Food Labeling Basics - CDPH Home

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2017Food Labeling BasicsPresented byCalifornia Department of Public HealthFood and Drug Branch (FDB)Phone: (916) 650-6500E-mail: FDBtraining@cdph.ca.govFood SafetyWhy?OverviewFood SafetyOur Common GoalOverviewFood Labeling Basics1

2017The California Department of Public Health –Food and Drug Branch (FDB) regulates foodmanufacturing, storage, distribution, andLABELINGOverviewPurpose Toinform consumers about a product and itscontents Toprotect consumers and provide a basis for aninformed buying decision Toprevent fraud, misrepresentation, and unfaircompetitionOverviewMisbranded Food – Falseor misleading in anyparticular Unregisteredcompany Non-conformancewith applicablelaws/regulations (described inHealth and Safety Code (H&SC)§ 110660 et seq.)OverviewFood Labeling Basics2

2017What We Are Doing Today* Label Parts* Claims* Warning Statements* Additional Considerations* ResourcesOverviewNot Doing Today* Copies of laws and regulations* Dietary Supplements and DSHEA* Acting as consultantsOverviewFood Labeling Laws and Regulations* Sherman Food, Drug and Cosmetic Law (H&SC §109875 et seq.)* Title 21, Code of Federal Regulations (CFR), Part 101* Food, Drug and Cosmetic Act (FD&C)* Fair Packaging and Labeling Act (FPLA)* Nutrition Labeling and Education Act (NLEA)* Food Allergen Labeling and Consumer Protection Act (FALCPA)* Dietary Supplement Health and Education Act (DSHEA)* Much more!OverviewFood Labeling Basics3

2017Five Required Componentsof Food LabelsPrinciple Display Panel (PDP)1. Identity2. Net QuantityInformation Panel (IP)3. Name and Place of Business4. Ingredients5. Nutrition FactsREQUIREDCOMPONENTSNutrition FactsIdentityIngredientsNet QuantityName & Place ofBusinessNutrition FactsIdentityIngredientsNet QuantityFood Labeling BasicsName & Placeof Business4

2017Principle DisplayPanel (PDP)The part of a label thatis most likely to bedisplayed undercustomary conditions ofdisplay for retail sale21 CFR 101.1PDP DefinitionNutrition FactsStatement of IdentityIngredientsNet QuantityStatementName & Placeof BusinessMust be one of the following:* Name specified in anyapplicable federal law* The common or usual nameof the food* An appropriately descriptiveterm, or when nature of thefood is obvious, a commonlyused fanciful name21 CFR 101.3(a) & (b)Statement of IdentityFood Labeling Basics5

2017Standards of Identityestablish Standards of Identityfor naming many foods. Some examples:21 CFR, Parts 130-169Milk and cream, yogurt 131, Cheese 133, Frozen desserts135, Breads 136, Cereals and Flours 137, Noodles 139,Canned fruits 145, Canned fruit juices 146, Fruit butters,jellies, preserves 150, Fruit pies 152, Canned vegetables 155,Vegetable juices 156, Frozen vegetables 158, Eggs and eggproducts 160, Fish and shellfish 161, Cacao 163, Tree nutsand peanuts 164, Beverages 165, Margarine 166, Sweetenersand table syrups 168, Food dressings and flavorings 169Statement of IdentityMust be one of the following:* Name specified in anyapplicable federal law* The common or usual nameof the food* An appropriately descriptiveterm, or when nature of thefood is obvious, a commonlyused fanciful name21 CFR 101.3(a) & (b)Statement of IdentityIdentify the fanciful namesused with these descriptivephrases.A.B.C.D.E.F.G.The Original Gourmet Jelly BeanPeanut Butter CupChocolate – Caramel – Cookie BarsMilk Chocolate – Coconut & AlmondChewy Caramel – Milk Chocolate –Crispy CrunchiesBursting with Peanuts, Rich Carameland Chewy NougatSour then Sweet – Soft and ChewyCandyStatement of IdentityFood Labeling Basics6

2017The name shall be:* In bold type* Parallel to the base ofthe package* In a size relative tothe most prominentprinted matter on thePDP21 CFR 101.3(d)Statement of IdentityLabels must declare theparticular form (whole, slices,diced, etc.) as part of thestatement of identity if the food issold in different forms.Exceptions:* If the form is visible through thecontainer* If the form is depicted by anappropriate vignetteStatement of IdentityA food is misbranded if it is animitation of another food andnot labeled as such andimmediately followed by thename of the food imitated.21 CFR 101.3(e)Statement of IdentityFood Labeling Basics7

