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“LOVE IS NOT AN INGREDIENT” - FOOD LABELING REGULATIONS © Copyright QFM 1
“LOVE IS NOT AN INGREDIENT” -
FOOD LABELING REGULATIONS
© Copyright QFM 1
Presentation Outline• Introduction and background
• When is labeling required?
• Definitions
• Five required labeling elements with enforcement letters• Statement of Identity• Manufacturer, packer, or distributor name and address• Net quantity of contents• Nutrition facts• Ingredient list
• Other labeling elements to consider
• New Regulations for Nutrition Facts Panel and Serving Size Changes
• Misbranded Product and Approved Source Connection
• Food Service Labeling
• Resources © Copyright QFM 2
Personal Introduction &Professional Background
• Natasha Rowley-Phipps
• BS in Bakery Science Management from Kansas State University
• Continued study in MS in Cereal Chemistry
• More than 20 years as a food safety professional, previously employed by Boston Market, New World Restaurant Group (Einstein Bagels), and Boulder Brands (Udi’s Gluten Free).
• Independent consultant serving as a resource to the food industry for all food safety, quality and regulatory program needs.
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WHEN IS LABELING REQUIRED?
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Hmm?
When is labeling required?
• Food products, for retail sale• FDA and USDA
• Food Service and Vending Foods
• Alcoholic beverages• most under TTB, but those under FDA have abbreviated requirements
• Food products that contain claims
• Exceptions for some or all required elements• Small packages of < 12 in2
• Insignificant nutrients - coffee and tea• Raw fruits and vegetables• Small business exceptions
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REQUIRED ELEMENTS OF
LABELINGDefinitions
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Definitions
• Principal Display Panel• PDP• Primary panel consumers see• Alternate Display Panels
• Information Panel• IP• To the right of the PDP when
facing the PDP• Exceptions• Not enough space on the
panel to the right – keep going right to find space
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Definitions
• Intervening Material
• Not to be placed between required elements
• Not to impede or overtake a required element
• Information not required by FDA with examples could be UPC barcode, images, vignettes or even words
• Warning letters often include this as an issue in labeling
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REQUIRED ELEMENTS OF
LABELINGStatement of Identity
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Statement of Identity
• Informs consumer what is in the package
• Not the brand name and typically not the marketing chosen name
• Consider regulations• Standard Name under Standards of Identity -19 categories including items such as
raisin bread, cheeses, milk chocolate• Common or Usual Name - Cookies and crackers• Descriptive Term -Asian-style rice• Fanciful Names - Vanilla wafers, marshmallows
• Where is the product name located?• Must be on the PDP and any alternate PDP• Must be bold type (conspicuous) and prominent• Generally parallel to the base of the package
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Statement of Identity
• Product form may need to be part of statement• When other forms are available such as whole, sliced, diced, etc.
• Other impacts to product name• Flavored products
• Warning letters often include this as an issue in labeling
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REQUIRED ELEMENTS OF
LABELINGManufacturer, packer, or distributor name and address
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Address• Also called the Signature Line displaying the responsible party for product
• Can be on the PDP or IP, but is typically on the IP after the ingredient list
• Must not have any intervening material between required elements
• Must be at least 1/16” in height based on the letter “o” • Unless all upper case letters used
• Must be prominent, conspicuous, and easy to read
• Must include• Business Name of the manufacturer, packer, or distributor• Street address, if not listed in a current directory• City or town• State or country • Zip code or mailing code if outside USA
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Address
• If not the manufacturer a descriptive phrase should precede name• Examples
• “Imported by”, “Distributed by”, Distributed for”, “Made exclusively for”
• Warning letters often include this as an issue in labeling
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REQUIRED ELEMENTS OF
LABELINGNet quantity of contents
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Net Quantity of Contents
• Statement that provides information for how much product is in the container or package, not to include the package weight
• The term(s) “Net”, “Net Weight”, “Net Contents” are not required, but if used should describe the product
• Can include count if package contains discrete units or is not misleading
• Water/Liquid packed products may or may not include the water
• Drained weight• Not included for items where liquid is not typically consumed, example - olives
• Sugar water packed• Typically consumed and is included, example fruit in a sugar syrup
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Net Quantity of Contents• Must be on the PDP in the bottom 1/3 of the PDP
• Type size requirements based on the area of the PDP
• 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 with term “net
weight”• For fluid - US gallon/quart/pint/fluid ounce and SI metric liters/milliliters with term “net”
or “net contents”• For count - Must also have weight or volume with term “net”
• Must appear as a distinct item on the PDP with no intervening material the size of the letter “N” surrounding the net quantity statement
• Cannot have any descriptive terms• Examples – Net Weight Large 12 oz (340 g)
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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)
• Warning letters often include this as an issue in labeling
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REQUIRED ELEMENTS OF
LABELINGNutrition Facts
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Nutrition Facts
• Specific format with very specific layout requirements.
