A GUIDE TO FEDERAL FOOD LABELING 

REQUIREMENTS FOR MEAT, POULTRY, AND 

 EGG PRODUCTS 

 

 

 

 

 

 

 

 

 

 

 

 

Edited by 

Post, R., Budak, C., Canavan, J., Duncan-Harrington, T., Jones, B. Jones, S., MurphyJenkins, R., Myrick, T., Wheeler, M., White, P., Yoder, L., Kegley, M. 

 

The Labeling and Consumer Protection Staff 

Office of Policy, Program, and Employee Development 

Food Safety and Inspection Service 

U.S. DEPARTMENT OF AGRICULTURE 

August, 2007 

Work performed under contract by 

Hogan & Hartson, LLP 

Washington, DC 
DISCLAIMER

This Guide is designed as a user-friendly introduction to the 

basic food labeling requirements for meat, poultry, and egg products. It does 

not represent, nor should it be relied upon as, an official or binding 

statement by the Labeling and Consumer Protection Staff, LCPS), Office of 

Policy, Program, and Employee Development (OPPED), of the Food Safety 

and Inspection Service (FSIS) of the U.S. Department of Agriculture 

(USDA). Users should consider changes in FSIS regulations and policies 

arising after the Guide’s publication date. 

* * * 

The impetus for the Guide was to create a user-friendly, 

comprehensive guide to assist food companies in the development of food labels 

that comply with the array of requirements policies. While not a substitute for 

careful review of the requirements referenced throughout, the Guide will 

provide the reader with a useful tool to identify and understand those 

requirements that shape the food label presented to consumers. Note: Guidance 

on egg product, labels can be found in Appendix A of this Guide. 

Building from the expertise and experience of the Labeling and 

Consumer Protection Staff, OPPED, the Agency sought to utilize a contractor 

who would offer an understanding of the rules in practice. The reader benefits 

from the day-to-day learning’s of those who are involved in the review and 

approval of labels and others who routinely assist companies in the application 

of the labeling rules. 

LCPS developed the scope and content of this Guide under a 

contract with Hogan & Hartson, LLP, Washington, DC. The Agency recognizes 

the contributions of the staff who served as editors and provided oversight in 

the creation of the Guide: Robert C. Post, Ph.D. MEd., MSc., Catherine Budak, 

Food Technologist, Jeffery Canavan, Food Technologist, Tawana DuncanHarrington, Program Analyst, Bill Jones, Chemist, Sally Jones, Senior 

Technical Advisor, Rosalyn Murphy-Jenkins, Senior Technologist, Tammie 

Myrick, Food Technologist, Mark Wheeler, Biological Scientist, Patricia White, 

Nutritionist, and Lynn Yoder, Program Analyst, Marlene Kegley, Program 

Analyst, served as contract coordinator. 

The contributions of attorneys at Hogan & Hartson, LLP in drafting 

the Guide are also acknowledged: Steven B. Steinborn, Ryan Shadrick-Wilson, 

Lorrin H. Tuxbury, Robert O. Winters, and Elizabeth B. Fawell. 

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TABLE OF CONTENTS 

Page

 I. TIPS AND PITFALLS IN DESIGNING A FOOD LABEL ..................... 3

II. INTRODUCTION TO FOOD LABELING........................................... 4

A. The Federal Agencies and Their Statutory Authority to 

Regulate Food Labeling ........................................................ 4

1. The United States Department of Agriculture’s 

Food Safety and Inspection Service (FSIS)................... 4

2. The U.S. Food and Drug Administration (FDA)............ 6

3. FSIS and FDA: Distinct Approaches to Labeling 

and Jurisdiction ......................................................... 7

4. The Federal Trade Commission (FTC).......................... 11

B. Role of the States -- Validity of State and Local 

Regulations that Affect the Food Label ................................. 13

III. FSIS LABELING – SURVEY OF BASIC PRINCIPLES ....................... 14

A. When Packaging Must Bear Required Labeling ..................... 14

B. The Prior Label Approval Process.......................................... 16

1. Treatment of Retail Labels .......................................... 18

2. Establishment Responsibilities ................................... 18

3. “Temporary” Label Approvals ...................................... 19

4. Generic Label Approvals ............................................. 20

5. Generic Modifications to Labels .................................. 21

C. Regulatory References – Resource Tools ............................... 22

IV. MANDATORY REQUIREMENTS -- INTRODUCTION ....................... 23

A. Principal Display Panel ........................................................ 24

B. Information Panel ................................................................ 25

 V. PRODUCT NAME........................................................................... 26

A. Overview .............................................................................. 26

1. Determining a Product’s Name.................................... 26

2. Placement and Prominence of Product Name............... 27

B. Standards of Identity............................................................ 28

C. Common or Usual Name ...................................................... 29

D. Descriptive Names ............................................................... 29

E. Imitation Food Products....................................................... 30

F. Geographic Origin................................................................ 32

G. Country of Origin................................................................. 35

 VI.USDA INSPECTION LEGEND......................................................... 35

VII.NET QUANTITY ............................................................................. 37

A. Expression of Net Quantity Statement.................................. 38

B. Placement............................................................................ 39

C. Prominence.......................................................................... 39

D. Exceptions and Other Special Requirements ........................ 40

VIII. INGREDIENTS STATEMENT LABELING ............................... 42

A. Overview: Basic Requirements............................................. 43

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\\\DC - 087466/000001 - 1978434 v7 
B. Artificial Flavorings, Colorings, and Chemical 

Preservatives........................................................................ 45

1. Flavors – Specificity or Generic Identification .............. 45

2. Color Additives ........................................................... 47

3. Chemical Preservatives ............................................... 47

C. Incidental Additives.............................................................. 47

D. Labeling of Ingredients of Public Health Concern.................. 49

IX. ADDRESS (SIGNATURE) LINE ....................................................... 50

 X.HANDLING STATEMENTS ............................................................. 50

XI. SAFE HANDLING INSTRUCTIONS ................................................. 51

XII.NUTRITION LABELING .................................................................. 53

A. Mandatory Nutrition Labeling - General Requirements ......... 53

B. Full Format.......................................................................... 56

C. Simplified Format ................................................................ 58

D. Tabular Format.................................................................... 59

E. Compliance Requirements Governing Nutrition Labeling ...... 60

F. Reference Daily Intakes and Daily Reference Values ............. 60

G. Exemptions from Mandatory Nutrition Labeling ................... 62

H. Voluntary Nutrition Labeling................................................ 63

I. Serving Sizes........................................................................ 64

1. General Requirements ................................................ 65

2. Common Household Measure ..................................... 66

3. Reference Amounts Customarily Consumed (RACC) 

Per Eating Occasion.................................................... 67

4. Converting Reference Amounts Customarily 

Consumed (RACCs) to Labeled Serving Sizes............... 69

a. Products in discrete units................................... 69

b. Bulk products .................................................... 70

c. Meal-type products ............................................ 70

d. Exceptions ......................................................... 71

5. Servings Per Container ............................................... 72

XIII.NUTRIENT CONTENT CLAIMS GENERALLY.................................. 73

A. General Requirements.......................................................... 73

1. Basic Principles Claims............................................... 73

2. Various General Requirements ................................... 75

3. Numeric and Percent Declarations .............................. 76

4. Relative Claims -- General Requirements .................... 77

a. Appropriate Reference Food................................ 77

b. Information that Must Accompany a Relative 

Claim ................................................................. 77

5. Claims for Main Dish and Meal-Type Products are 

Defined Separately...................................................... 78

6. Exemptions ................................................................ 79

B. Specific Nutrient Content Claims ......................................... 80

1. "High," “Good Source,” and “More” Claims.................... 80

a. “High” Claims..................................................... 80

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b. “Good Source” Claims ........................................ 81

c. “More” Claims .................................................... 81

2. “Light” and “Lite” Claims............................................. 81

3. "Sodium" and "Salt" Claims ........................................ 82

a. “Sodium Free” Claims......................................... 82

b. “Very Low Sodium” Claims ................................. 83

c. “Low Sodium” Claims ......................................... 83

d. “Reduced Sodium” Claims .................................. 84

e. “Salt” Claims...................................................... 84

4. "Nutrient Content" Claims for Fat, Fatty Acids and 

Cholesterol Content.................................................... 85

a. "Fat Content" Claims.......................................... 85

(1) “Fat Free” Claims ................................. 85

(2) “Low Fat” Claims.................................. 85

(3) “Reduced Fat” Claims........................... 86

(4) “Percent Fat-Free” Claims..................... 86

b. "Fatty Acid Content" Claims ............................... 87

(1) “Saturated Fat-Free” Claims................. 87

(2) “Low In Saturated Fat” Claims.............. 88

(3) “Reduced Saturated Fat” Claims........... 88

c. "Cholesterol Content" Claims.............................. 89

(1) “Cholesterol Free” Claims ..................... 89

(2) “Low in Cholesterol” Claims.................. 90

(3) “Reduced Cholesterol” Claims............... 90

d. “Lean” and “Extra Lean” Claims ......................... 91

5. "Fiber" Claims ............................................................ 92

6. “Healthy” Claims......................................................... 92

7. Claims Related to Usefulness in Reducing or 

Maintaining Body Weight............................................ 93

8. "Health" Claims .......................................................... 94

9. "Calorie Content" Claims ............................................ 95

a. "Calorie Content" Claims .................................... 95

(1) “Calorie Free” Claims ........................... 95

(2) “Low Calorie” Claims ............................ 95

(3) “Reduced Calorie” Claims ..................... 96

b. "Sugar Content" Claims...................................... 96

(1) “Sugar Free” Claims ............................. 96

(2) “No Added Sugar” Claims ..................... 97

(3) “Reduced Sugar” Claims....................... 998 

APPENDIX A I. EGG PRODUCTS LABELING...........................99 

 a. Product Name.................................................99 

 b. Manufacturer's Name....................................100

 c. Official Identification.....................................100 

d. USDA Approval Number..........................................101 

 e. Ingredients Statement...................................102 

 f. Net Weight Statement....................................102 

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 g. Nutrition Information.....................................103 

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PREFACE

The food label is important to food companies and consumers 

alike. A company’s most direct (and sometimes only) way to communicate with 

the consumer is via the food label. For consumers, the food label contains a 

wealth of information, which allows for informed purchase decisions. The U.S. 

Department of Agriculture (USDA), by statute, is charged with assuring that 

meat and poultry products in interstate or foreign commerce, or that 

substantially affect such commerce, are wholesome, not adulterated, and 

properly marked, labeled and packaged. 1 Responsibility for the development 

and application of the labeling requirements applicable to meat and poultry 

products rests principally with USDA’s Food Safety and Inspection Service 

(FSIS). 2 FSIS is charged with developing the labeling policy by which it is 

determined if a meat or poultry product is misbranded or adulterated. 3 FSIS 

food labeling regulations have evolved over the years, reflecting the evolution of 

the food processing industry and consumer interest. Food manufacturers are 

responsible for compliance with the FSIS labeling rules and adherence to the 

process maintained by FSIS for the evaluation and approval of meat and 

poultry product labels.

This Guide provides the basic information necessary to devise a 

label for meat and poultry products and to understand the regulatory process 

administered by FSIS. Answers to the most commonly asked questions are 

incorporated. This Guide cannot possibly anticipate or address the large 

number of issues that may arise in developing product labeling. The FSIS 

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website (www.fsis.usda.gov) is a good source of information, providing the 

complete statutes, regulations, and policies. Included throughout the Guide 

are cross references to the relevant sources, found primarily in the End Notes. 

Some issues, particularly policy issues, will often require consultation with the 

Labeling and Consumer Protection Staff (LCPS), OPPED, within FSIS. 

Before delving into the details, the Guide begins with an overview 

of the principal jurisdiction over the label, labeling and advertising of foods at 

the federal level. The scope of USDA’s jurisdiction and statutory reach with 

respect to covered and exempt meat and poultry products is detailed. The role

of the states in regulating food labeling is also addressed, along with an 

explanation of the consistency required between state and federal law. 

Section II provides an overview of the basic food labeling 

requirements, including the prior label approval process, establishment 

responsibilities, temporary label approvals, and other facets of the preapproval 

process. Sections III through XII address in detail each of the up to eight 

mandatory features that must be present on a meat or poultry label and other 

mandatory and optional information that may be on such a label. Appended to 

the Guide (Appendix A) is a discussion of the labeling requirements for egg 

products, which are also administered by FSIS. Other useful excerpts of 

labeling regulations and illustrations are included in various appendices as 

noted throughout the Guide. 

This Guide cannot substitute for a careful review of the underlying 

statutes, regulations, policies, and guidance referenced throughout the Guide. 

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Consultation of the appropriate regulation, directive, and other guidance 

document, as well as the FSIS website, provides valuable information on 

devising an acceptable and compliant food label. 

I. TIPS AND PITFALLS IN DESIGNING A FOOD LABEL

• Begin label design with the mandatory labeling features required by FSIS 

regulations. Deviation from these requirements to accommodate marketing 

or other communication objectives does not ensure compliance. 

• Ensure that placement and prominence requirements for each mandatory 

feature of the food label are met. 

• Review brand names, marketing copy, and all other information presented 

on the label to determine if a regulated term is included. 

• Make sure that foods subject to a standard of identity comply with the 

applicable FSIS requirement. 

• Make sure that ingredients/components are properly declared in the 

ingredients statement. 

• Novel or innovative products that trigger unique labeling issues should not 

be submitted to be evaluated by FSIS staff as part of the sketch-approval 

process. Instead, they should be addressed through direct contact with the 

staff. Firms should build into the product launch schedule the time 

necessary to allow for agency consideration of policy issues. 

• Review ingredients statement for accuracy and completeness against 

formulation information. Fully consult ingredient suppliers to obtain all 

pertinent information as part of this review. 

• Keep labeling files complete and current. Document generic approvals and 

permitted modifications along with final approvals that must be retained by 

the firm. 

• Products that are not amenable and thus not subject to FSIS inspection 

must still comply with applicable labeling rules. Similarly, products not 

subject to prior approval (e.g., retail labeling) also must comply with 

applicable labeling requirements. 

• Fully consult the resources available at the FSIS website and always consult 

the regulations, directives and other policies referenced in this Guide. 

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• If a label is not accurate, the label should not be used unless a temporary 

approval is obtained. 

II. INTRODUCTION TO FOOD LABELING

A. The Federal Agencies and Their Statutory Authority to Regulate 

Food Labeling

The federal regulatory agencies that have jurisdiction over food 

products derive their authority to govern the labeling of these products from 

several principal statutes -- the Federal Meat Inspection Act (FMIA), the Poultry 

Products Inspection Act (PPIA), the Egg Products Inspection Act (EPIA), the 

Agricultural Marketing Act (AMA), the Federal Food, Drug and Cosmetic Act 

(FFDCA), and the Fair Packaging and Labeling Act (FPLA). In addition, food 

advertising – which in certain instances serves as an extension of food labeling 

-- is subject to regulation by the Federal Trade Commission (FTC) under the 

Federal Trade Commission Act, which prohibits false and deceptive advertising. 

1. The United States Department of Agriculture’s Food Safety 

and Inspection Service (FSIS)

 FSIS has primary responsibility for the regulation of food labeling 

for meat and poultry products under the FMIA 4 and the PPIA 5 and is also 

authorized to regulate food labeling for exotic species of animals under the 

Agricultural Marketing Act of 1946. The FMIA and PPIA define the food “label,” 

in pertinent part, as “a display of written, printed, or graphic matter upon the 

immediate container of any article,” and define “labeling” as “all labels and 

other written, printed or graphic matter (1) upon any article or any of its 

containers or wrappers, or (2) accompanying such article.” 6 USDA is 

authorized under the FMIA and the PPIA to regulate marking, labeling, or 

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packaging of meat, poultry, or processed parts to prevent the use of any false 

or misleading mark, label, or container. This broad definition makes FSIS 

regulations applicable to product labels and materials that accompany a 

product but are not attached to it, such as point-of purchase (POP) materials. 7 

The scope of what constitutes a food label is discussed in further detail below. 

The FMIA specifies the circumstances when products are 

misbranded. The FMIA provides, in part, that any carcass, meat or meat 

product is “misbranded” (1) if the product’s labeling is false or misleading in 

any particular way; (2) if it is offered for sale under the name of another food; 

(3) if it is an imitation of another food, unless it is labeled as such; (4) if its 

container is misleading; (5) unless it bears a label with the name of the 

manufacturer, distributor, and net quantity of contents; (6) if its labeling is not 

prominent and conspicuous; (7) if it purports to be a food with a standard of 

identity without conforming to the standard; (8) if it misrepresents itself as a 

food with a standard of fill; (9) if it does not bear a common or usual name 

(provided it is not covered by a standard of identity) and declare ingredients by 

common or usual name; (10) if it purports to be a food for special dietary use 

without conforming to FDA regulations on such products; (11) if it contains 

artificial flavoring, artificial coloring, or chemical preservatives that are not 

declared (with exceptions); and (12) if it fails to bear an inspection legend and 

establishment number. 8 It is intended that these provisions apply within the 

scope of the exceptions that may exist in the act. FSIS has similar authority 

under the PPIA with regard to poultry products. 9 False or misleading labeling 

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can trigger a charge of misbranding pursuant to the wide range of labeling 

requirements summarized in this Guide. 

If a product is deemed misbranded, its manufacturer faces a wide 

range of penalties that can be imposed by FSIS. 10 These include withholding 

(rescinding) the use of labeling; product retention (prohibiting shipment); 

product detention (prohibiting sale from anywhere in the chain of commerce); 

request for product recall, press releases, and/or fines; and criminal 

prosecution. In addition, the facility producing misbranded product faces the 

possibility of inspection suspension or withdrawal. 11

2. The U.S. Food and Drug Administration (FDA)

FDA has primary statutory authority to establish labeling 

requirements for foods and food ingredients under its purview pursuant to the 

Federal Food, Drug and Cosmetic Act (“FFDCA”). 12 The FFDCA states, in a 

fashion similar to the statutes enforced by USDA, that a food product is 

misbranded, and is, therefore, in violation of the statute, if “its labeling is false 

or misleading in any particular ....” 13 

Similar to the FSIS-enforced statutes, the FFDCA defines a “label” 

as “a display of written, printed, or graphic matter upon the immediate 

container of any article.” 14 Further, the FFDCA defines “labeling” as: “labels 

and other written, printed, or graphic matter (1) upon any article or any of its 

containers or wrappers, or (2) accompanying such article.” 15 This broad 

definition makes FDA regulations applicable to product labels and materials 

that accompany a product but are not attached to it. In addition, FDA has 

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regulatory authority under the Fair Packaging and Labeling Act (“FPLA”), a 

companion statute to the FFDCA. 16

3. FSIS and FDA: Distinct Approaches to Labeling and 

Jurisdiction

Prior approval by FSIS is required for all labels used for meat and 

poultry products before those products may be marketed in interstate 

commerce. There are distinct categories of prior approval, discussed below, 

that dictate the precise manner in which a label is “approved.” FSIS derives its 

authority for label approval from the provision in the Acts that states that no 

food article “shall be sold or offered for sale by any person in commerce under 

any name or other marking or labeling ...but established trade names and 

other marking and labeling and containers which are not false or misleading 

and which are approved by the Secretary.” 17 USDA interprets this statutory 

language as mandating the preapproval of all food labels before products that 

bear the mark of inspection may be offered for sale. 

Responsibility for USDA’s pre-market label approval process rests 

with the FSIS Administrator. 18 Regulations and policies establish 

requirements for the content and design of labeling to ensure that labeling is 

truthful, accurate, and not misleading in order to prevent products from being 

misbranded. 19 Annually, FSIS evaluates approximately 60,000 labels that are 

sent to the Agency for evaluation and approval before they may be applied to 

product destined for commerce. Many more new and revised labels are subject 

to prior approval but are not submitted first for evaluation by the Agency, 

provided manufacturers ensure that such final labels fall within the conditions 

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specified in the generic labeling regulations (as elaborated upon below). In 

specified circumstances, labels that the Agency approved may be modified by 

manufacturers without resubmitting them to FSIS for evaluation. However, 

outside of these circumstances or instances where specific exceptions exist 

(e.g., for random weight packages), only labeling that has been approved by 

FSIS may be applied to meat and poultry products. 

In contrast, FDA does not require prior label approval for food 

products under its jurisdiction. 20 FDA has promulgated regulations 

establishing requirements for all aspects of labeling and monitors labeling 

compliance primarily through random post-marketing surveillance. FDA 

reviews only a small portion of labels on food products falling under its 

jurisdiction. FDA’s label review generally arises in connection with an informal 

request for review by a manufacturer, a trade complaint by a competitor, a 

consumer inquiry, or an FDA on-site inspection of a manufacturing facility. 

Although FSIS has jurisdictional authority over food labeling for 

products containing meat and poultry, the FMIA and the PPIA explicitly 

authorize USDA (through FSIS) to exempt from its regulatory coverage food 

products which contain meat or poultry “only in relatively small portion or 

historically have not been considered by consumers as products of the meat 

food industry ....” 21 By statute, the Secretary may (not, must) exempt product 

applying either of the two stated criterion. Therefore, the statutes have long 

been applied by the Agency as including all products containing meat or 

poultry under FSIS jurisdiction (and, therefore, inspection). By default, all 

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other foods fall under the jurisdiction of FDA (and the statutes under which it 

operates), including the products of exotic species of livestock and kinds of 

poultry, (e.g., deer, elk, and pheasant.) 22

The determination of whether a product falls under the jurisdiction 

of FSIS or FDA is referred to as “amenability.” Amenability decisions are based 

on how a product is formulated, not the composition of the finished product. 

USDA has set a rule that any food product containing the following is not 

subject to the FMIA or PPIA (i.e., to FSIS inspection): (1) 3 percent or less raw 

meat or less than 2 percent cooked meat, or (2) less than 2 percent cooked 

poultry meat, less than 10 percent of cooked poultry skins, giblets, or fat, 

separately, and less than 10 percent of cooked poultry skins, giblets, fat, and 

meat in combination, (i.e., specific condition,) provided the poultry ingredients 

were prepared under domestic or foreign inspection and the product is not 

represented as a poultry product. 23 FSIS has formally adopted this rule with 

regard to poultry, but has not done so for meat products. Nonetheless, 

through decades-old policy, FSIS has applied a threshold level of meat that 

makes meat food products amenable consistent with the poultry regulations. 

Examples of meat products exempt from FSIS jurisdiction under one or the 

other criteria specified in the FMIA and implementing regulations include 

spaghetti sauces with less than 2 percent cooked meat, pork and beans, bagel 

dogs, and gravy mixes. Because the regulations state that the Secretary may

exempt products, industry is strongly advised to seek clarification from FSIS in 

cases where the status of jurisdiction is in question. 

