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Labels 101

General requirements for food labels.

What is a food label?

Under the Food, Drug, and Cosmetic Act, the main law in the US that governs the label for most food products, a food label can be more than just the paper or plastic attached to your food product. The law defines a label as “the display of written, printed or graphic material that comes with a product,” meaning it could also include anything that accompanies the product even if not physically attached.

What government agencies regulate food labeling?

The two main agencies that regulate food labeling in the US are the Department of Agriculture (USDA) and the Food and Drug Administration (FDA). These agencies are responsible for ensuring that foods sold in the United States are safe, wholesome, and properly labeled. The Federal Trade Commission (FTC) also has a role in regulating some labeling claims by preventing and prosecuting misleading labeling in coordination with FDA.

USDA regulates labeling for most meat, poultry, and egg products while FDA regulates labeling for all other food products. The FTC often works with FDA to regulate food labeling claims.

FDA gets its authority to regulate food labels from the Food, Drug, and Cosmetic Act (FDCA); Nutrition Labeling and Education Act (NLEA); Fair Packaging and Labeling Act (FPLA); Public Health Service Act (PHS); and Food Allergen Labeling and Consumer Protection Act (FALCPA). FDA has also developed many regulations to implement these laws. While FDA has a number of requirements for information that must be included, it does not preapprove food product labels prior to use.

FDA has a few general requirements for any labels it regulates. All food labels must include the following:

  • Name of the food
  • Net quantity of contents
  • Name and location of the business
  • List of ingredients if the food is comprised of more than one ingredient
  • Nutrition Fact Label (for packaged products sold at retail)
  • Allergen disclosure information for products which contain one or more of the eight major food allergens (e.g., processed in a facility with nuts)

Find additional FDA guidance on various labeling requirements here. These guides cover topics from how to properly label sugar to menu and vending machine labeling requirements.

The name of a food product may be defined by a “statement of identity.” A statement of identity is either the name established by law, or the usual name of the food if there is no legal definition.

FDA enforces food labeling by conducting inspections of production facilities. When FDA finds a food label that qualifies as a “violation of regulatory significance,” it will issue the manufacturer a warning letter requesting a labeling correction. In less severe cases, FDA will issue an advisory letter. In the most severe cases, FDA has the authority to issue a mandatory recall, though this is rare. Some examples of labeling violations can be found here. You can read more about FDA enforcement here.

USDA gets its authority to regulate food labels from the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), which prohibit misbranding of meat and poultry products.

Like FDA, USDA requires several components on the food labels it regulates, including:

  • Name of the food
  • Inspection legend and establishment number (a symbol showing that a carcass or parts of carcasses were inspected in an official establishment in accordance with all federal regulations)
  • Handling statement (e.g., “Keep Frozen”)
  • Safe handling instructions (required if the meat or poultry component of a product is raw or partially cooked)
    • Statement must read: “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.” May have additional instructions afterward.
  • Net weight statement
  • Ingredients statement (must list ingredients when product is made from 2 or more ingredients, listed in order of weight of ingredients)
  • Address line (trade name or place of business of the manufacturer, packer, or distributor)
  • Nutrition facts

Like FDA-regulated products, the name of the food that appears on the label is the “statement of identity.” A statement of identity is either the name established by law, or the usual name of the food if there is no legal definition. See the USDA Food Standards and Labeling Policy Book for more information. You can find an overview of USDA label requirements here.

Unlike labels for products regulated by FDA, labels on meat and poultry products must be preapproved by USDA before entering the market. USDA also performs inspections of establishments to ensure manufacturers are in compliance with regulations. Additionally, individuals and industry members can file complaints about labeling violations, such as labels not in compliance with USDA Organic regulations. When labels are found to violate USDA regulations, USDA may issue a warning letter or retain, condemn, or recall the product so as to ensure the misbranded product does not enter the food system. You can read more about USDA compliance and enforcement here.

I. Regulated Voluntary Label Claims

Food labels include all sorts of claims about the food’s content, nutrition, the place the food comes from, and much more. As discussed above, some of those claims are required to be on the labels, like nutrition facts. Other claims are not required, but food producers can choose to include them because it makes their product more valuable or appealing to consumers. These voluntary label claims are very common and they are the claims consumers often use to make important purchasing decisions. Some of these claims are defined by law and others are not. For those voluntary label claims that are not specifically defined, the law still prohibits them from being false and misleading to consumers. Both USDA and FDA have defined certain voluntary label claims, examples of which are provided below.

