Food Labeling – An Overview

Introduction

Governmental intervention in food labeling typically aims at improving human health and safety, supporting domestic agricultural and food manufacturing industries, and averting international trade disputes. The main source of legislation that food manufacturers should be aware of when designing the labels of their products is the Federal Food Drug and Cosmetic Act (FFDCA) and its amendments. However, there are specific statutes that deal with the labeling of meat, poultry, and egg products.

In the United States, food labeling is regulated mainly by two agencies: the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA). Within the USDA, the Agricultural Marketing Service (AMS) oversees the National Organic Program (NOP) and food grading system. Also within the USDA is the Food Safety Inspection Service (FSIS) which regulates the labeling of meat, poultry, and shelled egg products. However, the FDA and USDA are not the only two agencies that play a role in regulating food labeling. Other agencies are also involved in the regulation of certain labels. These agencies include the United States Federal Trade Commission (FTC) which ensures labels are fair and not deceptive; the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the Department of the Treasury, which governs alcohol labels; and the Office of the United States Trade Representative (USTR) which is involved in treaty negotiations concerning food labeling and international trade. Additionally, various states and municipalities impose food labeling requirements, although there have been efforts in recent years to negate these local mandates.

Food labeling laws and regulations address packaging and point-of-purchase advertising for food and supplements sold in retail establishments, menus in restaurants, and alcoholic beverage labeling. Food labeling laws and regulations also cover claims made by marketing endeavors, including claims about the purity of food products or health benefits.

History

In response to Upton Sinclair’s book, The Jungle, which exposed unsanitary conditions in meat-packing plants and concerns surrounding chemical preservatives in food, in June 1906 Congress passed the Pure Food and Drug Act (PFDA) and the Federal Meat Inspection Act (FMIA). The PFDA aimed to prevent the manufacturing, sale, and transportation of adulterated and misbranded foods, drugs, medicines, and liquors. The FMIA also aimed to prevent adulteration and misbranding but specifically in the meat industry. Congress tasked USDA’s Bureau of Chemistry with administering the PFDA and tasked USDA’s Bureau of Animal Industry with administering the FMIA.  In 1927, USDA’s Bureau of Chemistry was renamed to the Food, Drug, and Insecticide Administration, and was again renamed in 1931 to the Food and Drug Administration (FDA). In 1940, FDA was moved out of USDA and into the Federal Security Agency which preceded the Department of Health and Human Services, where FDA currently resides.

In 1938, following the death of 107 people due to ingestion of Elixir of Sulfanilamide which contained anti-freeze, Congress passed the Federal Food, Drug, and Cosmetic Act (FFDCA) which preempted the PFDA. The FFDCA focused on the issues of food misbranding and adulteration and still serves as the primary authority for FDA’s regulations. The FFDCA created food standards, authorized inspections of factories, and provided for court injunctions as a remedy for violations, in addition to the already existing seizure and prosecution remedies.

The general trend toward federal regulation of food also entailed a movement toward disclosure of food contents. The 1938 FFDCA required that the label of every processed and packaged food to contain the name of the food, its net weight, and the name and address of the manufacturer or distributor. Furthermore, a list of ingredients was required on certain products. The law also prohibited false or misleading statements on food labels and prevented the introduction of adulterated or misbranded food in interstate commerce. 21 U.S.C. § 331. Violations were treated with injunctions, monetary penalties, and potential jail time. 21 U.S.C. §§ 332-333. Since 1938, Congress has amended the FFDCA a number of times and has enacted related laws. The evolution of U.S. food labeling law has been a response to food safety problems, nutrition concerns, economic issues, environmental issues, agricultural protection, and food security threats.

In 1957, in response to more Americans eating poultry products, Congress passed the Poultry Products Inspection Act (PPIA). The PPIA mirrors the FMIA but applies to poultry products such as chicken and turkey. Similarly, Congress passed the Egg Products Inspection Act (EPIA) in 1970 which granted FSIS jurisdiction over the labeling and safety of egg products. If a product contains egg, and in making that product the processor or manufacturer broke, filtered, mixed, stabilized, blended, pasteurized, cooled, froze, or dried the egg then the egg product falls under FSIS’s jurisdiction. FDA retains jurisdiction of shelled eggs.

Congress, in 1990, passed the Nutrition Labeling and Education Act (NLEA). NLEA gave FDA the authority to set uniform nutrition labeling standards. Before 1990, information such as serving size, the number of calories, and the measure of fat, carbohydrates, fiber, ectara was not required on food labels. NLEA focused on the relationship between food contents and healthy diets, and was the start of providing information to consumers regarding the content of food beyond an ingredient list. The NLEA also regulates nutrition content claims and health claims. As a result of the NLEA, most food products, were required to have a nutrition fact panel by the mid-1990s. FDA revised the regulations implementing NLEA, thus changing the look of the nutrition fact panel, in 2020.