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As noted, by regulation, FSIS has further defined certain products 

as exempt from the definition of a “poultry product.” 24 These exemptions 

include product that contains less than 10 percent of cooked poultry skins, 

giblets, or fat separately and less than 10 percent of cooked poultry skins, 

giblets, fat, and meat or “mechanically separated skins of poultry,” as defined, 

and are not represented as a poultry product. Other exemptions include 

product in an institutional pack and used as soup bases or flavorings 

containing less than 15 percent cooked poultry meat and provided the specified 

conditions (as noted above) of the regulation are met. 25 Bouillon cubes, 

poultry broths, gravies, sauces, and flavorings also are exempt under the 

specified conditions (as noted above). 26 

These exemptions are null if the kind of poultry is listed in the 

product name without appropriate qualification. Appropriate qualification is 

using a term, such as “flavored,” that must be included as part of the product 

name (e.g., “Chicken Flavored Noodle Soup”) to distinguish the food product as 

different than a “poultry product” and, therefore, preserve the exemption. 

Products that meet the exemption factors and conditions, and that are labeled 

in this fashion, are subject to jurisdiction and regulation by FDA. 27 

FSIS has concurrent jurisdiction with FDA over the setting of 

standards of identity for food products. 28 The FMIA and PPIA state that 

USDA’s standards for any meat and poultry food products may not be 

inconsistent with standards established under the FFDCA. 29 

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Finally, FDA has authority to approve the safety of food ingredients 

to be used in the production of food products, including meat or poultry 

products. 30 The meat and poultry inspection laws explicitly permit only FDAsanctioned food ingredients (e.g., additives, GRAS substances, color additives) 

to be used in the production of meat and poultry products, which FSIS also 

must approve as suitable for use under prescribed conditions. 31 

FSIS requirements regarding legal status as safe for use in food 

differ somewhat from FDA. FSIS has developed policies and procedures to 

streamline its evaluation and approval of ingredients in meat and poultry 

products through close coordination with FDA. 32 FSIS has provided a great 

deal of useful guidance governing permitted use of safe and suitable 

ingredients. Beyond the scope of the Guide, there are several regulatory 

references that should be consulted.33

4. The Federal Trade Commission (FTC)

Section 12 of the Federal Trade Commission Act specifically states 

that the FTC shall prohibit the false advertisement of “foods, drugs, and 

cosmetics.” 34 Although the definition of “advertisement” excludes labeling, 

FTC has additional authority pursuant to section 5 of the FTC Act to prevent 

“unfair or deceptive acts or practices in or affecting commerce.” 35 This broad 

authority enables FTC to proceed against all unfair business practices, 

including false and misleading labeling of food products. 36 The FTC Act 

makes the dissemination of any false advertisement an unfair or deceptive 

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practice for the purpose of inducing, or that is likely to induce, the purchase of 

food or having an effect on interstate commerce. 37 

An advertising claim may be deemed false or misleading if it is not 

adequately substantiated pursuant to FTC guidelines. 38 FTC requires that 

companies that make claims about their products be able to substantiate these 

claims before they are made. FTC policy guidelines essentially provide that a 

representation of objective fact implies that the claimant has a reasonable 

basis for such fact. Different types of claims warrant different levels of 

substantiation. 39 

The courts have explicitly upheld FTC’s authority to proceed 

against false labeling of food products. 40 FTC has statutory authority to 

obtain injunctive relief, and in some instances, damages. 41 FTC may also 

require “corrective” advertising if necessary to remedy the effects of past 

deception. 42 Thus, FTC is responsible for regulating claims about food that 

appear in advertising and certain other forms of labeling that may also 

constitute advertising. 

FSIS and FTC, in practice, generally coordinate their activities to 

avoid duplication. FSIS takes the lead in addressing the labeling of meat and 

poultry products. Advertising of meat and poultry products is within the 

purview of the FTC. It is prudent to consult FSIS labeling regulations, rules 

and policies when developing advertising for meat and poultry products.

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B. Role of the States -- Validity of State and Local Regulations that 

Affect the Food Label

State requirements adopted under state law may not differ from, or 

conflict with, existing federal labeling laws and regulations. States are, 

therefore, prohibited from imposing requirements different from or in addition 

to federal labeling requirements. When state law directly conflicts with federal 

law, or attempts to regulate in an area Congress intended to be regulated solely 

by federal law, the state law is generally preempted, or superseded, by federal 

law. This is known as the “federal preemption” doctrine. 43 

The FMIA and the PPIA explicitly preempt state laws regulating 

labeling of meat and poultry products by providing that “marking, labeling, 

packaging, or ingredient requirements in addition to, or different than, those 

made under this Act may not be imposed by any State.” 44 

The federal preemption established by the FMIA and PPIA was 

upheld by the United States Supreme Court in a case involving California net 

weight labeling requirements. 45 The Court held that the California law was 

different from the USDA net weight standard which permitted manufacturing 

deviations and allowances for variations caused by moisture loss. The 

California law was thus declared preempted by federal law, and therefore, 

unenforceable. Federal courts have repeatedly and consistently upheld federal 

preemption of FSIS labeling requirements in the face of differing state labeling 

rules or practices. 46 

A federal district court has ruled more recently that food packages 

that meet federal net weight labeling requirements may not be subjected to 

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sanction by state or local weights and measures officials based on the findings 

of limited retail inspections. In Kraft Foods North America v. Rockland County 

Department of Weights and Measures, the court held that reliance on limited 

retail inspection data gathered from small retail lot inspections to support a 

“short weight” violation conflicts with federal recognition of the “reasonable 

variation” that inevitably arises over the course of a production run. As 

previously stated, all labels on meat and poultry products destined for 

commerce must be in accordance with all applicable federal rules and approved 

by FSIS. Therefore, if a manufacturer’s product is accurately labeled under 

federal rules when packaged, product remains accurately labeled, regardless of 

where a portion of a given production lot is ultimately offered for sale. 47 

III. FSIS LABELING – SURVEY OF BASIC PRINCIPLES

A. When Packaging Must Bear Required Labeling

FSIS labeling authority is very broad, extending from the labels 

appearing on the food package, before they are applied to the product, to pointof-purchase materials, including promotional brochures and shelf-talkers. 48 

As mentioned previously, a “label” is a display of any printing, graphics 

stickers, seals or other written, printed or graphic matter upon the immediate 

container. 49 This regulatory authority over the food label can affect the 

processing and manufacturing operations of food companies. Meat and poultry 

products that do not bear the USDA-approved label, unless expressly exempt, 

may not be distributed in interstate commerce. 

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The manner in which a meat or poultry product is packaged when 

shipped from an inspected establishment determines what information should

appear on the label of the packaged product. The rules vary depending upon 

whether the product is a processed or prepared meat or poultry product, or an 

unprocessed meat cut, or a poultry product, and upon the type of package or 

container in which the product is packed and shipped. 

Immediate containers (e.g., bags, cardboard cartons, tray packs, 

and film bags enclosing processed or prepared meat products) can be 

considered “protective coverings” and exempt from marking and labeling 

requirements if placed within a shipping container that meets all mandatory 

labeling requirements (product name, handling statement, legend, 

establishment number, net weight, ingredients statement, signature line, 

nutrition facts, and safe handling instructions when required). 50 This 

exemption does not include the mandatory identification and marking required 

for the inner container of the meat food product. The shipping container that

contains exempt immediate containers must be marked “Packed for 

Institutional Use Only” or with an equivalent statement of intended limited 

distribution from one federal establishment to another. The unlabeled product 

within the shipping container may not be removed for further distribution nor 

displayed or offered for sale at retail. 

For unprocessed meat cuts, transparent film bags enclosing 

individual meat cuts in an unprocessed state can be considered “protective 

coverings” and exempt from the mandatory labeling requirements when 

- 15 - 
required information appears on the shipping container in which the 

immediate containers are placed. Unlike processed meats, unprocessed meats 

when shipped may be removed from the shipping container for resale and 

further distribution to retailers, hotels, restaurants, and similar institutions if 

the product itself or the film bag bears a legible official mark of inspection and 

the establishment number. 

Poultry whole birds or individual cuts in protective coverings for 

export or sold to hotels, restaurants, or institutions only are exempt from the 

mandatory labeling of immediate containers, and no marking or labeling is 

permitted except in limited situations. The shipping container is considered 

the immediate container and should, therefore, include all mandatory features 

(product name, handling statement, legend, poultry plant number, net weight 

statement, ingredients statement, signature line, nutrition facts, and safe 

handling instructions when required.) A statement of limited use is not 

required to appear on the shipping container. Beyond these general 

requirements are specific provisions for certain types of products. 51 

B. The Prior Label Approval Process

Prior approval of all food labels affixed to a meat or poultry product 

must be consistent with FSIS regulations. The evolution of the prior label 

approval process provides useful context for understanding the current 

requirements. 

For many years, each label affixed to a meat or poultry product 

had to be submitted to FSIS for evaluation and approval. Any modifications to 

- 16 - 
the approved label required resubmission to FSIS for a new final approval. 

Only in certain instances could minor modifications be approved at the 

inspected establishment by the FSIS inspector. Over time, the number of label 

submissions for final approval grew substantially as the number of new and 

modified products increased. The current regulations reflect the Agency’s 

decision to modify its prior label approval authority in a fashion that has 

dramatically reduced the number of labels that must actually be submitted for 

evaluation and approval by FSIS staff. The local inspector no longer plays a 

role in the preapproval process but has the authority to retain product that 

bears non-compliant labels. 

Under the current regulations, final approval has been replaced 

with sketch approval based on submission of a label application to FSIS. 52 A 

sketch-approved label can be modified unilaterally by the company consistent 

with the flexibility specified by regulation, discussed below. In addition, 

specified types of product labels can be applied to meat and poultry products 

according to the generic labeling regulations without the need for submittal to 

FSIS, as long as the labels are in conformance with all applicable statutory, 

regulatory, and policy requirements. [To enhance the efficiency of its priorapproval process, FSIS encourages establishments to make use of the 

generically-approved labeling provisions. Establishments should consult with 

FSIS staff to resolve any uncertainty in this regard.] 

- 17 - 
1. Treatment of Retail Labels

Generally, no claims may appear on retail labels unless prior 

approval is obtained. Although FSIS labeling policies apply at retail, 

FSIS does not require that point-of-purchase material receive prior approval 

unless it is shipped with the product (e.g., stickered-labels applied by the 

retailer placed in the shipping container at the establishment where product is 

packed.) FSIS will evaluate and seek necessary correction of such material 

brought to its attention or identified by routine marketplace surveillance. 53 

Despite the absence of required preapproval, meat and poultry labels applied at 

retail must conform to all applicable FSIS labeling regulations. 

A notable exception arises for so-called animal production claims 

(e.g., “raised without antibiotics”) whereby only claims that have been approved 

by FSIS through submission of a label application may appear on “retail 

labels.” The labels applied at retail are not required to have sketch approval, 

but the animal production claims must be preapproved by the Agency (i.e., via 

the label affixed to the shipping carton). A prerequisite for FSIS approval is an 

establishment’s written protocol that sets forth the parameters of the program 

to ensure the accuracy of the claim. Sometimes referred to as an “affidavit” or 

“testimonial” program, appropriate documentation validating adherence to the 

FSIS-accepted protocol must be submitted to the Agency. 54 

2. Establishment Responsibilities

An establishment operates under a grant of inspection and bears 

certain responsibilities as a part of the label approval process. The processing 

- 18 - 
facility must create records of all final labeling, including sketch labels that 

have been approved. 55 Establishment records are to reflect modifications 

made to a sketch approval to the label prior to printing of the final labels. 

Records that must be maintained include all final labeling and “temporary” 

label approvals. The prior-approval process does not excuse an establishment 

from ensuring that its labeling fully complies with applicable FSIS labeling 

requirements. It is prudent for an establishment to contact FSIS staff directly 

when proposed product formulations or label claims raise policy issues or an 

establishment is unsure how to apply the labeling requirements. 

Only labeling that is approved or expressly permitted may appear 

on product destined for interstate commerce. One cannot otherwise 

unilaterally modify labels unless a specific regulation allows for such change or 

addition (e.g., random weight packages.) 

3. “Temporary” Label Approvals

FSIS recognizes that in certain circumstances a manufacturer has 

labels that contain one or more minor errors. On a case-by-case basis, FSIS 

will allow for temporary use of a nonconforming label if the criteria set forth by 

regulation are met. Use of a label that is in error renders a product 

misbranded unless temporary approval is granted by FSIS for the particular 

label. 

Temporary labels may be granted under the following 

conditions: 

(i) The proposed labeling would not misrepresent the product; 

- 19 - 
(ii) The use of the labeling would not present any potential health, safety, or 

dietary problems to the consumer; 

(iii) Denial of the request would create undue economic hardship; and 

(iv) An unfair competitive advantage would not result from the granting of 

the temporary approval. 

An application requesting temporary approval must address each 

of these considerations.56

Temporary approvals may be granted for a period not to exceed 

180 calendar days. FSIS may also grant extensions of temporary approvals if 

the applicant demonstrates that new circumstances, meeting the above 

criteria, have developed since the original temporary approval was granted. 57 

4. Labels Approved Under the Generic Labeling Regulations

FSIS allows generically approved labels to be applied to meat and 

poultry products in the exercise of its broad prior label approval authority. By 

regulation, FSIS specifies when generic approval can be undertaken by an 

establishment, foregoing the need to obtain a sketch approval requiring a 

submission of a label application directly to FSIS. 58 Products for which a 

standard of identity applies may be generically approved, provided that the 

labeling does not contain any special claims, including quality claims, nutrient 

content or health claims, negative claims, geographical origin claims, or 

guarantees. For labeling that is not for domestic product (i.e., marked “for 

export only”), the addition or deletion of the direct translation of a foreign 

language may be generically approved. 

- 20 - 
The final rule specifies numerous other types of labeling that are 

generically approved and, thus, need not be submitted to FSIS for sketch 

approval: single-ingredient products that bear no claims; products sold under 

contract specifications to the Federal government; labeling of shipping 

containers that contain fully- and properly-labeled immediate (inner) 

containers; food not intended for human consumption; meat inspection 

legends; inserts, tags, and other materials that bear no reference to the product 

and are not misleading; and the labeling for consumer test products not 

intended for sale. 

5. Modifications of Labels Made Under the Generic Labeling 

Regulations 

FSIS also specifies the changes that can be made to a sketchapproved label whereby the modified label is not resubmitted for a new “sketch” 

approval. 59 Any change not authorized by regulation triggers the need for 

submission of the revised label for sketch approval. Consultation with FSIS 

staff is prudent to ensure that, in a given circumstance, the flexibility afforded 

these requirements is fully realized. All such modifications should be 

documented by the establishment, similar to generic label-approval 

recordkeeping discussed above. 

Permitted modifications or changes extend to the following features 

of a sketch-approved label: (1) proportionately enlarged or reduced labels; (2) 

substitution of any unit of measurement with its abbreviation, or vice versa; (3) 

a master or stock label from which the name and address of the distributor are 

omitted but to be applied before being used; (4) wrappers or other covers 

- 21 - 
bearing pictorial designs or illustrations; (5) change in the language or 

arrangement of opening or serving directions; (6) addition, deletion or 

amendment of on-pack coupons, cooking instructions, packer product code 

information or UPC information; (7) any change in the manufacturer’s 

identification and address; (8) net weight statement; (9) recipe suggestions; (10) 

change in punctuation; (11) newly-assigned or revised establishment number; 

(12) open date information; (13) change in packing material; (14) brand name 

changes, provided there are no design changes and the name does not connote 

quality or other characteristics of the product; (15) deletion of the word “new”; 

(16) special handling statements; (17) safe handling instructions; (18) the 

amount of an ingredient that does not change the order in which the 

ingredients are declared; (19) color; (20) vignettes, provided they do not render 

the product labeling misleading; (21) company-initiated change in 

establishment number; (22) nutrition values, except that the serving size 

cannot be modified; (23) deletion of any claim or nonmandatory features of the 

label; and (24) addition or deletion of a direct translation of the English 

language into a foreign language for products marked “export only.” 

C. Regulatory References – Resource Tools

FSIS labeling requirements and policies are found in the relevant 

statutes, implementing regulations, FSIS directives (including Policy 

Memoranda), FSIS notices, and the Food Standards and Labeling Policy Book. 

FSIS directives and FSIS notices are the two primary types of issuances that 

instruct FSIS inspection workforce and technical employees on how to carry 

- 22 - 
out their responsibilities. FSIS directives contain instructions of an indefinite 

duration, while notices are temporary instructions scheduled to expire no later 

than one year from the issuance date. The Food Standards and Labeling Policy 

Book is a compilation of policy and informal standards that have been 

established over years of labeling decisions assembled in a dictionary format. 

All of these useful references are found at the FSIS website 

(www.fsis.usda.gov). As part of its prior-approval process, FSIS routinely 

reviews policy issues on an ongoing basis. Therefore, it is important to consult 

these resources which are updated periodically. New policy questions should 

be directed to the appropriate FSIS staff. 

IV. MANDATORY REQUIREMENTS -- INTRODUCTION

There are up to eight specific requirements for each product label: 

(1) product name, (2) inspection legend and establishment number, (3) 

handling statement, (4) net weight statement, (5) ingredients statement, (6) 

address line, (7) nutrition facts, and (8) safe handling instructions. Each of 

these requirements is discussed in detail below. The information must or may 

appear on specified areas of the label. In designing a label, it is important to 

understand what information must go where. 

The placement and prominence of information of the mandatory 

requirements are specified by regulation. Generally, any required label 

information must be prominent, conspicuous (as compared to other words, 

statements, and designs on the label), and in such terms as “to render it likely 

to be read and understood by the ordinary individual under customary 

- 23 - 
conditions of purchase and use.” 60 To ensure that this threshold requirement 

is met, the regulations specify where and in what fashion certain required 

information must appear. These provisions vary depending on the particular 

required label statements, and are specified in the appropriate sections below. 

A. Principal Display Panel

 [9 C.F.R. § 317.2(d) (meat); 9 C.F.R. § 381.116(b) (poultry)] 

The principal display panel, or “PDP,” is the part of the label most 

likely to be displayed, presented, shown, or examined under customary 

conditions to the consumer. 61 When a label bears alternate PDPs, information 

required to appear on the PDP shall be duplicated on each PDP. The PDP must 

include the name of the product, net quantity of contents, the official 

inspection legend, number of the official establishment, and, if necessary, a 

handling statement. The PDP must be large enough to accommodate 

mandatory labeling information required by statute or regulation. 62 

In determining the area of the PDP, the tops, bottoms, flanges at 

the top or bottoms of cans, and shoulders and necks of bottles and jars are 

excluded. The PDP is specifically defined as follows. 

• For rectangular packages, one entire side, the area of which is at least 

the product of height times the width of that side. 

• For a cylindrical or nearly cylindrical container, the area that is 40 

percent of the product at the height of the container times the 

circumference of the container or a panel, the width of which is one-third 

of the circumference and the height of which is as high as the container. 

- 24 - 
• For a container with any other shape, 40 percent of the total surface area 

is considered the PDP. 

Certain other special circumstances for placement of the PDP are specified as 

well. 

B. Information Panel

 [9 C.F.R. § 317.2(m) (meat); 9 C.F.R. § 381.116(c) (poultry)] 

The information panel typically is that part of the label immediately 

contiguous and to the right of the PDP. The information panel also can be the 

back panel or, for some boxes, any panel contiguous to the PDP. All 

information required to appear on the label of a package must appear either on 

the PDP or the information panel unless otherwise specified by regulation. 63 

Certain other label information that may be placed on the information panel 

(unless on the PDP) includes: an ingredients statement, name and address of 

the manufacturer or distributor, and nutrition labeling, if required. The safe 

handling instructions may be placed anywhere on the label. 

As with the PDP, information appearing on the information panel 

must be prominent and conspicuous. 64 Certain exemptions are permitted by 

regulation where the label is below a certain size due to the overall size of the 

food product’s package. 65 An establishment may not deviate from regulatory 

requirements in an effort to accommodate optional information (e.g., product 

name not prominent to allow for large “new and improved” claim.) 

- 25 - 
V. PRODUCT NAME

 [9 C.F.R. § 317.2(c) (meat); 9 C.F.R. § 381.117 (poultry)] 

A. Overview

1. Determining a Product’s Name

All meat and poultry products must be identified by a product 

name on the PDP. The regulations state that the product must be identified by 

the name specified by the standard, if there is one, or a common and usual 

name, or a truthful descriptive designation of the product. The regulations are 

intended to ensure that the product name accurately informs a consumer of a 

product’s identity. In addition, there are detailed requirements in the 

regulations and labeling policies to ensure that the product identity is clear 

and prominent to the consumer. 

In brief, if the product is represented as a product for which a 

standard of identity is established, the product must be identified by that name 

on the labeling, (e.g., “Chili con Carne” or “Chicken Soup”.) If no standard of 

identity is established for a product, one must next consider if the product is 

identified by a common or usual name, if one exists (e.g., “Beef Shoulder Clod” 

or “Pork Loin”.) Such a name may be established by regulation or common 

usage, and it must describe the basic nature of the product or its 

characterizing ingredients. In the absence of either a standard of identity or 

appropriate common or usual name, the identity statement must be a 

descriptive name. The descriptive name should accurately identify or describe 

- 26 - 
the basic nature of the food or its characterizing properties or ingredients (e.g., 

“Beef and Vegetables in Dough” or “Breaded Nugget-shaped Chicken Patty”.) 

2. Placement and Prominence of Product Name

The product name must appear prominently on the principal 

display panel. Certain regulations and Policy Memoranda specify the size (or 

relative size) of terms that appear as part of the product name. In general, 

words in product names or fanciful names may be of a different size, color, or 

type, but in all cases the words must be prominent, conspicuous, and 

legible. 66 No word in a product name (standardized name, a common or usual 

name, or descriptive name) should be printed in letters that are less than onethird the size of the largest letter used in any other word of the product name. 

This same requirement is applicable to fanciful names as well. For example, 

for a product labeled Chili Mac—Beans, Macaroni and Beef in Sauce, “Chili 

Mac” is the fanciful name, and “Beans, Macaroni, and Beef in Sauce” is the 

product name. No letter in “Chili Mac” may be smaller than one-third the size 

of the largest letter in “Chili Mac.” Furthermore, no letter in the true product 

name, (i.e., “Beans, Macaroni, and Beef Sauce,”) may be smaller than one-third 

of the largest letter in the true product name. 

Product names in certain instances must be accompanied by a 

qualifying statement deemed necessary to ensure that the product name is not 

misleading. For example, for a turkey-ham product, “turkey” must appear in 

the same size, style, and color and on the same background as the word “ham.” 

