LABELING, FOOD

LABELING, FOOD. Food products offered for sale in the United States are subject to a number of legal requirements regarding what information must, may, and may not appear on the package label. Food labels serve many purposes. The label identifies what the product is and how much of it there is, alerts individuals to the presence of allergenic ingredients, and provides nutritional information to enable consumers to make healthy dietary choices. Many of the regulations governing food labeling are extremely detailed, often specifying the placement and minimum type size of required information.

The term "label" refers to any written, printed, or graphic matter on the food's immediate container. "Labeling" includes the label and any other written, printed, or graphic matter accompanying the product in commerce (e.g., point-of-sale pamphlets). Most label information is required to appear on either the "principal display panel" (PDP) or the "information panel." The PDP is the part of the label most likely to be displayed to, and examined by, consumers under customary conditions of retail sale. The information panel is generally the panel contiguous to, and to the right of, the PDP. If that panel is unusable or too small, the next panel to the right of it may serve as the information panel. If the top of the container is the PDP, the information panel may be any panel adjacent to the PDP.

Government Agencies and Governing Laws

The U.S. Food and Drug Administration (FDA) is the federal government agency that administers and enforces labeling requirements for all foods (except meat and poultry) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act. The U.S. Department of Agriculture (USDA) administers and enforces labeling rules applicable to meat and poultry products under the Federal Meat Inspection Act and the Poultry Products Inspection Act. While the FDA does not require, or offer, prior approval of food labels, the USDA requires government approval of most meat and poultry product labels prior to their use in U.S. commerce.

Other federal agencies play a role in regulating food labeling as well. The U.S. Customs Service requires country-of-origin marking on the labels of imported food products. The U.S. Treasury Department's Bureau of Alcohol, Tobacco, and Firearms (BATF) regulates the labeling of alcoholic beverages. The Federal Trade Commission (FTC) regulates the advertising of food products.

Federal law preempts inconsistent state laws in most areas of food labeling, but there are some aspects of labeling where states may and do impose their own requirements. For example, some states have promulgated their own labeling requirements regarding safety warnings, use-by or sell-by dating, and religious dietary laws.

General prohibition against misbranding. Federal law provides that a food product may be deemed "misbranded" if any part of its labeling is false or misleading. This general provision establishes misbranding even where no specific regulatory requirement has been violated. A food also may be deemed misbranded if any required information is not presented prominently enough—that is, likely to be read and understood by the ordinary consumer under usual conditions of purchase and use.

Mandatory Label Information

Statement of identity. The statement of identity (i.e., the name of the product) must be presented on the PDP. Both the FDA and the USDA have regulations establishing "standards of identity" for certain foods. These regulations prescribe the composition of a food and specify the name of the food to be used in labeling. For example, a food composed of tomato concentrate, vinegar, and spices must be identified as "catsup," "ketchup," or "catchup." However, not all statements of identity are dictated with such specificity. For any given product, the statement of identity is one of the following:

1. The name of the food as specified in any applicable federal law or regulation, such as a standard of identity (e.g., "ketchup") or a federal common or usual name regulation (e.g, "peanut spread")
2. The common or usual name of the food, established by common usage (e.g., "French toast")
3. An appropriately descriptive term (e.g., "hard candy")
4. A fanciful name commonly used by the public when the nature of the food is obvious (e.g., "candy corn").

Net quantity of contents. The net quantity of contents must be presented on the PDP of the food label in measures both English avoirdupois (i.e., ounces, pounds, etc.) and metric (i.e., liters, grams, etc.). For meat and poultry products, the net contents declaration is required to appear only in avoirdupois measure.

Nutrition facts. The amounts of certain nutrients present in one serving of the food product must be presented in the "nutrition facts" panel. Similar products have the same serving size so that consumers can easily compare nutrient levels. Nutrition facts must state the serving size (i.e., the size of one serving) and, unless the product contains only a single serving, the number of servings in the package. Generally, the following nutrients must be declared: calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. If other vitamins or minerals are added to the food, they also must be declared.

