Food Labeling – An Overview
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. Pursuant to the Federal Food Drug and Cosmetic Act (FDCA) and its amendments, food labeling addresses nutritional information and is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, and drinks. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary.
In the United States, food labeling is generally regulated by the United States Department of Agriculture (USDA), the United States Food & Drug Administration (FDA), and the United States Federal Trade Commission (FTC). The Food Safety and Inspection Service (FSIS) is the public health agency within the USDA responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled and packaged. Other agencies are involved in the regulation of certain labels including, the Bureau of Alcohol and Tobacco Tax and Trade 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.
In response to Upton Sinclair’s book, The Jungle, that exposed unsanitary conditions in meat-packing plants and concerns surrounding chemical preservatives in food, the Food and Drugs Act was passed in June 1906 and prohibited interstate commerce in misbranded or adulterated food items from entering interstate commerce.
Following the death of 107 people due to ingestion of elixir of sulfanilamide, which contained poisonous diethylene glycol (anti-freeze), the Food, Drug, and Cosmetic Act (FDCA) was passed in 1938 and preempted the Food and Drugs Act. The FDCA focused on the issues of food misbranding and adulteration and serves as a basic framework for food regulation by the FDA and the USDA. It 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. Since 1938, the FDCA has been amended a number of times and related laws have been enacted. The evolution of U.S. food law has been a response to food safety problems, nutrition concerns, economic issues, environmental issues, agricultural protection, and food security threats.
The movement toward federal regulation of food also entailed a movement toward disclosure of food contents. The 1938 FDCA required that the label of every processed and packaged food 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 in food labeling 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).
Congress, in 1990, passed the Nutrition Labeling and Education Act requiring uniform nutrition labeling. The labeling standards focused on the relationship between food contents and healthy diets, and labeling standards began to provide adequate information to consumers regarding the content of food. The Nutrition Labeling and Education Act also regulated nutrition content claims and health claims.
The Dietary Supplement Health and Education Act of 1994 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. On November 23, 2010, FSIS established January 1, 2014 as the uniform compliance date for new meat and poultry product labeling regulations issued between January 1, 2011 and December 31, 2012. FSIS argues that this rule will minimize the economic impact of labeling changes because the meat and poultry industry will have two years to adapt to the new requirements and with less frequent labeling changes. This, in turn, will avoid multiple short-term label revisions that would increase food cost for producers, retailers, and consumers.
On May 27, 2016, the FDA published two final rules, the Nutrition Facts Label Final Rule and the Servings Size Final Rule. These rules allow for a new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. FDA hopes that the new label will help consumers make better informed food choices. The label features a “refreshed” design that requires certain words to be bolded, reflects updated information about nutrition science, such as the requirement for added sugars to be displayed in grams and percent daily value, and updates serving sizes and labeling requirements for certain package sizes.
Sample of Food Labeling Issues
Country of Origin Labeling– An overview article can be found in the Country of Origin (COOL) 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. The claims must be supported by credible scientific evidence. They do not have to meet the 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. If a health claim is not regulated under 21 C.F.R. 101.14, an individual or organization may petition the FDA and request issuance of a regulation regarding a health claim. The requirements for health claims petitions are in 21 C.F.R. 101.70.
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 in meat and poultry product names were authorized in 2005 pursuant to an FSIS final rule and went into effect on January 1, 2008.
Trans fat labeling- Trans fats are chemically modified food ingredients that raise levels of cholesterol and are linked to heart disease. Since January 1, 2006, trans fats must be included on nutrition labels. FDA now requires trans fat content to be separately listed on the Nutrition Facts label of all packaged foods. This requirement does not apply to food served at restaurants. However, some cities have taken measures to limit trans fat in foods sold in restaurants. In December 2006, New York City was the first city to ban trans fats in restaurant food that became effective on July 1, 2007, with full compliance required by July 1, 2008. Philadelphia enacted a similar measure that required restaurants to comply by September 1, 2007.
Food allergens- The Food Allergen Labeling and Consumer Protection Act (FALCPA) went into effect on January 1, 2006, and applies to all packaged foods that are regulated under the FDCA. FALCPA requires that a “major food allergen” 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, and soybeans (21 U.S.C. 321qq). An ingredient can be exempted if the petitioner proves that it “does not cause an allergic reaction that poses a risk to human health” as noted in 21 U.S.C. 343(w)(6). 21 U.S.C. 343(w)(7) lays out the procedure for requesting an exemption from FDA.
