Update on Nutritional Labeling Requirements · Nutritional Labeling Compliance Dates for Non-exempt...

Update on Nutritional Labeling Requirements

Wisconsin Association for Food ProtectionFood Safety Workshop

June 13, 2017

Stefan C. Boerboom, R.S.

Manufactured Food Specialist

Wisconsin Department of Agriculture, Trade and Consumer Protection

Scope

What are the changes to nutritional labeling?

Who and what are exempt from nutritional labeling?

When must the new requirements be met?

Where can I find more information?

Why are these changes being made?

How far along is pending legislation?

What are some highlights and a few details of the changes?

Serving Sizes of Foods that Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints;and Technical Amendments

What are the changes to nutritional labeling?

4 Final Rules

Revision of the Nutrition and Supplement Facts Labels

Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Calorie Labeling of Articles of Food in Vending Machines

Who and what are exempt from nutritional labeling?packaged food and food sold

in bulk or by individual pieces

menus and vending machines


Standard Menu Items in Restaurants and Similar Retail Food Establishments


• Fewer than 20 chain locations

• Doing business under different names

• Offering for sale substantially differentmenu items

• Fewer than 20 machines

• Purchaser can view calories

• Front of the package

• Nutrition facts label on the food

• Reproduction of nutrition facts label

Must have at least one of the above Must have at least one of the above

Operator may also voluntarily register to be subject to the rule.


A product is NOT exempt if any labels, labeling, or advertising provide nutrition information or make a nutrient content or health claim.

ex) “Low fat”

ex) “Contains 5 g Fiber”

ex) “Part of a heart healthy diet”

Who and what are exempt from nutritional labeling?packaged food and food sold

in bulk or by individual pieces

menus and vending machines

Small Business Nutrition Labeling Exemption

Exemptions and Special Provisions of 21 CFR 101.9(j)(1-18)

Modified Nutritional Labeling Required

No Nutritional Labeling Required,

Optional Nutritional Labeling Defined• 20 most frequently consumed

• raw fruits

• raw vegetables

• raw fish

• Packaged single-ingredient fish or game meat

• Game meats may have info in binder, other

No Nutritional Labeling Required• Non-covered restaurant, retail or similar,

vending

• Donated/free

• Insignificant amounts of nutrients and food

components

• ex) coffee, tea, food coloring, most spices

• Medical foods

• Bulk foods shipped for further processing,

labeling or repacking before retail sale.

• Custom-processed fish and game meats.

• Small packages that have a total surface area

available to bear labeling of less than 12

square inches

• Package labeled "This unit not labeled for

retail sale" within multi-unit package, and outer

wrapper bears all required label statements

low volume products

food manufacturers, packers,

and distributors

certain

retailers

A product is NOT exempt if any labels, labeling, or advertising provide nutrition information or make a nutrient content or health claim.

Small Business Nutritional Labeling Exemption forRetailers

21 CFR

101.9(j)(1)

Separate from

menu labeling

exemption

Small Business Nutritional Labeling Exemption for Food Manufacturers, Packers, and Distributors

21 CFR

101.9(j)(18

)

Nutritional Labeling Compliance Dates



May 7, 2018 December 1, 2016• No visible FOP labeling

• Electronic displays

• Unpackaged products

July 26, 2018• Visible FOP labeling

• Gums

• Mints

• Roll candy

Common Sense Nutrition

Disclosure Act of 2017May postpone menu labeling

If act passes then 2+ years after regulation

published before enforcement

Nutritional Labeling Compliance Dates



May 7, 2018 December 1, 2016• No visible FOP labeling

• Electronic displays

• Unpackaged products

July 26, 2018• Visible FOP labeling

• Gums

• Mints

• Roll candy

Common Sense Nutrition

Disclosure Act of 2017May postpone menu labeling

If act passes then 2+ years after regulation

published before enforcement

CSPI & NCL v. FDAFiled June 7, 2017

Lawsuit seeks to reinstate compliance of

rule within 15 days of court decision

Nutritional Labeling Compliance Dates for Non-exempt Food Manufacturers, Packers, and Distributors

• July 26, 2018 for manufacturers with $10 million or more in annual food sales

• July 26, 2019 for manufacturers with less than $10 million in annual food salesFoods imported to the United

States will need to meet the

final requirements.