Nutrient Content Claims

According to FDA, a “Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food.” So, any claims about the nutrients in a food (except for the “Nutrition Facts” panel) are considered nutrient content claims because they describe the amount of a nutrient in the food rather than just stating the specific quantity (e.g., 3 grams of sugar). Nutrient content claims can make statements about the presence of a nutrient, the relative levels of a nutrient, and the absence of a nutrient. There are several kinds of nutrient content claims; the information below explains some of the most common. For more information on nutrient content claims, visit this summary of Nutrient Content Claims.

a) Relative claims: Relative nutrient claims, like “low,” “free,” “high,” “light,” and “reduced,” are used to differentiate a product from similar products based on its nutrient content. “Free” and “low” claims, like “fat-free” or “low sodium,” imply that the marketed food has a legally defined amount of fat, calories, cholesterol, sodium, or sugar per serving. “Reduced,” “less,” “light,” and “high” are considered relative terms and are defined in relation to the regular version of the product. Food labels using relative claims must state which food is being used for comparison and the specific measured difference between the two foods, such as “50 percent less fat than (reference food).”

For labels that compare a food to the nutrient levels in a different food (including claims like “less,” “fewer,”  and “more”), the food must actually meet those label claims when compared to a reference food in the same category. For example, comparing potato chips to pretzels, or comparing mozzarella cheese to cheddar cheese.

For “light,” “reduced,” “added,” “extra,” “plus,” “fortified,” and “enriched” claims, the marketed food must be compared to the same food. So, reduced sodium potato chips would need to be specifically made to have less sodium than similar potato chips; light cream cheese would be compared to regular cream cheese.

Note that claims about fat and cholesterol are more specifically regulated. “Reduced fat” foods must have at least 25% less fat than reference foods, and “low fat” foods have 3g of fat or less per serving. “Fat-free” and “skim” products have less than 0.5g of fat per serving. “Cholesterol-free” foods have less than 2 mg of cholesterol per serving. Foods that claim “low cholesterol” or similar claims have less than 20 mg of cholesterol per serving.

For more information on legal requirements about relative claims, see FDA’s regulations.

  • High/Good Source of/More: FDA regulates claims about whether a food is a “good source of” a particular nutrient or vitamin. Generally, labels may make “good source of” claims if the food contains between 10 and 19 percent of the reference daily intake or daily reference value ordinarily consumed. To use the term “more,” the food must contain at least 10 percent more of the nutrient than a reference food of the same serving amount. The term “high” can be used if the food contains at least 20 percent more of the nutrient than a reference food of the same serving amount. See FDA regulations for more information.

b) Implied nutrient content claim: Implied nutrient content claims are claims that describe a food or ingredient in a way that suggest that a specific nutrient is present or absent in amounts (like “high in oat bran”) or suggest the food is useful in maintaining some healthy dietary practice because a certain ingredient is present or absent. An implied nutrient content claim is not the same as simply saying that some ingredient is or is not present. The claim must lead the consumer to connect the nutrient to some additional dietary assumption about the presence or absence of the nutrient or ingredient. FDA only allows some nutrient content claims on labels. These claims are listed in FDA regulations. Outside of these pre-established claims, an implied nutrient content claim cannot appear on a food label.

c) Healthy, healthful, healthiness: FDA allows the use of the term “healthy” (or related terms such as “healthful,” “healthily,” “healthiness,” etc.) as an implied nutrient content claim on food labels when it is useful for creating a diet consistent with dietary recommendations. The  nutrient conditions necessary for a “healthy” diet include specific criteria for nutrients to limit in a diet, such as total fat, saturated fat, cholesterol, and sodium. The nutrient criteria to use this claim varies for different food categories, and are different for raw fruits and vegetables than for frozen or canned fruits and vegetables, enriched cereal products, and seafood or meat products. For more information on this term, see FDA’s Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products.

