Food Labels

Section 201(m) of the FD&C Act discusses labels for food and other products not only because of what they say or imply by their design but "also the extent to which the labeling or advertising fails to reveal facts" that a consumer would want to know. Food labels must provide certain information such as ingredients, the identity of food, and the quantity. Labels are the "written, printed or graphic" material that appears on a food package, but materials that accompany the food or are part of the package also are considered labeling under the FD&C Act.

• The Center for Food Safety and Applied Nutrition discusses Food Labeling requirements in detail on its food labeling page, in an FDA Backgrounder, and in a Food Labeling Guide that still is relatively up-to-date (1994, revised 1999). The Center also has a web site addressing common consumer concerns about food labeling and other aspects of its products entitled Food, Nutrition, and Cosmetics Questions & Answers. Consumers also may obtain more information about the FDA’s dietary supplement and food labeling activities by signing up to receive the FDA’s Dietary Supplements/Food Labeling Electronic Newsletter.
  
  
• The FDA specifies that the name of the food and the net quantity must be placed on the "principal display panel" or the portion of the package most likely to be viewed by the consumer while other requirements can be satisfied by providing the information on an information panel to the right of the principal display panel (thus on a box, the principal display panel would be in front, facing the consumer on the store shelf, while the information panel would be on the right side of the box).
  
  
• Labeling information must be displayed in a certain size and font to ensure that it is visible to consumers although there are some exceptions to these rules for soft drink bottles and some packaged foods.
  
  
• Either the information panel or the principal display panel should contain the ingredients, location of the manufacturer, and nutrition information. The information must be in English but may be in a foreign language as well.
  
  
• The label must contain an ingredients statement listing the common name of ingredients in descending order by weight contained in the final product unless they represent under 2% of the food's weight, in which case the ingredients may be listed as "contains _ percent or less of _." Listing ingredients as "natural flavors" or "spices" is sufficient if the ingredients represent less than 2% of the foods weight (Kracov, pp. 190; CFSAN, A Food Labeling Guide). Water is considered an ingredient.
  
  
• Food additives present at insignificant or trace levels need not be included unless the ingredient has a "function or technical effect in the finished product."
  
  
• The purpose of chemical preservatives must be described along with their name; for instance, "sodium benzoate added to preserve freshness" or "preservative" or "to help protect flavor."
  
  
• Labels also must indicate the country of origin if the product has been imported from outside the United States.
  
  
• The "responsibility statement" lets consumers (and health officials) know the manufacturer's name and location.
  
  
• A "net quantity of contents statement" tells consumers the weight or amount of the product contained within the package.
  
  
• The "identity statement" tells consumers the name of the food. Under section 401 of the FD&C Act the FDA can establish standards or definitions for certain foods.
  
  
• Drinks containing juices must inform consumers of the percentage of juice contained in the product on the information panel. For instance, the label on Minute Maid Lemonade Iced Tea states that the drink contains "_ percent lemon juice." Juices from concentrate and beverages containing 1% or less of juice must be labeled as such.
  
  
• Nutrition information listing certain nutrients or "nutrition facts" is a required part of the label and should be placed on the principal display panel or information panel.
  
  
• The Nutrition Labeling and Education Act requires that labels must contain from top to bottom the amount of each of the following in each serving of the food: Total Calories, Calories from Fat, Total Fat, Saturated Fat, Cholesterol, Sodium, Total Carbohydrate, Dietary Fiber, Sugars, Protein, Vitamin A, Vitamin C, Calcium and Iron. Type and font sizes for nutrition information has been specified by the FDA.
  
  
• Manufacturers can voluntarily indicate calories from saturated fat, polyunsaturated and monounsaturated fat, soluble and insoluble fiber, sugar alcohols, other carbohydrates, other vitamins besides vitamins A and C and minerals such as potassium and copper.
  
  
• The Daily Values of fat, saturated fat, total carbohydrates, protein, cholesterol, dietary fiber, sodium and potassium also must be indicated on the label. The daily values for these are calculated by the FDA based on a 2,000 calorie diet. The FDA has established a reference daily intake for certain vitamins and minerals and this information also must appear in the nutrition information section.
  
  
• Labels must indicate the serving size based on the FDA's lists of reference amounts customarily consumed and the number of servings per container.
  
