fractdion
	pieces, slices, crackers, pretzels, chips, etc.
	amount of mix that gives the RACC for the finished 		product

## Labeled Serving Size Designations

***Labeled Serving Size Designations***

- Bulk products (e.g., soup, gravy):
- household measure closest to reference amount
- Discrete large unit (e.g., pizza, quiche):
- fraction closest to reference amount

- USDA-FSIS

- June 15, 2006

**Notes:**
For bulk products and many others, there is no way to covert RACC to label serving size other than to measure and weigh.

Will illustrate later.

## Labeled Serving Size Designations

***Labeled Serving Size Designations***

- Discrete individual units (e.g., sausage, sliced luncheon meat):
- >50% but <200% of RACC= 1 unit
- _<_50% RACC = number of units closest to reference amount
- >50 but <67% = 1 or 2

- USDA-FSIS

- June 15, 2006

**Notes:**
Note special provisions for discrete individual units.

If a units weighs more than 50% but less than 200% of the RACC, i unit is label serving size.
	cookies with 30 g RACC
	>15 and <60 g cookies would be one serving

If cookies weighs 15 g or less, divide 30 by weight and round to nearest whole number
	cookies weigh 12 g
	30/12 = 2.5 = 3 (rounded)

If unit weight is more than 50% but less than 67%, can use 1 or 2 as label serving size

## Labeled Serving Size Designations

***Labeled Serving Size Designations***

- If contents are <200% RACC
- declare as one serving
- If RACC is >100 grams _and_ contents are >150 but <200%
- may be declared as 1 or 2

- USDA-FSIS

- June 15, 2006

**Notes:**
200% of a 100 g RACC is a very large single serving.

Therefore, if the RACC is large (>100 g) and unit weighs >150 but <200% have option to use o or 2 as servings per container (package).

## Label Serving Size Designations 

***Label Serving Size ******Designations ***

- Consumer friendly fractions
- 1/2  1/3  1/4  1/5  1/6 and fractions obtained dividing these by 2 or 3
- 1/7  (not a consumer friendly fraction)
- 1/2  2 = 1/4   1/4  3 = 1/12

- USDA-FSIS

- June 15, 2006

**Notes:**
Consumer friendly fractions used for large units such a pizza, pies, cakes, etc.

## Label Serving Size Example

- Soup
- RACC = 245 g - Label serving size is in cups
- measure 245 g (14.5 fl oz)
- the nearest 1/4 or 1/3 cup = 14 fl oz =
-    1-3/4 cup
- serving size: 1-3/4 cup (236 g/14 oz)

- USDA-FSIS

- June 15, 2006

**Notes:**
With product like soup, RACC is in g and appropriate label serving size would be in cups.

Must weight and measure.

Round according to regulations.

Recalculate parenthetical g declaration for actual label serving in round cup measurement.

## Label Serving Size Example

- Jerky
- RACC = 30 g
- if 2 g pieces: number of pieces closest to 30g
- 15 pieces (30 g)
- if large piece: size of chunk closest to 30 g
- 1 piece (25 g)
- If pieces vary by 100% (10g to 20g)
- 1 oz (28 g)

- USDA-FSIS

- June 15, 2006

**Notes:**
Sliced cheese is relatively straight forward.

With cheese spread where RACC is in grams and appropriate household measure would be tablespoons, must measure and round according to regulations.

We large piece of cheese, must cut and weigh - probably more than once!

## Label Serving Size Example

***Label Serving Size Example***

- Pizza
- RACC = 140 g
- weight = 24 oz (1-1/2 lb)
- 1.5 x 454 = 681 g
- 681/140 = 4.86 pieces (or slices)
- 4.86 = 5 which is a consumer friendly fraction
- 681/5 = 136.2 g = 136g
- serving size: 1/5 pizza (136 g)

- USDA-FSIS

- June 15, 2006

## Compliance Criteria

***Compliance Criteria***

- Class I (Nutrients added in fortification or fabrication of food) (NONE for FSIS)
- Class I vitamin, protein, dietary fiber, or potassium = 100% of declared value
- Class II (naturally occurring nutrients)
- Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium  = at least 80% of declared value
- Calories, total fat, saturated fat, cholesterol, sodium, and sugars = no more than 120% of declared value

- USDA-FSIS

- June 15, 2006

**Notes:**
FDA does not specify how declared values are to be determined, but manufacturer is responsible for accuracy.

FDA will composite 12 units and analyze using “appropriate” methodolgy.

80/120 rule: no less than 80% of good nutrients and no more than 120% of undesirable components based on label declaration.

## Choosing a Format

- Amount of “space available for labeling”
- Amount of continuous vertical space
- Dual declaration - “As Packaged” & “As Prepared”
- Dual declaration - Combination with another food
- Aggregate declaration - Variety of foods
- Bilingual declaration - English & another language
- Food represented as food for children

- USDA-FSIS

- June 15, 2006

## Full Vertical Format

- Package has more than 40 square inches of space available for labeling
- At least 3 continuous vertical inches

- USDA-FSIS

- June 15, 2006

## Side-by-Side 

- Full vertical format with footnote on the side (information following vitamin and mineral listing**)**

- USDA-FSIS

- June 15, 2006

## Full Tabular 

- Insufficient vertical space (less the 3 inches)
- Foot note is required

- USDA-FSIS

- June 15, 2006

## Tabular (Small and Intermediate-Sized Packages)

-  40 sq. in. or less available for labeling
-  “Nutrition Facts” on any label panel

