Prepared by the University of the West Indies, Jamaica for the Bureau of Standards Jamaica An e-book designed for Jamaican manufacturers for compliance with labelling requirements according to the US Code of Federal Regulation A Food Labelling Guide Exporting to the USA
Table of Contents Introduction......................................................................................................3 How to use this guide ......................................................................................3 Checklist for General Labelling Requirements...............................................4 Principal Display Panel (PDP) .....................................................................5 Information Panel .........................................................................................7 Identity Labelling .......................................................................................10 Labelling Checklist for Food......................................................................13 Nutrition Labelling of Food .......................................................................18 Presentation of Nutrition Information ........................................................20 Reference Amounts Customarily Consumed per Eating Occasion ...........25 Nutrient Content Claims.............................................................................26 Health Claims.............................................................................................28 Food Labelling Warning, Notice and Safe Handling Statements..............29 Misbranding of Food ..................................................................................29 Specific Food Labelling Requirements.........................................................30 Nutrient Content Claims..............................................................................38 Gluten Claim..................................................................................................80 Exemptions....................................................................................................81 Further Information .......................................................................................83 Glossary of Terms..........................................................................................95 Guidance Documents- Food Labelling..........................................................99 Appendix A..................................................................................................100 Appendix B..................................................................................................101 Appendix C..................................................................................................102 Appendix D..................................................................................................103 Appendix E..................................................................................................104
3 Introduction The labelling of food is important for the provision of information to consumers. Food labels provide consumers with an ingredient listing, instructions for preparation, handling, storage among other material for the consumer to make informed decisions about the food product. With an increase in food product manufacture and export from Jamaica to countries, primarily the United States (US) it is important for manufacturers to comply with label requirements. These requirements are outlined in the Title 21 of the Code of Federal Regulations (21 CFR). Proper labelling of packages in accordance with 21 CFR increases trade, distribution and reputation whilst preventing recalls and fines. This guide presents the general labelling requirements for food products produced and imported into the US. It is intended for informational purposes only and in no way replaces labelling regulations and statutes. The guide’s purpose is to assist in producing food labels that comply with the 21 CFR. Disclaimer The contents of this guide are accurate as of July 3, 2022. Changes and updates to the electronic Code of Federal Regulations (eCFR) are done periodically, therefore, the manufacturer (exporter) is encouraged to ensure that they are using the current regulations. How to use this guide This guide provides mandatory requirements as well as voluntary information for the label display. As manufacturers and/ or exporters peruse the document, requirements applicable to the product of interest can be easily identified and compliance level noted. On conclusion, the manufacturers and/ or exporters can use the information to determine whether the food label is acceptable or requires additional work. Adhering to this guide ensures nothing of importance is excluded from the label.
4 Checklist for General Labelling Requirements
5 Principal Display Panel (PDP) The principal display panel (PDP) is the front facing portion of a food package that is usually visible to consumers at first glance when viewed on the grocery store shelves. PDP must comply to requirements of the Food and Drug Administration (FDA) and the CFR. The location of the principal display panel and the information panel on food packages are depicted below: Source of Image: Food Labelling Guide (fda.gov) Labelling Checklist for Principal Display Panel (PDP) Requirements Yes No 1. Large enough to accommodate all mandatory label information required. 2. Clear and visible (no designs or vignettes hidden; not crowded). 3. Information required is duplicated on alternate principal display panels where applicable. 4. There is uniformity in type/font size in declaring the quantity of the contents for packages of the same size.
6 Source of Images: Kathyrn Dresser, NIST Special Publication 1020-3, Consumer 2005. Principal Displ Requirements The determined space for displaying the principal panel in the following ca a) In the case of a rectangular package, where one entire side c properly considered to be the principal display panel side, it is the h multiplied by the width of that side. b) In the case of a cylindrical or nearly cylindrical container, it is 40 p the height of the container multiplied by the circumference. The re information to appear on the principal display panel must appear w 40 percent of the circumference which is most likely to be displaye presented, shown, or examined under customary conditions of disp retail sale. c) In the case of any otherwise shaped container, it is 40 percent of th surface of the container. Where certain containers present an obvio “principal display panel” e.g., the top of a triangular or circular pa of cheese, the principal display area shall consist of the entire top s
6 r Package Labelling Guide: Selling by Count, US Department of Commerce, ay Panel (PDP) Are You Compliant? Yes No Not Applicable ases: can be height percent of elevant within that ed, play for he total ous ckage surface.