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. Part 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. The regulations provide for four approved organic labeling claims based on four distinctions of organic content. To label a product “100 percent organic,” the product must be composed of wholly organic ingredients and must not have any nonorganic ingredients or additives. To label a product “organic,” the product must contain at least 95 percent of organically produced ingredients. To label a product “made with organic ingredients,” the product must contain 70 percent organic ingredients. Other products with less than 70 percent organic ingredients can only specify the organic ingredient(s) in the ingredients statement. The USDA seal can be placed only on foods that qualify as “100 percent organic” and “organic.”
For more information on organic food labeling, visit the National Organic Program Reading Room.
Natural food labeling- Both FDA and USDA have policies regarding natural food labeling. They both provide that “natural” means that no artificial or synthetic ingredients have been added. USDA specifically prohibits artificial flavor, coloring ingredients, or chemical preservatives. USDA allows minimal processing, specifying that such processing is limited to traditional processes used to make food safe for human consumption or to preserve it or to processes that do not alter the raw product. FDA allows a limited group of chemical reactions (roasting, heating, and enzymolysis can be used to produce natural flavors).
Animal production claims and hormone labeling- The FSIS’s claims guidance documents define animal production claims as statements about how the animals from which the meat products are derived were raised (i.e., claims such as “raised without added hormones” or “corn fed”). Those claims are an alternative or complement to the use of the term “organic” on meat and poultry. Pursuant to the FSIS’s outline of current processes for animal production claims, hormones are only allowed for use in beef cattle and lamb production. Since hormones are prohibited in poultry, hogs, veal calves or exotic, nonamenable species, hormone labeling on those species will not be approved unless it contains a disclaimer such as “Federal regulations prohibit the use of hormones in poultry.”
Irradiated food labeling – Pursuant to 21 C.F.R. Part 179.26, whole foods that have been irradiated must bear a label such as “Treated with Radiation,” “Treated by Radiation,” or they must bear the Radura symbol. 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.
Biotech Food Labeling
The question of marketing and selling genetically modified foods is being debated nationally and internationally. In the U.S., given FDA’s science-based conclusion that there is nothing inherently unsafe about food biotechnology, the federal government does not require that genetically modified foods be labeled unless they differ significantly in safety, nutritional value, or functionality from their conventional counterparts. Some states have passed state-level regulation of genetically modified foods, beginning a patchwork of varying labeling policies across the nation.
Currently, three U.S. states have laws on the books mandating the labeling of genetically modified foods. Connecticut and Maine respectively passed their laws in June 2013 and January 2014, both including a trigger clause requiring four neighboring states to pass similar legislation. In April 2014, Vermont became the first state to pass labeling laws without a trigger clause. However, these state laws are now preempted by the National Bioengineered Food Disclosure Standard discussed in detail below.
In addition to this broader debate, another debate specifically questions whether labeling of foods containing genetically modified organisms should be mandatory or voluntary. Contrary to U.S. federal policy, where labeling of genetically modified organisms is voluntary, other parts of the world such as the European Union, Japan, China, and others require labeling of products that contain genetically modified ingredients. The following are a few examples of countries’ labeling policies regarding genetically modified organisms.
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. The Agricultural Marketing Service (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. Many critics of the Standard believe the digital link/QR code label is inefficient for consumers and discriminates against those without access to a smartphone.
European Union – According to the regulations of the European Union, if the genetically modified foodstuff is authorized pursuant to Regulation (EC) No.1829/2003, Regulation (EC) No.1830/2003 requires labeling of food products consisting of or containing genetically modified organisms (GMO). Specifically, food products that consist of GMO or contain GMO or products derived from GMO but no longer containing GMO (if there is still DNA or protein resulting from the genetic modification present) must be labeled as such. However, genetically modified organisms that are in a proportion no higher than 0.9% are exempt from the labeling requirement, provided that these traces are adventitious or technically unavoidable.
China – Decree No. 10 of the Ministry of Agriculture of the People’s Republic of China (January 5, 2002) also makes compulsory the labeling of certain listed agricultural genetically modified organisms: soybean seed, soybean, soybean powder, soybean oil and soybean meal; corn seeds, corn, corn oil and corn powder; rape seed for planting, rape seed, rape oil and rape meal; cotton seed; and tomato seed, fresh tomato and tomato jam.
Australia/New Zealand – The Australia New Zealand Food Standards Code, Standard 1.5.2 requires labeling of food produced using gene technology.
Japan – The Labeling Standard for Genetically Modified Foods, Notification No. 517 of the Ministry of Agriculture, Forestry and Fisheries (March 31, 2000) also requires labeling of genetically modified foods.
Brazil – Decree No. 4,680 of 24 April 2003, mandates the labeling of food products for animal and human consumption that contain over 1% of genetically modified organisms.
For additional information, visit the Biotechnology Reading Room.