  
• Subject to certain exemptions, the FDA has specified that Warning or "safe handling" statements must be placed on the principal display panel of some products. For example, packages with contents under pressure, such as whipped cream, must contain the statement "WARNING—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperate above 120 deg. F. Keep out of reach of children."
  
  
• Other warning statements apply to these items:
  
  
  • Foods that derive more than 50% of their caloric content from protein or amino acid mixtures (must advise consumers about the dangers of low-calorie protein diets)
    
    
  • Dietary supplements with iron and iron salts (must advise consumers that children under 6 may suffer poisoning due to accidental overdose with iron-containing products)
    
    
  • Juices that have not been pasteurized (advising consumers that unpasteurized juice "may contain harmful bacteria")
    
    
  • Eggs (advising consumers that eggs should be cooked to prevent bacterial contamination)
    
    
  • Olestra ("This product contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E and K have been added.")
    
    
  • Aspartame ("Phenylketonurics: contains phenylalanine")
    
    
  • Foods with more than 50 grams of sorbitol (that too much sorbitol may "have a laxative effect")
    
    
  • Psyllium seed husk products that make a health claim between fiber and reduced risk of heart disease (must advise consumers to consume with water)
    
    
  • Until recently, under a 1977 law saccharin-containing products had to be labeled with the statement "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals." However, this requirement was repealed as part of an appropriations bill in 2001.
  
  
• The Nutrition Labeling and Education Act provided for the FDA to issue regulations for voluntary nutrition labeling for the 20 most frequently consumed raw fruits, raw vegetables and fish. The FDA recently has proposed a rule that would update and revise this list with respect to listings of the 20 most commonly consumed raw fish species.
  
  
• The FDA is in the process of finalizing a regulation first proposed in 1999 that will require labeling of trans-fatty acids - a type of unsaturated fatty acid with a chemical structure that resembles saturated fats and is associated with high cholesterol and high blood pressure. Foods such as margarine and vegetable shortening and doughnuts have relatively high levels of trans fatty acids, according to an Institute of Medicine report and University of Delaware database.

The U.S. Department of Agriculture Nutrient Data Laboratory’s home page contains information about the nutrient composition of more than 6200 foods. Consumers can search the Nutrient Database for Standard Reference and access other nutritional information. The Nutrient Data Laboratory’s Web site also includes information about carotenoid, isoflavone, oxalic acid, and transfatty acid content of certain commonly consumed foods.

• Nutrient Descriptors and Implied Claims
  
  
  • Manufacturers may claim that their food is "reduced fat" or "light." These types of claims, known as nutrient content claims or nutrient descriptors are defined as "claims on a food product that directly or by implication characterizes the level of a nutrient in the food" and are regulated by the FDA.
    
    
  • Nutrient claims may be made if the FDA issues a regulation in response to petitions from food manufacturers or if the statement is consistent with an "authoritative statement" from a U.S. government agency or the National Academy of Sciences. These claims usually apply to nutrients for which daily values have been established.
    
    
  • Manufacturers are permitted to make 2 kinds of nutrient content claims: absolute claims and relative or comparative claims.
    
    
    • Comparative claims must inform the consumer what product the food is being compared to and the percentage or quantity that has been changed. The product also must compare the amount of nutrient per serving in the manufacturer's product to the subject of the comparison. Examples of comparative claims include "light" (such as light potato chips), "reduced," "added," "fortified," "enriched," "more," and "less."
      
      
    • Absolute claims can be made about total fat, saturated fat, cholesterol, sugar, and sodium. Examples include "free" or "low." The FDA has specific definitions for which foods can be labeled as free or low for each of these characteristics. For instance, a cholesterol-free food is defined as a food having less than 2 mg per reference amount and per labeled serving where the reference amount is the amount of food customarily consumed in a serving.
    
    
  • The FDA has recognized and defined other nutrient content claims including: "lean," "extra lean," "high potency," "modified," "fiber," and "antioxidant."
    
    
  • Implied claims, such as "healthy," "contains 3 grams of fat," and "made with oat bran," are permitted only if provided by FDA regulations. But a manufacturer can say that its product is a good source of a nutrient (for example "a good source of oat bran") or claim that its product "contains as much [nutrient] as a [food]" (such as "contains as much vitamin C as an 8-ounce glass of orange juice").
    
