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Packaging, Labeling, Advertising and Consumer Education

This page addresses the issues of 1) food packaging (both the container and its label) and 2) providing information to the consumer (via product labeling, advertising and education).  These two distinct topics are intertwined at several points, especially on the issue of product labeling.

This page first addresses food packaging and labeling; it then addresses the broader issue of consumer information.

Packaging

• Authorizing statute: 21 U.S.C. §343(d)
  • "A food shall be deemed to be misbranded ... (d) Misleading container If its container is so made, formed, or filled as to be misleading."
• Excessive "slack fill" and deceptive containers are prohibited; see FDA regulation prohibiting misleading containers: 21 CFR 100.100
  • "a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does not allow the consumer to fully view its contents shall be considered ... misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein."
• Also see FDA regulations addressing Fill Standards: 21 CFR 130.12 and 130.14(b).

Do not overlook that packaging materials can be defined as an "indirect food additive;" see 21 CFR parts 174-179. Improper packaging could cause the product to be considered adulterated.

The next topic is labeling; if the food package is not properly labeled, the food will be considered misbranded.

Major Statutes Addressing Food Labeling

• Food Drug and Cosmetic Act (administered by FDA)

  prohibits the sale of misbranded food which implies that food products must be properly labeled.

• Fair Packaging and Labeling Act (administered by FDA):

  "Informed consumers are essential to the fair and efficient functioning of a free market economy. Packages [of consumer commodities] and their labels should enable consumers to obtain accurate information as to the quantity of the contents and should facilitate value comparisons." 15 U.S.C. §1451

  "consumer commodity ... does not include ...any meat or meat product, poultry or poultry product, or tobacco or tobacco product" 15 U.S.C. §1459

  Meat and poultry labeling is regulated by the USDA; as discussed subsequently.

• Nutritional Labeling and Education Act:

  "...the Nutrition Labeling and Education Act of 1990 (NLEA), which, among other things, requires nutrition labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA-approved health claims. Meat and poultry products regulated by USDA are not covered by NLEA. However, USDA's regulations closely parallel FDA's rules..." taken from The Food Label

• Food Allergen Labeling and Consumer Protection Act of 2004

• Food labeling statutes codified at 21 U.S.C. §§343-1 and 343-2; also see 21 USC § 607 and 21 USC §457.
• FDA food labeling regulations, see 21 CFR 101
• USDA Food Labeling - administered by FSIS, see Labeling Policies of FSIS. Regulations found at 9 CFR part 317 and 9 CFR §§381.115 to 381.140.

• Improperly labeled food is considered misbranded food.
• Note -- the previous discussions of ingredients, sanitation, manufacturing processes, etc (including contact substances from packaging) are addressed under the broad prohibition against adulterated food.
• Labeling regulations significantly blur the distinction between food safety issues and nutritional issues; that is, many of the labeling requirements address the goal of providing consumers information on which they can base their food purchasing decisions; the emphasis is on nutritional information. There are few labeling regulations that directly address food safety concerns, e.g., disclosure on labels of allergens used to manufacture the food. However, it is appropriate to study labeling requirements because the food must be properly labeled for it to be sold in interstate commerce, and the same agencies (FDA and FSIS) have primary responsibility for both food safety and food labeling.
• The jurisdictional distinction between FDA and USDA/FSIS continues in regulating labels; as a general rule, FDA regulates the labeling of all food except those regulated by USDA/FSIS (meat and poultry products) and those regulated by Alcohol, Tobacco and Firearms (ATF).
• "...commercially processed egg products, and meat and poultry product, including combination products (e.g., stew, pizza), containing two percent or more poultry or poultry products, or three percent or more red meat or red meat products ... are regulated by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS)."
• "All alcoholic beverages, except wine beverages (i.e., fermented fruit juices) containing less than 7% alcohol, are regulated by the Bureau of Alcohol, Tobacco and Firearms of the Department of Treasury."
• Taken from FDA's Food and Cosmetic Regulatory Responsibilities

Requirements for Labeling Food Products

• Five basic label requirements for food: product name, quantity of content, nutritional information, ingredients, and manufacturer or distributor.
• See Food Labeling -- Overview; an FDA web page with links to numerous other pages describing labeling requirements.
• See "A Food Labeling Guide" as of April 2008.
• Food Labeling & Nutrition -- Guidance for Industry
• Claims That Can Be Made for Conventional Foods and Dietary Supplements
  • "Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims."
• See Food Labeling -- Specific Topics and Categories for links to web pages addressing biotechnology, BSE, eggs, and other food labeling topics.

