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The New Food Label

Grocery store aisles have become avenues to greater nutritional knowledge.

The new food label makes it possible. Under new regulations from the Food and Drug Administration of the Department of Health and Human Services and the Food Safety and Inspection Service of the U.S. Department of Agriculture, the food label offers more complete, useful and accurate nutrition information than ever before.

The purpose of the food label reform was simple: to clear up confusion that has prevailed on supermarket shelves for years, to help consumers choose more healthful diets, and to offer an incentive to food companies to improve the nutritional qualities of their products.

Among key features are:

• nutrition labeling for almost all foods. Consumers now can learn about the nutritional qualities of almost all of the products they buy.
• a new, distinctive, easy-to-read format that enables consumers to more quickly find the label and the information they need to make healthful food choices
• information on the amount per serving of saturated fat, cholesterol, dietary fiber, and other nutrients that are of major health concern to today's consumers
• nutrient reference values, expressed as %Daily Values, that help consumers see how a food fits into an overall daily diet
• uniform definitions for terms that describe a food's nutrient content--such as "light," "low-fat," and "high-fiber"--to ensure that such terms mean the same for any product on which they appear. These descriptors are particularly helpful for consumers trying to moderate their intake of calories or fat and other nutrients, or for those trying to increase their intake of certain nutrients, such as fiber.
• claims about the relationship between a nutrient or food and a disease or health-related condition, such as calcium and osteoporosis, and fat and cancer. These are helpful for people who are concerned about eating foods that may help keep them healthier longer.
• standardized serving sizes that make nutritional comparisons of similar products easier
• declaration of total percentage of juice in juice drinks. This enables consumers to know exactly how much juice is in a product.
• voluntary nutrition information for many raw foods.

The image is a clickable map. Click on any part of the food label to go to the relevant sections of the document.

NLEA

These and other changes are part of final rules published in the Federal Register in 1992 and 1993. FDA's rules implement the provisions of the Nutrition Labeling and Education Act of 1990 (NLEA), which, among other things, requires nutrition labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA-approved health claims.

Meat and poultry products regulated by USDA are not covered by NLEA. However, USDA's regulations closely parallel FDA's rules, summarized here.

Nutrition Labeling--Applicable Foods

The regulations, most of which went into effect in 1994, call for nutrition labeling for most foods. In addition, they set up voluntary programs for nutrition information for many raw foods: the 20 most frequently eaten raw fruits, vegetables and fish each, under FDA's voluntary point-of-purchase nutrition information program, and the 45 best-selling cuts of meat, under USDA's program.

Although voluntary, FDA's program for raw produce and fish carries a strong incentive for retailers to participate. The program will remain voluntary only if at least 60 percent of a nationwide sample of retailers continue to provide the necessary information. (In a 1994 survey, FDA found that more than 70 percent of U.S. food stores were complying.

Nutrition information also will be provided for some restaurant foods. The current regulations require nutrition information for foods about which health or nutrient-content claims are made on restaurant signs or placards. In June 1993, FDA proposed similar requirements for restaurant menu items with such claims. Under that proposal, restaurants would have to provide a "reasonable basis" for making claims. They would be given some flexibility in demonstrating that reasonable basis. For example, they could rely on recipes endorsed by medical or dietary groups.

Nutrition Labeling--Exemptions

Under NLEA, some foods are exempt from nutrition labeling. These include:

• food served for immediate consumption, such as that served in hospital cafeterias and airplanes, and that sold by food service vendors--for example, mall cookie counters, sidewalk vendors, and vending machines
• ready-to-eat food that is not for immediate consumption but is prepared primarily on site--for example, bakery, deli, and candy store items
• food shipped in bulk, as long as it is not for sale in that form to consumers
• medical foods, such as those used to address the nutritional needs of patients with certain diseases
• plain coffee and tea, some spices, and other foods that contain no significant amounts of any nutrients.

Food produced by small businesses also is exempt, under 1993 amendments to NLEA. The NLEA amendments provide for a system in which exemptions are based on the number of people a company employs and the number of units within a product line it makes yearly.