    
  • The terms "fresh" and "frozen" are defined by the FDA but are not considered nutrient content claims.
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  • Disclosure statements are required when nutrients such as sodium, cholesterol, and fat exceed certain levels. For instance, the disclosure statement might advise the consumer to "[s]ee nutrition information for sodium content."
    
    
  • Foods claiming to be "healthy" must have low levels of fat and saturated fat as defined by the FDA and cannot contain high levels of cholesterol and sodium that would require a disclosure statement. Healthy foods also must have 10% of the daily value of vitamins A, C, calcium, iron, protein, or fiber.
    
    
  • The term "natural" has not been defined by the FDA, although the agency does regulate the use of the term "natural flavoring." Meat and poultry products, which are regulated by the USDA, are governed by that agency’s definition of "fresh" or "natural" (USDA Food Safety and Inspection Service, Meat and Poultry Labeling Terms, 2001). The FDA has suggested that the term natural implies that "'a food is made without chemical food additives or refined ingredients'" (Hutt, 1998).
    
    
  • A current report from the National Consumers League (NCL), a nonprofit consumer association, suggests that consumers may be confused about how the term "natural" is used on cosmetic, drug, foods, and dietary supplements. The report suggests that consumers may be unaware that because the FDA has not specifically defined how the term natural is used on foods and dietary supplements and because "there is a lack of consensus on what the term 'natural' actually means" for a product, some products labeled as natural or "plant-derived" actually may contain synthetic substances and substances that have not been proven safe and effective. For instance, the report cites examples of botanical products and other supplements that are believed to be responsible for some adverse events in consumers even though advertised as natural or derived from a plant. Other supplements contained traces of heavy metals or pharmaceuticals. The NCL has urged stricter regulation of the use of the term "natural" on labels of FDA-regulated products.
    
    
  • One illustration of how confusing the term "natural" can be occurred in September 2002 when the Center for Science in the Public Interest criticized ice-cream and frozen yogurt maker Ben & Jerry’s for describing its products as "all natural" even though some of these products may "contain artificial flavors, hydrogenated oils, or other factory-made substances" (CSPI, 2002; "Ben & Jerry’s. Case Highlights, 2002). For instance, CSPI said that the company’s Chocolate Fudge Brownie Low Fat Frozen Yogurt includes corn syrup and partially hydrogenated soybean oil. Ben & Jerry’s said that it would study and address this issue but also pointed out that "there is no agreed-upon definition of all-natural" (Ben & Jerry’s, Ben & Jerry's Response, 2002).
    
    
  • Use of the term "organic," describes not only the food but the way it is produced, is regulated by the U.S. Department of Agriculture not the FDA. The USDA recently established guidelines for the labeling of foods as organic (Sagon, 2002; USDA, Veneman Marks Implementation, 2002).
  
  
• Health claims
  
  
  • FDA-approved health claims are permitted on labels of foods and dietary supplements if the FDA has issued a regulation allowing the claim. Health claims tout the benefit of a given nutrient in treating a disease or condition rather than the amount or level of the nutrient in a food. For instance, the FDA has approved the claim that consumption of calcium is linked to lower risk of osteoporosis.
    
    
  • There are 2 basic types of health claims for foods: claims authorized under section 403 of the FD&C Act as amended by the 1990 Nutrition Labeling and Education Act and claims based on authoritative statements by a government agency or the National Academy of Sciences.
    
    
  • Foods making health claims must have at least 10% of the daily value for vitamins A and C and iron, calcium, protein, and fiber and must not contain high levels of saturated fat, sodium, or cholesterol.
  
  
• NLEA Claims
  
  
  • Under authority granted it by the 1990 Nutrition Labeling and Education Act, by 2000 the FDA had approved 12 health claims regarding
    
    
    • Calcium and osteoporosis
    • Low sodium and hypertension
    • Dietary saturated fat and cholesterol and risk of heart disease
    • Plant sterol/stanol esters and risk of coronary heart disease
    • Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
    • Fiber-containing grain products, fruits, and vegetables and cancer
    • Dietary fat and cancer
    • Fiber-containing products and risk of coronary heart disease
    • Folate and neural tube defects
    • Sugar alcohol and tooth decay (dental caries)
    • Fiber-containing grain products, fruits and vegetables and cancer
    • Soy protein and reduced risk of coronary heart disease
      
    
    
  • These claims are approved if there is "substantial scientific agreement" about the relationship between the nutrient and the disease or condition. The FDA carefully defines the requirements for each of these claims and provides model claim statements.
  