The product name must be qualified with the statement “cured turkey thigh 

- 27 - 
meat.” The qualifying statement must be contiguous to the product name 

(when triggered), without intervening type or designs, not less than one-half the 

size of the product name but not less than one-eighth inch in height, and shall 

be in the same style and color and the same background as the product name 

and in the same size, style and color, and same background as the word 

“ham.” 67 

B. Standards of Identity

[9 C.F.R. Part 319 (meat); 9 C.F.R. § 381 Subpart P (poultry)] 

USDA has statutory authority to establish standards of identity for 

meat and poultry products. Under the FMIA and the PPIA, a product is 

“misbranded” if: 

It purports to be or is represented as a food for which a definition 

and standard of identity or composition has been prescribed by 

regulations . . . unless (A) it conforms to such definition and 

standard, and (B) its label bears the name of the food specified in 

the definition and standard. 68 

A standard of identity prescribes a manner of preparation and the ingredients 

of a product that is to be labeled with a particular name. Numerous product 

standards have been established by regulation. 69 FSIS also has established 

informal policy standards by Policy Memoranda and through entries in its Food 

Standards and Labeling Policy Book. Foods subject to a standard of identity 

must be labeled with the name specified in the standard. A food that bears the 

name of a standardized food that does not satisfy the requirements of the 

applicable standard is misbranded. Examples of standardized products 

- 28 - 
include: “Ham,” “Ham Water Added,” “Hot Dogs,” “Chicken and Noodles,” and 

“Spaghetti Sauce with Meatballs.” 

C. Common or Usual Name

 [9 C.F.R. § 319.1 (meat); 9 C.F.R. § 381.117 (poultry)] 

The FMIA and PPIA authorize FSIS to promulgate common or 

usual names for meat and poultry food products. A product is misbranded 

unless it bears “the common or usual name of the food, if any there be.” 70 

FSIS regulations state further that any product “for which there is a common 

or usual name must consist of ingredients and be prepared by the use of 

procedures common or usual to such products, insofar as specific ingredients 

or procedures are not (otherwise) prescribed or prohibited.” Examples of 

common or usual names include red meat primals, (e.g., beef round,) and 

subprimals, (e.g., beef sirloin steak.)

D. Descriptive Names

 [9 C.F.R. § 317.2(e) (meat); 9 C.F.R. § 381.117(a) (poultry)] 

Descriptive terms may be used as a product’s statement of identity 

provided that no standard of identity or common or usual name exists. For 

meat products, “any descriptive designation used as a product name for a 

product which has no common or usual name shall clearly and completely 

identify the product.” For poultry products, FSIS requires “a truthful 

descriptive designation” absent a standard of identity or common or usual 

name. Product which has been prepared by a specific method, such as salting, 

smoking, drying, or chopping, must be so described unless the name implies, 

- 29 - 
or the manner of the packaging shows, that the product is subject to the 

particular form of processing. Examples of descriptive names include “Chicken 

and Vegetable in Dough” or “Breaded Nugget-shaped Chicken Patty.” 

Unqualified meat terms common to the industry but uncommon to 

consumers, such as “picnic,” “butt,” and “loaf” must not be used as product 

names unless accompanied by terms descriptive of the product or with a list of 

ingredients, if the Agency determines that this is necessary to ensure that the 

label is not false or misleading. This labeling convention is only true for certain 

(non-specific) meat products. In contrast, the poultry regulations provide that 

“kind” (poultry species) be specified in the product name. 

Manufacturers may also make use of a fanciful name accompanied 

by a descriptive term or name that is designed to ensure that consumers are 

not misled as to the identity, amount, or composition of a product. A product 

with the fanciful name “Fiesta Mexicana”, along with the descriptive term 

“Chicken Breasts with Salsa and Peppers”, is such an example. Use of fanciful 

names is especially common for a whole array of new or newly-formulated food 

products. A truly fanciful name will not convey a meaning that in any way 

relates to the nature of the product (e.g., Moon Pie.) 

E. Imitation Food Products

[9 C.F.R. § 317.2(j)(1) (meat); 9 C.F.R. § 381.1(b) (poultry)] 

A label for a product that is an imitation of another food shall bear 

the term “imitation” immediately preceding the name of the food imitated and 

in the same size and style of lettering as the product’s name. An ingredients 

- 30 - 
statement must follow the imitation product name. USDA has informally 

followed FDA’s approach with regard to imitation labeling and products not 

being nutritionally inferior. Products that resemble but are not nutritionally 

inferior to standardized meat or poultry products need not bear the “imitation” 

designation, provided that the meat or poultry content is conspicuously 

disclosed. 71 If a product is nutritionally inferior to the standardized product, 

it must be labeled “imitation” as part of the product name. 72 

FSIS regulatory policy permits the marketing of products that are 

technically imitation solely because they do not adhere to the compositional 

requirements established for a standardized product or other traditional food 

with generally recognized, established contents (e.g., Ground Beef and Textured 

Vegetable Protein (TVP) Product.) This policy enables a food manufacturer to 

make a product that is nutritionally inferior and is designed to serve consumer 

preferences without the use of the stigmatizing term “imitation.” 

In response to consumer preference for lower fat alternatives to 

standardized foods, FSIS allows products to be nutritionally modified to reduce 

the fat, cholesterol, or sodium content through the addition of ingredients for 

fat or sodium replacement precluded or restricted by applicable standards. 73 

Pursuant to this policy, qualifying products may bear the standardized name in 

conjunction with an appropriate nutrient content claim provided that 

consumers are informed of the actual components through labeling and certain 

other guidelines are followed. For example, meat products that combine fresh 

sausage, ground beef, or hamburger and other safe and suitable ingredients for 

- 31 - 
the principal purpose of replacing fat may be descriptively labeled. Such 

products are “Lean Ground Beef, Water, and Carrageenan Product,” “Low Fat 

Ground Beef With X% Solution of ...,” “Lean Beef Sausage, Water, and 

Carrageenan Product,” or “Reduced Fat Pork Sausage, Water, and Binders 

Product,” provided, in part, that the regulatory requirements for the nutrient 

content claims are satisfied. 74 Breakfast sausages, cooked sausages, and 

fermented sausages with modified fat content also may be identified by a 

nutrient content claim and a standardized or traditional name, such as “Low 

Fat Pepperoni” or “Reduced Fat Frankfurter.” 75 

F. Geographic Origin

[9 C.F.R. § 317.8(b)(1) (meat); 9 C.F.R. § 381.129(b)(2) (poultry)] 

By regulation, terms having geographic significance generally may 

appear without qualification on the labeling of meat only when the product is 

made in the geographic area mentioned. Terms of geographic significance 

referring to a locality other than where the product was made may appear on 

the label of meat products only if qualified by the words “Style,” “Type,” or 

“Brand,” accompanied by a “Made In ...” phrase that properly identifies where 

the product is manufactured. The provisions governing poultry products are 

somewhat different and are separately described below. 

Significant geographic areas that are qualified by the terms “style” 

and “type” may appear on the labels of meat products when there is a generally 

recognized style or type of product produced in that particular geographic area. 

FSIS permits use of geographic terms when accompanied by the qualifying 

- 32 - 
term if the manufacturer can demonstrate that there is a recognized “style” or 

“type.” 76 Therefore, a chili produced in California can be labeled “California 

Chili con Carne,” or since it is made in the southwestern United States, it could 

be labeled “Southwestern Chili con Carne.” On the other hand, a chili made in 

Nebraska could be labeled “Nebraska” or “Nebraska Style Chili con Carne,” or 

since there is a recognized southwestern style, it could be labeled 

“Southwestern Style Chili con Carne,” if it meets the style. 

“Brand” is used as part of a product name or claim when a style or 

a type is not recognized or met. A qualifying statement identifying the place 

where the product is actually made must appear in proximity to “brand” when 

such qualifying term is required. Therefore, using the example of chili made in 

Nebraska above, if the products did not comply with the definition for 

“Southwestern Style,” the product must be labeled “Southwestern Brand Chili 

con Carne, Made in Nebraska.” The word “Brand” must be the same size and 

style of lettering as the geographic term, and it must be accompanied with a 

prominent qualifying statement identifying the particular locality in which the 

product is prepared. 77 

Where a geographic term has come into general usage as a trade 

name and has been approved by FSIS as not being geographically significant 

and, thus, generic, the term may be used without qualification, such as “Old El 

Paso.” 78 The regulation specifically states that the terms “Vienna,” “Genoa,” 

“Polish,” “Italian,” and other similar terms need not be accompanied with a 

qualifying descriptive term when used on the standardized product. In 

- 33 - 
addition, some trade names have been used so long and exclusively by a 

manufacturer so that it is generally understood by consumers to mean the 

product of a particular manufacturer, such as “Swiss Chalet.” 79

In contrast to the meat regulations, FSIS poultry regulations 

specify that a geographic term only may be used to identify a poultry product if 

the product was actually produced in the locality stated on the label. 80 

However, as a matter of policy, FSIS has modified its treatment of geographic 

terms for poultry products to parallel the policy applied to meat products. 

The underlying issue with respect to geographic origin is whether a 

product name truly connotes geographic significance to consumers or merely 

implies a product’s style and the importance this information is to consumers. 

A truthful representation of geographic origin is permitted, such as “Virginia 

Ham” that is produced in the Commonwealth of Virginia, or “Tennessee 

Peppersteak,” made in Tennessee. 

When the term “Style” is used, there must be a method of 

preparation or other product attributes that distinguish or characterize the 

product in a manner similar to products peculiar to a geographic region. An 

establishment must demonstrate that such a style exists in order to use the 

geographic claim. By informal policy, FSIS has allowed establishments to rely 

upon an independent third-party authority (e.g., culinary institute) to establish 

that a particular “style” is associated with a specific geographic area and that 

the particular product(s) bearing the claim comport with this recognized style.

- 34 - 
G. Country of Origin

[9 C.F.R. § 327.14-.15] 

FSIS requires imported meat and poultry products to bear the 

name of the country of origin, preceded by the words “Product of.” 81 On an 

immediate container, this country of origin statement must be immediately 

under the name of the product. 82 On an outside container, this statement 

accompanies the product name and establishment number in a prominent, 

legible manner. 83 

VI. USDA INSPECTION LEGEND

[9 C.F.R. § 312 (meat); 9 C.F.R. § 381.96 (poultry)] 

USDA regulations require a prominently displayed inspection 

legend and establishment or plant number on the principal display panel of all 

federally-inspected meat or poultry product containers unless there is a 

specific exception (e.g., on a metal clip.) 84 An official inspection legend is any 

symbol prescribed by regulations showing that a carcass or parts of carcasses 

were inspected and passed by FSIS in an official establishment in accordance 

with all federal regulations. An official establishment number is assigned to 

each establishment granted inspection service. The establishment number is 

used to identify all containers of inspected products prepared in the 

establishment. A product will be deemed “misbranded” if it fails to bear these 

features on its containers. 85 

The regulations prescribe requirements for the relative dimensions 

and placement of the inspection legend; and this inspection legend must be of 

- 35 - 
a sufficient size and of such color as to be conspicuously displayed and readily 

legible. 86 The use of a foreign language for all aspects of a label is acceptable 

provided the inspection legend and establishment or plant numbers also 

appear in English.87 The products themselves are not required to be branded 

when shipped in properly-labeled containers or when shipped under an official 

government seal. There are regulations that specify in great detail the precise 

manner, method and location by which the legend must be placed on the label 

of an inspected product. 

The required official inspection legend for inspected and passed 

poultry products should include the following wording, “Inspected for 

wholesomeness by U.S. Department of Agriculture.” 88 The establishment 

number is prefaced by a “P” designating that the product is a poultry product. 

This wording should be contained within a circle. The form and arrangement 

should be exactly as indicated in 9 C.F.R. 381.96. The appropriate official 

plant number (P-and the federal number) should be shown, but, if the number 

appears elsewhere on the labeling material, it may be omitted from the 

inspection mark.89 If the number appears off the exterior of the container (e.g., 

on a metal clip,) a statement of its location must be printed contiguous to the 

legend (e.g., “Est. No. on metal clip”.) 

Products consisting of mixed meat and poultry ingredients must 

contain either the official meat inspection legend or official poultry inspection 

legend, depending on which ingredients are present in greater amounts. If 

meat or poultry ingredients exist in equal proportions, either official legend 

- 36 - 
may be used. If meat and poultry ingredients exist in exact proportions and 

both appear in the product name, the official legend must reflect the ingredient 

appearing first in the product name. 

VII. NET QUANTITY

[9 C.F.R. § 317.2(h) (meat); 9 C.F.R. § 381.121 (poultry)] 

USDA statutes and regulations establish specific labeling 

requirements governing statements of the net quantity of the food package 

offered for sale to the consumer in a retail setting. This information facilitates 

value comparisons among similar products by consumers. All labels on food 

sold at retail must bear an accurate statement of the quantity of the package 

content in terms of weight, measure, or numerical count. 90 Such a 

statement must appear on the principal display panel of all containers to be 

sold at retail intact. 91 The statement must be in terms of the package 

contents -- solid, liquid, semi-solid, or viscous. 92 

Reasonable quantity variations from the stated weight, caused by 

loss or gain of moisture during the course of good distribution practices or by 

unavoidable deviation in good manufacturing practices, are recognized and do 

not render a product to be misbranded. 93 Reasonable variations are 

permitted because of the nature of certain foods and the impossibility of 

developing completely accurate means of packaging. 94 Such variation may 

not be unreasonably large. 95 The Supreme Court held that the federal net 

weight requirements preempt state law requirements that do not permit 

reasonable variations, including unavoidable variations caused by moisture 

- 37 - 
loss during the course of good distribution practice. 96 Federal courts on 

several occasions have ruled that state or local enforcement practices in 

conflict with the FMIA or PPIA are preempted. 97

A. Expression of Net Quantity Statement

The statement of quantity shall be expressed in terms of 

avoirdupois weight or liquid measure. The use of metric measurement as it 

relates to the net weight statement is voluntary because the FPLA exempts 

meat and poultry products from metric declaration. Where there is no general 

consumer usage to the contrary, the net quantity of contents statement for 

products sold in the U.S. should be expressed in terms of liquid measure if the 

product is liquid, or in terms of weight if the product is solid, semisolid, 

viscous, or a mixture of solid and liquid. 98 For example, a chili product would 

be measured in ounces and pounds, while a beef broth would be measured in 

fluid ounces. Thus, FSIS regulations require the terms “net weight” or “net wt.” 

to appear with the net quantity of contents when expressed in terms of weight 

and “net contents” or “content” when expressed in terms of fluid measure. 99 

Packages containing at least one pound or pint, but not more than 4 pounds or 

1 gallon, must be expressed as a “dual declaration.” 100 A dual declaration 

includes ounces or fluid ounces followed, in parenthesis, by the largest whole 

U.S. customary unit (e.g., pounds and pints or quarts and gallons.) Any 

remainder should be expressed in terms of ounces or common or decimal 

fractions of the pound for weight measure, and fluid ounces or common or 

decimal fractions of the pint or quart for fluid measure (e.g., “Net Wt. 24 oz. (1 

- 38 - 
lb. 8 oz.),” “Net Wt. 24 oz. (1.5 lbs.),” or “Net Wt. 24 oz. (1 1⁄2 lb.).” 101 

Exceptions for random weight, small, and multi-unit packages, as well as 

certain packages containing margarine and bacon, are discussed below. 102 

B. Placement

The net quantity of contents statement must appear in the lower 

30 percent of the principal display panel of containers sold at retail intact in 

the following manner.103 

• In lines generally parallel to the base of the containers. 104 

• In distinct contrast with other material on the package. 105

• Separated from other printed label information appearing above and 

below it by a space at least equal to the height of the lettering used in the 

statement. 106 

• Separated from information appearing to its right and left by a space at 

least equal to twice the width of the letter “N” of the style or type of 

lettering used in the declaration. 107 

Packages that have a principal display panel of five square inches or less do 

not have to place the net quantity statement in the lower 30 percent of the 

principal display panel, provided that the declaration meets all other USDA 

requirements. 108 

C. Prominence

Additionally, USDA prescribes specific type requirements for the 

net quantity statement. 

• The declaration must be in “conspicuous and easily legible boldface print 

or type.” 109 

• The lettering may be no more than three times as high as it is wide. 110 

- 39 - 
• The minimum type size for the statement is dependent on the area of the 

PDP, as described in the table below. 111 

• When both upper and lower case letters are used in the declaration, the 

height of the lower case “o” or its equivalent must meet the minimum 

type size requirements. 112 

• When only upper case letters are used, the height of the upper case 

letters must meet the minimum type size criteria. 113 

• When fractions are used, each numeral of the fraction must meet onehalf the minimum height standards. 114 

Area of the PDP 

In Square Inches 

Minimum Type 

Size 

In Inches 

< 5 1/16 

> 5-25 1/8 

> 25-100 3/16 

>100-400 1/4 

> 400 1/2 

D. Exceptions and Other Special Requirements

USDA permits the following exceptions from its requirements for 

the net quantity statement. 

• Individually–Wrapped, Random–Weight, Consumer-Size Packages 

Shipped in Bulk Containers; and 

• Certain Meat and Poultry Products Subject to Shrinkage Through 

Moisture Loss 

The above-referenced products are not required to bear a net weight 

statement when shipped from an official establishment, provided that the 

shipping container bears a net weight shipping statement that expresses 

accurately the net quantity of contents in the container and is not 

- 40 - 
otherwise false or misleading. The individual, random–weight, 

consumer-size packages must bear a net weight statement prior to retail 

display and sale. The declarations on the shipping container and 

individual packages are exempt from the type size, dual declaration, and 

placement requirements described above, if an accurate net weight 

declaration is shown “conspicuously” on the principal display panel of 

the shipping container or package.115 

• Small Packages in Shipping Containers -- Individually-wrapped and 

labeled packages of less than 1⁄2 ounce net weight and random weight 

consumer size packages are exempt from USDA’s net quantity of 

contents labeling requirements, provided that the packages are in a 

shipping container that expresses accurately the net quantity of 

contents in the container and is not otherwise false or misleading. 116 

• Small Packages in General -- Individually-wrapped and labeled 

packages of less than 1⁄2 ounce net weight with labels declaring net 

weight, price per pound, and total price are exempt from the type size, 

dual declaration and placement requirements described above if an 

accurate statement of net weight is shown “conspicuously” on the 

principal display panel of the package. 117 

• Sliced, Shingle-Packed Bacon in Rectangular Packages; and 

• Margarine in One Pound Rectangular Packages (except packages 

containing whipped or soft margarine or packages containing 

more than four sticks)

Provided that an appropriate net quantity statement appears on the 

principal display panel of the above-referenced products in a 

“conspicuous manner,” the statement is exempt from the dual 

declaration requirement and the requirement that the net quantity of 

contents declaration appear in the bottom 30 percent of the PDP. 118 

• Certain Types of Consumer Packages of Poultry Products – The 

Administrator may approve the use of labels that do not bear a net 

weight statement on the above-referenced packages, provided that: 

(1) the shipping container bears the statement, “Net weight to be 

marked on consumer packages prior to display and sale”; (2) the total 

net weight of the contents of the shipping container is marked on the 

container; (3) the shipping container also bears the statement: “Tare 

weight of consumer package” in “close proximity” to the tare weight of 

the consumer packaging, weighed to the nearest 1/8 ounce or 

less. 119 

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Special net weight labeling rules are specified for multiunit retail 

packages (MRPs). An MRP is defined as a package containing two or more 

individually-packaged units that: (1) contain the identical commodity; (2) 

contain the same quantity of food; and (3) are intended to be sold as part of the 

MRP but are capable of being individually sold in full compliance with USDA 

regulations. 120 A net quantity statement is required on the outside label of 

the MRP. The statement must comply with the same requirements applicable 

to net quantity statements generally, as discussed above. In addition, net 

quantity statements for MRPs must also include the following: 121 

• The number of individual units;

• The quantity of each individual unit; and

• In parenthesis, the total quantity of contents of the multiunit package, 

except that the declaration of total quantity need not be expressed as a 

“dual declaration” (e.g., the declaration in ounces need not be followed by 

an additional parenthetical declaration in terms of the largest whole U.S. 

customary units.) 

Examples of products that might bear this type of information could include 

pizza or soups. 

VIII. INGREDIENTS LABELING

[9 C.F.R. § 317.2 (meat); 9 C.F.R. § 381.118 (poultry)] 

The ingredients statement provides the consumer with detailed 

information as to the constituents of a meat or poultry product. The number of 

ingredients, the multiple functions of ingredients, and the sophisticated 

methods for producing some ingredients create many challenges in applying 

the ingredient labeling requirements. Proper ingredients labeling requires 

- 42 - 
regulatory and technical expertise. An understanding as to the function an 

ingredient plays in the food is central to proper application of the ingredient 

labeling requirements. 

A. Overview: Basic Requirements 

An ingredients statement is required when a product is fabricated 

from two or more ingredients. 122 All ingredients must be declared by their 

common or usual names on the label in descending order of predominance by 

weight.123 Order of predominance is determined based on the weight of 

ingredients as added to the formulation. 124 An ingredients statement is not 

required when the product name provides a complete identification of all 

ingredients in the food (e.g., “Chicken Breasts with Rosemary Extract”.) 

Ingredients present in individual amounts of two percent or less may be listed 

in other than descending order, provided that they are listed at the end of the 

ingredients statement preceded by a phrase such as “less than __ percent of 

__,” with the blank filled in with the “appropriate” threshold level of two 

percent, 1.5 percent, one percent, or 0.5 percent. 125 These quantifying 

statements should start with the threshold level of 2.0% and move down in 

0.5% increments, (i.e., 1.5%, 1.0%, or 0.5%.) No ingredient in the quantifying 

statement may be greater than the stated threshold, and ingredients listed in 

the quantifying statement may be adjusted in the formulation without a change 

in the ingredients statement. 

When two meat ingredients comprise at least 70% of the meat and 

meat by-product ingredients of a formula, and when neither ingredient is less 

- 43 - 
than 30% by weight of the total meat and meat by-products used, these meat 

ingredients may be interchanged in the formula without a change to the 

ingredients statement. 126 In such cases, the word “and” must be used in lieu 

of a comma between the two ingredients. This same rule applies to products 

containing poultry. 127 However, it does not apply to mixtures of meat and 

poultry. 

An ingredient that conforms to a standard of identity (discussed 

above in connection with product names) is identified by the name specified by 

the applicable standard. When FDA standardized foods are used as 

ingredients in the preparation of meat or poultry products, the common or 

usual names of all ingredients in the standardized food must be listed, in 

parentheses, following the name of the standardized food (so-called “component 

listing”.) 128 The Code of Federal Regulations and the Food Standards contain 

definitions for various food ingredients. Absent a specific FSIS requirement, 

the appropriate common or usual name as set forth by FDA is appropriate. 129 

The Food Standards and Labeling Policy Book may also be consulted for 

recognized ingredient names. 