7 Information Panel 1. If the information panel is too small to accommodate the necessary information or is otherwise, unusable e.g., folded flaps or can ends, then the information panel is the next panel immediately to the right. If there are one or more alternate PDPs, then the information panel is to be located to the right of any of the PDPs. If the top of the container is the PDP and there is no alternate PDP, the information panel should be adjacent to the PDP. 2. Letter heights are based on upper case letters. However, when upper and lower or all lower-case letters are used, it is the lower case “o” or its equivalent that must meet the minimum height requirement. There are exemptions in some cases as smaller type sizes may be used on the information panel for very small food packages. Common 3. The manufacturer may apply or by petition make request to the Commissioner for him/her to establish by regulation an acceptable alternative method of disseminating such information to the public, e.g., a type size smaller than one-sixteenth inch in height, or labeling attached to or inserted in the package or available at the point of purchase. See definition for Commissioner in the glossary. Labelling Checklist for Information Panel of Package Form Food Requirements Yes No 1. The information panel is immediately touching or to the right of the principal display panel. 1 2. The requisite/specified information appears on the panel (e.g., name and address of manufacturer, packer, distributor, ingredients list, nutrition label and allergy warning). 3. Print/type size is prominent, visible and easy to read. 4. Letters and/or numbers are not less than one-sixteenth of an inch in height.2 5. Ratio of height to width for letters/numbers is correct (i.e., no number or letter is more than three times high as it is wide). 6. The lettering contrasts sufficiently with the background of the package making them easy to read. 7. All information on the panel appears in one place without any intervening material. 8. The label of the food package is adequate to accommodate all required information.3
8 Information Panel Requirements Are You Compliant? Yes No Not Applicable a) All information required to appear on the principal display panel (e.g., statement of identity, net weight, etc.) or on the informational panel (e.g., name and address of business, allergy declaration, nutrition information, etc.) must appear on the same panel unless there is insufficient space. [21 CFR 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.26, subpart D of 101] b) If there is insufficient space for all the information to appear on a single panel, it may be divided between the two panels except that any information required on a specified panel must appear on that same panel. c) A food with a label that is required to have the ingredient statement on the principal display panel must have all other relevant information mentioned above on the information panel.
9 Information Panel of Package Form Food Note: See special regulations applicable to soft drinks packaged in bottle [21 CFR 101.2] Follow the requirements as outlined above for placement of information on both panels. YES It is thus assumed that the body of the container contains both panels, therefore, the requirements can be followed as above. YES Exemptions from the placement requirements apply and the following is therefore not required on the container body since they appear on the lid: ◆ name and place of business information ◆ the nutrition information ◆ statement of ingredient
10 Identity Labelling Source of image: Michigan Department of Agriculture and Rural Development Food and Dairy Division: Food Labelling Guide, 2008. _ 1 . If the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the Statement. 2. If a food is not so labeled if it is an imitation, then it is considered to be misbranded. [21 CFR 101. 3 (e)]. Labelling Checklist for Identity Labelling of Food in Packaged Form Requirements Yes No 1. A statement of identity (i.e., name of the food) is present on the principal display panel and on alternate principal display panels where applicable. 2. The statement of identity is in terms of a name established by law or a common name or an appropriately descriptive fanciful common name. 3. Optional forms (e.g., whole, slices, diced, etc.) are part of the statement of identity and are declared in a print/type size that is reasonably proportional to the size of the letters forming the other components of the statement of identity.1 4. The statement of identity is written in print/font type that is prominent, bold, and reasonably related to the size of other printed matter (i.e., letters, graphics) on the principal display panel. 5. The statement of identity is in lines generally parallel to the base on which the package rests as it is designed to be displayed (depicted below). 6. The label bears in uniformed type size and prominence, the word "imitation” immediately following the name of the food imitated.2
11 Identifying an Imitation Food Product
12 Identity Labellingof Food in Packaged Form Requirements Are You Compliant? Yes No Not Applicable a) A label bearing the percentage(s) of a characterizing ingredient(s) or information concerning the presence or absence of an ingredient(s) or the need to add an ingredient(s) as part of the common or usual name is necessary. b) Dietary supplements must be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins). (See diagram below).
13 Labelling Checklist for Food ________________________ 1. Except those ingredients in dietary supplements that are listed in the nutrition label need not be repeated in the ingredient list. 2. The descending order of predominance requirements do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., “contains ___ percent or less of ___” or “Less than ____ percent of ____. The blanks can be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, etc. as appropriate. 3. Some ingredients can however be listed collectively as “flavours”, “spices”, “artificial flavouring”. 4. Unless some ingredients (i.e., sources) are identified within the nutrition label, in which case the ingredients listed outside the nutrition label must be in a list preceded by the words “Other ingredients”. Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients such as excipients, fillers, artificial colours, artificial sweeteners, flavours or binders may be included in the ingredient list. See the FDA CFR article for details on certain ingredients and how they must be declared (i.e., all forms of milk; bacterial cultures; whey; butteroil/butterfat; different forms of egg products; dietary botanical supplements). See also special requirements applicable to fats/oil ingredients; wheat flour; leavening agents; yeast nutrients; dough conditioners; food firming agents; sugar; wax and resin; fish protein ingredients; water used for reconstitution; nondairy caseinate). [21 CFR 101.4] Designation of Ingredients Requirements Yes No 1. All ingredients are listed on the label.1 2. The ingredients are listed visibly and prominently by common or usual names in descending order of predominance by weight.2 3. The name of ingredients must be a specific name and not a collective (generic) name.3 4. Ingredient list on dietary supplement products is located immediately below the nutritional label or to the right of the of the nutritional label and preceded by the word “ingredients” .4 An ingredient which itself contains two or more ingredients must be designated in the statement of ingredients on the label of such food by either of the following alternatives: Declare the established common or usual name of the ingredient followed by a bracketed listing of all ingredients contained therein in descending order of predominance. Optional ingredients may be declared within the bracketed listing. Include in the statement of ingredients in decending order of predominance in the finished food, the common name of every component of the ingredient without listing the ingredient itself.
