Nutrition Labeling
Retail and Food Service Labeling
Enforcement Acts
An Overview
© Copyright ACETGC
1
Webinar Outline
•
•
•
•
•
•
•
•
•
•
•
Introduction and background
Historical overview of food regulation
Impact of Food Labeling
When is labeling required?
Which agency regulates the labeling of your products?
What is actually required?
Overview of Claims
Allergen Labeling
The Compromised Approach
Food Service Labeling – The final rule
Proposed Updating of Nutrition Facts Label
© Copyright ACETGC
2
Introduction and Background
• Natasha Rowley-Phipps
• BS in Bakery Science
Management from Kansas State
University
• Completed first year of MS in
Cereal Chemistry
• Nearly 20 years as a quality
employee for Boston Market,
New World Restaurant Group
(Einstein Bagels), and Boulder
Brands (Udi’s Gluten Free)
• Independent consultant working
with ACET Global Consulting,
serving as a resource to the food
industry
• Contact Information:
[email protected]
720-394-3736
© Copyright ACETGC
3
History of FDA and Labeling
© Copyright ACETGC
4
Brief History of Labeling
• 1862 – FDA as a scientific organization
• 1906 – First Food & Drug Act – prohibiting misbranded and
adulterated food, drink and drugs.
• Lots of small regulatory action between 1906 and 1988
• 1988 – Food and Drug Administration Act
• 1990 – The Nutrition Labeling and Education Act is passed
• 1997 – FDA Modernization Act
• Since 2000 – Trans fat, Allergy Labeling & Consumer Act,
Gluten Free, and FSMA
• 2016 – Final rule for Food Service Labeling is enforced
• Future – Nutrition Facts Update final rule and enforcement
© Copyright ACETGC
5
Impact of Food Labeling
© Copyright ACETGC
6
Impact of Food Labeling
Food Manufacturers/Retailers
• Cost
• Staffing
• Direct the company
initiatives
• Marketing
• Litigation or recalls
• Success or failure
Consumers
• Consumer protection
• Informed and educated
• Affect decision making
© Copyright ACETGC
7
Regulatory Review
© Copyright ACETGC
8
When is labeling required?
•
•
•
•
Food products
Retail sale
Contains claims
Exceptions – small business, coffee, tea, and
some other exceptions
© Copyright ACETGC
9
Which agency?
• FDA – ALL foods except poultry, most meats,
certain egg products, and most alcoholic
beverages
• FDA – drugs and nutrition supplements
• FSIS – poultry, most meats, whole eggs
• TTB (Alcohol and Tobacco Tax and Trade
Bureau) – most alcohol labeling
© Copyright ACETGC
10
FDA Regulations
• Code of Federal Regulations
– 21 CFR Part 101
– Links are in resource slides
© Copyright ACETGC
11
What is actually required?
• Five basic labeling elements required
– Statement of Identity
– Manufacturer, packer, or distributor name and
address
– Net quantity of contents
– Nutrition facts
– Ingredient list
© Copyright ACETGC
12
What is actually required?
• Physical Packaging Elements
– PDP - Principal Display Panel
• Alternate Display Panels
– IP - Information Panel
© Copyright ACETGC
13
What is actually required?
• Area of the PDP is needed for formatting of
required elements.
– Calculate labeling area
• Rectangular = Length x Height
• Cylindrical =
40% of Height x circumference
© Copyright ACETGC
14
What is actually required?
• Statement of Identity
– Must be on the PDP and any alternate PDP
– Must be the common or accepted name or the
name established by regulation, i.e. standard of
identity
– Must be bold type (conspicuous) and prominent
– Generally parallel to the base of the package
© Copyright ACETGC
15
What is actually required?
• Statement of Identity
– Example – Brownie Mix
© Copyright ACETGC
16
What is actually required?
• Manufacturer, packer, or distributor name and
address
– Can be on the PDP or IP
– Typically on the IP after the ingredient list
– Must include
•
•
•
•
•
Name of the manufacturer, packer, or distributor
Street address, if not listed in directory
City or town
State or country if outside USA
Zip code or mailing code
© Copyright ACETGC
17
What is actually required?
• Net quantity of contents
–
–
–
–
Must be on the PDP
Must be in the bottom 1/3 of the PDP
The font size requirement is based on the area of the PDP
Must appear as a distinct item on the PDP with no
intervening material the size of the letter “N” surrounding
the net quantity statement
– Units must be in the most discrete unit of measure –
typically no more than 3 digits
• For weight - in avoirdupois pound/ounce and metric
kilograms/grams
• For fluid - US gallon/quart/pint/fluid ounce and SI metric
liters/milliliters
© Copyright ACETGC
18
What is actually required?
