General FDA Requirements for the Food Industry Y. Martin Lo, Ph.D. University of Maryland
Fifteen U.S. agencies regulate food safetyTop two federal regulatory units:U.S.D.A.F.D.A.
Where to find Laws and Regulations? U.S. Code (Public & Private Laws) http://www.gpoaccess.gov/plaws/index.html Code of Federal Regulations (CFR) http://www.gpoaccess.gov/cfr/index.html Most FDA Regulations: Title 21 Most USDA Regulations: Title 7 & 9
Regulatory ReferencesDefinition of Food StandardsRegulatory Information - CFR, PolicyMemos, Directives, Inspection ActsFDA vs. USDA Label ApprovalRequirements
Panel RequirementsPrinciple Display Panel (PDP) - thepanel the consumer sees firstInformation Panel - first usable panel tothe right of the PDP
What is information panel labeling?The “information panel labeling” refers tolabel statements that are generally requiredto be placed together, without any interveningmaterial, on the information panel, if suchlabeling does not appear on the PDP.These label statements include the name andaddress of the manufacturer, packer ordistributor, the ingredient list, nutritionlabeling and any required allergy labeling.
What is the prohibitionagainst intervening material?Information that is notrequired by FDA isconsidered interveningmaterial and is notpermitted to be placedbetween the requiredlabeling on theinformation panel (e.g.,the UPC bar code is notFDA required labeling).
What type size, prominence and conspicuousness is required?For information panel labeling, use a print ortype size that is prominent, conspicuous andeasy to read.Use letters that are at least one-sixteenth(1/16) inch in height based on the lower caseletter "o".The letters must not be more than three timesas high as they are wide, and the letteringmust contrast sufficiently with the backgroundso as to be easy to read.
What type size, prominence and conspicuousness is required? (cont.)Do not crowd required labeling withartwork or non-required labeling.Smaller type sizes may be used forinformation panel labeling on very smallfood packages as discussed in 21 CFR101.2(c) & (f)Different type sizes are specified for theNutrition Facts Label.
The name of the food statementThe statement of identity is thename of the food. It must appearon the front label, or PDP /alternate PDP.Generally, this is considered tobe at least 1/2 the size of thelargest print on the label.Place the statement of identity onthe PDP in lines generally parallelto the base of the package.
Modified Statement of IdentityLabels must describethe form of the food inthe package if the foodis sold in differentoptional forms such assliced and unsliced,whole or halves, etc.
Imitation ProductGenerally a new food that resembles atraditional food and is a substitute for thetraditional food must be labeled as animitation if the new food contains less proteinor a lesser amount of any essential vitamin ormineral.Use the same type size and prominence forthe word "imitation" as is used for the name ofthe product imitated.
More Required FeaturesSignature Line - use only name ofcompany, city, state and zip codeNet Weight - Location, Wording, Size &Spacing, Retail vs. FoodserviceInspection Legend - Meat vs. Poultry
Net Quantity of ContentThe net quantitystatement (net quantityof contents) is placedas a distinct item in thebottom 30 percent ofthe principal displaypanel, in lines generallyparallel with the base ofthe container.
What name and address must be listed on the label?Name and address of the manufacturer,packer or distributor. Unless the namegiven is the actual manufacturer, it mustbe accompanied by a qualifying phrasewhich states the firms relation to theproduct (e.g., "manufactured for "or"distributed by").
What name and address mustbe listed on the label? (cont.) Street address if the firm name and address are not listed in a current city directory or telephone book; City or town; State (or country, if outside the United States); and ZIP code (or mailing code used in countries other than the United States).
Where should the country of origin be declared on an imported food? The law does not specifically require that the country of origin statement be placed on the PDP, but requires that it be conspicuous. If a domestic firms name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering. If a foreign language is used anywhere on the label, all required label statements must appear both in English and in the foreign language.
Ingredient StatementsListing ingredients in descending order ofpredominance by weight means that theingredient that weighs the most is listed first,and the ingredient that weighs the least islisted last.Use a type size that is at least 1/16 inch inheight (based on the lower case “o”) and thatis prominent, conspicuous, and easy to read.
PreservativesWhen an approved chemical preservative isadded to a food, the ingredient list must includeboth the common or usual name of thepreservative and the function of the preservativeby including terms, such as “preservative,”“to retard spoilage,” “a mold inhibitor,” “to helpprotect flavor,” or “to promote color retention.”Example: “INGREDIENTS: Dried Bananas,Sugar, Salt, and Ascorbic Acid to Promote ColorRetention”
Food AllergensFood Allergen milkLabeling and eggConsumer fishProtection Act of2004 (FALCPA) Crustacean shellfish tree nuts (see table) wheat peanuts soybeans
Does FALCPA provide any specificdirection for declaring the presence ofingredients from the three food groups that are designated as "major food allergens (i.e., tree nuts, fish, and Crustacean shellfish?") Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp).