In 1994, Congress again amended the FFDCA with the Dietary Supplement Health and Education Act of 1994. This law defined “dietary supplements” and “dietary ingredients” and classified them as food. The law also established specific labeling requirements, provided a regulatory framework, and allowed FDA to enact manufacturing regulations for dietary supplements.

In 2006, Congress amended the FFDCA through the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FALCPA applies to all packaged foods that are regulated under the FFDCA and requires that all “major food allergens” be identified on the food label. A major food allergen is one of the following foods or food groups or an ingredient that contains proteins derived from one of the following foods: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, or sesame. 21 U.S.C. § 321qq. Sesame was added to the list of food allergens in 2021 under the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act.

Federal Regulatory Authority

In food labeling, administrative agencies such as USDA/FDA/EPA have been given authority by Congress to create regulations implementing the requirements of the federal law.  In 2024, the Supreme Court of the United States issued two rulings that are expected to have a major impact on how judges decide cases challenging those regulations and that agency authority.

Loper Bright Enters. v. Raimondo, 144 S. Ct. 2244 (2024) overruled the long-standing doctrine of deference established in Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984). Chevron deference was a two-step process that clarified how and when federal courts should defer to an agency regulation interpreting a statute.  Chevron only applied in situations where a court had determined that the statutory language the agency was interpreting was ambiguous.  If it was ambiguous, the court would consider whether the agency’s interpretation of the statutory language was “reasonable”.  If it was reasonable, the court was required to defer to the agency’s interpretation. If it was not, the court would overrule the interpretation.

Loper Bright formally overturned Chevron. In a 6-3 decision, the Supreme Court held that “courts may not defer to an agency interpretation of the law simply because a statute is ambiguous[.]” Following the ruling, courts are instead required to exercise independent judgment in determining whether an administrative agency has acted within its statutory authority.  Courts may still seek guidance from the agencies involved, but courts will no longer be required to defer to an agency’s interpretation of a statute.

In Corner Post, Inc. v. Bd. of Governors of the Fed. Rsrv. Sys., 144 S. Ct. 2440 (2024), the Supreme Court extended the period of time during which a party may file a lawsuit challenging federal agency actions. According to 28 U.S.C.S. § 2401(a), the six-year statute of limitations began to run when an administrative agency’s action was “final.”  In Corner Post, the Supreme Court ruled that an action becomes “final” when a plaintiff suffers an injury, rather than when a “final regulation” is released. This ruling expands the potential for plaintiffs to challenge federal agency rules and regulations that have been final for over six years.

While the full effect of these two rulings remains to be seen, it is highly likely that the agricultural industry will be impacted by the Supreme Court’s decisions. Importantly, the rulings fundamentally change how courts will resolve lawsuits challenging agency regulations for misinterpreting the agency’s statutory authority. Impacts are most likely to be felt in areas of the law, such as food labeling, dominated by statutes with relatively ambiguous language where Congress has relied on agency regulations to fill in specifics.

Label Approval

When it comes to label approval, FDA and FSIS take different approaches. This mainly stems from the agency’s authorizing statutes. The FFDCA, which gives FDA its authority to regulate most of the food supply, does not require the FDA to approve food labels before they hit the market. On the other hand, the FMIA, PPIA, and EPIA all require FSIS to approve the labels on meat, poultry, and egg products respectfully. However, FSIS has a system where the agency “generically approves” most labels. If there is an issue with a food label that was not pre-approved or received FSIS’s generic approval, the agencies have a few enforcement mechanisms available to them. For example, if FDA becomes aware of a misbranded food such as a nutrition fact panel that doesn’t comply with the regulations, FDA can issue a warning letter. FDA can also sue the food manufacturer or processor with the hope of seizing the misbranded product or having the court issue an injunction against the food manufacturer or processor. If a court issues an injunction, then the food manufacturer or processor usually must stop selling the misbranding product and stop misbranding the product. Apart from the agencies, consumers can challenge the label by bringing a products liability lawsuit or sue under one of the federal statutes regulating food labeling.

Although FSIS generically approves most meat, poultry, and egg product labels, there are four specific label claims which FSIS must approve before a product manufacturer or processor can include the label on the product. The four types of labels FSIS must approve include (1) labels for religious exempt products such as food that is labeled as kosher or halal, (2) labels on products destined for export to countries with deviations from the U.S. labeling requirements, (3) labels with special statements and claims such as “all natural” or “no preservatives”, and (4) labels that are temporarily approved but contain regulatory deviations that do not pose potential health, safety, or dietary problems to consumers. 9 C.F.R. § 412.1(c).