• Net quantity of contents
– Example – shows the net quantity as a distinct
item on the PDP, in the bottom 1/3 of the panel,
as well as in the correct units of measure.
© Copyright ACETGC
19
What is actually required?
• Net quantity of contents
– Font size requirements
© Copyright ACETGC
20
What is actually required?
• Net quantity of contents
– Examples of units and how to use the most
discrete unit of measure
– Example - For Weight 19 oz (539 g)
• This is incorrect. It should be 1 lb 3 oz (539 g) or 1.19 lb
(539 g)
– Example - For Liquid 5 qts (4.7 L)
• This is incorrect. It should be 1 gal 1 qt (4.7 L) or 1.25
gal (4.7 L)
© Copyright ACETGC
21
What is actually required?
• Nutrition Facts
– Can be on the PDP or IP
– Specific formats are to be used based on the area
of package available for labeling
– Specific rounding rules for nutrients
– Serving size requirements
© Copyright ACETGC
22
What is actually required?
• Nutrition Facts
– Specific format with very specific layout
requirements.
© Copyright ACETGC
23
What is actually required?
Nutrition Facts
• Mandatory Nutrients
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
• Voluntary Nutrients
– Calories from
saturated fat
– Polyunsaturated and
Monounsaturated Fat
– Potassium
– Soluble and insoluble
fiber
– Sugar alcohol
– Other Carbohydrates
– Other Vitamins and
Minerals
– Beta Carotene
Calories
Calories from fat
Total fat
Saturated Fat
Trans Fat
Cholesterol
Sodium
Total Carbohydrates
Dietary Fiber
Sugars
Protein
Vitamin A
Vitamin C
Iron
Calcium
Specific Nutrient Rounding and Declarations found in 21 CFR 101.9
© Copyright ACETGC
24
What is actually required?
• Nutrition Facts
– Formats
•
•
•
•
Full
Simplified vertical
Tabular
Linear
Format
< 40 in²
40 in² or less
< 12 in²
Full
w/footnote
Yes
Yes
Yes
Full w/o
footnote
No
Yes
Yes
Simplified
Vertical w/o
footnote
Yes
Yes
Yes
Tabular w/o
footnote
No
Yes
Yes
Tabular w/
footnote
Yes
Yes
Yes
Linear
No
Yes
Yes
Address to
obtain info
only
No
No
Yes, w/o
claims
© Copyright ACETGC
25
What is actually required?
• Nutrition Facts
– Serving Size and Servings Per Container
•
•
•
•
RACC – Reference Amount Customarily Consumed
Serving Size
Household measure
Servings per container
© Copyright ACETGC
26
What is actually required?
• Nutrition Facts – Serving Size and Servings per
Container.
– RACC-Reference Amounts Customarily Consumed
– Web link in resources
© Copyright ACETGC
27
What is actually required?
• Nutrition Facts –
– Household Measure
• A visual or measured representation of the serving size
• RACC gives guidance in second column
Examples of terminology used to represent serving sizes
mL
pieces
g
chips
cup
1/6 of pie
teaspoon
© Copyright ACETGC
28
What is actually required?
• Ingredient List
– Can be on the PDP or IP
– Minimum of 1/16th of inch based on letter “o” for
font
– All ingredients declared by common name unless
regulation provides specific guidance
– Ingredients should be sub listed if they are a multi
component ingredient in descending order of
predominance in parenthesis
• Example …..butter (cream, salt)
© Copyright ACETGC
29
Claims
© Copyright ACETGC
30
Claims
• Types of Claims
– Nutrient Content Claims
– Health Claims
– Qualified Health Claims
– Structure/Function Claims
© Copyright ACETGC
31
Claims
• Nutrient Content Claims
– Relatively “simple” claims
– Claim that directly or indirectly by implication
characterizes the level of a nutrient in food
– Some claims will require a disclosure statement and/or
additional nutrient disclosure in facts panel
• “See Nutrition Panel For Nutrient Content”
– Examples
•
•
•
•
Low Fat
High in Vitamin A
Contains 0 mg sodium
Healthy
– *note on healthy there are specific requirements for this claim
© Copyright ACETGC
32
Claims
• Health Claims and Qualified Health Claims
– More complicated and have to be pre-authorized by
the FDA
– Claims made on the label that states or implies a
relationship to disease or a health related condition
– Certain requirements for nutrients not associated with
claim
– Include vignettes, symbols, romance copy verbiage
– Example Health Claim – “Diets low in saturated fat
and cholesterol may reduce the risk of heart disease”
– Example Qualified Health Claim - Folic acid and Neural
Tube Defects
© Copyright ACETGC
33
Claims
• Structure/Function Claims
– Claims directly related to a nutrient and its affect
on a part of the body or a function of a part of the
body
– Must be truthful and not misleading
– Are not pre-reviewed or authorized by FDA
– Example – “Calcium builds strong bones”
© Copyright ACETGC
34
Allergen and Gluten Free
Labeling
© Copyright ACETGC
35
Allergen Labeling
• Big 8 allergens
– Milk, eggs, fish, peanuts, soybeans, crustacean shellfish,
wheat, tree nuts
• Allergens must be declared
– By common name in the ingredient statement
• Example …….butter (milk), ……..