Under this system, the allowances for each factor are gradually lowered. Between May 9, 1995, and May 8, 1996, a food is exempt from nutrition labeling if the company whose name appears on the label employs fewer than 300 full-time equivalent employees and makes fewer than 400,000 units of the product yearly. After May 1997, only businesses with fewer than 100 full-time equivalent employees producing fewer than 100,000 units within a product line for U.S. distribution can qualify for an exemption.

Almost all companies seeking an exemption will have to notify FDA that they meet the criteria. Those that do not have to notify FDA are U.S. firms with fewer than 10 employees making fewer than 10,000 units of a food in a year.

Although these foods are exempt, they are free to carry nutrition information, when appropriate--as long as it complies with the new regulations. Also, they will lose their exemption if their labels carry a nutrient content or health claim or any other nutrition information.

Nutrition information about game meats--such as deer, bison, rabbit, quail, wild turkey, and ostrich--is not required on individual packages. Instead, it can be given on counter cards, signs, or other point-of-purchase materials. Because few nutrient data exist for these foods, FDA believes that allowing this option will enable game meat producers to give first priority to collecting appropriate data and make it easier for them to update the information as it becomes available.

Nutrition Panel Title

The new food label features a revamped nutrition panel. It has a new title, "Nutrition Facts," which replaced "Nutrition Information Per Serving." The new title signals that the product has been labeled according to the new regulations. Also, for the first time, there are requirements on type size, style, spacing, and contrast to ensure a more distinctive, easy-to-read label.

Serving Sizes

The serving size remains the basis for reporting each food's nutrient content. However, unlike in the past, when the serving size was up to the discretion of the food manufacturer, serving sizes now are more uniform and reflect the amounts people actually eat. They also must be expressed in both common household and metric measures.

FDA allows as common household measures: the cup, tablespoon, teaspoon, piece, slice, fraction (such as "1/4 pizza"), and common household containers used to package food products (such as a jar or tray). Ounces may be used, but only if a common household unit is not applicable and an appropriate visual unit is given-for example, 1 oz (28g/about 1/2 pickle).

Grams (g) and milliliters (mL) are the metric units that are used in serving size statements.

NLEA defines serving size as the amount of food customarily eaten at one time. The serving sizes that appear on food labels are based on FDA-established lists of "Reference Amounts Customarily Consumed Per Eating Occasion."

These reference amounts, which are part of the regulations, are broken down into 139 FDA-regulated food product categories, including 11 groups of foods specially formulated or processed for infants or children under 4. They list the amounts of food customarily consumed per eating occasion for each category, based primarily on national food consumption surveys. FDA's list also gives the suggested label statement for serving size declaration. For example, the category "breads (excluding sweet quick type), rolls" has a reference amount of 50 g, and the appropriate label statement for sliced bread or roll is "___ piece(s) ( _ g)" or, for unsliced bread, "2 oz (56 g/ inch slice)."

The serving size of products that come in discrete units, such as cookies, candy bars, and sliced products, is the number of whole units that most closely approximates the reference amount. Cookies are an example. Under the "bakery products" category, cookies have a reference amount of 30 g. The household measure closest to that amount is the number of cookies that comes closest to weighing 30 g. Thus, the serving size on the label of a package of cookies in which each cookie weighs 13 g would read "2 cookies (26 g)."

If one unit weighs more than 50 percent but less than 200 percent of the reference amount, the serving size is one unit. For example, the reference amount for bread is 50 g; therefore, the label of a loaf of bread in which each slice weighs more than 25 g would state a serving size of one slice.

Certain rules apply to food products that are packaged and sold individually. If such an individual package is less than 200 percent of the applicable reference amount, the item qualifies as one serving. Thus, a 360-mL (12-fluid-ounce) can of soda is one serving, since the reference amount for carbonated beverages is 240 mL (8 ounces).

However, if the product has a reference amount of 100 g or 100 mL or more and the package contains more than 150 percent but less than 200 percent of the reference amount, manufacturers have the option of deciding whether the product can be one or two servings.