The graphic requirements for nutrition facts are highly detailed. Nutrition facts generally must appear on the PDP or the information panel. They must appear on the same panel as the ingredients list and the signature line, unless there are space constraints.

Raw fruits and vegetables and raw seafood, which frequently are sold in unpackaged form, are exempt from mandatory nutrition labeling. Instead, the twenty most frequently consumed varieties of fruits, vegetables, and seafood are subject to voluntary nutrition labeling guidelines that apply to retailers of these products. Single-ingredient raw meat and poultry products are likewise subject to a voluntary, retail-level nutrition-labeling program. It should also be noted that restaurant and food-service foods are exempt from nutrition-labeling requirements.

Ingredients list. Each ingredient present in a food product must be listed by its common or usual name in descending order of predominance by weight. While most ingredients must be identified by their specific name, use of generic names is permitted for certain ingredients (e.g., "spices," "natural flavor"). Special rules apply to the listing of certain types of ingredients. For example, chemical preservatives must be listed by their name, followed by a description of their function—such as "BHT (a preservative)." Certified color additives must be identified by their specific name (e.g., "Yellow 5" or "FD&C Blue 1 Lake"), but color additives not subject to certification may be listed using a generic term (e.g., "artificial color") or a specific name followed by a description of its function (e.g., "caramel color").

An ingredient that itself contains two or more ingredients must be listed in one of two ways:

1. By declaring the common or usual name of the ingredient followed by a parenthetical listing all of its components—for example, "milk chocolate (sugar, cocoa butter, milk, chocolate liquor, soy lecithin, vanilla)," or
2. By listing each component of the multicomponent ingredient without declaring the multicomponent ingredient itself—for example, "sugar, cocoa butter, milk, chocolate liquor, soy lecithin, vanilla."

The ingredients list may appear on either the PDP or the information panel, but it usually appears on the information panel. It must appear on the same panel as the nutrition facts and the signature line unless space constraints prevent such placement.

Signature line. The name and place of business of the manufacturer, packer, or distributor is typically called the "signature line" and must be presented on the same panel as the ingredients list and nutrition facts (usually the information panel), unless space constraints preclude such placement. If the name is not that of the manufacturer, it must be preceded by a qualifying phrase stating the firm's relation to the product (e.g., "manufactured for" or "distributed by"). The signature line must include a city or town, state (or country, if outside the United States), and ZIP code (or mailing code if outside the United States). A street address must be provided unless the firm is listed in a current city or telephone directory.

Label Information Required in Specific Cases

In specific circumstances—particularly when additional information could protect or otherwise benefit the consumer—specialized labeling may be required.

Warning and information statements. Certain products are required to present warning or information statements on their labels. For example, foods containing the artificial sweetener aspartame must bear the following statement in capital letters: "phenylketonurics: contains phenylalanine." Other food products required to bear warning or information statements on their labels include the following:

1. Foods that contain the fat replacer olestra
2. Foods that contain the artificial sweetener sorbitol (daily ingestion of 50 grams or more)
3. Foods that contain the artificial sweetener mannitol (daily ingestion of 20 grams or more)
4. Foods that contain dry psyllium husk and that bear a health claim linking consumption of soluble fiber from psyllium husk with reduced risk of coronary heart disease
5. Irradiated foods
6. Fresh eggs (in consumer packages)
7. Foods packaged in self-pressurized containers and intended to be expelled from the package under pressure
8. Foods that contain, or are manufactured with, chlorofluorocarbon or other ozone-depleting substances
9. Juices or juice-containing beverages that have not been processed so as to produce a minimum five-log (i.e., 100,000-fold) reduction in the most resistant pathogen of public health significance (e.g., E. coli ) likely to occur in that product
10. Meat and poultry products that require special handling to maintain wholesomeness
11. Foods that contain any meat or poultry that is not ready-to-eat.