Structure/Function claims

A structure/function claim describes the effect that an individual nutrient or substance has on the normal structure and function of the body; for example, “calcium builds strong bones,” or “fiber maintains bowel regularity.” The key aspect of a structure/function claim is that it relates to the normal function of the human body, which is different from a health claim that deals specifically with diseases and the disease-reducing or -preventing qualities of a product. These types of claims do not require preapproval from FDA. If a producer wants to make a structure/function claim they must include the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

USDA Grades

Grades are distributed by the USDA Agricultural Marketing Service. They are voluntary, and the service is requested and paid for by meat and poultry producers and processors. Grades can refer to quality or yield. All shell eggs that include the USDA grade-shield on the label must include the size of the egg.

USDA Organic

This term means that a product has been produced according to the standards in the Organic Foods Production Act (OFPA) and certified by USDA’s National Organic Program or a state’s organic program which meets the same minimum standards as USDA’s program. A label may only use the “USDA Organic” seal if the food is actually certified organic. However, a package may still note which ingredients, or percent of ingredients, are USDA organic. Some producers, such as organic farmers who sell less than $5,000 in food per year, may also market their products as organic without certification.

Organic products are grown and processed according to federal standards on soil quality, pest and weed control, and use of chemical fertilizers, among other areas. According to USDA, “[o]rganic producers rely on natural substances and physical, mechanical, or biologically based farming methods to the fullest extent possible.” Additionally, the use of genetically modified organisms (GMOs) is “prohibited in organic production or handling.”

The amount of organic ingredients in a food matters for labeling. A “100% organic” product may only have ingredients that are organic. A food that has at least 95 percent organic ingredients may have the term “organic” on its label, if the organic ingredients are specifically noted somewhere on the package. If the product has at least 70 percent organic ingredients, the package may use the term “organic” to list the specific qualifying ingredients, but may not use the USDA Organic seal. Foods with organic ingredients, but which are less than 70 percent organic, may only use the term “organic” in the ingredient list or the percentage of organic ingredients.

USDA regulations require that the labels of certain agricultural products include language identifying the name of the certifying agent with language like “Certified organic by ____” which can enable consumers and others to know who certified the product as organic.

For more information on organic ingredient labeling, see the USDA Organic Labeling Standards website.

USDA Process Verified

USDA offers this seal to producers as a marketing tool. Participating producers submit the standards they have created themselves for consideration. and once USDA grants approval of those standards, the department conducts audits to verify that the company is following its own standards. For example, the meaning of a term such as “responsible use of antibiotics” can vary widely among producers, yet all are eligible to receive USDA Process Verified approval for the claim so long as each is following its own standards.

II. Undefined Voluntary Label Claims

As you will see by exploring Labels Unwrapped, many of the claims we see first on food packages are undefined voluntary claims. As stated above, voluntary label claims are used to market the product and make it stand out, like “sustainable” or “superfood.” Producers have a fair amount of discretion to choose what terms they use, and what those terms mean. However, they must ensure these claims are not false or misleading. A claim can be false and misleading not only based on what the label says or what imagery is included, but also what the label fails to say or even how the claims appear.

Third-Party Certifications

Independent third-party organizations offer various label certifications based on their own set of standards. Examples of third-party certifications include Fairtrade International, Certified Humane, and Non-GMO Project Verified. These independent certifiers set their own rules, standards, and accountability measures. Third-party certification standards are not vetted by any government agency, and have varying levels of transparency and reliability. Violations of the standards may be enforced through internal rules, like removing certification, or in some cases through private lawsuits. However, labels may make independent claims that relate to the same standards like “humane” or “ethical” without any certification.

Frequently Asked Questions

  1. How accurate are food label claims? Which ones can I trust, and how do I know I can trust them?

    Under the Federal Food, Drugs, and Cosmetic Act, labels cannot be false or misleading. FDA has the power to regulate labels to ensure that the information on the label does not deceive the consumer. However, label claims that are allowed by FDA can still be confusing—if they weren’t, this website wouldn’t be needed! The resources on this website are here to help you learn how to read food labels and understand the meaning of many of the labels you see. When label claims are regulated by FDA, you can feel confident the product meets the standards required for that claim, and if it doesn’t, you can report the product to FDA. For other label claims, you might consider doing a bit of research to understand how the company using the claim defines it. Extreme claims such as “cure-all” or “totally safe” should also be treated with caution. The nutrition panel and ingredients list are the most reliable sources for understanding the nutritional content or attributes of a product.