“Contains…”If a "Contains" statement is used on a food label, thestatement must include the names of the foodsources of all major food allergens used asingredients in the packaged food.For example, if "sodium caseinate," "whey," "eggyolks," and "natural peanut flavor" are declared in aproducts ingredients list, any "Contains" statementappearing on the label immediately after or adjacentto that statement is required to identify all threesources of the major food allergens present (e.g.,"Contains milk, egg, peanuts") in the same type (i.e.,print or font) size as that used for the ingredient list.
If You Failed to Label Allergens… A company and its management may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements. FDA may also request seizure of food products where the label of the product does not conform to FALCPAs requirements. In addition, FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or distributor.
More Required FeaturesHandling StatementSafe Handling InstructionsNutrition Facts Panel
Other TermsServing Suggestion - must be next to allpictures of the productGeographic Terms - if no standard inthe regulation, then use brand - made in...
Product StandardsUSDA has product standards in the 9CFR & the Food Standards & LabelingPolicy Book which can be found on line(www.gpo.gov,www.fsis.usda.gov/About_FSIS/labeling_&_consumer_protection/index.asp )
Product StandardsUSDA has finished product standards(i.e. lasagna & meatballs) & FDA hasstandards for ingredients (i.e. cheddarcheese & enriched flour)
Product Standard ExamplesLasagna with meat & sauce: 12% meatLasagna with meat sauce: 6% meatMeat lasagna: 12% meatMeatballs: must contain 65% meat, nomore than 12% binders or extendersPoultry salad: at least 25% cookedpoultry
Nutrition PanelsNutrition panels are required on all retailproducts unless you fall under one ofthe exemptionsSpecific guidelines for the formatSpecific guidelines for the serving size
What are the minimum type sizes and other format requirements for the Nutrition Facts label?
Daily Value (DV)The followingtable lists theDVs based on acaloric intake of2,000calories, foradults andchildren four ormore years ofage.
In order to calculate the % DV,determine the ratio between theamount of the nutrient in a servingof food and the DV for the nutrient.That is, divide either the actual(unrounded) quantitative amount orthe declared (rounded) amount (seenext section) by the appropriate DV.
The nutrients listedbelow may be omittedfrom the list of nutrientsand included in a singlesentence when presentat “zero” levels in afood. This is done byputting the labelstatement (“Not asignificant source of_________”) immediatelybelow the listing ofvitamins A and C,calcium, and iron.
Serving SizeServing size determined from RACCTables (Reference Amount CustomarilyConsumed)Can be discreet, non-discreet, meal orotherServing size needs to be as close to theRACC amount as possible
Serving Size: How to Start? Locate the appropriate food category and Reference Amount Customarily Consumed (RACC) for your product in the two tables in Section 101.12(b) of the food labeling regulations. Table 1 is for infant and toddler foods. Table 2 is foods for the general population. FDA established RACCs for 139 food product categories, and these values represent the amount of food customarily consumed at one eating occasion.
Serving Size: How to Start? (cont.) Determine the serving size for your multi- serving product using the RACC for the product (21 CFR 101.9(b)(2),(3), and (4)). The serving size is expressed as a common household measure followed by the equivalent metric quantity in parenthesis (e.g., “1/2 cup (112 g)”). Acceptable household measures are listed in order of appropriate use in 21 CFR 101.9(b)(5). Rounding rules for metric quantities and a few additional format options are included in 21 CFR 101.9(b)(7).
Trans Fatty AcidsTrans fatty acids should be listed as“Trans fat” or “Trans” on a separateline under the listing of saturated fatin the Nutrition Facts label (seefigure). The word “trans” may beitalicized to indicate its Latin origin.Trans fat content must be expressed asgrams per serving to the nearest 0.5-gram increment below 5 grams and tothe nearest gram above 5 grams. If aserving contains less than 0.5gram, the content, whendeclared, must be expressed as “0 g.”
Labels for Infants and Small ChildrenNutrition Facts labels for foods specifically forchildren less than 4 years do not provide % DailyValues for the macronutrients or footnotes.Foods specifically for children less than 2 years ofage must not present information on calories from fatand calories from saturated fat and quantitativeamounts for saturated fat, polyunsaturated fat,monounsaturated fat and cholesterol.In both cases, % Daily Value is declared only forprotein, vitamins, and minerals.
Permitted AbbreviationsFood packages with a surface area of 40 sq. in. or lessavailable for labeling may use the following abbreviationsin the Nutrition Facts label:
Small BusinessIf a company produces $51,000 worth offood, but had a total gross sales for allproducts, food and non-food, of $490,000,do they have to nutrition label?
Is a manufacturer that producesinstitutional and restaurant foods required to provide nutrition information? Foods which are served or sold for use only in restaurants and other establishments in which food is served for immediate consumption are exempt from nutrition labeling. However, if there is a reasonable possibility that the product will be purchased directly by consumers (e.g., club stores), nutrition information is required.