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Nutrition Facts
• Formats based on available labeling space • Full • Simplified vertical • Tabular• Linear• None – with address
reference only
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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
Nutrition Facts
• Mandatory Nutrients• Calories• Calories from fat• Total fat• Saturated Fat• Trans Fat• Cholesterol• Sodium• Total Carbohydrates• Dietary Fiber• Sugars• Protein• Vitamin A• Vitamin C• Iron• Calcium
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Specific Nutrient Rounding and Declarations found in 21 CFR 101.9
• 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
Nutrition Facts• Serving Size
• In general the RACC – Reference Amount Customarily Consumed is used to determine this value
• Must include a Household Measure• A visual or measured representation of the serving size• RACC gives guidance to this measure in second column of the table found in regulations
• Mandatory Nutrient Declarations
• Nutrients in the Facts Panel are based on the determined serving size
• Specific rounding rules for each nutrient found in regulations
• Claims on package could influence declarations and mandatory nutrients
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Nutrition Facts
• Example Calculation
• Serving Size and Servings Per Container Example
• R&D has formulated a cookie that weighs 15 grams for adults with a full package weighing 450 g
• Determine the serving size• RACC for cookies = 30 g• How many cookies equal the RACC – 2 cookies for 30 grams• Identify the serving size as 2 cookies (30 g)
• Determine the Servings per Container• 450 g divided by 30 grams = 15 • Servings per container = 15
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Nutrition Facts
• Warning letters often include this as an issue in labeling
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REQUIRED ELEMENTS OF
LABELINGIngredient List
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Ingredient List
• Ingredients must be listed by their standardized or common name just as product statements of identity are declared
• Ingredients must be listed in order of predominance, with the largest percentage ingredient listed first
• Ingredients should be sub listed if they are a multi component ingredient in descending order of predominance in parenthesis
• Example …..butter (cream, salt)
• Can be on the PDP or IP• Minimum of 1/16th of inch based on letter “o” for font
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Ingredient List
• Allergen declaration should be in the ingredient statement by common name of allergen or listed in a contains statement
• Other considerations for processing aids, flavors, colors, spices, ……….
• Warning letters often include this as an issue in labeling
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OTHER ELEMENTS TO CONSIDER
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Other Elements
• Allergen Regulations
• % Juice Labeling
• Claims
• Verbiage or Romance Copy
• Social Media, Website, etc. are NOT excluded from oversight and enforcement.