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  3. Does a food label have to be approved before it is used?

    The food labels on USDA-regulated products generally require preapproval to ensure the information is truthful, accurate, and not misleading.

    The labels on FDA-regulated products generally do not need to be preapproved by the agency before sale, although some specific types of claims may require the agency’s approval. For example, health claims about food must be authorized by FDA before use on a label.

    As you explore food labels, you can look to see what specific language is mandatory or required and regulated by the agencies versus what is voluntary or not required and sometimes undefined by the agencies. This site is intended to help you determine the difference and help you understand how to read food labels.

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  5. What types of products have to be labeled?

    Generally, labeling is required for all foods and drinks, including meat, poultry, and egg products. However, there are different requirements for restaurants and retail establishments selling “away from home” food. The law defines the term “food” broadly to include anything used for food or drink by humans or animals. This means substances like additives, some processing agents, and even food packaging materials can be regulated as food if those things become part of the final food product. Manufacturers generally are not required to get a food label approved before placing it on a product for sale. Depending on the category of food, there are different legal requirements for labeling.

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  7. What is considered a “fresh” food?

    Fresh means that the food is unprocessed, in its raw state, and has not been subject to any thermal processing or any other form of preservation. A product can still be labeled as fresh if coated in approved waxes, sprayed post-harvest with approved pesticides, rinsed in a mild chlorine or mild acid wash, or treated with ionizing radiation. Some “fresh” food is more specifically regulated like “fresh” whole poultry and cuts, which have never been held below 26°F.

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  9. What is a processed food?

    In general, a processed food can be: (1) any food that is not a raw fruit or vegetable; or (2) raw fruits and vegetables that have been subject to some sort of processing.

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  11. What are Raw Agricultural Commodities (RACs)?

    Raw agricultural commodities, or RACs, are fresh fruits, raw vegetables, grains, nuts, eggs, raw milk, meats, and similar produce in its natural, unprocessed state. The labeling of these products is typically exempt from the majority of requirements listed in this guide.

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  13. What is an imitation food?

    An imitation food is a food that is nutritionally inferior to the food it resembles or substitutes for. Under the Federal Food Drug and Cosmetic Act, imitation food must be labeled using the word “imitation” with the real food immediately following. For example “imitation crab” would be an acceptable way to label a product that is not crab and is nutritionally inferior to crab, but resembles or substitutes for crab.

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  15. Why doesn’t my food have a label?

    The Nutrition Labeling and Education Act requires most food to have a label; however, it excludes some food from this requirement. For example, produce can be sold without a label at the point of sale. This means that even though your apple doesn’t have a label declaring it to be an apple, the signage where you selected the apple meets certain requirements. Food sold in restaurants, made-to-order food, and bulk foods are exempt from some labeling requirements.

    For the full text of the Nutrition Labeling and Education Act, see here. To learn more about label requirements generally, see FDA’s Food Labeling Guide.

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  17. What do the dates on food packages actually mean?

    The US does not regulate expiration dates except for infant formula. Common phrases included on food product labels are “use by,” “sell by,” “best by,” and “better if used by.” Labels may utilize a familiar date listing or may use the Julian Calendar, where each number of the year is assigned a number from 1-365. Providing a date on a food is not required and is voluntary. These dates indicate quality, not safety.

    1. Best if Used By/Before date indicates when a product will be of best flavor or quality. It is not a purchase or safety date.
    2. Sell-By date tells the store how long to display the product for sale for inventory management. It is not a safety date.
    3. Use-By date is the last date recommended for the use of the product while at peak quality. It is not a safety date except when used on infant formula as described below.
    4. Freeze-By date indicates when a product should be frozen to maintain peak quality. It is not a purchase or safety date.

    For more information about dates on food, see the USDA’s Food Product Dating Guidance, available here.

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  19. What are “conventional” foods?

    “Conventional” is not defined by USDA or FDA. Generally, this word has been used to differentiate products that do not have the organic certification and may apply to foods that have not been bioengineered or do not contain bioengineered or genetically modified  food ingredients.

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  21. What is “fair trade” food?