There are two methods by which ingredients and sub-ingredients 

may be declared within the ingredients statement. The ingredients of a 

standardized food that is used as an ingredient in a food may either (1) be 

declared parenthetically following the name of the standardized ingredient (i.e., 

“component” labeling,) e.g., “cheddar cheese (milk, enzymes, salt)” or (2) 

declared by dispersing each ingredient in its order of predominance in the 

- 44 - 
ingredients statement of the product in which they are used without naming 

the standardized food specifically (i.e., “composite” labeling). Composite listing 

does not name the standardized food, (e.g., “meatballs” from various sources, 

each having similar but different formulations.) The affected ingredients in a 

composite declaration must be minor in nature and should be identified using 

one of the following acceptable formats: 

1) Pepperoni (pork, beef, water, salt, spices, sodium nitrate (may also 

contain lactic acid starter culture, sugar, and sodium ascorbate)); 

2) Bacon bits (cured with water, salt, dextrose and/or sugar, and 

sodium nitrite); or 

3) Pepperoni (pork, beef, water, sweeteners (contains one or more of 

the following: sugar, dextrose, fructose, corn syrup), salt, spices, 

sodium nitrate). 130 

FSIS allows the use of both component labeling and composite 

labeling within a singular ingredients statement. 

Certain naming conventions, including the grouping of ingredients 

identified by a single term, are specified by FDA regulation and followed by 

FSIS. 131 The ingredient name usually must be specific as opposed to generic. 

Synonymous terms are interchangeable. Examples of interchangeable terms 

are frank, hot dog, and weiner, or corn syrup and corn syrup solids. 

B. Artificial Flavorings, Colorings, and Chemical Preservatives

1. Flavors – Specificity or Generic Identification

Rules governing the labeling of artificial flavorings, colorings, and 

chemical preservatives are focused on ensuring that a product’s ingredients 

statement adequately informs a consumer of the product’s content. 132 A 1995 

“Question and Answer” document issued by FSIS remains a valuable resource 

- 45 - 
to address these and other ingredient labeling issues.133 FSIS permits the term 

“flavorings” to designate natural spices and natural spice extractives. “Spices” 

may be used to designate natural spices. 134 

The meat species and poultry “kind” must be identified as part of a 

flavor (e.g., “Dried (species or kind) stocks,” “Dried (species or kind) broth”.) 

Such ingredients may not be declared simply as “flavors” because dried stocks, 

dried broth and extracts, and blood fractions are of animal origin and must be 

so designated as “Dried (species) stock,” “Dried (species) broth,” “(species) 

extract,” or “Dried (species) plasma.” 

Only ingredients that fall within the regulatory definition may be 

declared as “natural flavor,” “natural flavoring,” “flavor” or “flavoring.” These 

include essential oils, oleoresins, and spice extractives. 135 The term “spice” is 

used to refer to those spices listed in FDA regulations. 136 

Certain types of ingredients that are hydrolyzed must be identified 

by the source and cannot be identified generically as a “flavor.” Examples 

include: hydrolyzed (source) proteins, gelatin, hydrolyzed meat and meat byproducts, autolyzed yeast, and autolyzed yeast extract. 

The terms “artificial smoke flavoring added” or “smoke flavoring 

added” must be on the product label next to the product name and identified in 

the ingredients statement. 137 The same requirement applies with respect to 

meat products in several specific instances in which artificial colorings are 

added to the product. 138 

- 46 - 
2. Color Additives

FSIS requires color additives or the lake of a color additive subject 

to FDA certification to be identified by its common or usual name or the 

abbreviated names such as “FD&C Red No. 40,” “Red 40,” “FD&C Blue No. 1 

Lake,” or “Blue 1 Lake.” 139 Color additives not subject to certification may be 

declared generically such as “Artificial Color” or “Color Added,” or they may be 

designated as “Colored with ____” or “_____ color,” with the blank filled with the 

name of the color additive. 140 Products containing any artificial coloring must 

note that fact on the immediate container of the product or, if there is none, 

the product itself. 141 

3. Chemical Preservatives

Containers of products containing any chemical preservative must 

state that fact on the label. 142 Additional rules apply to antioxidants and other 

additives (e.g., possible product name qualifiers.) With respect to poultry 

products containing chemical preservatives, FSIS clarifies that the label 

statement must name the chemical preservative and the purpose of its use. 143 

C. Incidental Additives

Federal regulations require that all ingredients used to formulate a 

meat or poultry product must be listed by their common or usual name on 

labeling. There are two exceptions to the rules. An ingredient that is classified 

by FDA as a secondary direct additive does not need to be labeled because it 

has only a momentary technical effect in food by definition. The other 

exception is for incidental additives according to FDA’s labeling regulations. 144 

- 47 - 
FSIS exempts the mandatory declaration of “incidental additives” 

from an ingredients statement if they are present in insignificant amounts and 

serve no technical or functional effect in food, are used as a processing aid, or 

have migrated to food from equipment or packing materials. 145 Processing 

aids are a subcategory of incidental additives and are not considered 

ingredients since they are essentially substances that are added to a food for 

their technical or functional effect in the processing but are present in the 

finished food at insignificant levels and do not have any lasting technical effect 

in that food. 

FSIS does not have a definition for incidental additives or 

processing aids. However, if a company believes that the use of a substance in 

the manufacture or formulation of a meat or poultry product is consistent with 

FDA’s labeling definition for an incidental additive processing aid, then data 

needs to be submitted to FSIS to substantiate conformance with the FDA 

regulation. FSIS will determine on a case-by-case basis whether a request for 

the specific use of an ingredient is consistent with FDA’s labeling definition of 

an incidental additive processing aid and thus, exempt from labeling. 

These exceptions do not apply where FDA regulations require that 

use of a specific substance be disclosed for health or other reasons. For 

example, FDA requires that sulfiting agents that qualify as incidental additives 

must be labeled if present at levels exceeding an established level (10 ppm). 146 

- 48 - 
D. Labeling of Ingredients of Public Health Concern

Because there are foods and food ingredients to which some 

individuals may have a sensitivity (i.e., an allergic reaction or intolerance), FSIS 

emphasizes the importance of accurate, informative product labeling. FSIS 

supports including voluntary statements on labels to alert people who have 

sensitivities or intolerances to the presence of specific ingredients, particularly 

the “big 8” allergens (wheat, crustaceans (e.g., shrimp , crab, lobster), eggs, 

fish, peanuts, milk, tree nuts (e.g., almonds, pecans, walnuts), and soybeans) 

and other specific ingredients (monosodium glutamate (MSG), sulfites, lactose, 

and Yellow 5 (tartrazine). FSIS provides the following example: “Contains: 

milk, wheat gluten, soy.” FSIS further supports identifying the source of a 

specific ingredient in a parenthetical statement, (e.g., “whey (from milk)”.) 

FSIS authorizes the use of factual labeling statements about a 

product’s manufacturing environment, (e.g., “Produced in a plant that uses 

peanuts,”) where good manufacturing practices and effective sanitation 

standard operating procedures (SSOPs) cannot reasonably eliminate the 

unintended presence of certain ingredients. In certain circumstances, the 

phrase “may contain (name of allergenic ingredient)” may be used on meat and 

poultry product labeling. However, the use of factual statements about a 

product’s manufacturing environment, (e.g., “Produced in a plant that uses 

peanuts,”) and the use of “may contain” statements, (e.g., “may contain 

peanuts”) may only be used in cases where establishments show that adequate 

SSOPs cannot effectively eliminate the cross-contact issue. 

- 49 - 
The Agency will consider any non-misleading symbols, statements, 

or logos to inform consumers of the presence of ingredients of public health 

concern in meat, poultry, or egg products. All requests must be submitted to 

the Agency as a policy inquiry and not as label-approval submissions. 

IX. ADDRESS (SIGNATURE) LINE 

[9 C.F.R. § 317.2(c)(3) & (g) (meat); 9 C.F.R. § 381.122 (poultry)] 

FSIS requires the labels of meat and poultry products to include 

the name or trade name and place of business of the manufacturer, packer, 

or distributor for whom the product is prepared. 147 The manufacturer or 

packer name may appear on the label without qualification. The name of the 

distributor, however, must be preceded by a phrase such as “Prepared for __” 

or “Distributed by __.” If the business is listed in a telephone or city 

directory, the information listed for the place of business must include the 

city, state, and postal ZIP code. Otherwise, it must also include the street 

address. 

X. HANDLING STATEMENTS

[9 C.F.R. § 317.2(k) (meat); 9 C.F.R. § 381.125(a) (poultry)] 

Packaged products that require special handling to maintain their 

wholesome condition must have prominently displayed on the principal 

display panel the applicable handling statement “Keep Refrigerated,” “Keep 

Frozen,” or “Perishable—Keep Refrigerated or Frozen.”148 The FSIS 

Administrator may also approve additional phrases of similar importance. 

- 50 - 
The statement “Keep Frozen” must appear on shipping containers for 

products that are distributed frozen and thawed prior to or during display for 

sale. Consumer-size containers holding such products must bear the 

statement “Previously Handled Frozen for Your Protection, Refreeze or Keep 

Refrigerated.” With respect to perishable canned products, this statement 

must appear in upper case letters, 1⁄4 inch in height, for containers with a net 

weight of 3 pounds or less, or 1⁄2 inch in height for containers with a net 

weight over 3 pounds. 

XI. SAFE HANDLING INSTRUCTIONS

[9 C.F.R. § 317.2(l) (meat); 9 C.F.R. § 381.125(b) (poultry)] 

Safe handling instructions are required if the meat or poultry 

component of a product is raw or partially cooked (i.e., not considered 

ready-to-eat (RTE)), and if the product is destined for household consumers or 

institutional uses. 149 Safe handling instructions may appear on products that 

are not ready-to-eat (RTE) but include a fully cooked meat or poultry portion. 

Safe handling instructions should not be used on RTE products. Meat and 

poultry products intended for further processing at another official 

establishment also are exempt from this requirement. Under the heading 

“Safe Handling Instructions,” the safe handling information must appear on 

the label as follows. 

This product was prepared from inspected and passed meat and or 

poultry. Some food products may contain bacteria that could cause illness 

if the product is mishandled or cooked improperly. For your protection, 

follow these safe handling instructions. 

- 51 - 
This statement is in turn accompanied by the following additional required 

statements. 

• Keep refrigerated or frozen. Thaw in refrigerator or microwave. (This 

statement must appear next to a graphic illustration of a refrigerator.) 

150 

• Keep raw meat and poultry separate from other foods. Wash working 

surfaces (including cutting boards), utensils, and hands after touching 

raw meat or poultry. (This statement must appear next to a graphic 

illustration of soapy hands under a faucet.) 

• Cook thoroughly. (This statement must appear next to a graphic 

illustration of a skillet.) 

• Keep hot foods hot. Refrigerate leftovers immediately or discard. (This 

statement must appear next to a graphic illustration of a thermometer.) 

These instructions must appear in lettering no less than 1/16 

inch in height and be placed on the label “prominently with such 

conspicuousness as to render it likely to be read and understood under 

customary conditions of purchase and use.” The heading must be set in type 

size larger than the rationale statement and instructions. All safe handling 

information must be set off by a border and appear in one color printed on 

contrasting background of a single color. 151 

FSIS permits changes to the first statement and icon if specific 

handling information on the product conflicts with the safe handling 

instructions. For example, if the label of a frozen product states, “Do not 

thaw product, cook from frozen,” or “Do not thaw,” the first part of the safe 

handling statement may be changed to “Keep Frozen.” If a product is shelf 

stable and states, “No refrigeration necessary,” or “Refrigerate after opening,” 

- 52 - 
the icon of the refrigerator and the entire statement about refrigeration can be 

eliminated. 

XII. NUTRITION LABELING

A. Mandatory Nutrition Labeling - General Requirements

In 1994, USDA adopted sweeping new regulations mandating that 

most foods bear nutrition labeling. Nutrition labeling now is required for all 

meat and poultry products intended for human consumption and offered for 

sale, except single-ingredient, raw products and other exempt products. 

Exempt products include products produced by small businesses, products 

intended for further processing, products not for sale to consumers, products 

prepared and sold at retail, and products in small packages (individually 

wrapped packages of less than 1⁄2 ounce net weight). 152 These exemptions are 

discussed more fully below, but it is important to note that with these 

exemptions, a nutrition claim, or any other nutrition information provided on 

the label or in labeling or advertising in any context and in any form, negates 

the exemptions and triggers the mandatory nutrition labeling requirements. 

The exemptions for certain other products, such as products intended for 

export and custom-slaughtered products, are not negated by nutrition 

claims. 153 

Generally, nutrition information must appear on the label of meat 

and poultry products. Gift packs may display nutrition information at a place 

other than on a product label, such as product label inserts, provided the 

label bears no nutrition claim. 154 Meat and poultry products in packages 

- 53 - 
having a total surface area greater than 40 square inches, but lacking 

sufficient space on the principal display panel and information panel for all 

required information, may use an alternate panel that customers could 

readily see. 155 

A product’s nutrients are declared on its label. Certain nutrients 

must be declared, while others may be declared voluntarily. 156 The order in 

which certain nutrients must be declared, as well as certain definitions and 

requirements, are set forth below (the voluntary nutrients are identified as 

such). 157 

• Total Calories. 

• Calories from Fat. 

• Calories from Saturated Fat (voluntary). 

• Total Fat. Total fat is defined as the total lipid fatty acids and is 

expressed as triglycerides. 

• Saturated Fat. Saturated fat is defined as the sum of all fatty acids 

containing no double bonds. 

• Trans Fat (voluntary).

• Stearic Acid (voluntary). 

• Polyunsaturated Fat (voluntary). Polyunsaturated fat is defined as the 

cis, cis-methylene-interrupted polyunsaturated fatty acids. 

• Monounsaturated Fat (voluntary). Monounsaturated fat is defined as 

the cis-monounsaturated fatty acids. 

• Cholesterol.

• Sodium. 

• Potassium (voluntary). 

- 54 - 
• Total Carbohydrate. Total carbohydrate is determined by subtracting 

the sum of the crude protein, total fat, moisture, and ash from the total 

weight of the product. 

• Dietary Fiber. 

• Soluble Fiber (voluntary). 

• Insoluble Fiber (voluntary). 

• Sugars. Sugars are defined as the sum of all free mono- and 

disaccharides (such as glucose, fructose, lactose, and sucrose). 

• Sugar Alcohol (voluntary). Sugar alcohol is defined as the sum of 

saccharide derivatives in which a hydroxyl group replaces a ketone or 

aldehyde group and whose use in the food is listed by FDA. 

• Other Carbohydrate (voluntary). Other carbohydrate is defined as the 

difference between total carbohydrate and the sum of dietary fiber, 

sugars, and sugar alcohol, except that if sugar alcohol is not declared 

(even if present) other carbohydrates is defined as the difference 

between total carbohydrate and the sum of dietary fiber and sugars. 

• Protein. A statement of the number of grams of protein must be 

declared. Ordinarily it is not necessary to declare the percent of daily 

value of protein unless a protein claim is made for the product, or if the 

product is intended for children under 4 or infants. When the protein 

digestibility-corrected amino acid score (PDCAAS) of the food is less 

than 20 (for adults and children greater than 4,) or less than 40 (for 

children between 1 and 4,) either of the following shall be placed next to 

the protein content: (1) “not a significant source of protein,” or (2) a 

listing of the corrected amount of protein, expressed as percent of daily 

value. 

• Vitamin A, Vitamin C, Calcium, and Iron. The percent of daily value 

must be declared for vitamin A, vitamin C, calcium, and iron, in that 

order, and any other vitamin or mineral for which a claim is made, 

provided FDA has established a recommended daily intake (RDI) for 

such vitamin and mineral. 

• Vitamins and Minerals (voluntary). The declaration of the percent of 

daily value of other vitamins and minerals is voluntary if the vitamins 

and minerals are required for use in a standardized food that is used as 

an ingredient in another food or included solely for technological 

purposes. (The listing of other vitamins and minerals that may be 

- 55 - 
declared in the nutrition facts panel can be found in Section F of this 

part) 

Generally, nutrient information must be presented using the 

nutrient names in the regulation, except “sugar alcohol” which may be 

declared by its specific name (e.g., xylitol) when there is only one sugar 

alcohol in the food. Detailed requirements are set forth specifying when each 

mandatory or voluntary nutrient must be declared. For example, nutrients 

whose declaration is usually voluntary must be declared when a claim is 

made about the nutrient. 158 

With the exception of the core nutrients (calories, total fat, 

sodium, total carbohydrate, and protein), nutrients that are present in 

insignificant amounts may be omitted from the list of nutrients and grouped 

in a summary statement (e.g., “Not a significant source of ___”.) The level of a 

nutrient that can be declared as (rounded to) zero is specified. The 

regulations also state the analytical methods for measurement of each 

nutrient. 159 

B. Full Format

Nutrition information must be presented in a specified format and 

type size. 160 The order in which the nutrition information appears, and the 

headings that must be used, also are specified in regulations. 161 The 

quantitative amount of each nutrient must be declared, except for vitamins 

and minerals, which are expressed as a percent of daily value. 162 The 

percent of the Daily Reference Value (DRV), under the heading “% Daily 

- 56 - 
Value,” must be declared for total fat, saturated fat, cholesterol, sodium, 

potassium (if declared), total carbohydrate, and dietary fiber. The percent of 

daily value must be calculated and declared in the increments specified in the 

regulation. 163 

Typically, the nutrition panel also must contain a footnote, 

preceded by an asterisk that states: “Percent Daily Values are based on a 

2,000 calorie diet. Your daily value may be higher or lower depending on your 

calorie needs.” 164 Additionally, the footnote must list the recommended daily 

values for the macronutrients on the basis of a 2,000 and 2,500 calorie diet. 

Calorie conversion information on a per gram basis may follow the footnote 

(e.g., “Calories per gram: fat 9, carbohydrate 4, protein 4”.) 165 

Variations in the presentation of nutrition information are 

permitted under certain circumstances. For example, nutrition information 

may be presented for two or more forms of the food (e.g., “as purchased” and 

“as prepared”) per ounce” and “per 100 grams;”) The regulatory requirements 

for dual declarations must be followed. The primary column is the food as 

packaged. 166 

Additionally, meat products that contain two or more products in 

the same package or packages that are used interchangeably for the same 

type of product may use an aggregate display, specifying the identity of each 

food next to the nutrition information.167 This same format may be used to 

display information for two or more forms of the same product (e.g., raw and 

cooked.) 168

- 57 - 
C. Simplified Format

A simplified format for nutrition information is permitted when a 

meat product contains “insignificant” amounts of any required nutrient other 

than core nutrients (calories, total fat, sodium, total carbohydrate, and 

protein.) 169 

An “insignificant amount” of a nutrient is defined as that amount 

that may be rounded to zero in nutrition labeling, except that for total 

carbohydrate, dietary fiber, sugars, and protein, it is an amount that can be 

declared as less than 1 gram. 170 

The simplified format must include: 

(1) Total calories, total fat, total carbohydrate, protein, and sodium; 

and 

(2) Calories from fat, as well as any of the mandatory nutrients that 

are present in the food in more than insignificant amounts. 

If any required nutrient, other than a core nutrient, is present in 

an insignificant amount, it may be omitted from the tabular listing, provided 

the nutrition label includes the statement “Not a significant source of ____,” 

(with the blank filled in with the mandatory nutrients that are present in 

insignificant amounts). Otherwise, this statement is not necessary. 171 

The simplified nutrient information must be presented in 

essentially the same manner as required for the general format. The 

simplified format must also contain the statement, “Percent Daily Values are 

based on a 2,000 calorie diet,” and, if the term “Daily Value” is not spelled 

out, a statement that “DV” represents “Daily Value.” 

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D. Tabular Format

Packages with 40 square inches or less of available surface area 

may use a tabular label format. Extremely small labels that cannot 

accommodate the standard vertical column or tabular format may display the 

required nutrition information in a linear format specifically outlined by 

USDA. The use of this linear format is approved on a case-by-case basis. 

Because the linear format is very hard to read, companies must demonstrate 

that inability to fit the tabular format on the label. 172 Packages having 40 

square inches or less of available labeling space may also use approved 

abbreviations as part of the nutrition facts panel. Below is a listing of the 

authorized abbreviations: 

Serving size- Serv size

Servings per container- Servings

Calories from fat- Fat cal

Calories from saturated fat- Sat fat cal

Saturated fat- Sat fat

Monounsaturated fat- Monounsat fat

Polyunsaturated fat- Polyunsat fat

Cholesterol- Cholest

Total carbohydrate- Total carb

Dietary fiber- Fiber

Soluble fiber- Sol fiber

Insoluble fiber- Insol fiber

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Sugar alcohol- Sugar alc

Other carbohydrate- Other carb 173

E. Compliance Requirements Governing Nutrition Labeling

In calculating and presenting nutrition information, 

manufacturers must follow the compliance rules established by USDA. 

Methods for analyses are provided in the Agency’s “Chemistry Laboratory 

Guidebook.” If no USDA method is available or appropriate for a nutrient, the 

1990 edition of the “Official Methods of Analysis,” published by the AOAC 

International, should be followed. 174 

F. Reference Daily Intakes and Daily Reference Values

The label declaration of percent daily value of vitamins and 

minerals will be based on the following Recommended Daily Intake (RDI’s): 175 

• Vitamin A, 5,000 international units 

• Vitamin C, 60 milligrams 

• Calcium, 1.0 grams 

• Iron, 18 milligrams 

• Vitamin D, 400 international units 

• Vitamin E, 30 international units 

• Vitamin K, 80 micrograms 

• Thiamin, 1.5 milligrams 

• Riboflavin, 1.7 milligrams 

• Niacin, 20 milligrams 

• Vitamin B6, 2.0 milligrams 

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• Folate acid, 0.4 milligrams 

• Vitamin B12, 6 micrograms 

• Biotin, 0.3 milligrams 

• Pantothenic acid, 10 milligrams 

• Phosphorus, 1.0 gram 

• Iodine, 150 micrograms 

• Magnesium, 400 milligrams 

• Zinc, 15 milligrams 

• Copper, 2 milligrams 

The following Recommended Daily Intake (RDI) from the FDA 

regulations would also be permitted on a voluntary basis on USDA food 

products: 

• Selenium, 70 micrograms 

• Manganese, 2.0 milligrams 

• Chromium, 120 micrograms 

• Molybdenum, 75 micrograms 

• Chloride, 3,400 milligrams 

Immediately following the name of a nutrient or dietary 

component, the following synonyms may be used parenthetically: 

• Calories—Energy 

• Vitamin C—Ascorbic Acid 

• Thiamin—Vitamin B1 

• Riboflavin—Vitamin B2 

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• Folate—Folic acid or Folacin (Alternatively, folic acid or folacin may 

be listed without parentheses in place of folate.) 