National Bioengineered Food Disclosure Law(GMO labeling)

As of 5/26/17, no delay for nutrition facts label change to coordinate with USDA’s upcoming GMO mandatory disclosure program.

USDA to provide a plan by July 2018, but compliance to come 1+ years later.

This product includes ingredients sourced from genetically engineered (GE) crops, commonly known as GMOs. In the US, some agricultural crops, such as corn and soybeans are predominantly from GMO varieties. Ingredients from these crops are used in many food products.

Summary of Nutrition Facts Changes

Summary of Nutrition Facts Changes in Requirementsye olde

Serving Size on top

Servings Per Container on

bottom

servings per container on top

Serving Size is BOLD“Calories from Fat”

required“Calories from Fat”

removed

“Sugars

”“Total

Sugars”grams and %DV of “Added

Sugars”

Vitamins A and

CRequired: Vitamin D and

Potassium

Optional: Vitamins A and C

reference

values Certain reference values

updated

Prominence of Calories

increased

Footnote for two

diets Two diet footnote not

required

Records for certain nutrients

under specified

circumstances

Old

footnote

Revised footnote

No

nutrient

amountsnutrient

amount

s

Nutrition Facts Formats – 14 Example Variationsstandard

vertical

standard

vertical w/ side-

by-side

standard

vertical w/

voluntary

simplified

infants

up to 12 months

children

1-3 years

aggregate

(different foods) dual-column

per serving, per unit

dual-column

(per serving, per

container)

dual-column

two forms, same food

(as packaged, as

prepared)

tabular dual-

column

linear small

packages

tabular, small

packages

tabular

Nutrition Facts Formats

dual-column

per serving, per unit

dual-column

(per serving, per

container)

tabular dual-

column

Nutrition Facts Formats – New Dual-Column Displays

dual-column

per serving, per

unit

dual-column

(per serving, per

container)

tabular dual-

column

Daily Reference Values (DRV) for Adults and Children 4 and Up

Unchanged• Saturated Fat (20 g)

• Cholesterol (300 mg)

• Protein (50g)

Changed• Fat (78 g, was 65 g)

• *Dietary Fiber (28 g, was 25 g)

• Total carbohydrates (275 g, was 300 g)

• Sodium (2,300 mg, was 2,400 mg)

• Added Sugars is new (50 g)

• Potassium moved to RDI table

*Definition of dietary fiber has also changed

Reference Daily Intake (RDI) for Adults and Children 4 and Up

Unchanged• Iron (18 mg)

• Folate (400 mcg)

Changed• Choline is new (550 mg)

• All others changed, not just potassium and Vitamin D

Reference Amounts Customarily Consumed (RACC)

• 19 products changed

• 18 products added

product category product old RACC new RACC

(Infants and Young Children) Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type.Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type.60g 110g

Bakery Products Bagels 55g 110g

Bakery Products Scones, crumpets, English muffins none 55g (with biscuits by piece(s) (_g) )

Bakery Products Muffins, toaster pastries 55g 110g

Bakery Products Eggroll, dumpling, wonton, or potsticker wrappersnone 20 g _sheet (_g); wrapper (_g)

Bakery Products Crepes none 110 g prepaed for French toast, crepes, and pancakes; 40 g dry mix for variety mixes; (with French toast)

Bakery Products Pie crust 1/6 of 8 inch crust; 1⁄8 of 9 inch crust.Pie crust, pie shells, pastry sheets, (e.g., phyllo, puff pastry sheets)the allowable declaration closest to an 8 square inch surface area_fractional slice(s) (_g) for large discrete units; _shells (_g); _fractional _sheet(s) (_g) for distinct pieces (e.g., Pastry sheet).