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Other Elements
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• Warning letters often include this as an issue in labeling
NEW REGULATIONS FOR NUTRITION FACTS
PANEL AND SERVING SIZE CHANGES
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A Need for Change….• Only overall update to regulations in decades• Outdated• Behind Science
• Public Health Concerns• Type 2 Diabetes, Osteoarthritis, obesity and other weight related conditions
• Government Working Groups Findings• Obesity Working Group
• World Health Authorities
• Advocate Groups• American Heart Association, American Academy of Pediatrics
• Comments • Citizens, public, and other governments (Canada)
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IMPORTANT DATES TO UNDERSTAND
Effective Dates & Compliance Dates
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Dates to Understand• Anticipated to continue to be delayed due to HUGE impact to industry and
shear volume of changes
• Effective Dates• July 26, 2016
• Compliance Dates - 10 Million or greater Revenue• January 1, 2020
• Compliance Dates - <10 Million Revenue• January 1, 2021
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DESIGN CHANGES TO NUTRITION PANEL
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Source: http://www.lebrasse.com/jeremy-scotts-debut-collection-for-moschino/
Nutrition Panel Design Changes• Refreshed design• Same iconic design• Placement and prominence of calories, serving
size and servings per container• Fonts and Hairlines• Updated footnote• Required nutrients have been updated
• Serving Size• Increasing the type size• Bolding the measurement• Reverse the order, with servings per container
first
• Servings Per Container• List first on panel• Changes may be required based on RACC
changes
• Calories• Increasing the type size• Bolding the nutrient and value
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Source: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
Nutrition Panel Design Changes• Calories from Fat• Removed from panel
• Vitamin A and Vitamin C• No longer mandatory• Voluntary nutrients
• Iron & Calcium• Remain mandatory• Calcium % DV changed from 1000 mg to 1300
mg
• Potassium• Now a mandatory nutrient• % DV changed from 3500 mg to 4700 mg
• Vitamin D• Now a mandatory nutrient• Display the absolute amount in addition to %
DV• % DV changed from 400 IU to 20 mcg
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Source: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
Nutrition Panel Design Changes
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Source: http://www.esha.com/labeling-compliance/nutrition-facts-label-font-sizes/
Nutrition Panel Design Changes• Footnote• Modernized statement to ease understanding that is consistent with restaurant
labeling• Takes up less labeling space• “The % Daily Value 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.”
• Warning letters are already including this change in panel as an issue in labeling
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NEW LABELING FOR SUGARS
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New Labeling for Sugars
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New Labeling for Sugars
• Total Sugars• The sum of all free mono- and disaccharides (such as glucose, fructose, lactose,
and sucrose)
• Includes added sugars and those intrinsic in the product
• Mandatory nutrient
• Nutrient name change from “Sugars” to “Total Sugars”
• Includes the sub nutrient of added sugars
• Same rounding rules as “Sugars”
• No % DV for “Total Sugars”
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New Labeling for Sugars
• Added Sugars
• Includes free, mono- and disaccharides that are not intrinsic
• Syrups, brown sugar, HFCS, invert syrup, maltose, trehalose, honey, molasses, sucrose, lactose, maltose sugar, concentrated fruit juice
• Includes sugars added during processing or packaging
• If your product falls in juice, preserves, spreads, etc be sure to read the Questions and Answers from the resources slides link.
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New Labeling for Sugars
• Added Sugars
• Mandatory nutrient as a sub nutrient of “Total Sugars”
• Nutrient name is declared as “Includes X g Added Sugars”
• Same rounding rules as “Sugars” to the nearest 1 g
• % DV is 10% of calories from added sugars• 50 grams for adults > 4 years
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New Labeling for Sugars
• Record keeping requirements for this nutrient
• Sugar claims will be reviewed and updated• Changes are likely
• Additional guidance documents promised from FDA
• Industry document for Honey, Maple Syrup and certain cranberry products. Resource slide link.
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DIETARY FIBER
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Dietary Fiber
• New Definition
• Non-digestible soluble and insoluble carbohydrates and lignin from naturally occurring sources
And
• Isolated or synthetic sources that are determined by FDA to have beneficial health benefits
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Dietary Fiber
• Additional notices to be published providing review of 25 beneficial fibers• For example: 7 of them are – beta-glucan soluble fiber, psyllium husk, cellulose,
guar gum, pectin, locust bean gum, and hydroxypropylmethcellulose
• % DV will be 28 g from 25 g
• Could affect current claims on package
• Record keeping requirements
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TRANS FATReduction to Elimination
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Trans Fat
• Trans fat in PHO’s (Partially Hydrogenated Oils) that are commercially produced are now NOT on the GRAS list or Generally Recognized as Safe
• June 16, 2015 final release to register with compliance date of 3 years
• Compliance date of June 18, 2018 to have all non-approved PHO’s removed
• Trans fat will remain as a mandatory nutrient on the label• Natural occurring from ruminant sourcesand• Other small amounts may be approved through petitions of industrial produced
trans fat through approved petitions
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SERVING SIZE CHANGES AND
RACCS
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Serving Size Changes• Single Panel Labeling• Packages that are 200% or less of the RACC will be labeled as
1 serving
• Dual Column Labeling Required• Contain 200% and up to 300% of the RACC
• Nutrition presented in both per serving and per container
• Examples• Pint of Ice Cream
• Exemptions• Small packages• Products that require further processing• Varied weight products• Raw fruits and vegetables and seafood
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Reference Amounts Customarily Consumed
• Under regulation the serving size must be based on actual consumption not other factors
• Eating behaviors have changed and with it the RACC’s have been amended
• Some 20% of the 150 + RACC’s have been amended• Examples• Carbonated and non-carbonated beverages from 240 to 360 mL• Yogurt from 225 to 170 g
• 25 new RACC’s have been created• Examples• Egg roll, dumpling, wonton or potsticker wrappers 20 g• Appetizers, hors d’oeuvres and mini mixed dishes 85 g or with sauce 120 g• Dried seaweed sheets 3 g• After dinner confectioneries: small chocolate squares, butter mints 10 g
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RECORD KEEPING REQUIREMENTS
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Record Keeping Requirements• “The manufacturer must make and keep written records…..”