The label declaration of percent daily value of the following food 

components is based on the following Daily Recommended Value (DRV)’s: 

• Fat, 65 grams 

• Saturated fatty acids, 20 grams 

• Cholesterol, 300 milligrams 

• Total carbohydrate, 300 grams 

• Fiber, 25 grams 

• Sodium, 2,400 milligrams 

• Potassium, 3,500 milligrams 

• Protein, 50 grams 

G. Exemptions from Mandatory Nutrition Labeling

As discussed above, the regulations either exempt certain foods 

from the mandatory nutrition labeling requirements or subject other foods to 

special labeling requirements. Generally, these exemptions only apply when a 

product’s label and advertising make no nutrition claims and contain no 

nutrition information. The exemptions and the special labeling requirements, 

when applicable, are identified below. 176 

• Small Business. A company employing 500 or fewer people, specific 

products produced at 100,000 pounds of product per year or less 

qualifies for the exemption. All product based on the same formula is 

counted toward the 100,000-pound limit. For example, a business 

making pork sausage would aggregate the weight of its bulk, link, and 

patty products. Businesses may calculate the amount of pounds 

produced by averaging the most recent two years of production. 

• Products Intended for Further Processing. 

• Products Not for Sale to Consumers. For example, a free sauce packet 

included with egg rolls does not require nutrition labeling. This packet, 

however, may not be included in the product’s net weight. If the sauce 

packet is either included in the net weight or not free, nutrition labeling 

is required. 

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• Individually-Wrapped Small Packages. Individually-wrapped packages 

of less than 1⁄2 ounce net weight are exempt. 

• Products Custom Slaughtered or Prepared. 

• Products Intended for Export Only. 

• Certain Products Prepared and Sold or Served at Retail: 

o Ready-to-eat products packaged or portioned at retail 

o Multi-ingredient products (e.g., sausage) processed at retail 

• Restaurant Menus. 

• Foods for Infants and Children. Foods for children less than 2 years of 

age must bear nutrition labeling, except that the following nutrients 

may not be declared: calories from fat, calories from saturated fat, 

saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, 

and cholesterol. Foods represented or purported to be for infants and 

children less than four years of age must bear nutrition labeling, except 

that such information shall not include the percent of Daily Value (DV) 

and the footnote information. Nutrient names and quantitative 

amounts by weight must be presented in separate columns. 

• Small Packages. Foods in packages that have a total surface area 

available for labeling of less than 12 square inches are exempt, but the 

label must contain an address or telephone number that may be used 

to obtain the required nutrition information (e.g., “For nutrition 

information, call 1-800-123-4567”). When nutrition labeling is 

provided, either voluntarily or because of nutrition claims, all required 

information must meet certain size requirements. 

H. Voluntary Nutrition Labeling 

The nutrition labeling of single-ingredient, raw meat and poultry 

products is voluntary at this time. When voluntary nutrition labeling 

guidelines apply, a retailer or manufacturer must follow the mandatory 

nutrition labeling program with a few exceptions. Nutrition labeling may be 

declared “as consumed” or “as packaged,” and the number of servings per 

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container need not be included. The simplified labeling format also may be 

used. 

When a retailer provides nutrition information at the point-ofpurchase (e.g., signs or brochures), the listing of percent daily values of 

nutrients and required footnotes may be omitted, and formatting 

requirements do not apply. If a nutrition claim is made, however, all 

mandatory requirements apply. 

“Significant participation” in the voluntary nutrition labeling 

program is required; otherwise, the products under the voluntary nutrition 

labeling guidelines will become mandatory. A retailer is considered to be 

participating at a “significant” level if it provides appropriate nutrition 

information for at least 90 percent of the major cuts of single-ingredient, raw 

meat and poultry it sells. “Significant participation” is evaluated every 2 

years. Since participation in the voluntary nutrition labeling program was 

determined to be “not-significant” in 1996 and 1999, FSIS proposed 

mandatory nutrition labeling for products in the voluntary program. 

I. Serving Sizes

This section provides an overview of FSIS regulations concerning 

serving sizes, followed by a more detailed description of specific regulatory 

requirements such as how serving sizes are expressed on a product label. 

This section will also address reference amounts customarily consumed 

(RACC) per eating occasion and the conversion of RACC to labeled serving 

sizes (depending on the type and size of the product) and the exceptions to 

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these requirements. A summary of the procedures for determining the 

number of servings per container is also made available. 

1. General Requirements

For the purpose of nutrition labeling, nutrients and food 

components must be declared based on a serving of a food. “Serving size” is 

defined as the amount of food customarily consumed per eating occasion, 

expressed in an appropriate common household measure. 177 The serving 

size is based on the established RACC for the particular food. 

Conversion from reference amount to serving size depends upon 

the nature of the product. For all meat and poultry products, the declaration 

of nutrient- and food-component content should be based on the product “as 

packaged,” except single-ingredient, raw product may be declared “as 

consumed.” There are two exceptions to raw, multi-ingredient products 

declaring nutrition information on the “as purchased” basis. FSIS has 

determined that for bacon products with a cook shrink of at least 60 percent 

and pork sausage type products with a cook shrink of at least 24 percent, the 

nutrition information may be declared on the “as cooked” basis only, since the 

nutrition information on the “as packaged” basis will not be useful to the 

consumer because the nutrient profile changes dramatically upon cooking. 

Cooking instructions must be included on the labeling of the bacon- and pork 

sausage-type products. All products may be declared in a second column “as 

consumed” if preparation and cooking instructions are clearly stated. 

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2. Common Household Measure

The serving size must be expressed in a “common household 

measure” which is defined as a cup, tablespoon, teaspoon, piece, slice, 

fraction (e.g., 1⁄4 pizza), ounce, or other common household equipment used to 

package food products (e.g., jar, tray.) The regulation lists in order of 

preference the measure that is suitable for the individual food: (1) cups, 

tablespoons, or teaspoons should be used whenever possible; (2) units such 

as piece, slice, tray, jar, and fractions of a whole (most appropriate for 

products such as pizza or quiche) are used when cup, tablespoon or teaspoon 

measurements are not applicable; and if neither of the prior two options are 

appropriate; (3) ounces, which must be expressed in 0.5-ounce 

increments. 178 Rounding should be indicated by the use of the term, 

“about.”179 Permitted abbreviations are specified by regulation.180

The common household measure should be followed by the metric 

quantity in parenthesis (e.g., “2 slice [50 grams]”,) except for single-serving 

containers. If a manufacturer voluntarily provides the metric weight for a 

single-serving product in the net-weight declaration, the serving-size 

declaration need not include the metric conversion (e.g., “serving size 1 

package.”) However, if the metric weight is included in both the net-weight 

and the serving-size declaration, they must be identical. 

For single-serving products and meal-type products (e.g., can, 

box, package, meal, or dinner,) a description of the individual container or 

package should be used. For other products in discrete units (e.g., chop, 

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slice, link, patty,) a description of the individual unit should be used. For 

unprepared products used to prepare large discrete, units (e.g., pizza kit,) a 

fraction or a portion should be used.181 When no other unit is applicable, the 

serving size is described in ounces. FSIS also permits ounce declarations for 

serving size for products in units like chicken breasts, pork chops, etc., if the 

individual units vary by more than 100% by weight. For example, when 

chicken breasts weigh between 3 ounces and 6 ounces, companies are 

permitted to label the product by ounces as opposed to the piece. 

When a serving size, determined by the reference amount, falls 

exactly halfway between two servings sizes (e.g., 2.5 tbsp), the size should be 

rounded up to the next incremental size. 182 All gram and milliliter 

quantities equivalent to the household measure should be rounded to the 

nearest whole number, except quantities less than 5 g (mL). Quantities 

between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL), and 

quantities less than 2 g (mL) should be expressed in 0.1 g (mL) 

increments. 183 

3. Reference Amounts Customarily Consumed (RACC) Per 

Eating Occasion

The reference amounts reflect the amount of food customarily 

consumed per eating occasion and are based on the edible portion of food and 

on the major intended use of the food. There are alternate reference amounts 

for food intended for infants or children under 4 years old. 184 FSIS has 

approved the use of the following ready-to-serve RACCs listed below that are 

not codified in the regulation: 

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• Appetizers (e.g., Meat (or poultry) hors d’oeuvers, mini eggrolls, mini 

pizza rolls, bagel pizza) - 85 grams RACC 

• Beans with meat (or poultry), plain or in sauce - 130 grams for beans in 

sauce or canned in liquid and refried beans prepared; 90 grams for 

others prepared; 35 grams dry RACC 

• Meat hot dog (or poultry hot dog) chili sauce – 2 tbsp RACC 

• Paste for garnishing - 15 grams RACC 

• Stuffed cherry peppers - 30 grams RACC 

• Vegetables, sauce, and bacon bits (or poultry bacon bits) - 110 grams 

RACC 

• Rendered poultry fat – 1 tbsp RACC 

The reference amount of a product that requires cooking or the 

addition of water or other ingredients is the amount required to prepare one 

reference amount of the final product. The reference amount for products 

that represent two or more foods packaged and presented to be consumed 

together (e.g., lunch meat with cheese and crackers) is typically the sum of 

the proportional reference amounts for each individual food in the package, 

provided the reference amount for the combination product is not specifically 

listed. 

Reference amounts must be used to determine whether a product 

meets the criteria for nutrient content claims and health claims. Reference 

amounts may be established or amended by submitting a petition to FSIS. 

The petition requirements are specified by regulation. 185 

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4. Converting Reference Amounts Customarily Consumed 

(RACCs) to Labeled Serving Sizes

a. Products in discrete units 

The serving size for products in discrete units (e.g., hot dogs, sliced 

luncheon meats) and products consisting of two or more foods packaged to be 

consumed together (e.g., beef fritters and barbeque sauce) generally is the 

number of whole units that most closely approximates the reference amount 

for the product category. If a unit weighs 67 percent or more, but less than 

200 percent, of the reference amount, the serving size shall be one unit. If a 

unit weighs more than 50 percent, but less than 67 percent, of the reference 

amount, the manufacturer may declare one or two units as the serving size. If 

a unit weighs 200 percent or more of the reference amount, the manufacturer 

may declare the whole unit as one serving only if it can reasonably be 

consumed at a single eating occasion.186

The serving size for products in large, discrete units that are 

usually divided for consumption (e.g., pizza, quiche) is the fractional slice of the 

food that most closely approximates the reference amount for the product 

category. The fractions are 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that 

can be divisible by 2 or 3. For packages used to prepare the large, discrete unit 

(e.g., pizza kits), the serving size may be the fraction of the package used to 

make the reference amount of the large, discrete unit.187

For assortments of meat or meat food products (e.g., variety 

packs), nutrient content may be expressed for the entire package or individual 

products. 

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b. Bulk products 

The serving size for bulk products (e.g., whole roast beef, whole 

chicken, large cans of chili, Individually Quick Frozen (IQF) chicken, vegetable 

pasta, and sauce products) and products consisting of two or more foods 

packaged to be consumed together (e.g., roast beef and potatoes) is the amount 

in household measure that most closely approximates the reference amount for 

the product category. For “mixed dishes measurable by the cup” sold as IQF 

products, the serving size is the amount of frozen product it takes to make 1 

cup of the ready-to-serve product. This amount of frozen product is usually 

slightly larger than the 1 cup, ready-to-serve serving size since the product 

compacts when cooked. 

c. Meal-type products 

The serving size for meal products that come in single-serving 

containers is the entire content (“edible portion only”) of the package. The 

serving sizes for meal products that do not have RACCs are based on the RACC 

of the main ingredients and a portion of the other ingredients. For example if a 

meal consisted of a beef roast, gravy, and a separate package of potatoes, the 

company would base the serving size on 3 ounces of beef with the gravy and 

potato component proportioned evenly among the number of servings of the 

beef. Meal products do not base serving size on the sum of reference amounts. 

Additionally, FSIS has permitted companies to label multiple-serve meal 

products as a “meal for X” and a serving size of “1/x of package.” 

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For a package containing two or more foods packaged and 

presented to be consumed together where the main ingredient is presented in 

discrete units (e.g., chicken fritters and corn), the serving size is the number of 

discrete units of the main ingredient, plus proportioned minor ingredients used 

to make the reference amount. 

A package containing several varieties of single-serving units, or a 

product having two or more compartments containing different foods, must 

provide nutrition information for each variety of food per serving size that is 

based on the reference amount for each food category. For single-serving 

containers, the serving size must be one unit. 

A product that is packaged and sold individually (i.e., singleserving containers) and that contains less than 200 percent of the reference 

amount, must be labeled as one serving. Products that have reference 

amounts of 100 grams (or 100 milliliters) or larger may declare the number of 

servings as either one or two when the package contains more than 150 

percent but less than 200 percent of the reference amount. Packages sold 

individually that contain 200 percent or more of the reference amount may be 

declared as one serving if the entire package reasonably can be consumed in 

one eating occasion 188. 

d. Exceptions 

There are four specified exceptions to the rules for converting 

reference amount to serving size: weight control products, meal products, 

variety packages, and single-serving containers. For products intended for 

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weight control and available only through a weight control program, a serving 

size may be selected by the manufacturer that is consistent with the meal plan 

of the program. Such products must bear a statement, “for sale only through 

the underlying____________program (fill in the blank with the name of the 

appropriate weight control program,) (e.g., “Smith’s Weight Control”.) 

5. Servings Per Container

Detailed procedures are established for determining the number of 

servings per container, including the increments in which the serving should 

be declared and procedures for rounding. The number of servings should be 

rounded to the nearest whole number, except the number of servings between 

2 and 5 servings should be rounded to the nearest 0.5 serving. Rounding 

should always be indicated by “about.” 189

Random weight products may be declared as “varied” provided the 

nutrition information is based on the reference amount expressed in ounces. 

When the serving size is required to be expressed on a drained solids basis and 

the number of servings vary because of natural variations in unit size (e.g., 

pickled pigs feet,) the manufacturer may state the typical number of servings 

per container as “usually 5 servings.” 

The number of servings in packages containing single-serving 

containers should be the number of individual containers. For packages 

containing several multi-serving units, the number of servings is determined by 

multiplying the number of individual multi-serving units by the number of 

servings in each individual unit. 

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The nutrient- and food-component content should always be based 

on the product as packaged or purchased. Products packed in water, brine, or 

oil not customarily consumed, however, shall declare the content of the drained 

solids.190 If oil or broth is included in the net weight, nutrition information 

must be declared for both the oil and broth. Product that is sold “bone-in” 

must determine the average percentage of bone and deduct that amount when 

calculating the number of servings per container. 

Those products commonly combined with other ingredients or 

otherwise prepared before consumption may declare nutrient contents on the 

basis of the product alone or “as-consumed,” provided that the type and 

quantity of the ingredients to be added and the specific method of preparation 

is specified. For example, a cream soup mix may be labeled with one set of 

Daily Values for the dry mix (per serving) and another set for the soup when 

prepared. 191

XIII. NUTRIENT CONTENT CLAIMS GENERALLY

A. General Requirements

1. Basic Principles Claims

A food label may not bear an express or implied claim that 

characterizes the level of a nutrient in a food (nutrient content claim) unless 

the term has been defined by regulations. 192 An express nutrient content 

claim is considered to be “any direct statement about the level (or range) of a 

nutrient in the food” (e.g., “low sodium”.) An implied nutrient content claim 

includes any claim that describes the food or an ingredient therein in a 

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manner that suggests that a nutrient is absent or present in a certain amount 

(e.g., “high in oat bran” or “only 6 grams of fat”,) or suggests that the food, 

because of its nutrient content, may be useful in maintaining healthy dietary 

practices and is made in association with an explicit claim or statement about 

a nutrient (e.g., “healthy, contains 3 grams of fat”.) A manufacturer must 

comply with the nutrient content claim regulations if a label claim statement 

constitutes an express or implied claim. If a product label bears a nutrient 

content claim, nutrition labeling is required even if the product would 

otherwise be exempt. 

The RACCs are the basis for determining the serving size of foods 

and are used in determining whether a product meets the criteria for a nutrient 

content claim, unless otherwise specified. Claims may not be based on the 

level of a nutrient present in the declared serving size. If the declared serving 

size differs from the applicable reference amount and the product does not 

qualify for the claim based on the stated serving size, the claim must be 

followed by the criteria for the claim. In addition, the panel must include a 

statement referring the consumer to the nutrition label for information about 

the nutrient that is the subject of the claim (e.g., “very low sodium, 35 mg or 

less per 55 grams”.) The criteria for the claim must be immediately adjacent to 

the most prominent claim in legible print and in a size no less than that 

required for net weight. 193 

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2. Various General Requirements

The regulations for the nutrition labeling of meat and poultry 

products describe several general labeling requirements pertaining to nutrient 

content claims. For example, information provided as part of the nutrition 

panel is not considered a nutrient content claim. However, if this information 

is stated elsewhere on the label (e.g., on the principal display panel,) it could 

be considered an implied claim and regulated as such. 194 

FSIS regulations also define what constitutes a “substitute” food.

195 A “substitute” food is one that may be used interchangeably with 

another food that it resembles (i.e., to which it is organoleptically, physically, 

and functionally similar,) and to which it is not nutritionally inferior. 

Products that are intended to be “substitute foods,” but are nutritionally 

inferior, must be labeled as an imitation food. The regulations provide further 

guidance concerning this definition. What constitutes a “substitute food” is 

relevant to many of the defined claims. 

Foods that qualify for a “low” claim, or labels that represent that a 

nutrient is absent, without the benefit of special processing, alteration, 

formulation, or reformulation, must bear a qualifying statement immediately 

accompanying the claim (e.g., “lard, a sodium-free food”.) In addition, FSIS 

takes the position that “free” or “low” before the name of a food implies that a 

food is lower in the particular nutrient than other foods of the same type. 

Therefore, only if a food has been specially processed, altered, formulated, or 

reformulated to produce a lower amount of the particular nutrient may it bear 

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a “free” or “low” claim preceding the product name (e.g., “low sodium beef 

noodle soup”.) 196 

Placement and prominence requirements are specified for 

nutrient content claims. The type size and style of a nutrient content claim 

may be no larger than two times that of the statement of identity of the food 

for which the claim is made. The regulations setting forth the specific 

definitions for each of the claims explained below include detailed placement 

and prominence requirements. Labeling information required to accompany 

certain nutrient content claim, whose type size is not specified by regulation, 

is required to be no less than 1/16 in height.197 

3. Numeric and Percent Declarations

A statement about the amount or percentage of a nutrient that 

implicitly characterizes the level of a nutrient is permitted if the food qualifies 

for a defined claim (e.g., “less than 10 grams of fat per serving”.) 198 If the 

food bearing the factual claim does not qualify for an applicable claim for the 

nutrient that is the subject of the factual statement, it must be accompanied 

by a disclaimer adjacent to the statement that the food is not low in, or a good 

source of, the nutrient for which the claim is made (e.g., only contains 200 

milligrams of sodium per serving, not a low sodium food.) This requirement is 

intended to avoid a misleading impression that, for example, a food that 

contains “less than 300 calories” is a low calorie food. The regulations specify 

prominence and placement requirements for the disclaimer statement. 

Finally, a factual statement that does not implicitly characterize the level of a 

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nutrient and is not false or misleading is permitted and no disclaimer is 

required (e.g., “100 calories” or “5 grams of fat”.) Percent fat free claims are 

addressed separately and are explained below. 199 

4. Relative Claims -- General Requirements

Relative claims are those statements that compare the level of a 

nutrient in a food to the level of a nutrient in an appropriate reference food. 

Relative claims include: “light,” “reduced,” “less” (or “fewer”,) and “more.” This 

section of the Guide discusses the basic requirements applicable to all relative 

claims. Later sections of the Guide that address each of the specific claim’s 

definitions do not repeat these general requirements. 200 

a. Appropriate Reference Food 

FSIS regulations governing the use of reference foods must be 

followed. 201 Generally, for relative claims “less,” “fewer,” and “more,” the 

reference food may be a similar product or a dissimilar product. For “light,” 

“reduced,” and “added” claims, the reference product should be a similar 

product. 202 

b. Information that Must Accompany a Relative Claim 

The following explanatory information must accompany a relative 

claim: 

• identity of the reference food and the percentage (or a fraction) of the 

amount of the nutrient in the reference food by which the nutrient has 

been modified (e.g., 50 percent less fat than (reference food) or 1/3 

fewer calories than (reference food)); and 

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• a clear and concise quantitative information statement comparing the 

amount of the subject nutrient in the product per labeled serving with 

that in the reference food must appear adjacent to the most prominent 

claim or on the information panel contiguous to the nutrition panel 

(e.g., fat reduced from 10 g to 5 g or calories reduced from 200 to 120.) 

A relative claim describing a reduction in the level of a nutrient (e.g., “light,” 

“less”) is not permitted if the nutrient content of the reference food qualifies as 

“low” for that nutrient. This restriction is intended to avoid use of the claim 

to highlight trivial reductions in the level of a nutrient. 

Use of the term “modified” is separately defined. 203 A “modified” 

claim may be used in the statement of identity (i.e., the product name) of a 

food that bears a relative claim (e.g., “reduced”), if followed immediately by the 

name of the nutrient whose content has been altered (e.g., “modified fat 

product”.) The statement of identity must be accompanied by a comparative 

statement such as “contains 35% less than ____,” and provide the explanatory 

information required for relative claims, as explained above. 204 

5. Claims for Main Dish and Meal-Type Products are Defined 

Separately

[9 C.F.R. § 317.313(l)&(m) (meat); 9 C.F.R. § 381.413(l) &(m) 

(poultry)] 

For the purpose of making a nutrient content claim, a “main dish 

product” must do the following: 205 

• make a significant contribution to the diet by weighing at least 6 ounces 

per labeled serving; 

• contain at least two 40-gram portions of food, or combinations of foods, 

from two or more of the following four food groups: (1) bread, cereal, 

rice and pasta; (2) fruits and vegetables; (3) milk, yogurt and cheese; 

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and (4) meat, poultry, fish, dry beans, eggs and nuts; excluding most 

sauces, as well as gravies, condiments, relishes, pickles, olives, jams, 

jellies, syrups, breadings, or garnishes; and 

• be represented as, or is in a form of a “main dish” (e.g., not a beverage 

or dessert.) 