Juices. Certain categories of food products are subject to special labeling requirements. Among the most commonly consumed of such products are the numerous varieties of juices available on the market. Any beverage containing fruit or vegetable juice is required to present a percent juice declaration (e.g., "100 percent juice" or "contains 50 percent orange juice"). This declaration must appear near the top of the information panel and is usually placed directly above the nutrition facts. If a beverage contains less than 100 percent juice and its statement of identity includes the word "juice," it must also include a qualifying term such as "drink," "beverage," or "cocktail." If one or more of the juices in the product is made from concentrate, the statement of identity must be qualified with the words "from concentrate" or "reconstituted."

Country-of-origin marking. Imported foods are required to bear country-of-origin marking (e.g., "product of Italy"). Country-of-origin marking must appear in a conspicuous place and as legibly, indelibly, and permanently as possible. Placing country-of-origin marking immediately beneath the signature line is often ideal. If the signature line states a U.S. address, it should be followed by country-of-origin marking to avoid misleading consumers about the product's geographic origin.

Flavor designation. If the label (other than in the ingredients list), labeling, or advertising for a food makes a representation (such as by words or pictures) about the food's primary recognizable flavor, that flavor is considered its "characterizing flavor" and must accompany the statement of identity on the PDP.

Nutrient content claims. If a food product's label includes a relative nutrient content claim (e.g., "reduced fat," "light," or "added calcium"), the nutrient content claim must be accompanied by information identifying the reference food and explaining how much the nutrient in question has been reduced or added. In addition, use of certain nutrient content claims triggers the need to include additional nutrient declarations in the nutrition facts. For instance, a claim about potassium content triggers the requirement to declare the actual potassium content in the nutrition facts.

Optional Label Information

Nutrient content claims. A nutrient content claim is any representation that characterizes the level of a nutrient in a food product (e.g., "low fat," or "sugar free"). A nutrient content claim must comply with the specific criteria for that particular claim. For instance, to make a "low fat" claim, a food must contain three grams or less total fat per reference amount customarily consumed (RACC). (The RACC, as established by the FDA, is the amount of food normally consumed per eating occasion by persons four years of age or older.)

A label statement about the actual amount or percentage of a nutrient in a food ("5 grams of fat per serving") is permitted, provided it is truthful and not misleading and does not characterize the level of the nutrient in the food. If the statement implicitly characterizes the level of the nutrient ("just 5 grams of fat per serving"), it is an implied nutrient content claim and must either meet the requirements for the implied nutrient content claim ("low fat"), or bear a disclaimer that the food does not meet those requirements ("just 5 grams of fat per serving, not a low-fat food"). Statements such as "contains the same amount of potassium as a banana" or "as much calcium as milk" are permitted, provided the reference food qualifies as a "good source" of the nutrient and the labeled product has at least an equivalent level of the nutrient per serving.

Health claims. A health claim is any representation that characterizes the relationship between any substance and a disease (such as coronary heart disease) or health-related condition (such as hypertension). A "substance" is a specific food or component of a food. A health claim must either be authorized by FDA regulation, or be an accurate representation of a current "authoritative statement" of a scientific body of the U.S. government with official responsibility for public health research related to human nutrition (e.g., the National Institutes of Health). Health claims based on an authoritative statement require premarket notification to FDA—an example is the FDA-approved health claim regarding the substance potassium and the conditions hypertension and stroke. Since 2001 the FDA has authorized the following health claims by regulation:

USDA regulations currently prohibit meat and poultry products from bearing health claims.

Like nutrient content claims, health claims must comply with both general requirements applicable to all health claims and specific criteria for the particular health claim being made. For example, to be eligible to bear a claim about soy protein and risk of coronary heart disease, a food must contain at least 6.25 grams of soy protein per RACC, must qualify as a low-cholesterol and low-saturated-fat food, and must qualify as a low-fat food.

To bear a health claim, a food may not contain disqualifying levels of certain nutrients—total fat (13 grams), saturated fat (4 grams), cholesterol (60 milligrams), or sodium (480 milligrams)—per RACC or per labeled serving. Under what is known as the "jelly bean rule," a food making a health claim must contain per RACC, prior to any nutrient addition, a minimum level of at least one of the following nutrients: vitamin A (500 international units or more), vitamin C (6 milligrams or more), calcium (100 milligrams or more), iron (1.8 milligrams or more), protein (5 grams or more), or dietary fiber (2.5 grams or more). The purpose of the so-called jelly bean rule is to prevent a food of little nutritional value from bearing a health claim simply because the food has been fortified. Reasonably, the health claim that links sugar alcohols to dental caries is exempt from the jelly bean rule.