    Fair trade generally means that producers and farmers receive fair compensation for their products and better working conditions for laborers. The USDA Agricultural Marketing Service’s Fair Trade Practices Program has four divisions which enforce federal agricultural labor and labeling statutes. Compliance with these statutes is mandatory for producers, and USDA does not offer its own fair trade certification.

    There are also several third-party certifications offered to producers. One of the largest fair trade certifiers is Fairtrade International, which works with producers, brokers, and buyers to ensure fair price, labor, and environmental standards. Each third-party certifier sets their own standards and accountability measures.

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  23. What does it mean if a food is made using “sustainable” practices?

    The term “sustainable” is used widely and can have different meanings in different contexts. USDA defined sustainable agriculture as “an integrated system of plant and animal production practices having a site-specific application that will, over the long-term:

    • satisfy human food and fiber needs;
    • enhance environmental quality and the natural resource base upon which the agriculture economy depends;
    • make the most efficient use of nonrenewable resources and on-farm resources and integrate, where appropriate, natural biological cycles and controls;
    • sustain the economic viability of farm operations; and
    • enhance the quality of life for farmers and society as a whole.”

    However, this definition applies to USDA’s own agricultural research activities, not necessarily how producers may use the term to market foods. For producers, the term cannot be used in a way that is false or misleading, but producers have a lot of discretion in how they define “sustainable.”

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  25. What does “ethically sourced” mean?

    Neither USDA nor FDA defines the term “ethically sourced.” Like all food label claims, whatever appears on a label cannot be false or misleading. As stated above, some producers use labels of third-party certifications. One example of a third-party certification that focuses on ethical production is B Corps certification, a nonprofit that assesses companies’ impacts on “workers, customers, community, and environment.” However, third-party certifiers set their own guidelines and accountability standards, which are not enforced by the government. Beyond a third-party certification, producers are able to define what qualifies as “ethically sourced.”

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  27. What do food and diet fads mean when you see them on labels?

    Right now, FDA doesn’t regulate labels that suggest that a food adheres to a specialized diet or fad, because FDA regulates foods and products, not diets. However, some of the nutrient content or health claims that may be associated with trendy diets are regulated by FDA. FDA also warns against products promising miracle weight loss, and other fraudulent health products.  Here are some examples:

    • Keto: The ketogenic diet is a low carbohydrate, high fat diet. It is not regulated by FDA, but claims that may be associated with foods that adhere to ketogenic nutrient plans, such as “low carb” and others, are regulated by FDA. A food product that claims to be “keto” cannot make health claims on the label that suggest the food aids in treating, mitigating, or curing a disease.
    • Paleo: The paleo (paleolithic) diet consists of foods that could be hunted, fished, or gathered during prehistoric times. FDA does not regulate the use of the paleo claim. Claims that may be associated with paleo foods, such as “high protein,” or “low carb,” however, are regulated by FDA.
    • Vegan/plant-based: Vegan foods typically do not include any ingredient made or derived from an animal. The third party Certified Vegan seal indicates that a product has been verified to not include animal products or byproducts and was not produced using animal testing. This certification is administered through the Vegan Awareness Foundation. According to the website, the certification does not prohibit the use of shared machinery, so consumers with food allergies are encouraged to read the full ingredients label and allergen statements. Major allergens like milk, eggs, fish, and shellfish must be disclosed on food labels under the Food Allergen Labeling and Consumer Protection Act of 2004.
    • Superfood: There is no federal definition for a “superfood.” Rather, this term is mostly a marketing buzzword meant to note that a product is high in beneficial vitamins and nutrients.
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  29. What does “humane” mean?

    The meaning of this claim varies depending on the animal. Compliance is not verified by either USDA or FDA, but is verified through third-party, nongovernmental auditing from Humane Farm Animal Care. In general, “certified humane” certification signifies the animals have ample space to roam, access to fresh water and a healthy diet free of antibiotics and hormones, continual outdoor access, and producers have complied with a set of animal-specific standards. Certified humane farms are subject to inspections from Humane Farm Animal Care, and must use certified humane slaughter facilities as well. Feedlots are permitted to be certified humane, so long as they comply with requirements for space, dry mounds, sun shades, wind breaks, and drainage slopes. Certified humane standards vary based on the animal in question, and more information may be found here.

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