An example is a 15-ounce (420 g) can of soup. The serving size reference amount for soup is 245 g. Therefore, the manufacturer has the option to declare the can of soup as one or two servings.

Nutrition Information

There is a new set of dietary components on the nutrition panel. The mandatory (boldface) and voluntary components and the order in which they must appear are:

• total calories
• calories from fat
• calories from saturated fat
• total fat
• saturated fat
• polyunsaturated fat
• monounsaturated fat
• cholesterol
• sodium
• potassium
• total carbohydrate
• dietary fiber
• soluble fiber
• insoluble fiber
• sugars
• sugar alcohol (for example, the sugar substitutes xylitol, mannitol and sorbitol)
• other carbohydrate (the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol if declared)
• protein
• vitamin A
• percent of vitamin A present as beta-carotene
• vitamin C
• calcium
• iron
• other essential vitamins and minerals

If a claim is made about any of the optional components, or if a food is fortified or enriched with any of them, nutrition information for these components becomes mandatory.

These mandatory and voluntary components are the only ones allowed on the nutrition panel. The listing of single amino acids, maltodextrin, calories from polyunsaturated fat, and calories from carbohydrates, for example, may not appear as part of the Nutrition Facts on the label.

The required nutrients were selected because they address today's health concerns. The order in which they must appear reflects the priority of current dietary recommendations.

Thiamin, riboflavin and niacin are no longer required in nutrition labeling because deficiencies of each are no longer considered of public health significance. However, they may be listed voluntarily.

Nutrition Panel Format

The format for declaring nutrient content per serving also has been revised. Now, all nutrients must be declared as percentages of the Daily Values--the new label reference values. The amount, in grams or milligrams, of macronutrients (such as fat, cholesterol, sodium, carbohydrates, and protein) still must be listed to the immediate right of each of the names of each of these nutrients. But, for the first time, a column headed "%Daily Value" appears.

Requiring nutrients to be declared as a percentage of the Daily Values is intended to prevent misinterpretations that arise with quantitative values. For example, a food with 140 milligrams (mg) of sodium could be mistaken for a high-sodium food because 140 is a relatively large number. In actuality, however, that amount represents less than 6 percent of the Daily Value for sodium, which is 2,400 mg.

On the other hand, a food with 5 g of saturated fat could be construed as being low in that nutrient. In fact, that food would provide one-fourth the total Daily Value because 20 g is the Daily Value for saturated fat based on a 2,000-calorie diet.

Nutrition Panel Footnote

The %Daily Value listing carries a footnote saying that the percentages are based on a 2,000-calorie diet. Some nutrition labels--at least those on larger packages--have these additional footnotes:

• a sentence noting that a person's individual nutrient goals are based on his or her calorie needs
• lists of the daily values for selected nutrients for a 2,000- and a 2,500-calorie diet.

An optional footnote for packages of any size is the number of calories per gram of fat (9), and carbohydrate and protein (4).

Format Modifications

In limited circumstances, variations in the format of the nutrition panel are allowed. Some are mandatory. For example, the labels of foods for children under 2 (except infant formula, which has special labeling rules under the Infant Formula Act of 1980) may not carry information about saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, calories from fat, or calories from saturated fat.

The reason is to prevent parents from wrongly assuming that infants and toddlers should restrict their fat intake, when, in fact, they should not. Fat is important during these years to ensure adequate growth and development.

The labels of foods for children under 4 may not include the %Daily Values for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber. They may carry %Daily Values for protein, vitamins and minerals, however. These nutrients are the only ones for which FDA has set Daily Values for this age group.

Thus, the top portion of the "Nutrition Facts" panels of foods for children under 4 will consist of two columns. The nutrients' names will be listed on the left and their quantitative amounts will be on the right. The bottom portion will provide the %Daily Values for protein, vitamins and minerals. Only the calorie conversion information may be given as a footnote.