14 Labelling Checklist for Food __________________________ 1. In the case of an individual, partnership, or association, the name under which the business is conducted may be used. Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as “manufactured for ____”, “Distributed by ____”, or any other wording that expresses the facts. Name and Place of Business of Manufacturer, Packer, or Distributor Requirements Yes No 1. The label of the packaged food specifies clearly the name and place of business of the manufacturer, packer or distributor.1 2. It includes the street address, city, state (or country) and mailing code.
15 [21 CFR 101.7 (n); 21 CFR 101.7 (3)] Declaration of Net Quantity of Contents Requirements Yes No 1. The principal display panel (and alternate principal display panel where applicable) of the packaged food declares the net quantity of contents. 2. The net quantity of contents is expressed in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.1 3. Foods that are solid, semisolid, viscous or a mixture of solid and liquid are expressed in terms of weight and in terms of fluid measure if the food is liquid. 4. The declaration appears as a distinct item on the PDP and is separated from other printed label information appearing above, below, left or right of the declaration.2 5. No term qualifying a unit of weight, measure or count is included in the declaration that tends to exaggerate the amount of food in the container (e.g., “jumbo quart” or “full gallon”). 6. The net quantity of contents is placed within the bottom 30 percent of the principal display panel in lines generally parallel to the base on which the package rests as it is designed to be displayed.3 7. The declaration accurately reveals the quantity of food in the package exclusive of wrappers and other material packed therewith. 4 8. The net quantity of contents is stated in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) terms [e.g., Net wt 1 lb 8 oz (680g) or Net contents 1 gal (3.79 L)]. NB: See further information section of this booklet to see how the volume is to be expressed in relation to the temperature with respect to fluid measure. 9. The declaration appears in visible and easily legible boldface font in distinct contrast (by typography, layout, colour, embossing or moulding) to other matter on the package.5 10. The ratio of height to width of the letters is no more than three times as high as it is wide.6 11. Where fractions are used, each component numeral meets one-half the minimum height standards.7 12. Letters and/or numbers are not less than one-sixteenth of an inch in height on packages where the PDP has an area of 5 square inches or less; not less than oneeighth inch in height on packages where the PDP has an area more than 5 but not more than 25 square inches; not less than three-sixteenths in height on packages where the PDP has an area more than 25 but not more than 100 square inches and not less than one-fourth inch in height on packages where the PDP has an area of more than 100 square inches, except not less than ½ inch in height if the area is more than 400 square inches. 13. Where necessary, approved words, symbols or abbreviations for the units are used.8 14. Abbreviations that are not accompanied by periods or punctuation marks are optionally used. 15. Where necessary, abbreviations in the singular form are optionally used.
16 Declaration of Net Quantity of Contents See the CFR for details on certain requirements as it pertains to net quantity of contents declaration in varying circumstances and what should obtain in such instances. _______________________________ 1. When the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such statement of weight, measure, or size of the individual units of the food as will provide such information. 2. The separation for above and below is by at least a space equal to the height of the lettering used in the declaration and the separation for left or right is by at least a space equal to twice the width of the letter “N” of the style of type in the quantity of contents statement. 3. Except on packages having a PDP of 5 square inches or less, the requirement for placement within the bottom 30 percent shall not apply when the declaration meets the other requirements mentioned. 4. Provided that the in the case of foods packed in containers designed to deliver the food under pressure, the declaration should state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is included in the net quantity declaration e.g., whipped cream in a pressurized can. The net quantity is the weight or volume of the product that will be delivered from the can together with the weight of the propellant. 5. Except that a declaration of net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is so formed on the surface. If the aforementioned cases hold for plastic and glass surface rather than printing, typing, or coloring, the lettering sizes should be increased to one-sixteenth of an inch. 6. Letter heights are based on upper case letters. However, when upper and lower or all lower-case letters are used, it is the lower-case “o” or its equivalent that must meet the minimum height requirement. 7. The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction may be reduced to its lowest terms; a decimal fraction should not be carried out to more than two places. 8. If a manufacturer opts to use abbreviations for units, the following abbreviations shall be used: tbsp. for tablespoon; tsp for teaspoon; g for grams; mL for milliliter; oz for ounce; and fl oz for fluid ounce.
17 Note: Consult the 21 CFR 101.15 for reasons why prominent statements on food labels may lack the prominence and conspicuousness required. ___________________ 1. However, in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a territory where the predominant language is one other than English, the predominant language may be substituted for English. 2. See exceptions in 101.17 (c) (2) Prominence of Required Statements Requirements Yes No 1. All words, statements, and other information required by or under authority of the FDA Act to appear on the label appear thereon in the English language.1 2. If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label appear thereon in the foreign language.2 3. If any article of labelling (other than the designated label) contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label appear on such article of labelling.