-  May omit footnotes if another asterisk is placed at the bottom of panel with statement “Percent Daily Values are based on a 2,000 calorie diet”

- USDA-FSIS

- June 15, 2006

## Shortened Vertical

-  Instead of showing “zeros”, allows nutrients present at insignificant levels to be listed as “Not a significant source of _________”)

-  Listed in the order as they would in the regular format* *
-  “Insignificant is defined in 9 CFR 317.309(f)(1)

- USDA-FSIS

- June 15, 2006

## Simplified Vertical(FSIS)

***Simplified Vertical******(FSIS)***

-  When nutrients are added or voluntarily declared,

** ****5 core nutrients must always be listed**

-  Must list “zero” level nutrients, by adding statement “Not a significant source of _______”, (Names of nutrients present at insignificant levels)

- USDA-FSIS

- June 15, 2006

##  At least 7 of the designated nutrients are insignificant (calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron) 
 Five core nutrients must always appear 

-  Five core nutrients must always appear

***Simplified Vertical (FDA)***

- USDA-FSIS

- June 15, 2006

## Simplified Tabular (FDA)

***Simplified Tabular (FDA)***

-  May be used on any size package that qualifies for simplified format, when there is insufficient space for vertical simplified format.

- _ __Simplified format_  5 core nutrients listed; at least 7 insignificant nutrients; voluntarily added or listed nutrients

***Note – Trans fat content required***

- USDA-FSIS

- June 15, 2006

## Single-serving 

-  Omit “servings per container” and metric declaration of serving size
-  Must be description of container

- USDA-FSIS

- June 15, 2006

## Prepared Foods

***Prepared Foods***

- Quantitative amounts
- needed only for packaged
- food** **

-  Preparation according to package directions

-  Omit second column if nutrient values are the same

- USDA-FSIS

- June 15, 2006

## Combined Foods

- Vertical format with second column indicating nutrients added by combination of foods

-  Quantitative amounts needed only for packaged food

- USDA-FSIS

- June 15, 2006

## Variety Pack

-  Vertical format with additional columns indicating nutrients in the other foods

-  Package containstwo or more packaged foods

-  Foods are eaten individually
-  Packages used interchangeably

- USDA-FSIS

- June 15, 2006

## Linear 

-  Tabular display does not fit on small & intermediate sized packages (must prove)
-  Package shape cannot accommodate the nutrition information placed in columns

- USDA-FSIS

- June 15, 2006

## Bilingual

-  Separate nutrition facts panel may be used, or combined
-  Second language following the English text

-  Numeric characters identical in both languages need not be repeated
-  All required nutrition information must be included in both languages

- USDA-FSIS

- June 15, 2006

## Food for Children  	 (Less than 2 years old)

-  Certain nutrients cannot be listed
-  No %DV listed for several nutrients
-  Two column format - nutrient names & amounts by weight
-  % Daily Value required for protein, vitamins, and minerals

- USDA-FSIS

- June 15, 2006

## Food for Children  	(2 years to 4 years old)

-  Same as “Children under 2 years
-  Calories from fat allowed
-  Saturated fat allowed
-  Cholesterol allowed

- USDA-FSIS

- June 15, 2006

## “Very Small”

***“******Very Small”***

-  Less than 12 sq. in. available for labeling
-  No nutrient content claims or other nutritional information on label
-  Telephone number or address must be stated
-  Type size - no smaller than 6pt (uppercase) or not less than 1/16 inch

- USDA-FSIS

- June 15, 2006

## Exemptions and SpecialLabeling

-  Small businesses based on number of employees
- Low volume food products
- Products for further processing
- Products not for sale to consumers
- Products in small packages, less than 1⁄2        ounce
- Products custom slaughter
- Products for export

- USDA-FSIS

- June 15, 2006

## 
Following products prepared and served or sold at retail
RTE products packaged or portioned at retail
Multi-ingredient products processed at retail

- Following products prepared and served or sold at retail
- RTE products packaged or portioned at retail
- Multi-ingredient products processed at retail

***Exemptions and Special******Labeling***

- USDA-FSIS

- June 15, 2006

## Firm with 500 or fewer employees
Individual product produced at 100,000 pounds or less annually
All forms of a product are counted toward the 100,000 pounds, e.g., pork sausage, bulk, patties, links, consumer product, HRI product, hot/mild if the same nutrient profile

- Individual product produced at 100,000 pounds or less annually
- All forms of a product are counted toward the 100,000 pounds, e.g., pork sausage, bulk, patties, links, consumer product, HRI product, hot/mild if the same nutrient profile

***Exemptions and Special******Labeling – Small Business***

- USDA-FSIS

- June 15, 2006

## Exemptions and SpecialLabeling - Low volume food products

- Applies only to Nutrition Facts panel
- No nutritional claims permitted
- Firms not required to file or file annually for exemption

- USDA-FSIS

- June 15, 2006

## Differences Between FSISand FDA

- FSIS is not under NLEA
- Small business exemption & no approval/notification for the exemption
- No required “visual” for serving size declared in ounces
- Use of simplified format with one nutrient, other than core, declared as “0”
- FSIS Permits voluntary declaration of “stearic acid” indented under sat fat
- FSIS has no Class 1 nutrients since we do not permit fortification.

- USDA-FSIS

- June 15, 2006