Some foods qualify for a simplified label format. This format is allowed when the food contains insignificant amounts of seven or more of the mandatory nutrients and total calories. "Insignificant" means that a declaration of zero could be made in nutrition labeling, or, for total carbohydrate, dietary fiber, and protein, the declaration states "less than 1 g."

For foods for children under 2, the simplified format may be used if the product contains insignificant amounts of six or more of the following: calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins A and C, calcium, and iron.

If the simplified format is used, information on total calories, total fat, total carbohydrate, protein, and sodium--even if they are present in insignificant amounts--must be listed. Other nutrients, along with calories from fat, must be shown if they are present in more than insignificant amounts. Nutrients added to the food must be listed, too.

Some format exceptions exist for small and medium-size packages. Packages with less than 12 square inches of available labeling space (about the size of a package of chewing gum) do not have to carry nutrition information unless a nutrient content or health claim is made for the product. However, they must provide an address or telephone number for consumers to obtain the required nutrition information.

If manufacturers wish to provide nutrition information on these packages voluntarily, they have several options: (1) present the information in a smaller type size than that required for larger packages, or (2) present the information in a tabular or linear (string) format.

The tabular and linear formats also may be used on packages that have less than 40 square inches available for labeling and insufficient space for the full vertical format.

Other options for packages with less than 40 square inches of label space are:

• abbreviating names of dietary components
• omitting all footnotes, except for the statement that %Daily Values are based on a 2,000-calorie diet
• placing nutrition information on other panels readily seen by consumers.

A select group of packages with more than 40 square inches of labeling space is allowed a format exception, too. These are packages with insufficient vertical space (about 3 inches) to accommodate the required information. Some examples are bread bags, pie boxes, and bags of frozen vegetables. On these packages, the "Nutrition Facts" panel may appear horizontally, with footnote information appearing to the far right.

For larger packages in which there is not sufficient space on the principal display panel or the information panel to the right, FDA allows nutrition information to appear on any label panel that is readily seen by consumers. This intent lessens the chances of overcrowding of information and encourages manufacturers to provide the greatest amount of nutrition information possible.

For products that require additional preparation before eating, such as dry cake mixes and dry pasta dinners, or that are usually eaten with one or more additional foods, such as breakfast cereals with milk, FDA encourages manufacturers to provide voluntarily a second column of nutrition information. This is known as dual declaration.

With this variation, the first column, which is mandatory, contains nutrition information for the food as purchased. The second gives information about the food as prepared and eaten.

Still another variation is the aggregate display. This is allowed on labels of variety-pack food items, such as ready-to-eat cereals and assorted flavors of individual ice cream cups. With this display, the quantitative amount and %Daily Value for each nutrient are listed in separate columns under the name of each food.

Daily Values--DRVs

The new label reference value, Daily Value, comprises two sets of dietary standards: Daily Reference Values (DRVs) and Reference Daily Intakes (RDIs). Only the Daily Value term appears on the label, though, to make label reading less confusing.

DRVs have been established for macronutrients that are sources of energy: fat, carbohydrate (including fiber), and protein; and for cholesterol, sodium and potassium, which do not contribute calories.

DRVs for the energy-producing nutrients are based on the number of calories consumed per day. A daily intake of 2,000 calories has been established as the reference. This level was chosen, in part, because it approximates the caloric requirements for postmenopausal women. This group has the highest risk for excessive intake of calories and fat.

DRVs for the energy-producing nutrients are calculated as follows:

• fat based on 30 percent of calories
• saturated fat based on 10 percent of calories
• carbohydrate based on 60 percent of calories
• protein based on 10 percent of calories. (The DRV for protein applies only to adults and children over 4. RDIs for protein for special groups have been established.)
• fiber based on 11.5 g of fiber per 1,000 calories.

