Statement of Identity21

What it is: This is simply the name of the food product. For example, “peanut butter” is a statement of identity. The statement of identity can be either: (1) the name required by law for certain products (the FDA has specific regulations for what foods must contain to be called certain things; e.g., in addition to other specific requirements, for a product to be called peanut butter, it must consist of ground peanuts to which 10% of stabilizing agents can be added, however, those stabilizing agents cannot be artificial flavorings, artificial preservatives, chemical preservatives, or color additives;22 (2) the common or usual name of the food; or (3) an appropriately descriptive term or fanciful name.23

Required: Yes.24

Specific Requirements: The form of the food must be identified as part of the statement of identity if the product is available in different forms. For example, if canned sliced tomatoes are also available in diced, stewed, or chunky then the label must state “sliced tomatoes.”25

Imitation food must be identified as such. A product is considered imitation if it is a substitute for and resembles another food product but is nutritionally inferior.26 For example, imitation crab meat must be labeled as such because it is not crab, but rather processed seafood intended to resemble crab.

Net Quantity27

What it is: This indicates the amount of food that is in the container or package. The quantity must be expressed in either: (1) weight; (2) measure; or (3) numeric count.28 Only the amount of food in the package is included in the net quantity.29 The weight of the package, container, wrappers, or packing material is not included in the net quantity. However, any water or other liquid added to the food is included in the net quantity.

Required: Yes. The net quantity must be placed on the bottom of the principal display panel.

Specific Requirements: If the food is a product that may lose moisture or weight during shipping, the manufacturer or producer is permitted to reasonably estimate the net weight of the product.

Health Claim30

What it is: Any claim that expressly, or by implication, describes the relationship between: (A) the food product or any component of the food; and (B) a disease or health related condition. A claim on a label is only considered a health claim if it references disease risk reduction. These claims can either be in the form of an affirmative statement, such as “can help lower cholesterol and reduce the risk of heart disease” or they can be implied with the use of symbols or images. For example, a heart symbol placed on a package can imply that a food is heart healthy.

Required: No. This is a purely voluntary statement included by the producer or manufacturer.

Types of Health Claims:
Descriptions of general well being or dietary guidance—This type of health claim does not mention a particular disease or disease-related condition. Rather, this claim is simply a statement that links general well-being to the consumption of a certain nutrient. For example, “a multivitamin contributes to general good health.” These types of claims do not require FDA pre-approval before the statement is included on the label. However, these claims must be truthful and not misleading.31

Pre-approved claims—There are certain health claims that the FDA has expressly authorized by regulation. These claims have been evaluated and approved by the FDA because there was significant scientific agreement, among qualified experts, that the claim was supported by the weight of the evidence.32 A manufacturer may include any of these pre-approved claims on their label if used according to the terms of the regulation. An example of a pre-approved claim that might be seen on a food label is, “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.” The following claims have been pre-approved by the FDA: (1) calcium and vitamin D and the reduced risk osteoporosis;33 (2) dietary fat and the reduced risk of cancer;34 (3) sodium and the reduced risk of hypertension;35 (4) dietary saturated fat and cholesterol and the reduced risk of coronary heart disease;36 (5) fiber containing grain products, fruits, and vegetables and the reduced risk of cancer;37 (6) fruits and vegetables and the reduced risk of cancer;38 (7) folate and the reduced risk of birth defects;39 (8) certain sweeteners and tooth decay;40 (9) soluble fiber and the reduced risk of coronary heart disease;41 (10) soy protein and the reduced risk of coronary heart disease;42 and (11) plant sterol/stanol esters and the reduced risk of coronary heart disease.43

Authoritative statements claims44—This type of claim is one that has not been expressly authorized by a regulation. A food producer can submit a health claim to the FDA for approval if it is based on current, published, and authoritative statements from a scientific body with official responsibility for public health protection or research directly relating to human nutrition, such as the National Institute of Health, Centers for Disease Control, or the National Academy of Sciences. The FDA must act within 120 days after the health claim is submitted to prohibit the claim. If the FDA takes no action then the food producer can use the claim on its label. To date, only four health claims based on authoritative statements have been approved: (1) whole grain foods and risk of heart disease and certain cancers; (2) potassium and the risk of high blood pressure and stroke; (3) fluorinated water and reduced risk of tooth decay; and (4) saturated fat, cholesterol, and trans fat and the reduced risk of heart disease.

Qualified claims—The FDA cannot reject a requested health claim for lack of scientific evidence without first considering whether the use of a disclaimer could communicate meaningful, non-misleading information to the consumer.45 A qualified health claim is one that requires a disclaimer. These claims still must undergo FDA approval prior to use. Even if a health claim is not supported by the weight of scientific evidence, it can still be used with an appropriate disclaimer. An example of a qualified health claim is: “Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.” This disclaimer is meant to signify to the consumer that the health claim made on the label may or may not be accurate.

Structure Function Claim46

What it is: This is a type of claim that 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 pre-approval from the 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.”47

Required: No. This is a purely voluntary statement.

Nutrient Level Claim48

What it is: This is a claim that characterizes the level of an individual nutrient in the food product.49 For example, low fat, high in fiber, or reduced sodium. Only the following claims can be made with regard to any individual nutrient: (1) free; (2) low; (3) reduced; (4) fewer; (5) lean; (6) high; (7) less; (8) more; (9) extra lean; (10) good source; (11) light; and (12) healthy. There are specific criteria laid out in the regulations that govern when these terms can be used. For example, a label can say “fat free” if the products contains less than 0.5 grams of fat per serving.

Required: No. This is a purely voluntary statement.