  
• Authoritative Statement Claims
  
  
  • The Food and Drug Modernization Act of 1997 allowed manufacturers to make health claims about foods provided that these claims are based on a statement from "a scientific body of the United States with official responsibility for public health protection or research directly related to human nutrition . . . or the National Academy of Sciences (NAS) or any of its subdivisions."
    
    
  • The federal agencies specifically mentioned in the 1997 law were the Centers for Disease Control and Prevention and the National Institutes of Health. But the FDA states in its guidance that it also will accept claims based on statements by the Surgeon General or U.S. Department of Agriculture. In addition, the FDA evaluates articles in medical journals and considers the opinions of organizations such as the American Heart Association in determining if there is "significant scientific agreement" sufficient to support a health claim.
    
    
  • According to the FDA's 1998 guidance on these types of claims, statements should be "about the relationship between a nutrient and a disease or health-related condition" or "identify the nutrient level to which the claim refers" for a nutrient content claim." Statements also should be published and current, be based on a "consensus within the identified scientific body" and be issued after "deliberative review by the scientific body of the scientific evidence."
    
    
  • The FDA has authorized 2 claims based on authoritative statements concerning whole grain foods and risk of heart disease and certain cancers, and sodium and risk of high blood pressure and stroke.
  
  
• Allergens
  
  
  • Food allergies are a priority for the Center for Food Safety and Applied Nutrition (CFSAN) as recalls of food products because of undeclared allergens have increased in recent years, and inspections of food manufacturers have revealed problems with cross-contamination of foods by allergenic ingredients during production.
    
    
  • CFSAN Director Joseph Levitt writes in a May 1 letter that "the FDA's policy with respect to allergens is that products that contain an allergenic ingredient by design must comply with section 403(i)(2) of the Act, which requires each ingredient in a food to be declared."
    
    
  • The FDA has issued a compliance policy guide (CPG) entitled Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens that details the FDA's policy on the issue of labeling food products that may be allergenic. The CPG focuses on 8 foods that may be responsible for 90% of allergies: crustacea (shrimp and crabs), eggs, fish, milk, peanuts, soybeans, tree nuts, and wheat.
    
    
  • Labeling of products has been a challenge for the agency because certain ingredients such as spices, flavorings, and additives are present at "insignificant levels." However, these ingredients or components may provoke allergic reactions in susceptible individuals.
    
    
  • In addition, consumers may not understand certain terms used on food labels. Few consumers are likely to be aware that albumin is derived from eggs or whey from milk. The FDA, the Food Allergy and Anaphylaxis Network, and the National Food Processors Association, an industry trade association, encourage food manufacturers to use plain language labeling easily understood by consumers.
    
    
  • Products that cause contamination of food with allergenic ingredients may occur inadvertently during the manufacturing process. If a facility manufactures bakery products with peanuts or peanut-derived ingredients (peanut butter), residues may be found in items that one might expect to be peanut-free unless equipment is carefully cleaned at regular intervals. Some manufacturers label their products to indicate cross-contamination may occur. For example, plain chocolate M&Ms labels state that the same equipment is used to make the peanut version.
    
    
  • Inspections conducted by the FDA in conjunction with Wisconsin and Minnesota officials found high rates of cross-contamination of foods such as bakery, candy and ice cream products with egg and peanut allergen (CFSAN, Dear Colleague Letter, 2001; CFSAN, Questions and Answers, 2001). Labels will not contain information in such cases because the manufacturers may be unaware such contamination has occurred. The FDA has published guidance for its investigators about how to identify potential problems with allergenic ingredients in manufacturing, and the food industry has supported voluntary labeling, although the "approach by many companies appears inconsistent," applying to some products but not others (Id.; Hutt, Guide to U.S. Food Labeling Law, Ingredient Labeling, Tab 438; Winter, Id).
    
    
  • The Food Allergen Consumer Protection Act, introduced in both the House (HR 4704) and the Senate (S. 2499), would require "easy to read" labeling and punish manufacturers that failed to adequately label products to indicate the presence or possible presence of allergens.