– Advisory statements
• Contains milk, eggs, wheat
• May contain statements or Processed in a plant statements are not
required
– Tree Nuts, fish, and shellfish
• Must be declared by specific source, i.e. pistachio, cashew,
flounder, crab, etc.
© Copyright ACETGC
36
Gluten Free Labeling
• Defined the term “Gluten Free”
• Not Allowed
– Contains whole grains that contain gluten
– Refined whole grains containing gluten that still have the
presence of gluten
– If the presence of gluten in a product is unavoidable cross
contamination with > 20 ppm
• Allowable
– Inherently gluten free foods
– Foods that contain gluten containing ingredients that have been
refined to remove gluten to level < 20 ppm i.e. wheat starch
• No requirements for testing or other programs
© Copyright ACETGC
37
Gluten Free Regulation
• Proposed Rule for Gluten-Free Labeling of Fermented
or Hydrolyzed Foods November 2015
– Includes beers that regulated by FDA or those with malted
barley and no hops or with malted barley substitutes
(sorghum)
– Includes vinegars and distilled water
• The 2013 rule addressed uncertainty of hydrolyzed and
fermented foods regarding a gluten free definition and
compliance rules
– Testing methods were unreliable due to the product matrix
– Current state of rule
• Comment period was re-opened on February 12th for 60 days
© Copyright ACETGC
38
Gluten Free Regulation
• The 2013 rule still applies to these foods
– The usage of “gluten free” labeling
– The definition of > 20 ppm of unintentional gluten
• Proposed additions
– Record keeping showing
•
•
•
•
Food meets < 20 ppm prior to fermentation or hydrolysis
Process evaluation for risk of cross contact
If risk is found measures are implemented to prevent issues
Records could include test results, COA’s, processing
documents, etc.
• Keep for 2 years
© Copyright ACETGC
39
Compromised Approach
Regulatory Relationships
© Copyright ACETGC
40
The Compromised Approach
•
•
•
•
•
Build a collaborative relationship
Understand the regulation
Provide clear interpretation of regulations
Understand goals of marketing for a product
Provide guidance with options
© Copyright ACETGC
41
Food Service Labeling
Final Rule
Compliance Date December 1, 2016
UPDATE – Postponed to ONE year after
the final guidance is issued
© Copyright ACETGC
42
Food Service Labeling
The Final Rule - Restaurants
• Final rule compliance has been postponed until one year
after the final rule is published – timing unknown
• Applies to chains with 20 or more locations
• Calories provided on menu boards and menus
– There are some exclusions
– Includes alcoholic beverages
• 2 Statements on menu boards are required
– “2,000 calories a day is used for general nutrition advice, but
calorie needs vary”
– “Additional nutrition information available upon request”
• provide total calories, calories from fat, total fat, saturated
fat, trans fat, cholesterol, sodium, total carbohydrates,
fiber, sugars, and protein in writing for any requests
© Copyright ACETGC
43
Food Service Labeling
The Final Rule - Vending
• Applies to chains with 20 or more vending
units
• Calories provided on sticker, placard, poster, or
electronic sign near the product
• Statement on menu boards are required
– “2,000 calories a day is used for general nutrition
advice, but calorie needs vary”
• provide contact information for enforcement
© Copyright ACETGC
44
Proposed Updating of Nutrition
Facts Label
In review with FDA
Compliance Date Unknown
© Copyright ACETGC
45
Proposed Updating of
Nutrition Facts Label
• Public meeting was completed and comment
period is now closed
• Main ideas discussed
– Panel information would be updated
– Serving sizes would be reviewed and updated
– Refreshed design
• Supplemental Proposed Rules
– %DV added sugars
– Change to footnote
© Copyright ACETGC
46
Proposed Updating of
Nutrition Facts Label
• Nutrition Facts Update
– Require added sugars to be declared
– Update daily values
•
•
•
•
•
Sodium from 2,400 to 2,300 mg