18 Nutrition Labelling of Food Labelling Checklist for Nutrition Labelling of Food Requirements Yes No 1. The required nutrition labelling appears on the package placed together with the ingredients list and the name and address of the manufacturer, packer or distributor) on the information panel. 1 2. A column within the Nutrition Facts label lists the quantitative amounts and percent daily values per serving size for the product itself. 3. A second column within the Nutrition Facts label lists the quantitative amounts and percent daily values per serving size for individual unit where applicable (e.g., sliced products, individually packaged products within a multiserving package). 4. The heading ‘Nutrition Facts’ is the largest type size in the nutrition label (i.e., larger than 8-point) and extends throughout the width of the ‘Nutrition Facts’ box. 5. Other information in the nutrition label is at minimum 6 point and 8 point type sizes. 6. The typeface and style are readable and conspicuous. 7. All nutrient and food component quantities are declared in relation to a specified serving (i.e., an amount of food customarily per eating occasion). 8. The serving size declared on a product must be determined from the reference amounts customarily consumed per eating occasion.2 9. Serving sizes that fall exactly halfway between two serving sizes, e.g., 2.5 tbsp, are rounded up to the next incremental serving size. 10. Other nutrition information outside the Nutrition Facts label placed elsewhere on the package is treated as a nutrient content claim. 11. Only those nutrients listed in the FDA’s nutrition regulation as either mandatory or voluntary components of the nutritional label are included.3 12. Only the nutritional properties of the product as packaged is declared.4 13. Trans fat if present in the product is listed in the nutritional label as “Trans fat” or “Trans” in a separate line under saturated fat in the nutrition listing.5 14. Only foods containing significant amounts of all the nutrients and food components required to be included on the nutrition label are considered.6
19 Labelling Checklist for Nutrition Labelling of Food 1. The Nutrition Facts may be presented on a label panel where the total surface available for labelling is 40 or less square inches. Packages with more than 40 square inches of available space must place the nutrition information on either the PDP or information panel unless there is insufficient space, in such case the Nutrition Facts can be placed on any panel that will be readily seen by consumers. 2. See 21 CFR 101.12 on how to determine reference amounts per eating occasion. 3. See the FDA’s CFR article section 101.9 to ascertain the list of mandatory and voluntary nutrients. This section also outlines how voluntary nutrients such as certain vitamins and minerals must be listed 4. The nutritional properties for the product as packaged is required only. However, nutritional information may be voluntary presented for “as prepared”. For example, a dry mix product such as rice that will be later cooked, the nutritional information is only required for the dry product but the nutritional information may be voluntary provided for when the product has been prepared. 5. FDA is requiring that trans fatty acids be listed in nutrition labelling in response to a petition from the Center for Science in the Public Interest and to published human studies that show that intake of fatty acids, similar to the intake of saturated fatty acids, increases LDL-C in the blood. Trans fat is expressed as grams per serving to the nearest 0.5gram increment below 5 grams, to the nearest gram above 5 grams and 0 gram if a serving contains less than 0.5 gram. [21 CFR 101.9 (c) (2)]. 6. The regulations provide for an exemption for foods that has insignificant amounts of the nutrients and food components that has been stipulated to be included in the nutrition label. Examples of such exempted include coffee beans (whole and ground), tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts and food colors. [21 CFR 101.9(j)(4)]. As long as there is no nutrient content or health claims are made for a product, the product would be exempted from nutrition labelling if it contains insignificant amounts of all the nutrients required to be on the label. Note: 1. The suggested serving size for various packaged food products are presented in the FDA’s CFR article section 21 CFR 101.9. 2. To determine the number of servings per container of a product section 21 CFR 101.9 (8)((i) – (v)) and section 21 CFR 101.12 (tables 1 and 2) can be consulted. 3. Section 101.9 can also be consulted to calculate what values to declare on the nutrient facts label, total fat, calories in food, daily reference values (see tables 1 and 2 in 101.9), carbohydrates, etc. 4. See the ‘Further Information’ section of this booklet to see how products requiring the addition of water or other ingredients that contribute insignificant amounts of nutrients are to be treated. 5. Refer to the ‘Further Information’ section of this booklet to see how nutrients required to be included on the Nutrition Facts present at 0 grams are to be treated.
20 Presentation of Nutrition Information The FDA has introduced a new format for the Nutrition Facts Label which manufacturers with annual food sales > 10 million would have transition to by January 1, 2020, and those with annual food sales < 10 million by January 1, 2021. The diagram below shows the main differences between the old and the new label formats.