For the purpose of making a nutrient content claim, a “meal-type 

product” must do the following: 206 

• make a significant contribution to the diet by weighing at least 10 

ounces per labeled serving; 

• contain at least three 40-gram portions of food, or combinations of 

foods, from two or more of the following four food groups: (1) bread, 

cereal, rice and pasta; (2) fruits and vegetables; (3) milk, yogurt and 

cheese; and (4) meat, poultry, fish, dry beans, eggs and nuts; excluding 

most sauces, as well as gravies, condiments, relishes, pickles, olives, 

jams, jellies, syrups, breadings, or garnishes; and 

• be represented as, or is in a form commonly understood to be, a 

breakfast, lunch, dinner, meal, or entrée. 

6. Exemptions

Claims contained in the brand name of a product in use before 

November 27, 1991, that have not been defined are exempt from these 

specific regulatory restrictions, provided the brand name is not otherwise 

deemed false or misleading. 207 An exempt brand name must still comply 

with the requirements pertaining to the prominence of a claim, the referral 

statement, and disclosure of nutrients in the referral statement. An implied 

nutrient content claim may otherwise be part of a brand name if the claim 

has been authorized by FSIS. Claims that are part of a product name by 

virtue of a standard of identity, as of November 27, 1991, are not subject to 

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the nutrient content regulations, nor would the name be deemed an implied 

claim or subject to the referral statement or disclosure requirements. 

Apart from brand names, a statement that describes the 

percentage of a vitamin or mineral in the food in relation to a Recommended 

Daily Intake (RDI) level, unless the claim is specifically prohibited, is exempt 

from the nutrient content claims regulations. 208 

B. Specific Nutrient Content Claims

1. “High,” “Good Source” and “More” Claims

[9 C.F.R. 317.354 (meat) and 9 C.F.R. 381.454 (poultry)] 

A claim made about the level of a nutrient in a food in relation to 

the Recommended Daily Intake (RDI) or Daily Recommended Value (DRV) 

(excluding total carbohydrate) may only be made if the claim is defined within 

this section of the Guide. Therefore, claims may only be stated using the 

terms specified by the regulation. 209 

a. “High” Claims 

The terms “high,” “rich in,” or “excellent source of” may be used if 

the claimed nutrient is present in the individual food at 20 percent or more of 

the RDI or the DRV per reference amount customarily consumed (RACC). 

Main dish and meal products would qualify for this claim if the 20 percent 

level is reached and the label identifies the food component that is the subject 

of the claim (e.g., “the serving of broccoli in this product is high in vitamin 

C”.) 210 

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b. “Good Source” Claims 

The terms “good source,” “contains,” or “provides” may be used if 

the claimed nutrient is present in the individual food between 10 to 19 

percent of the RDI or DRV per RACC. Main dish and meal products would 

qualify for this claim if the 10 to 19 percent level is reached and the label 

identifies the food component that is the subject of the claim. 211 

c. “More” Claims 

The comparative claim “more” may be used to describe the level of 

protein, vitamins, minerals, dietary fiber, or potassium present in an individual 

food if the claimed nutrient is present in the food at 10 percent more of the 

applicable RDI or DRV per RACC as compared to an appropriate reference food. 

The explanatory information required for relative claims (explained above) must 

accompany the claim. 212 

A “more” or similar claim may describe a main dish or meal 

product if the food contains at least 10 percent more of the applicable RDI or 

DRV than an appropriate reference food, per 100 grams. The other 

requirements stated with respect to an individual food similarly apply to the 

claim when made for a main dish or meal product. 213

2. “Light” and “Lite” Claims

[9 C.F.R. 317.356 (meat) and 9 C.F.R. 381.456 (poultry)] 

The terms “light” and “lite” may be used without further 

qualification. If a product derives 50 percent or more of its calories from fat, 

its fat content must be reduced by 50 percent or more per RACC as compared 

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to an appropriate reference food. If a product derives less than 50 percent of 

its calories from fat, the number of calories must be reduced by at least onethird per RACC or its fat content must be reduced by 50 percent or more 

compared to an appropriate reference product. 

As required with other relative claims, the identity of the reference 

product must be clearly declared, and quantitative information comparing the 

fat and calorie content of the product must be prominent. A “light” or “lite” 

claim may not be made on a product that meets the definition of “low fat” or 

“low calorie.” 

The terms “light” and “lite” may be used on a main dish or mealtype product if the product qualifies for the “low calorie” or “low fat” claims 

and if a statement on the product’s PDP explains the meaning of the claim. 214

3. “Sodium” and “Salt” Claims 

a. “Sodium Free” Claims 

The terms “sodium free,” “free of sodium,” “no sodium,” “zero 

sodium,” “without sodium,” “trivial source of sodium,” “negligible source of 

sodium,” or “dietary insignificant source of sodium” may be used if the 

individual food contains less than 5 milligrams of sodium per reference 

amount (or in the case of a main dish or meal product less than 5 milligrams 

of sodium per labeled serving size). In addition, the food may not contain any 

ingredient that is sodium chloride or is generally understood by consumers to 

contain sodium unless the ingredient, as declared in the ingredients 

statement, is accompanied by an asterisk that refers consumers to the 

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statement, “adds a trivial amount of sodium,” or a similar specified statement. 

If the food meets these conditions without the benefit of special processing, it 

must include an appropriate qualifying statement (e.g., “leaf lettuce, a sodium 

free food”.) 215 

b. “Very Low Sodium” Claims 

The terms “very low sodium” or “very low in sodium” may be used 

if the individual food has an RACC that contains 35 milligrams or less per 

RACC (and per 50 grams if it is a small-serving size food). If the food qualifies 

for this claim without the benefit of special processing, an appropriate 

qualifying statement must accompany the claim (e.g., “potatoes, a very low 

sodium food”.) 216 

For a main dish or meal product, the sodium content is measured 

per 100 grams. The requirements for an individual food are otherwise 

applicable. 217 

c. “Low Sodium” Claims 

The terms “low sodium,” “low in sodium,” “little sodium,” 

“contains a small amount of sodium,” or “low source of sodium” may be used 

if the individual food contains 140 milligrams or less sodium per RACC (and 

per 50 grams if it is a small-serving size food). Individual products with an 

RACC greater than 30 grams, or 2 tablespoons, and containing 140 mg or less 

sodium per RACC also qualify. 218 If the food qualifies for the claim without 

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the benefit of special processing, an appropriate qualifying statement must 

accompany the claim (e.g., “spinach, a low sodium food”.) 219 

For main dish and meal products, the food would qualify for this 

sodium claim if it contained 140 milligrams or less sodium per 100 grams. 

d. “Reduced Sodium” Claims 

The terms “reduced sodium,” “reduced in sodium,” “sodium 

reduced,” “less sodium,” “lower sodium,” or “lower in sodium” may be used if 

the individual food contains at least a 25 percent reduction in sodium as 

compared to an appropriate reference food. The claim must be accompanied 

by explanatory information required for relative claims.220

For main dish and meal products, the 25 percent reduction in 

sodium is measured per 100 grams as compared to an appropriate reference 

food. The requirements for an individual food are otherwise applicable. No 

food may bear a “reduced sodium” claim if the reference food qualifies for a 

“low sodium” claim. 

e. “Salt” Claims 

“Salt” is not considered synonymous with “sodium.” References 

to salt content, such as “unsalted,” “no salt,” or “no salt added,” are deemed 

potentially misleading and subject to regulation. The term “salt free” may 

only be used if the food is “sodium free”. In addition, the terms “unsalted,” 

“without added salt,” and “no salt added” may be used for a food only if: 

(1) no salt is added during processing; (2) the food that it resembles and for 

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which it substitutes is normally processed with salt; and, (3) if it is not 

“sodium free,” the statement “not a sodium free food” is declared contiguous 

to the nutrition information on the information panel. 221 

4. “Nutrient Content” Claims for Fat, Fatty Acids and 

Cholesterol Content

[9 C.F.R. 317.362 (meat) and 9 C.F.R. 381.462 (poultry)] 

a. “Fat Content” Claims 

(1) “Fat Free” Claims 

The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” 

“nonfat,” “trivial source of fat,” “negligible source of fat,” or “dietaryily 

insignificant source of fat” may be used if the food contains less than 0.5 

grams of fat per RACC or in the case of a main dish or meal product less than 

0.5 grams of fat per labeled serving. In addition, the food may not contain 

any added ingredient that is a fat or is generally understood by consumers to 

contain fat unless the ingredient, as declared in the ingredients statement, is 

accompanied by an asterisk that refers consumers to the statement, “adds a 

trivial amount of fat,” or similar specified statement. If the food meets these 

conditions without the benefit of special processing, it must include an 

appropriate qualifying statement (e.g. “broccoli, a fat free food”). 222 

(2) “Low Fat” Claims 

The terms “low fat,” “low in fat,” “contains a small amount of fat,” 

“low source of fat,” or “little fat” may be used if the individual food contains 3 

grams or less of fat per RACC, and per 50 grams if it is a small serving size 

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food. If the food qualifies for the claim without the benefit of special 

processing, it must be accompanied by an appropriate qualifying statement. 

A main dish or meal must meet the 3 grams or fewer criterion per 

100 grams and not derive more than 30 percent of calories from fat. The 

requirements for an individual food are otherwise applicable. 223 

(3) “Reduced Fat” Claims 

The terms “reduced fat,” “reduced in fat,” “fat reduced,” “less fat,” 

“lower fat,” or “lower in fat” may be used if the individual food contains 25 

percent less fat than the appropriate reference food. The claim must be 

accompanied by the explanatory information required for relative claims. 

For main dish and meal products, the 25 percent reduction in the 

fat is measured per 100 grams as compared to an appropriate reference food. 

The requirements for an individual food are otherwise applicable. No food 

may bear a “reduced fat” claim if the reference food qualifies for a “low fat” 

claim.224

(4) “Percent Fat-Free” Claims 

A “percent fat-free” or “percent lean” claim is restricted to products 

that qualify as “low fat.” The percent reduction and the words “fat free” must 

be in uniform type size. Separately, a “100 percent fat-free” claim may only be 

made on foods that meet the criteria for “fat-free,” contain less than 0.5 grams 

of fat per 100 grams, and contain no added fat. A synonym for “percent fat 

free” is “percent lean.”225

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b. “Fatty Acid Content” Claims 

Manufacturers must disclose the level of total fat and cholesterol 

in immediate proximity to a saturated fat content claim. Placement and 

prominence requirements are specified. Declaration of cholesterol content 

may be omitted if the food contains less than two milligrams of cholesterol per 

RACC (or per labeled serving for main dish and meal products), and fat 

content may be omitted if fat is present at 0.5 grams or less per reference 

amount (or per labeled serving for main dish and meal products). The 

declaration of total fat may also be omitted if the food qualifies for a “low fat” 

claim. In addition to these general requirements, the regulation sets forth 

detailed requirements for specific claims that are permitted.226

(1) “Saturated Fat-Free” Claims 

The terms “saturated fat-free,” “free of saturated fat,” “no 

saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of 

saturated fat,” “negligible source of saturated fat,” or “dietary insignificant 

source of saturated fat” may be used if the food contains less than 0.5 grams 

of saturated fat and less than 0.5 grams trans fatty acid per RACC (or in the 

case of a main dish or meal product less than 0.5 grams of saturated fat and 

less than 0.5 grams trans fatty acid per labeled serving size). 227 

In addition, the food may not contain any ingredient that is a 

saturated fat or is generally understood by consumers to contain saturated 

fat unless the ingredient, as declared in the ingredients statement, is 

accompanied by an asterisk that refers consumers to the statement, “adds a 

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trivial amount of saturated fat,” or similar specified statement. If the food 

meets these conditions without the benefit of special processing, it must 

include an appropriate qualifying statement. 

(2) “Low In Saturated Fat” Claims 

The terms “low in saturated fat,” “low saturated fat,” “contains a 

small amount of saturated fat,” “low source of saturated fat,” or “a little 

saturated fat” may be used if the individual food contains 1 gram or less of 

saturated fatty acids per RACC and not more than 15 percent of calories from 

saturated fatty acids. If the food qualifies for the claim without the benefit of 

special processing, it must be accompanied by an appropriate qualifying 

statement, which clearly refers to all food of its type and not merely to the 

particular food to which the label is attached.228

For a main dish or meal product, the food must contain 1 gram or 

less of saturated fat and fewer than 10 percent calories from saturated fat, 

measured per 100 grams. The requirements for an individual food are 

otherwise applicable. 229 

(3) “Reduced Saturated Fat” Claims 

The terms “reduced saturated fat,” “reduced in saturated fat,” 

“saturated fat reduced,” “less saturated fat,” “lower saturated fat,” or “lower in 

saturated fat” may be used if the individual food contains 25 percent less 

saturated fat per RACC than an appropriate reference food. The explanatory 

information required for relative claims must accompany the claim.230

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For a main dish or meal product, the food must contain 25 

percent less saturated fat per 100 grams than an appropriate reference food. 

The requirements for an individual food are otherwise applicable. A food 

cannot be labeled with a “reduced saturated fat” claim if the reference food 

qualifies for a “low saturated fat” claim. 

c. “Cholesterol Content” Claims 

(1) “Cholesterol Free” Claims 

 

The terms “cholesterol free,” “free of cholesterol,” “zero 

cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of 

cholesterol,” “negligible source of cholesterol,” or “dietary insignificant source 

of cholesterol” may be used if: 

• the individual food contains 2 milligrams or less of cholesterol per 

reference amount (or in the case of a main dish or meal product per 

labeled serving size); 

• the food contains no ingredient generally understood by consumers 

to contain cholesterol, unless the ingredient, as declared in the 

ingredients statement, is accompanied by an asterisk which refers 

consumers to the statement, “adds a trivial amount of cholesterol,” 

or similar specified statement; 

• the food contains 2 grams or less of saturated fat per 

reference amount (or for a main dish or meal product 

per labeled serving); and 

• the food qualifies for the claim without the benefit of special 

processing, it must include an appropriate qualifying statement. 

A main dish or meal product may generally bear a “cholesterol

free” claim if it meets the requirements set forth above for individual foods, 

- 89 - 
but the 2 milligrams cholesterol and 2 grams saturated fat criteria are 

measured per 100 grams, rather than per reference amount. 231 

(2) “Low in Cholesterol” Claims 

The terms “low in cholesterol,” “low cholesterol,” “contains a small 

amount of cholesterol,” “low source of cholesterol,” or “little cholesterol,” may 

be used to describe food that does not exceed the applicable disclosure level 

for total fat if the food: 

• has a RACC greater than 30 g or greater than 2 tbsp; 

• contains 20 milligrams or less of cholesterol per reference amount 

and per 50 grams if it is a small-serving size food; 

• contains 2 grams or less of saturated fat per reference amount; and 

• qualifies for the claim without the benefit of special processing, it 

must include an appropriate qualifying statement. 

A main dish or meal product may generally bear a “low 

cholesterol” claim if it meets the requirements set forth above for individual 

foods, but the 20 milligrams cholesterol and 2 grams saturated fat criteria are 

measured per 100 grams, rather than per reference amount. 232 

(3) “Reduced Cholesterol” Claims 

The terms “reduced cholesterol,” “reduced in cholesterol,” 

“cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in 

cholesterol” may be used if the food: 

• has been specially formulated, altered or processed to reduce its 

cholesterol content by at least 25 percent from the reference food it 

replaces and for which it substitutes if the reference food has a 

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significant market share (i.e., 5 percent or more of a national or regional 

market); 

• contains 2 grams or less of saturated fat per reference amount; and 

• is accompanied by information required for relative claims. 

The placement and prominence requirements for the fat content 

statement are specified. A “reduced cholesterol” claim is not permitted for 

any food if the reference food qualifies for a “low cholesterol” claim. 

The “reduced cholesterol” claim also may be used on main dish or 

meal products if the product has been specifically formulated to reduce 

cholesterol by 25 percent, or if the main dish or meal contains 2 grams or less 

of saturated fat per 100 grams of product. 233 The identity of the reference 

product and the percent that the cholesterol has been reduced must be 

declared in immediate proximity to the “reduced cholesterol” claim. 234 

d. “Lean” and “Extra Lean” Claims 

The term “lean” may be used to describe an individual food as 

packaged when it contains less than 10 grams of fat, 4.5 grams or less of 

saturated fat, and less than 95 milligrams of cholesterol per reference amount 

and per 100 grams. For a main dish or meal to qualify as “lean,” it must meet 

these specified levels for fat, saturated fat, and cholesterol per 100 grams and 

per labeled serving. 

The term “extra lean” may be used to describe products that 

contain less than 5 grams of total fat, less than 2 grams of saturated fat, and 

less than 95 milligrams of cholesterol per reference amount and per 100 

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grams. For main dish or meal products, these levels apply per 100 grams and 

per labeled serving size. 235 

5. “Fiber” Claims

A claim that represents the level of dietary fiber in a food is 

permitted if the level of the nutrient would qualify for a claim (i.e., “high,” 

“more,” or “good source”.) If the food is not low in total fat, the label must 

disclose the level of total fat per labeled serving (e.g., “contains 12 grams (g) of 

total fat per serving”.) This statement must appear in immediate proximity to 

the claim. 236 

6. “Healthy” Claims

The term “healthy” or any other derivative of the term “health” may 

be used to describe an individual food provided the food (1) meets the 

requirements for “low fat” and “low saturated fat;” (2) does not contain more 

than 60 milligrams of cholesterol per RACC and labeled serving size (per 50 

grams if the RACC is less than 30 grams); (3) does not contain more than 480 

milligrams of sodium per RACC and labeled serving size (per 50 grams if the 

RACC is less than 50 grams); and (4) contains 10 percent or more of RDI or 

DRV per reference for one of the following: vitamin A, vitamin C, iron, calcium, 

protein, or fiber. Single-ingredient, raw foods need not meet the sodium 

requirement, and instead of meeting the fat and cholesterol requirements, 

single-ingredient, raw foods may meet the total fat, saturated fat, and 

cholesterol criteria for “extra lean.” 237 

A “healthy” main dish or meal must meet the requirements for low 

- 92 - 
fat and low saturated fat requirements for main dish and meal-type products 

(i.e., 3 grams or less of total fat per 100 grams of product and not more than 30 

percent of the calories from fat, and 1 gram or less of saturated fat per 100 

grams of product and less than 10 percent of the calories from saturated fat.) 

Main dish and meal-type products that weigh less than 12 ounces per serving 

(container) cannot contain more than 60 milligrams of cholesterol per labeled 

serving while main dish and meal-type products weighing more than 12 ounces 

per serving (container) may contain no more than 90 milligrams of cholesterol 

per labeled serving. Additionally, main dish and meal-type products may 

contain up to 600 milligrams of sodium. Main dish products weighing 6 to10 

ounces per serving need only meet the RDI or DRV level for two of the listed 

nutrients, and meal-type products weighing 10 or more ounces need only meet 

the level for three of the nutrients. 238 

7. Claims Related to Usefulness in Reducing or Maintaining 

Body Weight 

Any food that purports to be or is represented for special dietary 

use because of usefulness in reducing or maintaining body weight shall bear 

(1) nutrition labeling, unless exempt, and (2) a conspicuous statement of the 

basis upon which the food claims to be of special dietary usefulness. If the 

food achieves its special dietary usefulness by use of a non-nutritive 

ingredient (i.e., one not utilized in normal metabolism), the label must contain 

a statement that discloses the non-nutritive ingredient and its percentage by 

weight, except if such ingredient is a non-nutritive sweetener, in which case 

the percentage by weight does not have to be declared. 239 If a nutritive 

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sweetener, as well as a nonnutritive sweetener is added, the presence of both 

must be declared. 

Foods purporting to be “low calorie,” “reduced calorie,” or 

otherwise containing fewer calories than a reference food must comply with the 

nutrient content claim regulations. Except as provided below, a food may be 

labeled with terms such as “diet,” “dietetic,” “artificially sweetened,” or 

“sweetened with non-nutritive sweetener” only if the claim is not false and 

misleading and the food is labeled “low calorie” or “reduced calorie” or bears 

another comparative claim according to the nutrient content claim regulations. 

The exemptions to the previous requirement include (1) the use of a term that 

is specifically authorized by regulation governing a particular food, or, unless 

otherwise restricted by regulation, to any use of the term “diet” that clearly 

shows that the food is offered solely for dietary use other than regulating body 

weight (e.g., for low sodium diets); and (2) the use of a term on a formulated 

meal replacement or other food that is represented to be of special dietary use 

as a whole meal.240 

8. “Health” Claims

A “health” claim describes a relationship between a food and a 

disease or health-related condition. FSIS has not issued regulations 

providing for the use of a “health” claim. Many such claims have been 

authorized for use by FDA on labeling of food products subject to its 

jurisdiction. FSIS will consider on a case-by-case basis the use of an FDAregulated “health” claim or such a “health” claim in conjunction with a 

- 94 - 
third-party certification program. An example is the American Heart 

Association’s heart-check mark, which maintains its own criteria for 

eligibility and includes a “health” claim in conjunction with its certifying 

mark (e.g., “Meets American Heart Association food criteria for saturated fat 

and cholesterol for healthy people over age 2. While many factors affect 

heart disease, diets low in saturated fat and cholesterol may reduce the risk 

of this disease.”) 

9. “Calorie Content” Claims 

a. “Calorie Content” Claims 

(1) “Calorie Free” Claims 

The terms “calorie free,” “free of calories,” “no calories,” “zero 

calories,” “without calories,” “trivial source of calories,” “negligible source of 

calories,” or “dietary insignificant source of calories” may be used if the 

individual food contains less than 5 calories per reference amount. If the food 

meets the requirements without the benefit of special processing, the claim 

may be accompanied by a statement such as, “a low calorie food” (e.g., cider 

vinegar, a calorie free food.) 241 

(2) “Low Calorie” Claims 

The terms “low calorie,” “few calories,” “contains a small amount 

of calories,” “low source of calories,” or “low in calories” may be used if the 

individual food contains no more than 40 calories per reference amount 

(except for sugar substitutes) and per 50 grams for dehydrated products, etc., 

if it is a small-serving-size food. A small–serving-size food is a food with a 

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reference amount of 30 grams or less or 2 tablespoons or less (“small serving 

size food”). If the food qualifies for the claim without the benefit of special 

processing, it must be labeled to clearly refer to all products of its type and 

not merely the particular brand to which the label attaches (e.g., “celery, a low 

calorie food”.) 