• Examples of records• Analyses of databases, scientific data, recipes, formulations, information from recipes
or formulations, or batch records
• Must be kept for 2 years after product enters interstate commerce and be provided to FDA upon request
• Records must be accurate, legible, and kept as original documents or true copies
• Failure of the above will result in a misbranded product
• Nutrients which required record keeping• Added Sugars, Dietary Fiber, Vitamin E, and Folic Acid/Folate
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MISBRANDED PRODUCT AND
APPROVED SOURCE CONNECTION
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Misbranded Products and Approved Source Connection
• Labeling issues may be a clue to a product that is not from an approved source.
• Identified Labeling Issues• Decimals in the nutrition facts panels for nutrients, especially when value is > 5 • Intervening material ingredient list of E#’s• Dual language on only 1-2 required elements instead of ALL elements• No address line• Net weight not declared in both units of measure• Net weight not declared on the PDP in the bottom 1/3 of the panel• Non GRAS ingredients listed in ingredients – especially artificial colors
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FOOD SERVICE LABELING
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Food Service Labeling
• Who must comply?
• “Covered Establishment”
• Part of a chain with 20 or more locations• Doing business under the same name regardless of type of ownership• Offering food products that are substantially the same
• Location is defined as fixed position or site• Airplane/trains are excluded, for example
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Food Service Labeling
• What must be labeled?
• Standard menu items that are routinely offered• Examples
• Food for immediate consumption at sit down or quick service• Food purchased at drive through• Take out and delivery pizza• Hot pizza at grocery or convenience store• Grocery store intended for individual consumption (soups, salads, sandwiches)• Self service foods and foods on display that are intended for individual consumption• Sandwich, paninis, or wraps at deli counter, cookies from mall cookie counter, bagels, donuts,
and rolls offered for individual sale
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Food Service Labeling
• What does NOT need to be labeled?• Foods that are grocery-type, used to prepare foods later• Bulk bin foods such as beans, dried fruit, nuts• Foods intended to be eaten during several occasions• Foods sold by weight that are not intended for individual consumption (potato salad,
chicken salad)• Foods that are packed or prepacked at consumers request and typically used for further
prepared foods (deli meats and cheeses)• Condiments• Daily specials• Temporary menu items• Custom orders• Test market products• Self service food• Alcohol beverages from bottles behind the bar used to prepare mixed drinks
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Food Service Labeling
• Compliance Date• May 7, 2018
• Guidance document re-issued with updates as well as a note on enforcement• “………During the first year of implementation, the FDA will work cooperatively with
covered establishments to achieve high levels of compliance with the menu labeling requirements. The agency intends to allow establishments a reasonable opportunity to make corrections for minor violations and plans to continue with education and training. ……...”
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FOOD SERVICE LABELING
Menu Labeling Regulations
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Menu Labeling Regulations
• What are the labeling requirements?• Calories labeled for each required menu item
• Succinct Statement• Concise statement for daily intake of calories• “2,000 calories a day is used for general nutrition advice, but calorie needs vary.”