Because of current public health recommendations, DRVs for some nutrients represent the uppermost limit that is considered desirable.The DRVs for fats and sodium are:

• total fat: less than 65 g
• saturated fat: less than 20 g
• cholesterol: less than 300 mg
• sodium: less than 2,400 mg

Daily Values--RDIs

The RDI replaces the term "U.S. RDA," which was introduced in 1973 as a label reference value for vitamins, minerals and protein in voluntary nutrition labeling. The name change was sought because of confusion that existed over "U.S. RDAs," the values determined by FDA and used on food labels, and "RDAs" (Recommended Dietary Allowances), the values determined by the National Academy of Sciences for various population groups and used by FDA to figure the U.S. RDAs.

However, the values for the new RDIs remain the same as the old U.S. RDAs for the time being.

Nutrient Content Descriptors

The regulations also spell out what terms may be used to describe the level of a nutrient in a food and how they can be used. These are the core terms:

• Free. This term means that a product contains no amount of, or only trivial or "physiologically inconsequential" amounts of, one or more of these components: fat, saturated fat, cholesterol, sodium, sugars, and calories. For example, "calorie-free" means fewer than 5 calories per serving and "sugar-free" and "fat-free" both mean less than 0.5 g per serving. Synonyms for "free" include "without," "no" and "zero."
• Low. This term can be used on foods that can be eaten frequently without exceeding dietary guidelines for one or more of these components: fat, saturated fat, cholesterol, sodium, and calories. Thus, descriptors are defined as follows:
  • low-fat: 3 g or less per serving
  • low-saturated fat: 1 g or less per serving
  • low-sodium: 140 mg or less per serving
  • very low sodium: 35 mg or less per serving
  • low-cholesterol: 20 mg or less and 2 g or less of saturated fat per serving
  • low-calorie: 40 calories or less per serving.

Synonyms for low include "little," "few," and "low source of."

• Lean and extra lean. These terms can be used to describe the fat content of meat, poultry, seafood, and game meats.
  • lean: less than 10 g fat, 4.5 g or less saturated fat, and less than 95 mg cholesterol per serving and per 100 g.
  • extra lean: less than 5 g fat, less than 2 g saturated fat, and less than 95 mg cholesterol per serving and per 100 g.
• High. This term can be used if the food contains 20 percent or more of the Daily Value for a particular nutrient in a serving.
• Good source. This term means that one serving of a food contains 10 to 19 percent of the Daily Value for a particular nutrient.
• Reduced. This term means that a nutritionally altered product contains at least 25 percent less of a nutrient or of calories than the regular, or reference, product. However, a reduced claim can't be made on a product if its reference food already meets the requirement for a "low" claim.
• Less. This term means that a food, whether altered or not, contains 25 percent less of a nutrient or of calories than the reference food. For example, pretzels that have 25 percent less fat than potato chips could carry a "less" claim. "Fewer" is an acceptable synonym.
• Light. This descriptor can mean two things:

  First, that a nutritionally altered product contains one-third fewer calories or half the fat of the reference food. If the food derives 50 percent or more of its calories from fat, the reduction must be 50 percent of the fat.

  Second, that the sodium content of a low-calorie, low-fat food has been reduced by 50 percent. In addition, "light in sodium" may be used on food in which the sodium content has been reduced by at least 50 percent.

  The term "light" still can be used to describe such properties as texture and color, as long as the label explains the intent-for example, "light brown sugar" and "light and fluffy."

• More. This term means that a serving of food, whether altered or not, contains a nutrient that is at least 10 percent of the Daily Value more than the reference food. The 10 percent of Daily Value also applies to "fortified," "enriched" and "added" claims, but in those cases, the food must be altered.

Alternative spelling of these descriptive terms and their synonyms are allowed--for example, "hi" and "lo"--as long as the alternatives are not misleading.