The requirements for a “low calorie” main dish or meal product are 

similar. That is, these products must contain 120 calories or less per 100 

grams and meet the other requirements specified above for individual foods. 242 

(3) “Reduced Calorie” Claims 

The terms “reduced calorie,” “reduced in calories,” “calories 

reduced,” “fewer calories,” “lower calorie,” or “lower in calories” may be used if 

an individual food contains at least 25 percent fewer calories per RACC as 

compared to an appropriate reference food. The claim must be accompanied by 

explanatory information required for relative claims. For a main dish or meal 

product, the 25 percent reduction in calories is measured per 100 grams as 

compared to an appropriate reference food. The requirements for an individual 

food are otherwise applicable. The claim is not permitted for any food if the 

reference food meets the definition of “low calorie.” 243 

b. “Sugar Content” Claims 

(1) “Sugar Free” Claims 

The terms “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” 

“without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of 

- 96 - 
sugar,” or “dietary insignificant source of sugar” may be used if the food 

contains less than 0.5 grams of sugar per RACC (or in the case of a main dish 

or meal product per labeled serving.) In addition, the food may not contain 

any ingredient that is a sugar or is generally understood by consumers to 

contain sugars or sweeteners unless the ingredient, as declared in the 

ingredients statement, is accompanied by an asterisk that refers consumers 

to the statement, “Adds a trivial amount of sugar,” or a similar specified 

statement. The food must be labeled “low calorie” or “reduced calorie” or bear 

a relative claim of special dietary usefulness, or the “sugar free” claim must 

be accompanied by the statement, “not a low calorie food,” or a similar 

specified statement. 244 

(2) “No Added Sugar” Claims 

The terms “no added sugar,” “without added sugar,” and “no 

sugar added” may be used only if: 

• no amount of sugars, or any other ingredient that contains sugar that 

functionally substitutes for added sugars, is added during processing or 

packaging; 

• the product does not contain an ingredient containing added sugars, 

such as jam, jelly, or concentrated fruit juices; 

• the sugar content has not been increased by the amount present in the 

ingredients by the use of enzymes or similar means, except where the 

intended functional effect of the process is not to increase the sugar 

content of a food, and a functionally-insignificant increase in sugars 

results; and 

• the food that it resembles and for which it substitutes normally 

contains added sugars. 

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• In addition, if the food does not qualify as “low calorie,” a statement 

must direct the consumers’ attention to the nutrition panel for further 

information on sugar and calorie content. 

The requirements governing “sugar free” claims are not applicable 

to a factual statement that a food is unsweetened, or contains no added 

sweeteners in the case of a food that contains apparent substantial inherent 

sugar content (e.g., juices). 245 

(3) “Reduced Sugar” Claims 

The terms “reduced sugar,” “reduced in sugar,” “sugar reduced,” 

“less sugar,” “lower sugar,” or “lower in sugar” may be used if the sugar 

content in the individual food is reduced by 25 percent per RACC as 

compared to an appropriate reference food. The claim must be accompanied 

by the explanatory information required for relative claims. For main dish 

and meal products, the 25 percent reduction in sugars is measured per 100 

grams as compared to an appropriate reference food. The requirements for an 

individual food are otherwise applicable. 246 

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Appendix A 

Egg Products Labeling 

I. Egg Products Labeling 

Egg product labels bearing official USDA identification markers 

must be approved and comply with all applicable regulations. There are seven 

requirements for egg products labeling: product name; manufacturer’s name; 

official identification; USDA approval number; ingredients statement; net 

weight statement; and nutrition information. 

a. Product Name 

Eggs are defined as the “shell egg” of the domesticated chicken, 

turkey, duck, goose, or guinea. Egg products are any dried, frozen, or liquid 

eggs, with or without added ingredients. 247 All egg product labels must 

include the name and state of the product, (e.g., dried, frozen, liquid, or whole 

egg, egg yolks, egg whites,) and must appear in print size similar to the most 

prominent printing on the label. In addition, a trade name may be used in 

conjunction with the product identity. 

Products formulated from eggs that do not meet the applicable 

definitions must be identified by an appropriately descriptive name that is not 

false or misleading. Food products containing eggs in relatively small 

proportions or which historically have not been considered to be egg products 

may not be labeled as an egg product (e.g., omelet mix, egg nog mix, noodles, 

cake mixes). 248 These products, along with “imitation” egg products are 

eligible for identification with the USDA inspection legend only under the 

voluntary egg products inspection program. 249

Whole Eggs 

Liquid or frozen whole eggs are eggs of domestic hens broken 

from the shells with the yolks and whites in their natural proportion. 250 A 

combination of whites and yolks in other than natural proportions, such as 

“accidentally broken” whole eggs, may be identified as whole eggs provided the 

egg solids content is standardized to 24.2% or greater. 251 Whole eggs may be 

mixed, or mixed and strained, and must be pasteurized or otherwise treated to 

destroy all viable Salmonella micro-organisms. 

Dried eggs (or dried whole eggs) or frozen eggs are prepared 

by drying or freezing liquid eggs with such precautions that the finished food is 

free of viable Salmonella micro-organisms. If the glucose content of the eggs 

was reduced during the drying process, the statements “Glucose removed for 

stability “or” Stabilized, glucose removed” must immediately follow the product 

name. 252

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Egg Yolks 

Egg yolks, liquid egg yolks, yolks, and liquid yolks are yolks 

of eggs of the domestic hen so separated from the whites thereof as to contain 

not less than 43 percent total egg solids. 253 Egg yolks may be mixed, or mixed 

and strained, and must be pasteurized or otherwise treated to destroy all viable 

Salmonella micro-organisms. Egg yolks may be dried or frozen according to 

applicable regulations. 

Dried egg yolks (or dried yolks) or frozen egg yolks are 

prepared by either drying or freezing egg yolks with such precautions so that 

the finished food is free of viable Salmonella micro-organisms. Similar label 

statements for glucose removal must be included if necessary. 

Egg Whites 

Egg whites, liquid egg whites, or liquid egg albumen is the 

food obtained from eggs of domestic hens, broken from the shells and 

separated from the yolks. 254 Egg whites may be mixed, or mixed and strained, 

and must be pasteurized or otherwise treated to destroy all viable Salmonella

micro-organisms. Any optional use of ingredients such as whipping aids must 

be named on the PDP or panels of labels prominently and conspicuously so 

ordinary individuals under customary conditions of purchase are likely to 

understand them. 255 Egg whites may be dried or frozen according to 

applicable regulations. 

If egg whites are dried, the product name may be “dried egg 

whites,” “egg white solids,” “dried egg albumen,” or “egg albumen solids.” If 

the lysozyme and avidin content of the product is reduced during the drying 

process, the product name must be immediately preceded or followed by the 

statement “lysozyme and avidin reduced.” 256 When dried eggs are used in 

another fabricated food product, these statements do not need to follow the 

product name. 

b. Manufacturer’s Name 

Under the Fair Packaging and Labeling Act, the name and place of 

business of the manufacturer, packer, or distributor must be included on the 

PDP. 257/ The statement of the place of business must include the street 

address, city, state and zip code; however, the street address may be omitted if 

it is shown in a current city directory or telephone directory. 258/ 

c. Official Identification 

The U.S. Department of Agriculture maintains inspections of all 

official plants and the processing of egg products under the authority of the 

Egg Products Inspection Act. 259/ Each official egg processing plant granted 

- 100 - 
inspection services is assigned an official plant number. 260/ A shield 

containing the letters “USDA” is the official identification symbol, and when it 

is used in connection with an egg product, it constitutes a representation that 

the product has been officially inspected. Egg products that bear the 

inspection mark must be processed in an official plant from edible shell eggs or 

other edible egg products. 261/ Plants may not have more than one plant 

number. 

The official shield must be printed on the PDP of the label using 

the design and wording shown below. 

The plant number may be printed within the shield or elsewhere 

on the container. 262/ When the plant number is not printed within the 

shield, the letter “P” or the word “Plant” must precede it. When the official 

shield is used on more than one label panel, it must be identically printed for 

each use. If a label does not bear all mandatory labeling information, it may 

not bear the official shield. 

In addition, all shell eggs packaged for consumers must be labeled 

to indicate that refrigeration is required, (e.g., “Keep Refrigerated”,) or words of 

similar meaning. 263

d. USDA Approval Number

Labels for use on egg products must be preapproved. A separate 

label approval number containing one letter and a three-digit number (e.g., 

M001) is assigned to each label that has been approved. The assigned USDA 

approval number must be printed within a rectangular box and needs to be no 

larger than the smallest printing on the label. Labels identifying imported egg 

products will contain a two-letter prefix, (e.g., CN001) and labels approved for 

identification of products for export only will have a one-letter code. 

Self-adhesive strip labels may be used without approval; in 

conjunction with previously-approved printed labels provided the strip label 

does not cover any required labeling information showing the packer or 

- 101 - 
distributor’s name and address; the product identity for whole eggs, egg yolks, 

or egg whites; or the state of the product. 

duction of egg 

products. Each of the ingredients used in egg products must be declared on 

the label as required by 21 C.F.R. Parts 101 and 130. Ingredients must be 

 or frozen egg 

products. The percentage of water added must be declared on the label in the 

ingredients statement in descending order of proportion by weight and shown 

gredient is used, the label must 

bear the statement, “Not more than 1 percent silicon dioxide added as an 

anticaking a

ed 

t 

 the national office, the 

label must state that the additive has been added to color the product. This 

declaration may be made in the ingredients statement, (e.g., “annatto extract 

(artificial color)” or “colored with annatto extract.”) 267

e 

es 

 in the net weight statement. A dual declaration net weight 

statement is only required on retail packages containing less than 4 pounds. 

e. Ingredients Statement

Only food-grade ingredients may be used in the pro

listed in order of descending proportion by weight on the PDP. 

 When approved, potable water may be added as a carrier for 

certain ingredients and additives used in the formulation of liquid

as either “____% water” or “with ____% water as a carrier.” 264 

When optional ingredients, such as monosodium phosphate, are 

used as preservatives, the label must bear the statement “Monosodium 

phosphate (or monopotassium phosphate), with __ percent water as a carrier, 

added to preserve color.” 265 The blank must be filled in with the percent by 

weight of water used in proportion to the weight of the finished food. This 

optional ingredients statement must appear on the PDP or panels prominently 

and conspicuously. If an optional anticaking in

gent,” or “Less than 2 percent sodium silicoaluminate added as an 

anticaking agent,” whichever is applicable. 266

Color may not be added to whole eggs, egg yolks, egg whites, salt

or sugared whole eggs, and salted or sugared egg yolks. Any egg product tha

contains an additive which imparts color, including color additives certified as 

being natural, are considered to be artificially colored, and the product label 

must state that color has been added. If the color additive is derived from a 

natural source and a letter of certification is provided to

f. Net Weight Statement

Each egg product label must contain a net weight statement. Th

net weight statement must appear in the lower 30 percent of the label in lin

generally parallel to the base on which the package rests and must appear as a 

distinct item on the label. The statement must be separated from any other 

printing above, below, or to either side of it by a space at least equal to the 

height of the letters

- 102 - 
Regulations for the declaration of net quantity of contents can be found at 21 

C.F.R. § 101.105. 

must compl

rition labeling is required when nutrients, such as proteins, 

r information is presented on the labeling, except if a nutrient is included in 

the product solely for technological purposes. If a nutrient is included solely 

for technological purposes it may be declared solely in the ingredients 

statement. 269

g. Nutrition Information

Egg or egg product labels which may be distributed for retail sale 

y with FDA regulations governing nutrition labeling. 268 Egg 

products packaged for institutional use are not required to bear nutrition 

information, however, if a nutrient content or health claim is made, product 

labeling must comply with all nutrient content claim regulations. 

Nut

vitamins, and minerals are added to the product, or when a nutritional claim 

o

- 103 - 
End Notes

 

1 21 U.S.C. §§ 601 et seq. (meat); 21 U.S.C. §§ 451 et seq. (poultry). 

2 FSIS also regulates the labeling of egg products. These separate requirements are 

summarized at Appendix A of this Summary. 

3 A misbranded food bears false or misleading labeling, while an adulterated food contains a 

poisonous or deleterious substance or otherwise poses a risk to consumer health. See, 21 

U.S.C. §§ 453 and 601. 

4 21 U.S.C. § 601 et seq. 5 21 U.S.C. § 451 et seq. 6 21 U.S.C. § 601(o) and (p) (meat); 21 U.S.C. § 453(s) (poultry). 

7 21 U.S.C. § 607 (meat); 21 U.S.C. § 457 (poultry). 

8 21 U.S.C. § 601(n). 

9 21 U.S.C. § 453(h). 

10 See, e.g., 21 U.S.C. § 672-673 (meat); 21 U.S.C. § 467(a) – 467(b) (poultry). 11 21 U.S.C. § 671 (meat); 21 U.S.C. § 467 (poultry). 

12 21 U.S.C. § 301 et seq.

13 Id. § 343(a). 14 21 U.S.C. § 321(k). 

15 Id. § 321(m). Under the FFDCA a manufacturer can be sanctioned in several ways if it 

violates a labeling requirement. FDA may seek a court order preventing the production and 

sale of misbranded foods. Id. § 332. Misbranded foods may also be confiscated by the 

government. Id. § 334. Moreover persons violating the FFDCA can be imprisoned for selling or 

offering for sale misbranded foods. Id. § 333. 

16 15 U.S.C. § 1451 et seq. The FPLA establishes requirements for package labels of all 

consumer commodities, including most foods. It defines the package as “any container or 

wrapping in which any consumer commodity is enclosed for use in the delivery or display of 

that consumer commodity to retail purchasers.” Id. § 1459(b). 

17 21 U.S.C. § 607(d) (meat); 21 U.S.C. § 457(c) (poultry). USDA has similar authority over egg 

products under the EPIA, 21 U.S.C. §1036(b). 

18 Id. 19 9 C.F.R. Part 317 et seq. (meat); 9 C.F.R. § 381.115 et seq. (poultry). 

20 FDA has not taken the position adopted by USDA nor is it clear that the FFDCA or FPLA 

permit implementation of a preapproval system. 

21 21 U.S.C. § 601(j) (meat). 

22 “Meat,” “meat food product,” livestock,” “poultry,” and “poultry product” are defined by the 

FMIA and the PPIA (21 U.S.C. §§ 601 and 453), respectively, and the Federal meat and poultry 

inspection regulations (9 C.F.R. §§ 301.2 and 381.1, respectively) and do not include species of 

livestock or kinds of birds other than those specifically listed. 

23 Standards and Labeling Policy Book at “Amenability,” p.6 (meat); 9 C.F.R. § 381.15(a)(1) 

(poultry).

24 9 C.F.R. 381.15(a)(1)-(5). See regulation for complete listing of exempt poultry products. 

25 9 C.F.R. § 381.15(b). 

26 9 C.F.R. § 381.15(c). See also 9 C.F.R. § 381.15(d) (exception for fat capsules and 

sandwiches containing poultry products and/or specified conditions). 

27 See 9 C.F.R. § 381.15(e). 

28 21 U.S.C. § 607(c) (meat); 21 U.S.C. § 457(b) (poultry). 

29 Id. 30 21 U.S.C. §§ 348. 

31 21 U.S.C. § 601(m)(2); 21 U.S.C. § 453(g)(2). FSIS and FDA have established procedures for 

the joint review of ingredients that are not addressed in this Guide. See the FSIS website. 

32 See 9 C.F.R. Parts 310, 318, 319, and 381. FSIS regulations establish a general prohibition 

on the use in a meat or poultry product of any food ingredient that would render it adulterated 

- 104 - 
 

or misbranded, or which is not approved in Parts 424, 318, and 319 of the regulations, or "by 

the Administrator [of FSIS] in specific cases." The Section further provides that ingredients 

and sources of radiation listed or approved for use in meat and poultry products in 21 C.F.R. 

(i.e., FDA's regulations) will be listed for such use in FSIS's regulations "unless precluded from 

such use or further restricted in Parts 318 or 319 (pertaining to meat products), or Subparts O 

and P, of Part 381 (pertaining to poultry products). For example, a product standard might not 

permit the use in a particular product of an ingredient otherwise approved for use in meat or 

poultry. The Administrator may also list or approve for use in the new combined table of 

approved substances any such food ingredients or sources or radiation. 

33 [ADD ingredient references] 

34 15 U.S.C. § 52. 

35 15 U.S.C. § 45(a)(l). 

36 Fresh Grown Preserve Corp. v FTC, 125 F.2d 917 (2d Cir. 1942) (FTC has jurisdiction to 

prevent unfair competition by means of false labeling and misbranding, regardless of the kind 

of product). 

37 15 U.S.C. § 45. 

38 FTC’s deception and advertising substantiation policy statements have been adopted in 

Commission decisions, and are intended to guide manufacturers as to what level of 

substantiation is necessary to support a claim. See Deception Policy Statement, appended to 

Cliffdale Associates, Inc., 103 F.T.C 110, 174-184 (1983); Ad Substantiation Policy Statement, 

appended to Thompson Medical Co., 104 F.T.C. 648, 839-42 (1984), aff’d, 1986-1 Trade Cas. 

(CCH) ¶ 67,103 (D.C. Cir. 1986). [SBS Update cites]

39 For example, claims relating to health and safety concerns, such as claims about the 

healthfulness of a particular product, require a relatively high level of substantiation. See 

National Commission on Egg Nutrition, 89 FTC 89, 192 (1976), aff’d 570 F.2d 157 (7th Cir.), 

cert. denied, 439 U.S. 821 (1978); Thompson Medical Co., 104 FTC at 821. 

40 See Houbigant v. Federal Trade Commission, 139 F.2d 1019 (2d Cir. 1944), cert. denied, 323 

U.S. 763 (1944) (FDA does not have exclusive jurisdiction over false and misleading labeling); 

Fresh Grown Preserve Corp., 125 F.2d 917. [SBS Update cites] 41 15 U.S.C. §§ 52, 53(a). Upon violation of final cease and desist orders, FTC can seek: 

(1) consumer redress in the form of recession or reformation of contracts, refunds, or damages, 

15 U.S.C. § 57b(b); (2) civil penalties, 15 U.S.C. § 45(m); or (3) criminal penalties if a violation 

of section 12 was committed with intent to defraud or expose consumers to health and safety 

risks. 15 U.S.C. § 54(a). 

42 See Warner-Lambert Co. v. FTC, 562 F.2d 749 (D.C. Cir. 1977), cert. denied, 435 U.S. 950 

(1978). 

43 Under the Supremacy Clause of the U.S. Constitution, U.S. Const., Act VI cl. 2., federal laws 

and regulations are held to preempt state legislation in two circumstances. First, federal law is 

intended to preempt when a state legislates in a field that Congress intended to occupy. 

Second, when state and federal laws are in direct conflict, and compliance with both is 

impossible, federal law takes precedence. 

44 21 U.S.C. § 678 (meat); 21 U.S.C. § 467(e) (poultry). 

45 Rath Packaging Co., 430 U.S. 519 (1977). 

46 Id. See also American Meat Institute v. Pridgeon, 724 F.2d 45 (6th Cir. 1984) (state statute 

requiring posting of placards indicating product’s nonconformance with state ingredient 

standards held unconstitutional); Armour v. Ball, 468 F.2d 76 (6th Cir. 1972), cert. denied, 411 

U.S. 981 (1973) (marking, labeling, packaging, and ingredient requirements of FMIA preempt 

any state-imposed labeling requirements). 

47 Kraft Foods North America, Inc. v. Rockland County, (S.D.N.Y. Feb. 26, 2003) (Memorandum 

Order granting motion for summary judgment). An appeal of this decision was dismissed. 

48 As noted previously, labeling includes all labels or other written, printed, or graphic matter 

on or accompanying the article. 21 U.S.C. §§ 321(m), 601(o)(p), 453(s). See U.S. v. Jorgensen, 

144 F.3d 550, 558 (S.D. Cal. 1998)(brochures accompanying meat product are considered 

- 105 - 
 

labeling); see also Kordell v. United States, 335 U.S. 343 (1948); United States v. Sene X 

Eleemosynary Corporation, 479 F. Supp. 970, 979 (S.D. Fla. 1979) (neither physical 

attachment nor concurrent shipment of labeling is required to give FDA jurisdiction). 

49 See 9 C.F.R. § 317.2(a); 9 C.F.R. § 381.1(b). 

50 See 9 C.F.R. §§ 301.2 and 381.1(b) (definition of “immediate container”); 9 C.F.R. § 317.2 

(definition of “protective covering”); See also Policy Memo 090B (Directive 7220.1) and the Food 

Standards and Labeling Policy Book at 137 (“Protective Coverings, Poultry” entry). 

51 See, e.g., 9 C.F.R. § 316.10(b) (markings for smaller varieties of sausage); and 9 C.F.R. 

§ 327.14 (foreign meat cuts must bear “Product of (country of origin)”). 

52 “Sketch” labeling is a printer’s proof or equivalent, which clearly shows all labeling features, 

size, location and indication of final color. Sketch labels can be hand-drawn, computer 

generated or by other reasonable facsimile. 

53 FSIS Directive 7220.1 (including Policy Memorandum 114A (August 18, 1994)). 

54 At one time, raising claims relating to the absence of antibiotic drug residues were allowed 

by FSIS. Now, FSIS is requiring that the few remaining programs be phased out. See FSIS 

website for further information on regulation of animal production and related claims. 

55 9 C.F.R. § 317.4(a) (meat); 9 C.F.R. § 381.132(a), 9 C.F.R. § 320.14(b) (11)(meat); 9 C.F.R. § 

381.175(b)(6)

56 9 C.F.R. § 317.4(f) (meat); 9 C.F.R. § 381.132(f) (poultry). 

57 9 C.F.R. § 317.4(f)(2). 

58 Under the rule, FSIS will select samples of generically-approved labeling from the records 

maintained by companies and institute appropriate action if false or misleading labeling is 

identified. 

59 9 C.F.R. § 317.5 (meat); 9 C.F.R. § 381.133 (poultry). 

60 9 C.F.R. § 317.2(b); 9 C.F.R. 381.115(b). 

61 9 C.F.R. § 317.2(d) (meat); 9 C.F.R. § 381.116 (poultry). Various labeling rules specify 

particular prominence and placement requirements beyond this general requirement.

62 Such information may not be obscured by packaging or labeling design, vignettes, crowding, 

or lack of contrasting colors, which could be confusing and thus deemed misbranded under the 

labeling statutes. 9 C.F.R. 317.2 (meat); 9 C.F.R. § 381.116 (poultry). 

63 9 C.F.R. § 317.2 (meat); 9 C.F.R. § 381.116 (poultry). 

64 Id.

65 9 C.F.R. § 317.2 (meat); 9 C.F.R. §381.121 (poultry). 

66 See FSIS Directive 7220.1 (Policy Memorandum 87A) (September16, 1985)). 

67 9 C.F.R. § 381.171. 

68 21 U.S.C. § 601(n)(7) (meat); 21 U.S.C. § 453(h)(7) (poultry). 