2017Nutrition FactsIngredientsNet QuantityStatementName & Placeof BusinessState the amount of food in the container21 CFR 101.7* Solid, semisolid or viscous: state the weight (pounds,ounces, grams, etc.)* Liquids: state the fluid measure (gallons, fluid ounces,etc.)* When liquid is usually discarded, a drained weight isthe accurate measure, use “Dr. Wt.” or “Net Dr. Wt.”* Sometimes a numeric count is acceptableNet Quantity StatementMust be in easily legible boldfaceprint or type and in distinct contrastto other information on the package.21 CFR 101.7 (h)Net Quantity StatementFood Labeling Basics8

2017It must be located at the bottom30% of PDP 21 CFR 101.7 (f)Joe’s BakeryCookiesNN Net.Wt. 8 OZ. (227 g) NNNMargins:* Separated from informationabove and below by theheight of a capital letter “N”* Separated from informationto the left and right by twicethe width of a capital letter “N”Net Quantity StatementJoe’s BakeryJoe’s BakeryCookiesCookiesNet.Wt. 8 OZ. (227 g)Net. Wt. 8 OZ. (227 g)Net Quantity StatementArea of PrincipleDisplay Panel (PDP)Is the area of the sideor surface that bearsthe principle displaypanel21 CFR 101.1Net Quantity StatementFood Labeling Basics9

2017Area of Principle Display PanelFor cylindricalcontainers,or near cylinders, theformula is:40% X Height XCircumference21 CFR 101.1Net Quantity StatementMinimum Type SizeBased on area of PDP.21 CFR 101.7 (h) and (i)* If upper and lower case letters are used, the lower case “o” mustmeet the minimum type size* If only capital letters are used, the upper case “O” must meet theminimum type sizeArea of PDPMinimum Type Size5 sq. in. or less1/16 in.More than 5 sq. in. but not more than 25 sq. in.1/8 in.More than 25 sq. in. but not more than 100 sq. in.3/16 in.More than 100 sq. in. but not more than 400 sq. in.1/4 in.Over 400 sq. in.1/2 in.Net Quantity StatementDual Declaration ofNet Contents15 U.S.C. § 1453(a)(2)Use the most appropriate units of boththe customary (U. S.) system ofmeasure and the metric system.Net Quantity StatementFood Labeling Basics10

2017Dual Declaration ofNet ContentsCustomaryMetricWeightPounds (lbs)Ounces (oz)Kilograms (kg)Grams (g)VolumeGallons (gal)Quarts (qt)Pints (pt)Fluid Ounces (fl oz)Liters (L)Milliliters (mL)Net Quantity StatementThe Net Quantity Statement must not bedeceptive 21 CFR 101.7 (o)NO: Net Wt. 2 LARGE oz. (56.8 g)NO: Net Wt. 2 BIG oz. (56.8 g)NO: Net Wt. 2 generous oz. (56.8 g)YES: Net Wt. 2 oz. (56.8 g)Net Quantity StatementInformation PanelFood Labeling Basics11

2017INFORMATIONPANEL:Nutrition FactsIngredientsName & Placeof BusinessInformation Panel (IP) is thepanel to the right of the PDP.21 CFR 101.2(a)* If not usable, then the IP is thenext panel to the right* If the package has analternate PDP, the IP is to theright of any PDP* If the top of the container isthe PDP, the IP is any paneladjacent to the PDPInformation PanelNo interveningmaterial allowedon the InformationPanel 21 CFR, 101.2(e)Information PanelFood Labeling Basics12

2017Nutrition FactsIngredientsName & Placeof BusinessResponsibility Statement21 CFR 101.5Indicate the name of the responsible party, streetaddress, city, state, and ZIP. Mayomit street address if in local directory. Qualifyinglanguage “Manufactured for ” “Distributed by .”Name and Place of BusinessNutrition FactsIngredientsNet.Wt. 8 OZ. (227 g)Food Labeling BasicsName & Placeof Business13

2017Prominent and Easy to Read21 CFR 101.4(a); 101.2 (c) List ingredients by common name Descending order of predominance Minimum 1/16 inch type size (based onlowercase “o”)Ingredients ListIngredients List“Contains 2% or less of ”21 CFR, 101.4(a)(2)Ingredients ListFood Labeling Basics14