Beverages Carbonated and noncarbonated beverages, wine coolers, water)240 mL 360 mL

Beverages Coffee or tea, flavored and sweetened 240 mL 360 mL

Cereals and Other Grain Products Breakfast cereals, ready-to-eat weighing 20 g or more but less than 43 g per cup; high fiber cereals containing 28 g or more of fiber per 100 g.30g 40g

Cereals and Other Grain Products Breakfast cereals, ready-to-eat, weighing 43 g or more per cup; biscuit types.55g 60g

Dairy Products and Substitutes milk-substitute beverages, e.g. soy beverage none 240 mL (grouped with Milk)

Dairy Products and Substitutes Yogurt 170g 225g

Desserts Ice cream, ice milk, frozen yogurt, sherbet: all types, bulk and novelties (e.g., bars, sandwiches, cones).1/2 cup 2/3 cup

Desserts frozen flavored and sweetened ice and pops, frozen fruit juices85g 2/3 cup (grouped with ice cream)

Desserts Custards, gelatin, or pudding 1/2 cup 1⁄2 cup prepared; amount to make 1⁄2 cup prepared when dry

Dessert Toppings and Fillings Cake frostings or icings 35g 2 tbsp

Fish, Shellfish, Game Meats, and Meat or Poultry SubstituteFish, shellfish or game meat, canned 55g 85g

Fish, Shellfish, Game Meats, and Meat or Poultry SubstituteSubstitute for…seafood none 55g

Fruits and Fruit Juices Fruits used primarily as ingredients, avocado30g 55g

Fruits and Fruit Juices Fruits used primarily as ingredients, others (cranberries, lemon, lime)55g 50g

Miscellaneous Cocoa powder, carob powder, unsweetened none 1 tbsp

Miscellaneous Milk, milk substitute, and fruit juice concentrates (without alcohol) (e.g., drink mixers, frozen fruit juice concentrate, sweetened cocoa powder)none Amount to make 240 mL drink (without ice)

Miscellaneous Drink mixes (without alcohol): All other types (e.g., flavored syrups and powdered drink mixes)none Amount to make 360 mL drink (without ice)

Miscellaneous Seasoning oils and seasoning sauces (e.g., coconut concentrate, sesame oil, almond oil, chili oil, coconut oil, walnut oil)none 1 tbsp

Miscellaneous Seasoning pastes (e.g., garlic paste, ginger paste, curry paste, chili paste, miso paste), fresh or frozennone 1 tsp

Mixed Dishes Appetizers, hors 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 skinsnone 85 g, add 35 g for products with gravy or sauce topping

Soups Dry soup mixes, bouillon none Amount to make 245 g

Sugars and Sweets After-dinner confectioneries none 10g

Sugars and Sweets powdered candies, liquid candies none 15 mL for liquid candies; 15 g for all others

Sugars and Sweets All other candies 40g 30g

Sugars and Sweets Sugar 4g 8g

Sugars and Sweets Syrups 30 mL for syrups used primarily as an ingredient (e.g., light or dark corn syrup); 60 mL for all others.30 mL for all syrups used primarily as an ingredient (e.g., light or dark corn syrup); 60 mL for all others.

Vegetables Dried vegetables, dried tomatoes, sun-dried tomatoes, dried mushrooms, dried seaweednone 5 g, add 5 g for products packaged in oil

Vegetables Dried seaweed sheets none 3g

Vegetables jalapeno peppers, other hot peppers (added to chili peppers)none 30g

Vegetables Sprouts, all types: Fresh or canned none 1/4 cup

Reference Amounts Customarily Consumed (RACC), DRV and RDI Changes

Unresolved issues:• Foods with previously “insignificant amounts” of nutrients no longer

insignificant with new serving sizes

• ex) bottled water, others per 21 CFR 101.9(j)(4)• Former 8 oz. serving insignificant amount of sodium

• New 12 oz. serving not insignificant dual-column labeling required

• FDA will “consider refraining from taking regulatory or compliance actions” per January 2017 draft guidance

Summary of Nutrition Facts Changessingle-serving container definition 21 CFR 101.9(b)(6)

(6) A product that is packaged and sold individually and that contains less than 200 percent of the applicable reference amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving except for products that have reference amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the reference amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable reference amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.