Parts of a Label

• Principal display panel (PDP)
  • "portion of the package label that is most likely to be seen by the consumer at the time of purchase."
• Name of product
• Net quantity of contents, U.S. and metric terms in legible type and size, parallel to base of package
• Name and address of the manufacturer, packer or distributor
• No qualifying terms as "big" or "large" with the contents statement
• These requirements primarily stem from The Fair Packaging and Labeling Act, 1966 15 USC §§1451-1461; regulations are found at 21 CFR part 101

• Information panel
  • "panel immediately to the right of the PDP"
  • "refers to the label statements that are generally required to be placed together, without any intervening material, on the information panel"
• Nutrition label
• Nutrition Labeling
• Regulation found at 21 CFR 101.9
• Serving size and number
• Serving size is not set by government; it is determined by processor; will likely be acceptable as long as it is logical
• Per serving information presented in terms of content and % daily value
• Calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugar, protein, vitamins, A, C, calcium and iron
• Other nutrition information is included voluntarily
• Formats are standardized and specific labels.
• See Label Formats/Graphics Requirements.
• Nutrition label is required on most, but not on all, products; examples of exceptions:
• individual items such as candy bars from a box -- nutrition information is on box, individual items labeled as "not for sale as individual items;" selling items labeled in this manner violates the labeling law
• wholesale containers -- nutrition information must be provided to purchaser by another means such as a flyer
• container is too small to include all nutritional information (such as individual sugar packet) -- include as much as possible
• Statement of ingredients
• Descending order of predominance by weight
• Allergens
  • Labeling Allergens

"Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods." excerpt from FDA.

Also see Information about Food Allergens (an FDA web site)

Recommended Reading: FDA's guidance for industry at "Food Allergens Labeling"

Statutes: 21 USC §321(qq) (definition of major food allergen) and 21 USC §343(w) (food containing major food allergen will be considered misbranded unless properly labeled; also, provides businesses the opportunity to petition for an exemption from the labeling requirement).

Apparently no regulations yet (spring 2009).

• Name and address of manufacturer, packer, or distributor
• Statements/information on the information panel cannot be interspersed with or separated by other information; the other information has to follow these three items.

• Advertisement panel(s)
• May include instructions/directions for product preparation, UPC label, warnings (such as hot when prepared), quality guarantee statements, etc

• What does the date on the product mean?

  "What does the date on the package mean? "Open Dating" (use of a calendar date as opposed to a code) on a food product is a date stamped on the package of a product to help the store management determine how long to display the product for sale. It is a quality date, not a safety date. "Open Dating" is found primarily on perishable foods such as meat, poultry, eggs, and dairy products. If a calendar date is used, it must express both the month and day of the month (and the year, in the case of shelf-stable and frozen products). If a calendar date is shown, immediately adjacent to the date must be a phrase explaining the meaning of that date such as "sell by" or "use before." A "sell-by" date tells the store how long to display the product for sale. You should buy the product before the date expires. A "use-by" date is the last date recommended for the use of the product while at peak quality. In both cases, the date has been determined by the food processor.
  
  "There is no uniform or universally accepted system used for "Open Dating" of food in the United States. Although dating of some foods is required by more than 20 states, there are areas of the country where much of the food supply has almost no dating." Excerpt from FSIS' The Poultry Label Says "Fresh"

  Also see Product Dating at FSIS Labeling Policies, FSIS Food Product Dating, and FSIS Regulation for Package Dating.
  

Have the Labeling Requirements been Met?

• Label Approval
• FDA does not pre-approve labels; FDA may offer suggestions if the processor inquires; FDA will enforce law after the label is put in use.
• No pre-approval of label is required by FDA for products under its jurisdiction. It is the responsibility of the manufacturer or importer of a food to comply with current food labeling regulations." See question 8 of A Food Labeling Guide Chapter VII--Miscellaneous
• USDA requires the label to be pre-approved (e.g., 9 CFR 317.4);
• See FSIS USDA Labeling & Consumer Protection, for example.
• Pre-approval of label by USDA is required for products under its jurisdiction; e.g., 9 CFR 317.4
• "No final labeling shall be used on any product unless the sketch labeling of such final labeling has been submitted for approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and approved by such division ..."
• Accordingly, the steps a food processor will take in developing and beginning to use a label depends on whether the product is regulated by FDA or USDA.