Are spices, coffee, and tearequired to be nutrition labeled?The regulations provide for an exemption forfoods that contain insignificant amounts, asdefined in 21 CFR 101.9(j)(4), of all of thenutrients and food components required to beincluded in the nutrition label.Exempted foods include coffee beans (whole orground), tea leaves, plain instant unsweetenedinstant coffee and tea, condiment-typedehydrated vegetables, flavor extracts, and foodcolors.
Nutrient ClaimsCannot make a claim unless it is defined inthe 9 CFR or 21 CFR & must have NFP onlabelSupplements are not foods and fall underanother regulationThere are 2 types of claims-absolute &relative
Absolute ClaimsThese claims are defined in the 9 CFRfor meat & poultry products and 21 CFRfor FDA productsThe product must meet therequirements for the claim or youcannot use the claim on your label
Absolute ClaimsExamples of absolute claims would belean, low fat, a good source of VitaminAClaims are based on the RACC’s
Relative ClaimsThese claims are compared to anotherproduct & the % or fraction difference ison the labelThe comparison product depends onwhich claim you use
Relative ClaimsThese claims are also based on theRACC amountsExamples of relative claims would belite, reduced, less, and lower in
Antioxidant ClaimsThe antioxidant nutrient must meet the requirementsfor nutrient content claims in 21 CFR 101.54(b), (c),or (e) for “High” claims, “Good source” claims, and“More” claims, respectively.For example, to use a “high” claim, the food wouldhave to contain 20% or more of the Daily ReferenceValue (DRV) or RDI per serving.For a “good source” claim, the food would have tocontain between 10-19% of the DRV or RDI perserving (21 CFR 101.54(g)(3)).
Example: Beta CaroteneBeta-carotene may be the subject of anantioxidant claim when the level of vitamin Apresent as beta-carotene in the food usingthe claim is sufficient to qualify for the claim.For example, if the claim is “good source ofantioxidant beta-carotene,” then at least 10%of the RDI for vitamin A must be present asbeta-carotene per serving (21 CFR101.54(g)(3)).
Health ClaimsHealth claims on food labels are claims bymanufacturers of food products that their foodwill reduce the risk of developing a disease orcondition.For example, it is claimed by themanufacturers of oat cereals that oat brancan reduce cholesterol, which will lower thechances of developing serious heartconditions.
Qualified Health ClaimsAtopic Dermatitis Risk 100% Whey-Protein Partially Hydrolyzed Infant Formula and Reduced Risk of Atopic DermatitisCancer Risk Tomatoes and/or Tomato Sauce & Prostate, Ovarian, Gastric, and Pancreatic Cancers Calcium and Colon/Rectal Cancer & Calcium and Recurrent Colon/Rectal Polyps Green Tea & Cancer Selenium & Cancer Antioxidant Vitamins & Cancer
Example: CalciumCalcium and osteoporosis health claim: “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis" or "Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life." (21 CFR 101.72(e))
Ex: Calcium + Vitamin DCalcium, vitamin D, and osteoporosis: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis" or "Adequate calcium and vitamin D throughout life, along with physical activity, may reduce the risk of osteoporosis in later life." (21 CFR 101.72(f))
HACCPHazard Analysis and Critical Control PointPreventive, not reactiveA management tool used to protect the foodsupply against biological, chemical and physicalhazardsApplicable to all phases of food production,including basic agriculture, food preparation andhandling, food processing, food service,distribution, and consumer handling and use
IS REGISTRATION AND PROCESSFILING THE SAME FOR U.S. FIRMS AND FIRMS LOCATED IN OTHER COUNTRIES?Yes, registration and process filing is thesame for all commercial acidified and low-acid canned food processors located in theUnited States and processors in othercountries. However, processors in othercountries need to register and file processesonly for those foods that are to be importedinto the United States.
2002 – Public Health Security andBioterrorism Preparedness andResponse Act (The Bioterrorism Act) Requires all food manufacturers, domestic and foreign, that produce food for consumption in the U.S. to register with FDA. Requires notification to FDA before any food is imported into the U.S. Allows FDA to detain adulterated foods. Prohibits “port shopping”
2011 – Food Safety Modernization Act Amends Food Drug and Cosmetic Act of 1938 Regulatory paradigm shift from “reaction to outbreaks” to “prevention of outbreaks”. Three Major Food Laws for FDA-regulated foods: 1. 1906 Pure Food and Drug Act* 2. 1938 Food, Drug and Cosmetic Act 3. 2011 Food Safety Modernization Act * Replaced by 1938 FDCA
2011 – Food Safety Modernization Act Four Main Themes of the Legislation Prevention Inspections, Enhanced Compliance, Partnerships and Response Import Safety
Thank You!Y. Martin Lo, Ph.D.; firstname.lastname@example.orgProcess Authority for Acidified and LowAcid Canned FoodsMaryland HACCP CoordinatorEditor-in-Chief, Journal of FoodProcessing and PreservationEditor-in-Chief, Food Science andNutrition