Other Definitions

The regulations also address other claims. Among them:

• Percent fat free: A product bearing this claim must be a low-fat or a fat-free product. In addition, the claim must accurately reflect the amount of fat present in 100 g of the food. Thus, if a food contains 2.5 g fat per 50 g, the claim must be "95 percent fat free."
• Implied: These types of claims are prohibited when they wrongfully imply that a food contains or does not contain a meaningful level of a nutrient. For example, a product claiming to be made with an ingredient known to be a source of fiber (such as "made with oat bran") is not allowed unless the product contains enough of that ingredient (for example, oat bran) to meet the definition for "good source" of fiber. As another example, a claim that a product contains "no tropical oils" is allowed--but only on foods that are "low" in saturated fat because consumers have come to equate tropical oils with high saturated fat.
• Meals and main dishes: Claims that a meal or main dish is "free" of a nutrient, such as sodium or cholesterol, must meet the same requirements as those for individual foods. Other claims can be used under special circumstances. For example, "low-calorie" means the meal or main dish contains 120 calories or less per 100 g. "Low-sodium" means the food has 140 mg or less per 100 g. "Low-cholesterol" means the food contains 20 mg cholesterol or less per 100 g and no more than 2 g saturated fat. "Light" means the meal or main dish is low-fat or low-calorie.
• Standardized foods: Any nutrient content claim, such as "reduced fat," "low calorie," and "light," may be used in conjunction with a standardized term if the new product has been specifically formulated to meet FDA's criteria for that claim, if the product is not nutritionally inferior to the traditional standardized food, and the new product complies with certain compositional requirements set by FDA. A new product bearing a claim also must have performance characteristics similar to the referenced traditional standardized food. If the product doesn't, and the differences materially limit the product's use, its label must state the differences (for example, not recommended for baking) to inform consumers.
• Healthy:A "healthy" food must be low in fat and saturated fat and contain limited amounts of cholesterol and sodium. In addition, if it's a single-item food, it must provide at least 10 percent of one or more of vitamins A or C, iron, calcium, protein, or fiber. If it's a meal-type product, such as frozen entrees and multi-course frozen dinners, it must provide 10 percent of two or three of these vitamins or minerals or of protein or fiber, in addition to meeting the other criteria.

  Limits on sodium will be phased in. By January 1996, FDA-regulated individual foods labeled "healthy" must provide no more than 480 mg of sodium per serving. After Jan. 1, 1998, the sodium limit for FDA-regulated foods will drop to 360 mg per serving for individual foods and 480 mg per serving for meal-type products that carry the "healthy" claims. Effective dates for the sodium phase-in for USDA-regulated products are November 1995 and November 1997. The sodium limits match FDA's.

'Fresh'

Although not mandated by NLEA, FDA has issued a regulation for the term "fresh." The agency took this step because of concern over the term's possible misuse on some food labels.

The regulation defines the term "fresh" when it is used to suggest that a food is raw or unprocessed. In this context, "fresh" can be used only on a food that is raw, has never been frozen or heated, and contains no preservatives. (Irradiation at low levels is allowed.) "Fresh frozen," "frozen fresh," and "freshly frozen" can be used for foods that are quickly frozen while still fresh. Blanching (brief scalding before freezing to prevent nutrient breakdown) is allowed.

Other uses of the term "fresh," such as in "fresh milk" or "freshly baked bread," are not affected.

Baby Foods

FDA is not allowing broad use of nutrient claims on infant and toddler foods. However, the agency may propose later claims specifically for these foods. The terms "unsweetened" and "unsalted" are allowed on these foods, however, because they relate to taste and not nutrient content.

Health Claims

Claims for eight relationships between a nutrient or a food and the risk of a disease or health-related condition are now allowed. They can be made in several ways: through third-party references, such as the National Cancer Institute; statements; symbols, such as a heart; and vignettes or descriptions. Whatever the case, the claim must meet the requirements for authorized health claims; for example, they cannot state the degree of risk reduction and can only use "may" or "might" in discussing the nutrient or food-disease relationship. And they must state that other factors play a role in that disease.

The claims also must be phrased so that consumers can understand the relationship between the nutrient and the disease and the nutrient's importance in relationship to a daily diet.

An example of an appropriate claim is: "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease."