Labeling meat, poultry, and egg products

• Labels for meat and poultry products must be pre-approved by USDA.
• Labeling meat products (administered by USDA FSIS)
• 9 CFR 317 including nutritional labeling (9 CFR 317.300 - 317.400)
• Labeling poultry products (administered by USDA FSIS)
• 9 CFR 381, more specifically, sections 381.115 to 381.144 and 381.400 to 381.500; product name, ingredients, quantity of contents, weight, handling instructions, additives, manufacturer identification, date of packaging, and nutritional labeling.
• Suggested Label Submission Checklist (USDA FSIS web page) "A checklist which provides guidance on the preparation and submission of label applications."

• Irradiated meat and poultry -- 9 CFR §424.22(c)
  • "(1) General requirements. Meat food and poultry products may be treated to reduce foodborne pathogens and to extend product shelf-life by the use of sources of ionizing radiation as identified in 21 CFR 179.26(a). Official establishments must irradiate meat food and poultry products in accordance with 21 CFR 179.26(b), the Hazard Analysis and Critical Control Point (HACCP) system requirements in [9 CFR part 417], and the provisions of this section. "
  • "(4) Labeling. (i) The labels on packages of meat food and poultry products irradiated in their entirety, in conformance with this section and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end of this paragraph (c)(4)(i). Unless the word "Irradiated'' is part of the product name, labels also must bear a statement such as ``Treated with radiation'' or "Treated by irradiation.'' The logo must be placed in conjunction with the required statement, if the statement is used."
  • Also see FSIS Irradiation Resources

• Labeling egg products -- FDA and USDA share labeling authority; 9 CFR 590.411 and 9 CFR 590.680

Labeling Health Claims

What statements or claims may a firm make in promoting its product? If the statement is misleading, is the product considered misbranded? This section introduces the issue of product claims.

• "A "health claim" by definition has two essential components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. A statement lacking either one of these components does not meet the regulatory definition of a health claim."
• "Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition."
  • Health Claims -- see 21 CFR §101.14 and §§101.70 to 101.83.
    • "Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition."
    • A Food Labeling Guide:  Appendix C: Health Claims
  • Qualified Health Claims -- "Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers; Final Guidance"
  • "qualified health claims [--] when there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition. In this case, the evidence is not well enough established to meet the significant scientific agreement standard required for FDA to issue an authorizing regulation. Qualifying language is included as part of the claim to indicate that the evidence supporting the claim is limited." See Claims That Can Be Made for Conventional Foods and Dietary Supplements.
  • Nutrient Content Claims -- see 21 CFR §101.13 and §§101.54 to 101.69.
    • "Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite."
    • See Food Labeling Guide:  Appendix B: Additional Requirements for Nutrient Content Claims
  • Dietary Supplements -- see 21 CFR §101.36 and §101.93., and parts 119 and 190.
• Claims That Can Be Made for Conventional Foods and Dietary Supplements (Sept. 2003)
  • Also note discussion of Nutrient Content Claims and Structure/Function Claims
    • "Structure/function claims 1) describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones" ... 2) may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity" ... 3) may describe general well-being from consumption of a nutrient or dietary ingredient ... and 4) may describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States."
    • "The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading."
• Label Claims (an FDA web page with links to other sites/pages)
• Also see Chapter VIII. Claims in the " A Food Labeling Guide"

Labeling rules for special circumstances

• Food service products ; e.g., 21 CFR 101.10
  • "Nutrition labeling ... shall be provided upon request for any restaurant food or meal for which a nutrient content claim ... or a health claim ... is made, except that information on the nutrient amounts that are the basis for the claim (e.g., ``low fat, this meal provides less than 10 grams of fat'') may serve as the functional equivalent of complete nutrition information..."
• Wholesale - multi-units; e.g., 21 CFR 101.100( a)(2) and (d)
  • Food is exempt from having a "declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients [if the] ... food [is] received in bulk containers at a retail establishment [and] ... displayed to the purchaser with either: (i) The labeling of the bulk container plainly in view, provided ingredient information appears prominently and conspicuously ... or (ii) A counter card, sign, or other appropriate device bearing prominently and conspicuously ... the information required to be stated on the label ... "
  • "... a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of ... movement in interstate commerce ... from compliance with the labeling requirements ... if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment ... is made ... under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, ... will ensure [( if such specifications are followed)] that such food will not be adulterated or misbranded ... Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment ... of such food from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them."
• Nurtional labeling of raw fruits, vegetables, and fish -- this is voluntary; see 21 CFR 101.42 to 101.45
  • "The Food and Drug Administration (FDA) urges food retailers to provide nutrition information ... for raw fruit, vegetables, and fish at the point-of-purchase. If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines..."