• Additional information statement• Some variation of a statement expressing that additional written nutritional information
is available within the establishment• Example “Additional nutrition information available upon request”
• Additional nutrient information• Current mandatory nutrients from nutrition facts panel
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FOOD SERVICE LABELING
Documentation Requirements
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Nutrient ContentDetermination Methods
• Must use a method that has a reasonable basis for determination• Accurate and consistent• Reasonable steps must be taken to ensure accuracy in the preparation to
decrease the variability in the nutrient information provided
• Methods• Nutrient database• Laboratory analysis• Cookbooks• Other reasonable means:• USDA Database - http://ndb.nal.usda.gov/• FDA Nutrient Values for fish, raw fruits and vegetables
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Documentation Requirements• Database• Name and version of software/web application• Recipe or formula• Information related to the accuracy of data entered into system and the accuracy of the
calculations in the database• Listing of nutrient values determined• Any other relevant information to validate variations• Signed statement, by responsible individual, attesting to accuracy and completeness of
information• Signed statement, by responsible individual, attesting that reasonable steps have been
taken in the preparation methods to provide consistent and accurate menu items related to their nutrient content
• Cookbook• Name of book, author, publisher• If available, how the cookbook information was created• Copy of recipe used to prepare menu item• Signed statement, by responsible individual, attesting that reasonable steps have been
taken in the preparation methods to provide consistent and accurate menu items related to their nutrient content
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Documentation Requirements• Lab analysis• Copy of recipe used for the menu item that was analyzed• Name and address of laboratory• Copies of analytical documents • Signed statement certifying that the information contained in laboratory reports is
accurate and complete• Signed statement, by responsible individual, attesting that reasonable steps have
been taken in the preparation methods to provide consistent and accurate menu items related to their nutrient content
• Other Methods• Detailed description of method used• Recipe or formula used as the basis for determination• Any data used to derive this determination• Signed statement certifying that the information contained in determination report is
accurate and complete• Signed statement, by responsible individual, attesting that reasonable steps have
been taken in the preparation methods to provide consistent and accurate menu items related to their nutrient content
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RESOURCES
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Resource Links
• Historical Information FDA and Labeling• http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm1283
05.htm• http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm0560
44.htm
• FDA CFR Title 21 Search Window• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
• FDA Guidance Document Home Page for Labeling and Nutrition• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg
ulatoryInformation/LabelingNutrition/default.htm
• FDA Labeling Guide• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg
ulatoryInformation/LabelingNutrition/ucm2006828.htm
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FDA Website Resources
• Allergen Labeling Act• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg
ulatoryInformation/Allergens/ucm106890.htm
• Gluten Free Food Labeling Final Rule• https://www.federalregister.gov/articles/2013/08/05/2013-18813/food-
labeling-gluten-free-labeling-of-foods• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg
ulatoryInformation/Allergens/ucm362880.htm
• Gluten Free Proposed rule for fermented and hydrolyzed foods• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg
ulatoryInformation/Allergens/ucm472735.htm
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Resources• Siliker Nutrient and Health Claims• https://www.foodlabels.com/pdf/RegulatoryGuide.pdf
• Health Claims – appendix C – Displays allowable health claims• http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInform
ation/LabelingNutrition/ucm064919.htm
• Warning Letter to Industry – Examples of Claims Enforcements• http://www.fda.gov/Food/ComplianceEnforcement/WarningLetters/ucm202784.htm
• Food from Genetically Engineered Plants and Guidance for Industry• http://www.fda.gov/Food/FoodScienceResearch/GEPlants/• http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformati
on/ucm059098.htm
• Fresh and Fresh Frozen Claim Defined• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=101.95
• Qualified Health Claims – Letters of Enforcement Discretion• http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm07275
6.htm• http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm07399
2.htm#cancer
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Resource Links
• Menu and Vending Machines Labeling Requirements• https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulat
oryInformation/LabelingNutrition/ucm515020.htm
• Industry document for Honey, Maple Syrup and certain cranberry products.• https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocum
entsRegulatoryInformation/UCM596469.pdf
• Dietary Fiber Guidance and additional information for industry:• https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulat
oryInformation/ucm528532.htm• https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm528534.htm
• Trans Fat Regulation• https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngr
edients/ucm449162.htm
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