21 Presentation of Nutrition Information The FDA stipulates how the nutrition information in this new format is to be presented. See example below of what is required. It is similar to the look of the old Nutrition Label with some changes (e.g. shortened rule above added sugars declaration; calories are larger in type size; added sugars is a new feature, etc.). Source of image: 2017-04-24-NFL-REVS-6pages (fda.gov)
22 Presentation of Nutrition Information If there is insufficient space for the Nutrition Facts label to be oriented vertically (i.e., 3 inches in length), the label may be presented horizontally as shown below. Source of image: 2017-04-24-NFL-REVS-6pages (fda.gov)
23 Presentation of Nutrition Information However, for food packages with a surface area of 40 square inch or less, the Nutrition Facts label may be placed in the limited space (not necessarily on the information panel) providing that the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Source of image: 2017-04-24-NFL-REVS-6pages (fda.gov)
24 Presentation of Nutrition Information Another format (see below) acceptable for use on food packages with 40 square inch or less total surface area for the placement of the nutrition facts label is the string (linear) format. Nutrition facts presented in this fashion is done where the package is unable to accommodate all forms of tabular and column display. Source of image: 2017-04-24-NFL-REVS-6pages (fda.gov) Note: 1. Companies having difficulties in presenting nutrition information on certain packages (Due to insufficient space, not technologically feasible, etc.) can request a special allowance pursuant to 21 CFR 101.9 (g) (9) and appeal in writing to the Centre for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Graphics may be reduced to create more space according to 21 CFR 101.9 (d). See the CFR 101.9 for other stipulations as it pertains to label space. 2. Abbreviations are permitted in Nutrition Facts label for small and intermediate-sized packages. See these allowable abbreviations in 21 CFR 101.9 (j) (13) (ii) (B). Use of a telephone number or address in place of the Nutrition Facts label on very small packages is permitted according to 21 CFR 101.9 (j) (13) (i) as long as there are no nutrient claims or other nutrition information that needs to be declared.
25 Reference Amounts Customarily Consumed per Eating Occasion The reference amounts customarily consumed per eating occasion for various foods are provided. The details are outlined in 101.12 of the CFR. Please consult and be guided accordingly. An example of the relevant statement to be placed honey is cited in the Further information section of this booklet.
26 Nutrient Content Claims Labelling Checklist for Nutrient Content Claims – General Principles Requirements Yes No 1. Only nutrient content claims made in accordance with FDA regulations are included on food packages.1 2. No nutrient content claim(s) is made on food intended specifically for use by infants and children less than 2 years of age.2 3. Nutrition information existing outside of the Nutrition Facts label on the package is treated as a nutrient content claim. 4. The nutrient content claim type size is not larger than two times the statement of identity and is not unduly prominent compared to the statement of identity. 5. The disclosure statement "See nutrition information for __ content" is in easily legible boldface print or type, is in distinct contrast to other printed or graphic matter, and in a size no less than that required for the net quantity of contents statement (i.e., ratio of height to width for letters– no more than 3 times high as it is wide).3 6. The disclosure statement is immediately adjacent to the nutrient content claim and there is no intervening material other than, if applicable, other information in the statement of identity or any other information that is required to be presented. 7. Where the nutrient content claim appears on more than one panel of the label, the disclosure statement is adjacent to the claim on each panel except for the panel that bears the nutrition information where it may be omitted. 8. Where a single panel of a food label contains multiple nutrient content claims or a single claim is repeated several times, a single disclosure statement is made. The statement is adjacent to the claim that is printed in the largest type on that panel. 9. When relative claims are used, the level of nutrients in a food is compared to those in a reference food using the claim words “light”, “reduced”, “less” (or “fewer”) and “more”.5
27 Labelling Checklist for Nutrient Content Claims – General Principles Requirements Yes No 10. The label of foods with relative claims states the identity of the reference food and the percentage (fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs. 11. The relative claim when present is immediately adjacent to the most prominent claim and the type size is easily legible and the ratio of height to width for letters is no more than 3 times high as it is wide.6 12. A relative claim for decreased levels of a nutrient is not made on the food label if the nutrient content of the reference food meets the requirement for a "low" claim for that nutrient (e.g., 3 g fat or less). 13. For modified foods with a relative claim, the term "modified" is used in the statement of identity followed immediately by the name of the nutrient whose content has been altered (e.g., "Modified fat cheesecake"). This statement of identity is also immediately followed by the comparative statement e.g., “Contains 35 percent less fat than ___."7 _______________________ 1.Nutrients of the type required be in nutrition labelling under 101.9 or under 101.36 of the CFR. 2.Except for claims regarding vitamins and minerals described in 101.7q (3). 3. See the CFR, 101.13 (4)(i) for exceptions to the required claim size. See 101.13 (h) (1-3) for circumstances under which the disclosure statement “See nutrition information for ____ content” is required. 4. See CFR 101. 13 (4) (ii) and 101. 13 (j) (2) for examples of other information that may be required to be presented. 5. See the circumstances for which the claim words are to be used and appropriately applied [101. 13 (j)(1)(i)(A)-(j)(1)(ii)(B)]. 6. The determination of which use of the claim is in the most prominent location on the label is made based on the factors listed in 101.13 (2)(iii)(A-D).See other relevant points at 101.13(j)(2) (iii) and subsequently that speak to certain requirements that must be fulfilled for foods bearing relative claims. See also examples of foods for which claims are allowed and those for which they are disallowed. 7. The blank line would be filled in with the reference food. The label or labelling must also bear the information required by paragraph 101.13 (j) (2) of this section in the manner prescribed.