2017Ingredients ListList Sub-Ingredients21 CFR 101.4(b)(2)1. Main Ingredient (sub-ingredients)e.g., “Enriched Flour (Wheat Flour, Niacin,Reduced Iron, Thiamin Mononitrate,Riboflavin, Folic Acid),”or2. Report sub-ingredients along with mainingredients by weight-predominance.Ingredients ListIf product has two major components(e.g., turnover and filling), you may listthe ingredients for each componentseparately.Ingredients ListFood Labeling Basics15

2017Ingredients ListIncidental additives that are at insignificantlevels, and serve no function or technicaleffect are exempt from labeling requirements.21 CFR 101.100(a)(3)* Sulfiting agents 10 ppm 21 CFR 101.100(a)(4) NOTE: Food allergens are NOT exemptIngredients ListPreservatives21 CFR 101.22(j)Listed by common or usual name Listed with their function “ to promote color retention”“ to retard spoilage”“ a mold inhibitor”“ to help protect flavor”Ingredients ListFood Labeling Basics16

2017Ingredients ListSpices21 CFR 101.22Declaration1.2.“spice”common or usual nameExceptions “spice and coloring”onion, garlic, celery, etc.Ingredients ListFlavorings21 CFR 101.22May be declared as“natural flavor,” “artificialflavor,” “natural andartificial flavors.”* If singular natural flavor,say “strawberry flavor.”* If singular artificial flavor,say “artificial banana flavor.”Ingredients ListFood Labeling Basics17

2017Ingredients ListColoringsDeclare in two ways21 CFR, PARTS 74 and l1/content-detail.html1. Certified colors: list by specific orabbreviated color name and number(e.g., “FD&C Red No. 40” or “Red 40”)Certified color additives and their lakes are separateingredients. They must be declared separately(e.g., Blue 1 Lake). 21 CFR 101.22(k)(1)Ingredients ListIngredients ListFood Labeling Basics18

2017Colorings2. Non-Certified Colors: list by specificnames (e.g., “caramel coloring,” or collectively“artificial color,” or “artificial coloring”).Example: Carmine or Cochineal Extractmust be specifically listed.Ingredients ListFats, Oils, and Blends21 CFR 101.4(b)(14)* Declared by common or usual name(e.g., “cottonseed oil”)* Fat/oil blends: “Vegetable oil (PartiallyHydrogenated Palm Kernel Oil, Canola Oil)”* Hydrogenated oils must be declared accordingly “Hydrogenated” “Partially Hydrogenated”Ingredients ListHydrogenationCommonor usualnameIngredients ListFood Labeling Basics19

2017Eight MajorAllergens PeanutsFishMilkEggsWheatSoyCrustacean ShellfishTree NutsIngredients ListTwo ways to declareMajor Allergens:1. Within theIngredientsStatement:Ingredients List2. Immediatelyafter Ingredientswith a“Contains”Statement:Ingredients ListFood Labeling Basics20

2017Nutrition FactsIngredientsNet.Wt. 8 OZ. (227 g)Name & Placeof BusinessNutrition Facts shall be provided for allproducts intended for human consumptionand offered for sale 21 CFR 101.9* If packaged, use the specified label format* If not packaged, make informationavailable at the point of purchase(e.g., use a sign or card on the counter)* Even when exempted per 21 CFR 101.9(j), therecould still be special labeling requiredNutrition FactsSummary of Exemptions (21 CFR 101.9) Manufactured by small businessesFood served in restaurants for immediateconsumptionBulk food shipped for further processing/packagingFoods that provide no significant nutrition such asinstant coffeeDietary supplementsMedical foodsNutrition FactsFood Labeling Basics21

2017Point of Purchase Labeling21 CFR 101.9(a)(2)Nutrition FactsGENERAL REQUIREMENTS:Size: Based on reference amountcustomarily consumed (RACC). Use acommon household measure 21 CFR 101.12 Servings per container ServingNutrition FactsGENERAL REQUIREMENTS: Total Calories Calories from Fato 5 calories/serving – express as 0o 5 - 50 calories/serving – 5 calorie incrementso 51 calories –10 calorie incrementsNutrition FactsFood Labeling Basics22