The wording and placement of health claims are highly regulated.

Structure and function claims. A truthful statement that a food or any ingredient helps maintain a structure or any function of the body may be made in labeling (e.g., "cranberry juice may help maintain a healthy urinary tract"). The manufacturer or distributor making the claim must have scientific evidence supporting the claim.

Other claims. A number of other claims that may be made on food labels are also regulated. The FDA has requirements for claims that a food is "fresh" or "healthy." The USDA has regulations defining "organic." The FTC limits the use of the claim "new" to a period of six months after a product is introduced into the market. Provided the information given is truthful and not misleading, a food may bear a claim about the presence of an ingredient perceived to add value ("made with real fruit") or about the absence of a nonnutritive ingredient ("no preservatives").

Symbols on food labels. Food labels may bear a variety of symbols or logos. Some of these are required. For example, irradiated whole foods are required to carry the radura symbol (i.e., the international symbol of food irradiation, which resembles a flower in a circle), and all meat and poultry products are required to bear the USDA official inspection mark. Other symbols are optional. These include the Uniform Product Code (UPC; the most familiar bar code) and symbols indicating that a food product is kosher.

Recipes and miscellaneous information. Food labels may carry a wide variety of other optional items, including such things as recipes, promotions, and "romance copy" (e.g., information extolling the virtues of a product or describing its history). Such information is permitted, provided it is truthful and not misleading.

Prohibited Label Information

Any information that is false or misleading in any particular will render a product misbranded. In determining whether a food label is false or misleading, both affirmative representations and omissions of material facts may be considered. Certain information is clearly prohibited from the labeling of food products. This includes unauthorized nutrient content claims (for instance, claiming "high in omega-3 fatty acids"), health claims not authorized by FDA or supported by an authoritative statement, and disease claims (for instance, claiming "helps lower blood pressure" would subject a product to regulation as a drug).

Language Specifications

All mandatory label information in the United States must appear in English. If labeling includes foreign language words of a type that are likely to bring the product to the attention of consumers who do not understand English, then all mandatory information must appear in both English and the foreign language. Certain foreign language words will not trigger dual-language labeling—for example, an accepted name for which there is no English equivalent (such as "antipasto"), a foreign name used in a standard of identity (such as "spaghetti"), and the use of one or more foreign language words in a brand name, motto, or trademarked design.

In Puerto Rico and other U.S. territories where the predominant language is other than English, the predominant language may be substituted for English, except in the case of the USDA inspection mark on meat and poultry products, which must appear in English.

See also Additives; Food Politics: United States; Government Agencies, U.S.; Health and Disease; Inspection; Marketing of Food; Nutrition.

BIBLIOGRAPHY

Olsson, Philip C., Richard L. Frank, David F. Weeda, et al. U.S. Food Labeling Guide. Washington, D.C.: Food Institute.

U.S. Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development, and Evaluation. Labeling and Consumer Protection Staff: Ten Most Commonly Asked Questions. Available at 2002.http://www.fsis.usda.gov/OPPDE/larc/TenQuestions.htm.

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. A Food Labeling Guide. Available at http://www.cfsan.fda.gov/dms/flg-toc.html.

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food Labeling Questions and Answers. 1993. Available at http://vm.cfsan.fda.gov/lrd/qa2.html.

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food Labeling Questions and Answers, Volume 2: A Guide for Restaurants and Other Retail Establishments. 1996. Available at http://www.cfsan.fda.gov/frf/qaintro.html.

U.S. Food and Drug Administration, Office of Regulatory Affairs. Compliance Policy Guides Manual. 2002. Available at www.fda.gov/ora/compliance_ref/cpg.

Richard L. FrankRobert A. Hahn