28 Health Claims Labelling Checklist for Health Claims – General Requirements Requirements Yes No 1. Health claims declared on food labels are only those that are approved by the FDA.1 2. Label statements about the substance-disease relationship that is the subject of the claim are based on and consistent with the requisite regulations.2 3. The claims are complete, truthful, and not misleading. 4. Where factors other than dietary intake of the substances affect the relationship between the substance and the disease or health-related condition, such factors are addressed in the claim.3 5. All information required to be included in the claim appears in one place without any intervening material, except that the principal display panel of the label may bear the reference statement, "See ___ for information about the relationship between ___ and ___." 4 6. The claim(s) enables the public to comprehend the information provided and the relative significance of such information in the context of a total daily diet. 7. If the claim is about the effects of consuming the substance at decreased dietary levels, the level of the substance in the food is sufficiently low to justify the claim.5 8. If the claim is about the effects of consuming the substance at other than decreased dietary levels, the level of the substance is sufficiently high and in an appropriate form to justify the claim.6 9. Nutrition labelling is provided for foods for which a health claim is made.7 ________________________ 1. See 101.14 (5) (b) (1-3(i) and (ii)) of the CFR to determine eligibility of a substance to bear a health claim. 2. See ‘Health Claims’ under ‘Further Information’ of this booklet and the CFR to see the applicable regulations. 3. Such claim is addressed in the ‘Health Claims’ under ‘Further Information.’ 4. With the blanks filled in with the location of the labelling containing the health claim, the name of the substance, and the disease or health-related condition (e.g., "See attached pamphlet for information about calcium and osteoporosis"). With the entire claim appearing elsewhere on the other labelling, provided that, where any graphic material (e.g., a heart symbol) constituting an explicit or implied health claim appears on the label, the reference statement, or the complete claim may appear in immediate proximity to such graphic material. 5. See 101.14 (vi) of the CFR to see how this requirement can be met. 6. See 101.14 (vii) of the CFR to see how this requirement can be met. 7. Such health claims should be made in accordance with 101.9 or for dietary supplements according to 101.3 of the CFR.
29 Food Labelling Warning, Notice and Safe Handling Statements Note The warning, notice and safe handling statements differ based on how various foods are packaged. The specificities are outlined in 101.17 of the CFR. Please consult and be guided accordingly. Misbranding of Food Note Misrepresentation in the label of a food may cause such food to be misbranded, see 101.18 of the CRF for guidance.
30 Specific Food Labelling Requirements
31 Specific Food Labelling Requirements This section is applicable to the labelling of spices, flavorings, colorings, and chemical preservatives used in foods Requirements Did You Declare? Yes No Not Applicable 1. All artificial flavor and natural flavors should be listed (in letters not less than one-half the height of the letters used in the name of the food). 2. Color additives (artificial coloring) should be listed. 3. Chemical preservative should be listed. 4. Any artificial ingredient must be listed. These requirements are applicable to the foods purporting to be beverages that contain fruit or vegetable juice Requirements Did You Declare? Yes No Not Applicable 1. “Contains _ percent (or %) ___ juice” or “_ percent (or %) juice. N.B must be in the whole number. 2. If it contains non-juice ingredients if it is 100% juice. “With added ___,” the blank filled in with a term such as “ingredient(s),” “preservative,” or “sweetener,” as appropriate.
32 Specific Nutrition Labelling Requirements and Guidelines This section is applicable to the Nutrition Labelling of Dietary Supplements Requirements Did You Declare? Yes No Not Applicable 1. Serving size shall be listed under the Supplement facts to the left side of the nutrition label. 2. Serving per container shall be listed under serving size (also to the left of the nutrition label) unless otherwise declared in the net quantity. 3. Reference daily intake or reference daily value listed. 4. Dietary ingredients declared: total calories, total fat, saturated fat, trans fat, cholesterol, further, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol. 5. In the following order amount per servingcalories energy content per serving (kilo joules), Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), Vitamin A (90% (810 mcg) as beta-carotene). 6. The amount of vitamin and minerals (excluding sodium) listed should be per serving of the product (see figure 1 Multivitamins for children and Adults).
33 Specific Nutrition Labelling Requirements and Guidelines This section is applicable to the Nutrition Labelling of Dietary Supplements Requirements Did You Declare? Yes No Not Applicable 7. Percent of Daily Value shall be presented in one column aligned under the heading of “% Daily Value” and to the right of the column of amounts. The headings “% Daily Value (DV),” “% DV,” “Percent Daily Value,” or “Percent DV” may be substituted for “% Daily Value.” 8. “Percent Daily Values are based on a 2,000- calorie diet” must be placed at the bottom of nutrition label (see figure 2). 9. For declared subcomponents that have no DRVs or RDIs, a symbol (e.g., an asterisk) shall be placed in the “Percent Daily Value” column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by a statement “Daily Value not established” (See figure 3). 10. If calories are declared from saturated fat the space under the “% DV” column shall be left blank for these items. When there are no other dietary ingredients listed for which, a value must be declared in the “% DV” column, the column may be omitted. 11. Information on dietary ingredients for which RDI's and DRV's have not been established shall be declared by the common or usual name under the dietary supplement and quantitative by weight as per required for other nutrients (see figure 2).