2017REQUIREDTotal FatSaturated Fat Trans Fat VOLUNTARY Polyunsaturated Fat mandatory when monounsaturated fat isdeclared Monounsaturated Fat mandatory when making a claim aboutfatty acids or cholesterolNutrition FactsREQUIRED CholesterolSodiumoooRound to zero if 5 mgTo the nearest 5mg if 5mg to 140mgTo the nearest 10mg if more than140mgVOLUNTARY PotassiumooImmediately following sodiumsame rounding requirements as sodiumNutrition FactsREQUIRED Total Carbohydrate, Dietary Fiber,Sugars If 1g/serving, may use “Contains lessthan 1 gram” If 0.5 g/serving, may use 0Nutrition FactsFood Labeling Basics23

2017Protein 21 CFR 101.9(c)(7) List to the nearest gram (g). If less than 0.5g, may declare as 0.If greater than 0.5 g and less than 1g, may state “Contains less than 1gram”Nutrition FactsREQUIRED 21 CFR 101.9(c)(8)Vitamins and Minerals Vitamin DCalciumIronPotassiumOthers listed (24) if included as a nutrientsupplement or if a claim is made aboutthem.Nutrition FactsREQUIRED 21 CFR 101.9(c)(8)Vitamins and Minerals As a % of the Recommended Daily Intake(RDI) and expressed as a % of DV. To nearest 2% if 10% of RDI To nearest 5% if between 10% and 50% To nearest 10% increment above 50%Nutrition FactsFood Labeling Basics24

2017Consider hiring a 3rd party consultant orlaboratory to verify results. There are alsointernet-based programs that will help youcreate a Nutrition Facts Label. Try thesesearch terms: Free nutrition label generatorIngredients panel generatorCreate nutrition facts applicationCreate nutrition facts panelNutrition facts programNutrition FactsSmall Packages 40 sq. inches total surface areaAlternate FormatsSmall Packages 40 sq. inches total surface areaAlternate FormatsFood Labeling Basics25

2017Variety Packs Consumed IndividuallyAs Packaged/ As Prepared FormatBilingual FormatFood Labeling Basics26

2017Changes to the NutritionFacts LabelCompliance Dates7/26/20187/26/2019(for small businesses – those with less than 10 milliondollars of annual food sales)Serving SizeCalories Fats Added Sugars Micronutrients New Footnote Food Labeling Basics27

2017Dual ColumnDisplayMicronutrientsFood Labeling Basics28

2017www.FDA.govSearch for “Changes to the Nutrition Facts Label”Net.Wt. 8 OZ. (227 g)2 ways to format the PDP:21 CFR 101.2(b)1. Combine all required statements, includingthe PDP and Information Panel statements, onthe PDPOR2. Place only statement of identity netquantity statement on the PDP, remainder onthe Information PanelFood Labeling Basics29

2017ClaimsA.Nutrient eF.Gluten FreeNutrient Content Claims (NCC)Characterize the level of a food nutrient,directly or by implication 21 CFR 101.13(a) & (b)*****“Low Fat”“A Good Source of ”; “ High in ”“Less”; “Fewer”; “More”“Light”“Contains ”; “Provides ”A. Nutrient Content ClaimsFood Labeling Basics30

2017A claim must not be: Moreprominent than the Statement of Identity Largerthan twice the size of the Statement ofIdentity21 CFR 101.13(f)A. Nutrient Content ClaimsWhen a Nutrient Content Claim is made, nutrientlevels must meet labeling requirements. Per Reference Amount CustomarilyConsumed (RACC) 21 CFR 101.12OR Per the type of food:Meal products 21 CFR 101.13(l)Main dishes 21 CFR 101.13(m) A. Nutrient Content ClaimsRACC and Serving Size RACC 21 CFR 101.12 Serving Size based on survey data (1987) Derived from RACC Table 1 (infants/toddlers up to 4years old) Table 2 (children 4 years old toadults) Fractional amount of product incommon household measureand grams to the RACC) used to derive a serving sizeA. Nutrient Content ClaimsFood Labeling Basics31

2017Sample Calculation of Serving SizeServing Size for a 454 gram, whole pizza.1.2.3.RACC for Pizza from Table 2 in 21 CFR 101.12 (b) (140grams)Calculate the fraction of the pizza that is closest to the 140gram RACC (1/3 X 454 151 g; 1/4 X 454 113 g). Note151g is closer to 140gThe serving size is the pizza fraction closest to the RACC, withits corresponding gram weight (1/3 pizza or 151g)While the RACC is 140g for all pizzas, the serving size for thispizza is 151g.A. Nutrient Content ClaimsQualifying nutrient levels for making a claim are in:Appendices A and B of the FDA’sA Food Labeling tion/ucm2006828.htmA. Nutrient Content ClaimsLow Fat ChickenSoup!Requirement 21 CFR 101.62 (b) Individual Food 3g or less of total fatper RACCDetermination 245 g RACC Label A – 0 g fat Label B – 5 g fatA. Nutrient Content ClaimsFood Labeling Basics32