69 9 C.F.R. § 319 et seq. (meat); 9 C.F.R. § 381.155 et seq. (poultry). FSIS follows notice and 

comment rulemaking procedures prescribed by the Administrative Procedure Act in 

promulgating these standards. 

70 21 U.S.C. § 601(n)(9) (meat); 21 U.S.C. § 453(h)(9) (poultry). 

71 Policy Memorandum 69 (March 23, 1984). Nutritional inferiority is defined consistent with 

the requirement of 21 C.F.R. § 101.3(e)(4) as any reduction in the content of an essential 

nutrient that is present at 2% or more of the U.S. RDI per serving of protein or any of the 

vitamins or minerals for which U.S. RDIs are established. 

72 9 C.F.R. § 317.2(j) (meat); 9 C.F.R. § 381.1(b) (misbranded) (iii). Note, meat pizza containing 

(misbranding) (iii) cheese substitutes must have a ratio of at least 1 part cheese, 9 parts cheese 

substitutes. Products not meeting this cheese ratio standard require additional qualification 

about the characterizing ingredients to be stated in the food label. See Policy Memorandum 1 

(May 6, 1980); Anthony J. Pizza v. Wisconsin Dept. of Agriculture, 676 F.2d 701 (1982) 

(unreported; Circuit Court upheld USDA cheese policy preempting inconsistent Wisconsin 

regulation). 

73 9 C.F.R. § 319.10(meat); 9 C.F.R. § 381.172(poultry). 

74 9 C.F.R. § 319.10(meat); 9 C.F.R. § 381.172(poultry). 

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75 9 C.F.R. § 319.10(meat); 9 C.F.R. § 381.172(poultry). 

76 9 C.F.R. § 317.8(b)(1). See also USDA Policy Memorandum 68 (February 9, 1984). 

77 9 C.F.R. § 317.8(b)(1). 

78 Id. There is a city named “El Paso,” but there is no city named “Old El Paso.” Accordingly, 

FSIS does not consider “Old El Paso” a geographically significant location. 

79 Policy Memorandum 68 (February 9, 1984). 

80 9 C.F.R. § 381.129(b)(2). 

81 9 C.F.R. § 327.14. 

82 Id. The immediate container must also bear the establishment number assigned by the 

foreign meat inspection agency. 

83 9 C.F.R. § 327.15. 

84 The official establishment or plant number may appear in one of the following locations: 

(1) inside or outside of the legend; (2) anywhere on the exterior of the container; or (3) off of the 

exterior when a statement identifies the location of the number. When the official inspection 

legend is off the exterior of the container, it may be properly located on the back of a paper 

label of a canned product, on a metal clip used to close casings or bags, or on other packaging 

or labeling material in the container when a statement of its location is printed contiguous to 

the official legend, such as, “EST no. on metal clip.” See 9 C.F.R. §317.2(1) (meat); 9 C.F.R. 

§ 381.123 (poultry). 

85 9 C.F.R. § 301.2 (12) (misbranded) (meat); 9 C.F.R. § 381.1(b)(misbranded)(xii) (poultry). 

86 9 C.F.R. § 312.2(b)(1) (meat); 9 C.F.R. § 381.123(b)(2) (poultry). 

87 9 C.F.R. § 317.2(b) (meat); 9 C.F.R. § 381.128 (poultry). 

88 9 C.F.R. § 381.96 (poultry). This requirement is unique to poultry. 

89 Id. 9 C.F.R. § 381.96 (poultry). 

90 9 C.F.R. § 317.2(h) (meat); 9 C.F.R. § 381.121(a) (poultry). 

91 9 C.F.R. § 317.2(h)(1) (meat); 9 C.F.R. § 381.121(c) (poultry). 

92 See 9 C.F.R. § 317.2(h)(4) (meat); 9 C.F.R. § 381.121(c)(5) (poultry). 

93 9 C.F.R. § 317.2(h)(2) (meat); 9 C.F.R. § 381.121(c)(6) (poultry). 

94 Rath Packing, 430 U.S. at 536. See also Kraft Foods, supra. 

95 9 C.F.R. § 317.2(h)(2) (meat); 9 C.F.R. § 381.121(b)(6) (poultry). 

96 Rath Packing, 430 U.S. at 524. See also Kraft Foods, supra. 

97 See e.g., Rath Packing, 430 U.S. at 526; Kraft Foods, supra; Cook Family Foods v. Voss, 781 

F. Supp. 1458, 1466 (C.D. Cal. 1991)(finding express preemption under the FMIA). 

98 9 C.F.R. § 317.2(h)(4) (meat); 9 C.F.R. § 381.121(c)(5) (poultry). 

99 9 C.F.R. § 317.2(h)(3) (meat); 9 C.F.R. § 381.121(c)(5) (poultry). 

100 9 C.F.R. § 317.2(h)(5) (meat); 9 C.F.R. § 381.121(c)(5) (poultry). 

101 Id. 102 See 9 C.F.R. § 317.2(h)(9), (12) (meat); 9 C.F.R. § 381.121(c)(8), (9) (poultry). 

103 9 C.F.R. § 317.2(h)(3) (meat); 9 C.F.R. § 381.121(c)(2) (poultry). 

104 Id. Broth is an example of when this type of net weight declaration would be employed. 

105 Id. 

106 9 C.F.R. § 317.2(h)(8) (meat); 9 C.F.R. § 381.121(c)(4) (poultry). 

107 Id. 108 9 C.F.R. § 317.2(h)(3) (meat); 9 C.F.R. § 381.121(c)(2) (poultry). 

109 9 C.F.R. § 317.2(h)(1) (meat); 9 C.F.R. § 381.121(c)(2) (poultry). 

110 9 C.F.R. § 317.2(h)(7) (meat); 9 C.F.R. § 381.121(c)(3)(vi) (poultry). 111 9 C.F.R. § 317.2(h)(6) (meat); 9 C.F.R. § 381.121(c)(3)(i)-(v) (poultry). 

112 9 C.F.R. § 317.2(h)(7) (meat); 9 C.F.R. § 381.121(c)(3)(vi) (poultry). 

113 Id. 114 Id. 

115 9 C.F.R. § 317.2(h)(9)(i) (meat); 9 C.F.R. § 381.121(c)(9)(i) (poultry). 

116 9 C.F.R. § 317.2(h)(9)(ii) (meat); 9 C.F.R. § 381.121(c)(9)(ii) (poultry). 

117 9 C.F.R. § 317.2(h)(9)(iii) (meat); 9 C.F.R. § 381.121(c)(9)(iii) (poultry). 

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118 9 C.F.R. § 317.2(h)(9) (iv) and (v). 

119 9 C.F.R. § 381.121(a). 

120 9 C.F.R. § 317.2(h)(12) (meat); 9 C.F.R. § 381.121(c)(8)(ii) (poultry). 

121 Id. 

122 See 9 C.F.R. § 317.2(c)(2) (meat); 9 C.F.R. § 381.118 (poultry). 

123 9 C.F.R. § 317.2(f) (meat); 9 C.F.R. § 381.118(a)(1) (poultry). 

124 See Standards and Labeling Policy Book. 

125 9 C.F.R. §317.2(f)(1)(vi)(A) (meat); 9 C.F.R. § 381.118(a)(2)(i) (poultry). 

126 9 C.F.R. § 317.2(f)(1)(v). 

127 9 C.F.R. § 381.118(f). 

128 FSIS Directive 7237.1. 

129 FSIS has adopted a range of standards for certain product categories but otherwise has few 

defined ingredient names. FDA’s regulations provide detailed criteria from which a common or 

usual name designation may be used. See 21 C.F.R. § 102.5. 

130 Policy Memorandum 72 (May 18, 1984). 

131 See 21 C.F.R. § 101.4. For example, dried whole eggs, frozen whole eggs, and liquid whole 

eggs may be declared as “eggs.” See also 9 C.F.R. § 317.2(f)(1)(ii) (corn syrup and corn starch 

solids deemed synonymous). 

132 21 U.S.C. § 343(k) (FDA); 21 U.S.C. § 601(n)(11) (meat); 21 U.S.C. § 453(h)(11) (poultry). 

133 FSIS, Consumer Labeling and Protection, “Proprietary Mixture Suppliers and Manufacturers 

Questions and Answers,” March 17, 1995 available on FSIS website. 

134 9 C.F.R. § 317.2(f)(1)(i) (meat); 9 C.F.R. § 381.118(c) (poultry). 

135 9 C.F.R. § 317.2(f) (1)(i)(B) (meat); 9 C.F.R. § 381.118(c)(2) (poultry). 

136 21 C.F.R. §§ 182.10, 184. 

137 9 C.F.R. § 317.2(j)(3) (meat); 9 C.F.R. § 381.119 (poultry). Any other permitted artificial 

flavoring must be identified as “artificial flavoring” in the ingredients statement. 9 C.F.R. 

§ 317.2(j)(4). 

138 9 C.F.R. § 317.2(j)(5)-(7). 

139 FSIS Directive 7237.1. 

140 Id. 141 9 C.F.R. § 317.2(j)(9) (meat); 9 C.F.R. § 381.119(b) (poultry). See also Policy Memorandum 

113 (June 24, 1988). 

142 9 C.F.R. § 317.2(j)(12) (meat); 9 C.F.R. § 381.120 (poultry). 

143 9 C.F.R. § 381.120. 144 21 C.F.R. 101.100(a)(3). 

145 21 C.F.R. § 101.100(a)(3). USDA follows the FDA regulation as a matter of policy. USDA’s 

treatment of incidental additives differs from that of FDA in one respect. In declaring sulfites 

that are sometimes considered incidental additives, when the total product contains less than 

10 ppm sulfites but a separable component contains more than 10 ppm, USDA requires that 

the sulfiting agent be declared in the ingredients statement. Policy Memorandum 094B 

(December 17, 1986). FDA provides that a sulfite is exempt from labeling as an incidental 

additive if it is less than 10 ppm only for the product as a whole. 21 C.F.R. § 101.100(a)(4). 

146 21 C.F.R. § 101.100(a)(4). 

147 9 C.F.R. § 317.2(c)(3) and (g) (meat); 9 C.F.R. § 381.122 (poultry). 

148 9 C.F.R. § 317.2(k) (meat); 9 C.F.R. § 381.125(a) (poultry). 

149 9 C.F.R. § 317.2(l) (meat); 9 C.F.R. § 381.125(b) (poultry). 

150 Any portion of this statement in conflict with the product’s specific handling instructions 

may be omitted. 

151 9 C.F.R. §§ 317.2(l) (meat); 9 C.F.R.§ 381.125(b) (poultry). 

152 9 C.F.R. § 317.400 (meat); 9 C.F.R. § 381.500 (poultry). 

153 9 C.F.R. § 317.400 (meat); 9 C.F.R. § 381.500 (poultry). 

154 9 C.F.R. § 317.302(b) (meat); 9 C.F.R. § 381.402(b) (poultry). 

155 9 C.F.R. § 317.302(c) (meat); 9 C.F.R. § 381.402(c) (poultry). 

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156 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

157 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

158 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

159 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

160 9 C.F.R. § 317.309(d) (meat); 9 C.F.R. § 381.409(d) (poultry). 

161 9 C.F.R. § 317.309(d) (meat); 9 C.F.R. § 381.409(d) (poultry). 

162 9 C.F.R. § 317.309(d)(7) (meat); 9 C.F.R. § 381.409(d)(7) (poultry). 

163 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

164 9 C.F.R. § 317.309(d)(9) (meat); 9 C.F.R. § 381.409(d)(9) (poultry). 

165 9 C.F.R. § 317.309(d)(10) (meat); 9 C.F.R. § 381.409(d)(10) (poultry). 

166 9 C.F.R. § 317.309(e) (meat); 9 C.F.R. § 381.409(e) (poultry). 

167 9 C.F.R. § 317.309(d)(13) (meat); 9 C.F.R. § 381.409(d)(13) (poultry). 

168 9 C.F.R. § 317.309(e) (meat); 9 C.F.R. § 381.409(e) (poultry). 

169 9 C.F.R. § 317.309(f) (meat); 9 C.F.R. § 381.409(f) (poultry). 

170 9 C.F.R. § 317.309(f) (meat); 9 C.F.R. § 381.409(f) (poultry). 

171 9 C.F.R. § 317.309(f) (meat); 9 C.F.R. § 381.409(f) (poultry). 

172 9 C.F.R. § 317.309(g) (meat); 9 C.F.R. § 381.409(g) (poultry). 

173 9 C.F.R. §317.309(g)(2) (meat); 9 C.F.R. § 381.409 (g)(2) (poultry). 

174 9 C.F.R. § 317.309(h) (meat); 9 C.F.R. § 381.409(h) (poultry). 

175 9 C.F.R. § 317.309(c) (meat); 9 C.F.R. § 381.409(c) (poultry). 

176 9 C.F.R. § 317.400 (meat); 9 C.F.R. § 381.500 (poultry). 

177 9 C.F.R. § 317.312 (meat); 9 C.F.R. § 381.412 (poultry). 

178 9 C.F.R. § 317.309(b)(7) (meat); 9 C.F.R. § 381.409(b)(7) (poultry). 

179 9 C.F.R. § 317.309(b)(7) (meat); 9 C.F.R. § 381.409(b)(7) (poultry). 

180 The following abbreviations for units may be used: tbsp for tablespoon, tsp for teaspoon, g 

for gram, mL for milliliter, and oz for ounce. For the purposes of nutrition labeling, a 

teaspoon means 5 mL, a tablespoon means 15 mL, a cup means 240 mL, and 1 oz means 

28 g. 

181 9 C.F.R. § 317.309(b)(7) (meat); 9 C.F.R. § 381.409(b)(7) (poultry). 

182 9 C.F.R. § 317.309(b)(7) (meat); 9 C.F.R. § 381.409(b)(7) (poultry). 

183 9 C.F.R. § 317.309(b)(9) (meat); 9 C.F.R. § 381.409(b)(9) (poultry). 

184 9 C.F.R. § 317.312 (meat); 9 C.F.R. § 381.412 (poultry). 

185 9 C.F.R. § 317.312(g) (meat); 9 C.F.R. § 381.412(g) (poultry). 

186 9 C.F.R. § 317.309(b) (meat); 9 C.F.R. § 381.409(b) (poultry). 

187 9 C.F.R. § 317.309(b) (meat); 9 C.F.R. § 381.409(b) (poultry). 

188 9 C.F.R. § 317.312 (meat); 9 C.F.R. § 381.412 (poultry). 

189 9 C.F.R. § 317.309(b)(10) (meat); 9 C.F.R. § 381.409(b)(10) (poultry). 

190 9 C.F.R. § 317.309(b)(11) (meat); 9 C.F.R. § 381.409(b)(11) (poultry). 

191 9 C.F.R. § 317.309 (b)(15) (meat); 9 C.F.R. § 381.409 (b)(15) (poultry). 

192 9 C.F.R. § 317.313(b) (meat); 9 C.F.R. § 381.413(b) (poultry). 

193 9 C.F.R. § 317.313(p) (meat); 9 C.F.R. § 381.413(p) (poultry). 

194 9 C.F.R. § 317.313(c) (meat); 9 C.F.R. § 381.413(c) (poultry). 

195 9 C.F.R. § 317.313(d) (meat); 9 C.F.R. § 381.413(d) (poultry). 

196 9 C.F.R. § 317.313(e) (meat); 9 C.F.R. § 381.413(e) (poultry). 

197 9 C.F.R. § 317.313(f)(g) (meat); 9 C.F.R. § 381.413(f)(g) (poultry). 

198 9 C.F.R. § 317.313(i)(1) (meat); 9 C.F.R. § 381.413(i)(1) (poultry). 

199 9 C.F.R. § 317.313(i) (meat); 9 C.F.R. § 381.413(i) (poultry). 

200 9 C.F.R. § 317.313(j) (meat); 9 C.F.R. § 381.413(j) (poultry). 

201 9 C.F.R. § 317.313(j) (meat); 9 C.F.R. § 381.413(j) (poultry). 

202 9 C.F.R. § 317.313(j) (meat); 9 C.F.R. § 381.413(j) (poultry). 

203 9 C.F.R. § 317.313(k) (meat); 9 C.F.R. § 381.413(k) (poultry). 

204 9 C.F.R. § 317.313(j) (meat); 9 C.F.R. § 381.413(j) (poultry). 

205 9 C.F.R. § 317.313(l),(m) (meat); 9 C.F.R. § 381.413(l),(m) (poultry). 

206 9 C.F.R. § 317.313(l) (meat); 9 C.F.R. § 381.413(l) (poultry). 

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207 9 C.F.R. § 317.313(q) (meat); 9 C.F.R. § 381.413(q) (poultry). 

208 9 C.F.R. § 317.313(q) (meat); 9 C.F.R. § 381.413(q) (poultry). 

209 9 C.F.R. § 317.354 (meat); 9 C.F.R. § 381.454 (poultry). 

210 9 C.F.R. § 317.354(b) (meat); 9 C.F.R. § 381.454(b) (poultry). 

211 9 C.F.R. § 317.354(c) (meat); 9 C.F.R. § 381.454(c) (poultry). 

212 9 C.F.R. § 317.354(e) (meat); 9 C.F.R. § 381.454(e) (poultry). 

213 9 C.F.R. § 317.354(e) (meat); 9 C.F.R. § 381.454(e) (poultry). 

214 9 C.F.R. § 317.356 (meat); 9 C.F.R. § 381.456 (poultry). 

215 9 C.F.R. § 317.361 (meat); 9 C.F.R. § 381.461 (poultry). 

216 9 C.F.R. § 317.361 (meat); 9 C.F.R. § 381.461 (poultry). 

217 9 C.F.R. § 317.361 (meat); 9 C.F.R. § 381.461 (poultry). 

218 9 C.F.R. § 317.361(b)(4) (meat); 9 C.F.R. § 381.461(b)(4) (poultry). 

219 9 C.F.R. § 317.361 (meat); 9 C.F.R. § 381.461 (poultry). 

220 9 C.F.R. § 317.361(b)(6) (meat); 9 C.F.R. § 381.461(b)(6) (poultry). 

221 9 C.F.R. § 317.361(c) (meat); 9 C.F.R. § 381.461(c) (poultry). 

222 9 C.F.R. § 317.362(b)(1) (meat); 9 C.F.R. § 381.462(b)(1) (poultry). 

223 9 C.F.R. § 317.362(b)(2),(3) (meat); 9 C.F.R. § 381.462(b)(2),(3) (poultry). 

224 9 C.F.R. § 317.362(b)(5) (meat); 9 C.F.R. § 381.462(b)(5) (poultry). 

225 9 C.F.R. § 317.362(b)(6) (meat); 9 C.F.R. § 381.462(b)(6) (poultry). 

226 9 C.F.R. § 317.362(c) (meat); 9 C.F.R. § 381.462(c) (poultry). 

227 9 C.F.R. § 317.362(c) (meat); 9 C.F.R. § 381.462(c) (poultry). 

228 9 C.F.R. § 317.362(c)(2) (meat); 9 C.F.R. § 381.462(c)(2) (poultry). 

229 9 C.F.R. § 317.362(c)(3) (meat); 9 C.F.R. § 381.462(c)(3) (poultry). 

230 9 C.F.R. § 317.362 (c)(4) (meat); 9 C.F.R. § 381.462(c)(4) (poultry). 

231 9 C.F.R. § 317.362(d)(1) (meat); 9 C.F.R. § 381.462(d)(1) (poultry). 

232 9 C.F.R. § 317.362(d)(2),(3) (meat); 9 C.F.R. § 381.462(d)(2),(3) (poultry). 

233 9 C.F.R. § 317.362(d)(5) (meat); 9 C.F.R. § 381.462(d)(5) (poultry). 

234 9 C.F.R. § 317.362(d)(5) (meat); 9 C.F.R. § 381.462(d)(5) (poultry). 

235 9 C.F.R. § 317.362(e) (meat); 9 C.F.R. § 381.462(e) (poultry). 

236 9 C.F.R. § 317.354(d) (meat); 9 C.F.R. § 381.454(d) (poultry). 

237 9 C.F.R. § 317.363 (meat); 9 C.F.R. § 381.463 (poultry). 

238 9 C.F.R. § 317.363 (meat); 9 C.F.R. § 381.463 (poultry). 

239 9 C.F.R. § 317.380 (meat); 9 C.F.R. § 381.480 (poultry). 

240 9 C.F.R. § 317.380(e) (meat); 9 C.F.R. § 381.480 (e) (poultry). 

241 9 C.F.R. § 317.360(b)(1) (meat); 9 C.F.R. § 381.460(b)(1) (poultry). 

242 9 C.F.R. § 317.360(b)(2),(3) (meat); 9 C.F.R. § 381.460(b)(2),(3) (poultry). 

243 9 C.F.R. § 317.360(b)(4) (meat); 9 C.F.R. § 381.460(b)(4) (poultry). 

244 9 C.F.R. § 317.360(c)(1) (meat); 9 C.F.R. § 381.460(c)(1) (poultry). 

245 9 C.F.R. § 317.360(c)(2)(3) (meat); 9 C.F.R. § 381.460(c)(2)(3) (poultry). 

246 9 C.F.R. § 317.360(c)(4) (meat); 9 C.F.R. § 381.460(c)(4) (poultry). 

247 7 C.F.R. § 94.2 (2004). 

248 7 C.F.R. § 57.5 (2004). 

249 21 C.F.R. § 101.3 (2004). “Imitation” is defined as a food product formulated to resemble 

another food covered by a standard of identity, when the formulated product is nutritionally 

inferior. 

250 21 C.F.R. § 160.115 (2004). 

251 Id.

252 21 C.F.R. § 160.105 (2004). 

253 21 C.F.R. § 160.180 (2004). This percentage is determined by the method prescribed in 

“Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), 

sections 17.006 and 17.007 under “Total Solids, Vacuum Method (3) - Official Final Action,” 

which is incorporated by reference. 

254 21 C.F.R. § 160.140 (2004). 

255 21 C.F.R. § 160.145(d) (2004). 

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256 Id. Requirements for lysozyme and avidin content reduction are found in section 160.140(a). 

257 21 C.F.R. § 101.5 (2004). 

258 Id. 259 7 C.F.R. § 94.2 (2004). 

260 9 C.F.R. § 590.150 (2004). 

261 9 C.F.R. § 590.413 (2004). 

262 9 C.F.R. § 590.412 (2004). 

263 9 C.F.R. § 590.410 (2004). 

264 21 C.F.R. § 160.110 (2004). 

265 21 C.F.R. § 160.115 (2004). 

266 21 C.F.R. § 160.105 (2004). The use of anticaking agents is specified in paragraph (a). 

267 21 C.F.R. § 101.22(k)(2) (2004). 

268 21 C.F.R. Part 101 (2004). 

269 9 C.F.R. § 590.411 (2004). 

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