34 Specific Nutrition Labelling Requirements and Guidelines This section is applicable to the Nutrition Labelling of Dietary Supplements Requirements Did You Declare? Yes No Not Applicable 12. Expressed in appropriate metric units. 13. A dietary ingredient that is a liquid extract shall be presented as volume or weight of total extract and condition of starting material (dried or green). 14. Dietary ingredients contained in the proprietary blend must be declared in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend”. 15. The title, “Supplement Facts,” shall be set in a type size larger than all other print size in the nutrition label and, unless impractical, shall be set full width of the nutrition label. The title and all headings shall be bolded to distinguish them from other information. 16. The nutrition information shall be enclosed in a box by using hairlines. 17. All information within the nutrition label shall utilize: (i) A single easy-to-read type of style, (ii) All black or one-color type, printed on a white or other neutral contrasting background whenever practical, (iii) Upper- and lowercase letters, except that all uppercase lettering may be utilized for packages that have a total surface area available to bear labelling of less than 12 square inches, (iv) At least one point leading (i.e., space between lines of text), and (v) Letters that do not touch.
35 Specific Nutrition Labelling Requirements and Guidelines This section is applicable to the Nutrition Labelling of Dietary Supplements Requirements Did You Declare? Yes No Not Applicable 18. A heavy bar shall be placed: (i) Beneath the subheading “Servings Per Container” except that if “Servings Per Container” is not required and, as a result, not declared, the bar shall be placed beneath the subheading “Serving Size.” 19. A light bar shall be placed beneath the headings “Amount Per Serving” and “% Daily Value.” 20. If the product contains two or more separately packaged dietary supplements that differ from each other, the quantitative amounts and percent of Daily Value may be presented as specified in this paragraph in individual nutrition labels or in one aggregate nutrition label.
36 Specific Nutrition Labelling Requirements and Guidelines Examples of Specific Nutrition Labelling Figure 1 Multi-vitamin for children and adults (excludes Servings Per Container which is stated in the net quantity of contents declaration) Figure 2 Dietary supplement containing dietary ingredients with and without RDIs and DRVs
37 Specific Nutrition Labelling Requirements and Guidelines Examples of Specific Nutrition Labelling Figure 3 Illustrates the supplement facts representation if the space is not adequate to list the required information. As shown, the list may be split and continued to the right as long as the headings are repeated. The list to the right must be set off by a line that distinguishes it and sets it apart from the dietary ingredients and percent of Daily Value information given to the left. Note The percentages based on RDI's and on DRV's shall be expressed to the nearest whole percent, except that for dietary ingredients for which DRV's have been established, “Less than 1%” or “<1%” shall be used to declare the “% Daily Value” when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the “% Daily Value” when rounded to the nearest percent is zero. Certifications from suppliers of any artificial flavors or additives added. This certification should be available upon request by FDA.
38 Nutrient Content Claims
3 Nutrient Con This section is applicable to foods for which a nutrient content claim Claim Requirements “High in”, “rich in”, “excellent source of” 1. Food must be ≥ 20% of the RDI/ DR customarily consumed and for main d products, a particular food contained criterion. “Good source/ contains/ provides” 1. Food must be within 10-19% of the R amount customarily consumed and fo meal products, a particular food conta criterion. More claims (“more”, “fortified”, “enriched”, “added”, “extra” and “plus”) 1. This may be used for protein, vitamin fibre and potassium, except for in me dish products, if the food has ≥ +10% vitamins/ minerals of the DRV for pro potassium per customarily consumed. carried out, this must be in accordanc policy. “High potency” 1. This term can only be used if vitamin present at ≥100% of the RDI per refer 2. The vitamin/ mineral must be clearly 3. Can be used to identify a multi-ingred the vitamins/ minerals listed in 101.9 RDI. 4. Fortification must be in accordance w
9 ntent Claims m for “good source”, “high”, “more” and “high potency” is made Are You Compliant? Yes No Not Applicable RV per reference amount dish products or meal must meet that RDI/ DRV per reference or main dish products or ained must meet that ns, minerals, dietary al products and main % of the RDI for otein, dietary fibre or . Where fortification is e with the fortification ns and minerals are rence amount. identified. dient product if ≥2/3 of are ≥100% of their with fortification policy
4 Nutrient Con This section is applicable to foods for wh Claim Requirements Antioxidant Claims 1. The RDI of all nutrients must be esta 2. Nutrients must have recognized antio (preventing free radical-initiated che 3. The level of each nutrient qualifies f “more” claims 4. The names of nutrients must be inclu 2. For the list of nutrients: Font must be type size of the largest nutrient conte Fibre Claims 2. If food is “high” in, a “good source” fibre AND food is not “low” in total total fat per serving must be disclose appear in close proximity to the claim than half the font size.