(6) A product that is packaged and sold individually that contains less than 200 percent of the applicable reference amount shall must be considered to be a single-serving container, and the entire content of the product must be labeled as one serving. except for products that have reference amounts of 100 g (or mL) or larger, manufacturers may decide whether a package In addition to providing a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per serving, for a product that is packaged and sold individually that contains more than 150 percent but and less than 200 percent of the applicable reference amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable reference amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion., the Nutrition Facts label may voluntarily provide, to the left of the column that provides nutrition information per container (i.e., per serving), an additional column that lists the quantitative amounts and percent Daily Values per common household measure that most closely approximates the reference amount.

ye olde

55g 100%

1 serving

110g+

200%+1 serving if reasonably consumed in one

eating occasion, otherwise 2 servings

55g 50%

1 serving

110g 100%

1 serving

muffin RACC:

55g

muffin RACC:

110g


ye olde

muffin RACC:

55g

muffin RACC:

110g

168g 305%

1 serving if reasonably consumed in

one eating occasion, otherwise 2

servings

168g 153%

1 serving

Manufacturer may optionally list

quantitative amounts and percent

Daily Values per common

household measure that most

closely approximates the

reference amount


ye olde

muffin RACC:

110g

168g 153%

1 serving

Manufacturer may optionally list

quantitative amounts and percent

Daily Values per common

household measure that most

closely approximates the

reference amount


Nutrient Content Claim…

Reference amount or per-label serving size?

• Typically based on reference amount

• May need to be based on both

• Must be followed by a statement that sets

forth the basis on which the claim is made

• Must be truthful and not misleading

Requirement For Dual-column Labeling on Certain Packages

• discrete units• 21 CFR 101.9(b)(2)(i)(D)

• packaged and sold individually• 21 CFR 101.9(b)(12)(i)



• ex) sliced bread

• ex) pancakes & syrup (2+ foods consumed together, main ingredient discrete units)

• One unit is 200% to 300% of reference amount

• Left column per serving size, approximates reference amount

• Right column per unit



• ex) sliced bread

• RACC = 50 g

100g to 150g slices

200% to 300% of RACC

Serving Size = 1 slice

Nutrition labeled:

• Left column per 1/2 slice or per 1/3

slice

• Right column per slice

50g slices

100% of RACC

Serving Size = 1 slice

Nutrition labeled per

serving

>150g slices

>300% of RACC)

Serving Size = 1/3 slice


serving



• ex) soda

• 200% to 300% of reference amount

• Left column for serving based on reference amount

• Right column based on entire package



• ex) soda

32 fl. oz.

200% to 300% of RACC

Serving Size = 1 bottle

Nutrition labeled:

• Left column per reference amount

• Right column per serving (1 bottle)

16.9 fl. oz. (500 mL)

141% of RACC

Serving Size = 1 bottle


serving

>36 fl. oz.

>300% of RACC

Serving Size = 12 oz.


serving


Exceptions:• Tabular, linear formats

• Raw fruits, vegetables, and seafood with voluntary nutrition labeling

• Further preparation

• Consumed in combination

• 2+ age groups

• Popcorn providing info per 1 cup popped

• Varied-weight products

Summary

4 new rules regarding nutritional labeling

<20 exempt from menu & vending; small business exemption, others

Compliance

12/1/16 certain vending

5/7/18 menus – watch bill and lawsuit for updates

7/26/18 remaining vending

7/26/18 larger manufacturers, packers, distributors

7/26/19 smaller manufacturers, packers, distributors

Summary

New Nutrition Facts content & format; Dual Column Labeling

New and Changed Definitions

• Added Sugar

• Dietary Fiber

• Serving Sizes

• Reference Amounts (DRV, RDI, RACC)

• Single Serving Container

Sources of More Information

datcp.wi.gov

[email protected] manufactured food

[email protected] retail food

fda.gov Industry Resources on the Changes to the Nutrition Facts Label

• Final Rules

• Draft Guidance for Industry

ecfr.gov Electronic Code of Federal Regulations

• 21 CFR 101

federalregister.gov Federal Register

• Search for legislative rules for more details behind the rules

3rd Party Labeling Services

• Internet search “food label consultant”

Questions?

Thank You!

Stefan C. Boerboom, R.S.

Manufactured Food Specialist

Wisconsin Department of Agriculture, Trade and Consumer Protection

Update on Nutritional Labeling Requirements · Nutritional Labeling Compliance Dates for Non-exempt...

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