What each claim means: The FDA has written regulations with specific guidelines that address when these specific claims can be used. To see a chart that includes the definitions of these different terms, visit the FDA’s website here: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064911.htm.

Ingredient List50

What it is: This is a list of the ingredients that make up the product. The ingredients must be listed individually, by their common name, and in descending order of predominance by weight. This means that the ingredients listed first weigh more than those listed later. While this sounds simple enough, it means a manufacturer can use enough of an ingredient so that it makes up the majority of the food product, but choose to use different variations of that ingredient to avoid listing it as the primary ingredient. For example, a manufacturer might use a combination of corn syrup, cane juice, fructose, glucose, etc. to make their product sweet, but avoid listing sugar as the main ingredient.

The following items do not have to be included on the ingredient list:51 (1) processing aids;52 (2) incidental additives that are present in foods at insignificant levels and do not have any technical or functional effect in the food; and (3) substances that migrate into the food from equipment or packaging.53

Required: Yes. The ingredient list is typically found on the information panel of the product; however, it can also be placed on the principal display panel. It must be immediately below the nutrition facts box.

Specific Requirements: Chemical preservatives that are added to foods must be disclosed on the food label. A chemical preservative is any chemical added to food to prevent spoilage. These substances must be listed by their common name, but the label must also specify the function of the preservative. For example, a manufacturer must state that the addition of BHT is meant to act as a preservative.54 However, this requirement does not include any substance added to food by direct exposure, for example, chemical pesticides applied to food.55

Spice, natural flavors, or artificial flavors can be listed individually by their common name or simply with the declaration “spices,” “flavor,” “natural flavor,56” or “artificial flavor.57

Food Additives

What they are: Food additives are broadly defined and include any substances added to food with a few narrow exceptions. Importantly, the definition includes any substance that has been used in the production, processing, treatment, packaging, transportation, or storage of food. Additives have historically been used in foods for many different reasons—to promote flavor, act as a preservative, to thicken or affect the consistency of the product, etc. There are two different types of food additives recognized by the law: direct food additives (those which have been directly added to food for a specific purpose, e.g., absorbic acid to promote color retention) and indirect food additives (those that become part of the food product because of packaging, storage or handling—food packaging manufacturers must prove that all materials coming in contact with food are safe before they can be used, e.g., BPA, which is used in packaging can migrate into the food product).

Required: Yes, with some exceptions.

Specific Requirements: Food additives are presumed unsafe by the FDA and require pre-market approval before use unless there is already a regulation in place permitting use of the additive and specifying the conditions of use, or the substance has been determined to be generally recognized as safe or is a prior sanctioned substance by the FDA. Some examples of substances that are exempted from the definition of food additives are those commonly used in foods and considered safe based on their historical use, e.g., salt and sugar. Otherwise, for a new food additive, a manufacturer must file a petition with the FDA to receive approval.

Color Additives

What they are: Any dye, pigment, or substance that produces color when added or applied to a food. Color additives are presumed unsafe unless they are either: (1) certified by the FDA; or (2) exempt from certification in the interest of public health.

Required: Yes.

Specific Requirements: By law, the manufacturer must disclose any color additives included in the product and these require pre-market approval by the FDA before use. In the United States, there are nine color additives certified for use in foods (FD&C Blue No. 1 , FD&C Blue No. 2 , FD&C Green No. 3 , Orange B , Citrus Red No.2 , FD&C Red No. 3 , FD&C Red No. 40 , FD&C Yellow No. 5 , FD&C Yellow No. 6 ) and each has a corresponding regulation that specifies the conditions under which it may be used. Those color additives that are exempt from certification are derived from natural sources such as vegetables, minerals, or animals and include coloring derived from the annatto seed, grapes, saffron, etc. During the approval process, the FDA must consider whether the color additive is safe under the proposed conditions of use by taking into account several different factors. Additionally, color additives included in human food are subject to the Delaney Clause, which prohibits the listing of any color additive that is shown to cause cancer in humans or animals.

Nutrient Facts

What it is: This where the basic nutritional information about the product must be contained. This nutritional information must include: (1) serving size; (2) number of servings per container; (3) calories per serving; (4) calories from fat per serving; (5) total grams of fat per serving; (6) total grams of saturated fat per serving; (7) total grams of trans fat per serving; (8) total milligrams of cholesterol per serving; (9) total milligrams of sodium per serving; (10) total grams of carbohydrates per serving; (11) total grams of dietary fiber per serving; (12) total grams of sugar per serving; (13) total grams of protein per serving; and (14) a percent of daily value of vitamins and minerals per serving. Most of these must also be declared as a percent daily value on the label.58

Required: Yes. Typically the nutrition facts box is on the information panel, however, it can also be on the principal display panel.59 The information must be presented in the standard form illustrated by the image at left.60

Specific Requirements: There are several exemptions to this requirement, some of which include:

Manufacturer, Packer, or Distributor

What it is: This is the name, street address, city or town, state, and zip code of the party responsible for the product.66 The country of origin will also be located near this information. This is the company to contact with any questions or concerns about the product.

Required: Yes.

Specific Requirements: FDA guidance requires that the country of origin of the product must also appear in close proximity to the signature line in at least comparable size lettering. If, however, a foreign manufacturer is listed within the signature line, then the country of origin is part of the address and the words "Product of" can be shown after the signature line or any other conspicuous place on the label.

Allergen Information

Major food allergens must be identified either: (1) in the ingredient list; or (2) below the ingredient list following the word “Contains.” The more common practice is to have a separate line listing the allergens, for example “Contains: Wheat, Milk, Egg, and Soy.” The major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans.67