Labeling Organic Products according to The National Organic Program

• Labeling Packaged Products -- USDA AMS web page
  • "These requirements do not preempt Food and Drug Administration; USDA, Food Safety and Inspection Service; or the Bureau of Alcohol, Tobacco and Firemans labeling regulations or label approval requirements."
  • Note the categories of "100 percent Organic," "Organic" and "Made with Organic Ingredients."
  • Regulations -- 7 CFR part 205, sections 308, 309, 605, 606.
  • Labeling and Marketing Information -- USDA AMS web page
• Labeling Alcohol Beverage Containers

Labeling products regulated by Bureau of Alcohol, Tobacco and Firemans

• 27 U.S.C. §215 Mandates government warning on label.
• 27 CFR parts 4, 5, 7, 13 and 16

Labels requirements by other nations

• Other nations also have labeling requirements; e.g., EUROPA Food and Feed Safety -- Labeling and Nutrition. These requirements must be met by food businesses that want to export to these other nations. Note that the labeling requirements differ from those imposed by the US; e.g., GMO labeling.
• Recall that a businesses wanting to import to the US must comply with US food laws, including US food labeling laws.

Advertising

Another step is to assure consumers are not deceived by advertising claims.

• FDCA -- Regulates the advertising of certain foods 21 U.S.C. §378
• Advertising (misleading advertising) can cause the product to be declared "misbranded"
• See CFR Title 16
• FDA is required to notified FTC of any enforcement action FDA is contemplating as a result of "misbranding due to advertising;" if FTC takes action against the alleged misbranding, FDA is prohibited from also taking action.
• Dietary supplements draw considerable attention
• Enforcement Policy Statement on Food Advertising; although prepared in May 1994, it provides a good background description.
• Business Guide For Dietary Supplement Industry Released by FTC Staff
• Dietary Supplements: An Advertising Guide for Industry
• Dietary Supplement Advertising Cases

Consumer education

• Consumer still need to make their own decisions; labeling addresses the concern of making sure the consumer has access to appropriate information about the product; consumer education focuses on whether the consumer is able to use that information to make a meaningful decision. Advertising and discretionary information on labels are additional ways to inform and educate, but these too are somewhat regulated to assure boundaries are not overstepped.
• The food industry is dynamic -- consumers have different information, understanding and expectations than they did several decades ago; consumers' demand changes as they grow older, as their family and career situation changes, and as their income changes. Technology is changing. Simple matters such as packaging, degree of processing and additives/ingredients are changing. How do these changes impact the person responsible for food safety within a food business?
• Distinction between nutrition, food safety and promotion becomes quite blurred; much of the mandatory/required information on the label is nutritional information; much of the discretionary information is to encourage the consumer to use the product due to its convenience, taste, etc. Neither of these objectives appeared to emphasize food safety.
• There also are (formal?) educational programs about safe food preparation and (formal?) educational programs about nutrition.
• Food Label Education Tools & General Information -- FDA web site with links
• Guidance on How to Understand and Use the Nutrition Facts Panel on Food Labels -- web site for consumers to learn how to read food packaging labels.

 

• Consumer Nutrition and Health Information -- another FDA web site with numerous links
• USDA My Pyramid -- "MyPyramid was developed to carry the messages of the dietary guidelines and to make Americans aware of the vital health benefits of simple and modest improvements in nutrition, physical activity and lifestyle behavior."
• USDA FSIS food safety magazine:  "be FoodSafe: The FSIS Magazine is a quarterly publication that focuses on food safety behavior trends, emerging science and research, inspection issues (domestic and international), and education programs for food workers, consumers and caregivers."
  

 

• Safe Food Handling -- WIC web site with links to information for consumers about safe food handling
• Fight BAC! -- educational program on food safety for consumers

Last updated April 16, 2010

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