0 ntent Claims hich an antioxidant or fibre claim is made Are You Compliant? Yes No Not Applicable ablished oxidant activity emical reactions) for “high”, “good” or uded e ≥1/2 the size of the ent claim or 1/16 ” of or contains “more” fat, then the level of ed. this disclosure must m and must be no less
4 Nutrient Con This section is applicable to foods for which a nu Claim Requirements “light” or “lite” claims 1. If the food derives ≥50% of calories from be reduced by ≥50% per reference amoun food. 2. If the food derives less than 50% of its ca number of calories must be reduced by 1/ or its fat content should be reduced by 50 compared to reference food or the food it “Light” or “lite” claims for fat or calorie content 1. Conventions should be followed for relati the Labelling Checklist for Nutrient Cont Principles of this guide. 2. If the reference food fits the definition of calorie.”, then a “light” claim may not be 3. If the labeled food contains less than 40 c fat per reference amount customarily con by which the nutrient was reduced can be 4. “Light” or “lite” may be used on the labe meal product and a main dish product if t calories” or “low in fat” Also, it must be display panel whether “light” is used to m calories,” or both (e.g., “Light Delight, a the statement should be no less than one- “light” or “lite” claim.
1 ntent Claims utrient content claim for “light” or “lite” is made Are You Compliant? Yes No Not Applicable m fat, its fat content must nt compared to reference alories from fat, the /3 per reference amount 0% per reference amount t’s substituting. ive claims as outlined in tent Claims – General f “low fat” and “low made on a food calories or less than 3 g nsumed, then the amount e omitted. l or in the labelling of a the food is either “low in stated on the principal mean “low fat,” “low low fat meal”) and -half the type size of the
4 Nutrient Con This section is applicable to foods for which a nu Claim Requirements “Light” or “lite” for sodium content 1. The term “light” or “lite” may be used wi qualification if it is reduced by 50 percen content compared to the reference food. 2. Conventions should be followed for relati the Labelling Checklist for Nutrient Cont Principles of this guide. 3. A product for which the reference food co calories or more than 3 g fat per reference consumed may use the term “light in sodi if it is reduced by 50 percent or more in s to the reference food, provided that “light immediate proximity with “in sodium” an presented on the information panel. 4. Other than meal products and main dish p sodium” claim may not be made on a foo reference food meets the definition of “lo 5. The term “lightly salted” may be used on been added 50 percent less sodium than is reference food, provided that if the produ be stated (“not a low sodium food”) adjac of the food bearing the claim, or, if the nu information panel, it may appear elsewhe panel and the information required to acc shall appear on the label or labelling as is instructions of this document.
2 ntent Claims utrient content claim for “light” or “lite” is made Are You Compliant? Yes No Not Applicable ithout further nt or more in sodium ive claims as outlined in tent Claims – General ontains more than 40 e amount customarily ium” or “lite in sodium” odium content compared t” or “lite” is presented in nd the entire term is products, a “light in od if the corresponding ow in sodium.” n a product to which has s normally added to the uct is not This fact must cent to the nutrition label utrition label is on the ere on the information company a relative claim s required as per the
4 Nutrient Con This section is applicable to foods for which a nu Claim Requirements “Light” or “lite” for sodium content 6. “light in sodium” or “lite in sodium” may in the labelling of a meal product and a m provided that the food meets the definitio “Light” or “lite” and “in sodium” are pres size, style, color, and prominence. 7. Even if reduced in sodium by 50%, the te not be used to refer to a food that is not re percent, or, if applicable, in calories by 1⁄ a. It describes some physical or organol and the information (e.g., “light in co clearly conveys the nature of the prod b. The attribute is in the same style, colo the type size as the word “light” and i thereto. Other uses of “light” or “lite” 1. If it can be demonstrated that the word “l through common use, with a particular fo organoleptic attribute (e.g., light brown su light molasses) to the point where it has b statement of identity, the term “light” sha nutrient content claim subject to the requi
3 ntent Claims utrient content claim for “light” or “lite” is made Are You Compliant? Yes No Not Applicable y be used on the label or main dish product on of “low in sodium” and sented in uniform type erm “light” or “lite” may educed in fat by 50 ⁄3 unless: leptic attribute of the food olor” or “light in texture”) duct. or, and at least one-half in immediate proximity ight” has been associated, ood to reflect a physical or ugar, light corn syrup, or become part of the all not be considered a irements in this part.
4 Nutrient Con This section is applicable to foods for which a nutr Claim Requirements “Calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” 1. The food must contain less than 5 amount customarily consumed and If the food naturally meets this conditi interventions to lower the caloric conte disclosed that calories are not usually p “cider vinegar, a calorie free food”). The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” 1. Greater than 30 grams (g) or great the food is typically consumed (re does not provide more than 40 cal 2. 30 g or less or 2 tablespoons or les consumed which does not provide 3. Does not include sugar substitutes dehydrated foods that must be reco consumption with water or a dilue insignificant amount, of all nutrien customarily consumed, the per 50 “as prepared” form).