2017Low Fat Pizza!Requirement 21 CFR 101.62 (b)Nutrition FactsNutrition FactsServing Size: 1 slice (140 g)Serving Size: 1 slice (140 g)Meal/Main Dish3g or less of total fat per100 g 30% calories from fat 3gDeterminationLabel A – meets bothLabel B 3 g of fat 37.5% calories from fat A. Nutrient Content ClaimsRelative Claims21 CFR, 101.13(j)For example, “Reduced ” ; “Lite ” etc.Two ways to displayrelative claims:The % or fraction relativeto a reference food1. Adjacent to most prominentclaimComparison of amount ofnutrient per serving to areference food2. Adjacent to claim or on IPA. Nutrient Content Claims“A Good Sourceof Calcium”* Must contain 10-19%of the DV per RACCA. Nutrient Content ClaimsFood Labeling Basics33

2017“Healthy” – Health, Healthful,Healthfully, Healthier 21 CFR 101.65 (d)(2)Total FatSaturated FatSodiumCholesterolBeneficial NutrientsFortification 21CFR 104.20A. Nutrient Content Claims Describesrelationshipbetween food componentand a disease/condition Cannotclaim to diagnose,cure, mitigate, treat Disqualifyingnutrientlevels21 CFR 101.14B. Health Typicallyused for dietarysupplements only Theeffects must be derivedfrom the nutritive value of thefood. Supportedby substantialscientific evidence.21 CFR 101.93C. Structure/Function (S/F)Food Labeling Basics34

2017 California Organic Products Act(COPA) H&SC 110810 – 110959 USDA’s National Organic Program(NOP) Title 7 CFR Part 205 Products labeled “Organic” mustbe certified by accredited 3rd party Certifier’s name must be on IPD. Organic Claims “100% Organic”: all ingredients areCertified Organic ingredients (COI) “Organic”: 95% COI “Made With Organic”: 70-95% COI “Made with organic ” Three or fewer organic items listed in statement May have more identified in ingredient listD. Organic ClaimsProhibited Organic Claims“Transitional Organic”“Organic When Available”Similar terminologyD. Organic ClaimsFood Labeling Basics35

2017Juice is the aqueous liquidexpressed or extractedfrom a fruit or vegetable,the purees from the edibleportion, or any concentrateof such liquid or puree.21 CFR 120.1E. JuicesBeverages that are 100% juice or purport tocontain juiceDeclare % on the IP, near the top* “Contains 50 percent Apple Juice”* “50% Apple Juice”If less than 1% juice, total percentage shall bedeclared as“Less than 1 percent juice” or“Less than 1 percent juice”E. JuicesStandardized naming conventions for beveragesthat contain fruit or vegetable juice.21 CFR 102.33 Examples “Cherry Juice from concentrate” “Diluted grape juice beverage” “grape juice drink” Details and exemptions21 CFR 101.30E. JuicesFood Labeling Basics36

2017Gluten Free is defined as either food that:* Is inherently gluten free, or* Has a final gluten concentration 20 ppm It is a voluntary claim The threshold is required, but testing is not Compliance deadline was August 5, g-of-foodsF. “Gluten Free” ClaimsWarning StatementsandRequired DeclarationsA. Federal1. Self Pressurized Containers 21 CFR 101.17(a), (b)2. Chlorofluorocarbon 21 CFR 101.17(c),40 CFR Part 823. Protein Products 21 CFR 101.17(d)4. Dietary Supplement (Iron/Iron Salt) 21 CFR101.17(e)5. Psyllium Husk 21 CFR 101.17(f)6. Juices 21 CFR 101.17(g)7. Shell Eggs 21 CFR 101.17(h)A. FederalFood Labeling Basics37

2017B. California1.2.3.4.5.Potentially Hazardous Foods (H&SC 110700)Stimulant Laxatives (1

Jul 26, 2018 · party Certifier’s name must be on IP. D. Organic Claims. “100% Organic”: all ingredients are Certified Organic ingredients (COI) “Organic”: 95% COI “Made With Organic”: 70-95% COI “Made with organic _

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