Dietary fiber from 25 to 28 g
Potassium from 3500 to 4700 mg
Calcium from 1000 to 1300 mg
Vitamin D 400 IU to 20 micro grams
© Copyright ACETGC
47
Proposed Updating of
Nutrition Facts Label
• Nutrition Facts Update
– Define Dietary Fiber
• FDA is behind on this initiative
• Change caloric value and define soluble and insoluble
– Calories from fat to be removed
• Proposed to be not permitted
– Define sub population daily values
• Proposed change 7 – 12 months, 1 through 3 years, as
well as addition of lactating women
© Copyright ACETGC
48
Proposed Updating of
Nutrition Facts Label
• Nutrition Facts Update
– Absolute amounts of vitamins rather than units
• No IU, but rather micro gram and milligram
– Require declaration of Potassium and Vitamin D
• Calcium and iron would remain possible for vitamin A
and C to be voluntary
– Record Keeping
• In regards to nutrients sugar, fiber, vitamins
• Distinguish between forms
© Copyright ACETGC
49
Proposed Updating of
Nutrition Facts Label
• Serving Sizes
– Serving sizes or RACC (Reference Amount
Customarily Consumed) were established 20 years
ago
– Single serve packages
• Require them to be labeled as such
– Dual Column labeling for multi or single serve
• Provide both sets of information for decision making
© Copyright ACETGC
50
Proposed Updating of
Nutrition Facts Label
New Proposed Design
Current Design
© Copyright ACETGC
51
Proposed Updating of
Nutrition Facts Label
© Copyright ACETGC
52
Proposed Updating of
Nutrition Facts Label
• Alternate Proposed Design
© Copyright ACETGC
53
Proposed Updating of
Nutrition Facts Label
• Supplemental Proposed Rule
– Added Sugars
• Added sugars are said to contribute to much of the caloric
intake of consumers
• Propose to include a %DV for added sugars
– Footnote
• Help consumers understand %DV concept
• “The percent 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”
© Copyright ACETGC
54
Proposed Updating of
Nutrition Facts Label
• Waiting on final rule
• FDA has proposed 6 months to prepare and 2
years to implement changes after final rule
© Copyright ACETGC
55
Conclusion
• Important to keep up to date
• Subscribe to blogs, newsletters, and email
alerts
• Read non-compliance letters from FDA
© Copyright ACETGC
56
Resources
Natasha Rowley-Phipps
ACET Global Consultants
[email protected]
720-394-3736
© Copyright ACETGC
57
FDA Website Resources
• Historical Information FDA and Labeling
– http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm1
28305.htm
– http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm05
6044.htm
• FDA CFR Title 21 Search Window
– https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cf
m
• Reference Amount Customarily Consumed - RACC
– http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cf
m?fr=101.12
• FDA Labeling Guide
– http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsR
egulatoryInformation/LabelingNutrition/ucm2006828.htm
© Copyright ACETGC
58
FDA Website Resources
• Claims
– http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutri
tion/ucm111447.htm
• Allergen Labeling Act
– http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsR
egulatoryInformation/Allergens/ucm106890.htm
• Gluten Free Food Labeling Final Rule
– https://www.federalregister.gov/articles/2013/08/05/201318813/food-labeling-gluten-free-labeling-of-foods
– http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsR
egulatoryInformation/Allergens/ucm362880.htm
• Gluten Free Proposed rule for fermented and hydrolyzed foods
– http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsR
egulatoryInformation/Allergens/ucm472735.htm
© Copyright ACETGC
59
FDA Website Resources
• Menu and Vending Machines Labeling
Requirements
– http://www.fda.gov/Food/IngredientsPackagingLa
beling/LabelingNutrition/ucm217762.htm
• Proposed Changes to Nutrition Facts Label
– http://www.fda.gov/Food/GuidanceRegulation/G
uidanceDocumentsRegulatoryInformation/Labelin
gNutrition/ucm385663.htm
© Copyright ACETGC
60
Questions?
© Copyright ACETGC
61