Sample of Food Labeling Issues

Animal production claims and hormone labeling- FSIS defines animal production claims as statements about how the animals were raised (i.e., claims such as “raised without added hormones” or “grass fed”). Those claims are an alternative or complement to the use of the term “organic” on meat and poultry. Pursuant to FSIS’s outline of current processes for animal production claims, hormones are only allowed for use in beef cattle, swine, and lamb production. Since hormones are prohibited in poultry, veal calves, or exotic nonamenable species (bison, buffalo, elk, and venison), hormone-free labeling on those species will not be approved unless it contains a disclaimer such as “Federal regulations prohibit the use of hormones in poultry.” As of 2019, FSIS no longer requires such a disclaimer on pork products because according to FSIS “Federal law permits the use of certain hormones in swine, e.g. for gestation.”

Biotech Food Labeling– On December 20, 2018, USDA announced the National Bioengineered Food Disclosure Standard (“the Standard”). The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature. AMS developed the List of Bioengineered Foods to identify the crops or foods that are available in a bioengineered form throughout the world and for which regulated entities must maintain records. The Standard requires food manufacturers, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. Regulated entities have several disclosure options: text, symbol, electronic or digital link, and/or text message. Additional options such as a phone number or web address are available to small food manufacturers or for small and very small packages. Before the U.S. implemented its standard, other parts of the world such as the European Union, Japan, China, and others already required labeling of products that contain genetically modified ingredients.

For additional information, visit the Biotechnology Reading Room.

Country of Origin Labeling– An overview article can be found in the Country of Origin (COOL) Reading Room.

Irradiated food labeling – Pursuant to 21 C.F.R. § 179.26(c), whole foods that have been irradiated must bear a label such as “Treated with Radiation” or “Treated by Radiation,” and include the Radura symbol depicted in the regulations. However, the labeling requirement does not apply to irradiated ingredients in processed food. Similarly, restaurants and other foodservice establishments are not subject to the labeling requirement.

Natural food labeling- Both FDA and FSIS have policies, but not regulations, regarding natural food labeling. They both provide that “natural” means that no artificial or synthetic ingredients have been added. According to FSIS a product labeled as natural contains no artificial ingredients or added colors and is only minimally processed. FSIS states minimal processing means that the product was not fundamentally altered during processing.

Nutrient content claims- Nutrient content claims are used to disclose the level of certain nutrients, calories, cholesterol, or fiber in the product, and they include terms like “free,” “lean,” “extra lean,” “high,” “low,” “good source,” “reduced,” “less,” “light,” “fewer,” and “more.” The definitions of each of these terms are highly specific. Nutrient content claims are found on both FSIS and FDA regulated products.

Organic food labeling- For foods to be labeled and sold as organic, they must be produced and processed according to the National Organic Program standards under 7 C.F.R. § 205. The farm where organic food is grown, as well as the companies that handle or process the organic food, must meet the USDA organic standards.

For more information on organic food labeling, visit the National Organic Program Reading Room.

Qualified health claims– Qualified health claims are statements on food labels regarding a relationship between a food or food component and a disease or health-related condition (e.g., high blood pressure). The claims must be supported by credible scientific evidence. They do not have to meet a “significant scientific agreement” standard, provided they do not mislead consumers. These claims occasionally must be accompanied by disclaimers or other qualifying language. The requirements for health claims are contained in 21 C.F.R. § 101.14. According to FDA, FDA must review all health claims (which includes both qualified and authorized health claims) through a petition process.

Standards of identity- The Code of Federal Regulations lists standards of identity for certain foods. For example the regulations state that for food companies to advertise their product as “peanut butter” the product must contain at least 90% peanuts. There are standards of identity for many different foods. Standards of identity are found at 21 C.F.R. §§ 130-169.

Trans fat labeling- Trans fats are chemically modified food ingredients that raise levels of cholesterol and are linked to heart disease. In 2015, FDA determined that partially hydrogenated oils (PHOs), the main source of trans fat, are no longer generally recognized as safe. June 18, 2018 was the date FDA set for most food manufactures to come into compliance and stop producing and using PHOs, however FDA allowed a few foods to have an extended compliance date. Prior to this ban, FDA required food manufacturers to include grams of trans fat on the nutrition facts label.

Additional information regarding food labeling can be found in the reading rooms devoted to International Trade, Checkoff Programs, Food Safety, and other related topics.