The allowed nutrient-disease relationship claims and rules for their use are:

• Calcium and osteoporosis: To carry this claim, a food must contain 20 percent or more of the Daily Value for calcium (200 mg) per serving, have a calcium content that equals or exceeds the food's content of phosphorus, and contain a form of calcium that can be readily absorbed and used by the body. The claim must name the target group most in need of adequate calcium intakes (that is, teens and young adult white and Asian women) and state the need for exercise and a healthy diet. A product that contains 40 percent or more of the Daily Value for calcium must state on the label that a total dietary intake greater than 200 percent of the Daily Value for calcium (that is, 2,000 mg or more) has no further known benefit.
• Fat and cancer: To carry this claim, a food must meet the descriptor requirements for "low-fat" or, if fish and game meats, for "extra lean."
• Saturated fat and cholesterol and coronary heart disease (CHD): This claim may be used if the food meets the definitions for the descriptors "low saturated fat," "low-cholesterol," and "low-fat," or, if fish and game meats, for "extra lean." It may mention the link between reduced risk of CHD and lower saturated fat and cholesterol intakes to lower blood cholesterol levels.
• Fiber-containing grain products, fruits and vegetables and cancer: To carry this claim, a food must be or must contain a grain product, fruit or vegetable and meet the descriptor requirements for "low-fat," and, without fortification, be a "good source" of dietary fiber.
• Fruits, vegetables and grain products that contain fiber and risk of CHD: To carry this claim, a food must be or must contain fruits, vegetables and grain products. It also must meet the descriptor requirements for "low saturated fat," "low-cholesterol," and "low-fat" and contain, without fortification, at least 0.6 g soluble fiber per serving.
• Sodium and hypertension (high blood pressure): To carry this claim, a food must meet the descriptor requirements for "low-sodium."
• Fruits and vegetables and cancer: This claim may be made for fruits and vegetables that meet the descriptor requirements for "low-fat" and that, without fortification, for "good source" of at least one of the following: dietary fiber or vitamins A or C. This claim relates diets low in fat and rich in fruits and vegetables (and thus vitamins A and C and dietary fiber) to reduced cancer risk. FDA authorized this claim in place of an antioxidant vitamin and cancer claim.
• Folic acid and neural tube defects: On Jan. 4, 1994, FDA authorized the use of a health claim about the relationship between folic acid and the risk of neural tube birth defects for dietary supplements and for foods in conventional food form that are naturally high in folic acid. (In 1992, the U.S. Public Health Service had recommended that all women of childbearing age consume 0.4 mg folic acid daily to reduce their risk of giving birth to a child affected with a neural tube defect.) FDA plans to issue a final rule to allow the folic acid-neural tube defect claim for fortified foods, too.

Ingredient Labeling

The list of ingredients has undergone some changes, too. Chief among them is a requirement for full ingredient labeling on "standardized foods," which previously were exempt. Ingredient declaration is now required on all foods that have more than one ingredient.

Also, the ingredient list includes, when appropriate:

• FDA-certified color additives, such as FD&C Blue No. 1, by name
• sources of protein hydrolysates, which are used in many foods as flavors and flavor enhancers
• declaration of caseinate as a milk derivative in the ingredient list of foods that claim to be non-dairy, such as coffee whiteners.

The main reason for these new requirements is that some people may be allergic to such additives and now may be better able to avoid them.

As required by NLEA, beverages that claim to contain juice now must declare the total percentage of juice on the information panel. In addition, FDA's regulation establishes criteria for naming juice beverages. For example, when the label of a multi-juice beverage states one or more--but not all--of the juices present, and the predominantly named juice is present in minor amounts, the product's name must state that the beverage is flavored with that juice or declare the amount of the juice in a 5 percent range--for example, "raspberry-flavored juice blend" or "juice blend, 2 to 7 percent raspberry juice."

Economic Impact

It is estimated that the new food label will cost FDA-regulated food processors between $1.4 billion and $2.3 billion over the next 20 years. The benefits to public health--measured in monetary terms--are estimated to well exceed the costs. Potential benefits include decreased rates of coronary heart disease, cancer, osteoporosis, obesity, high blood pressure, and allergic reactions to food.

Obtaining Regulations and Related Information

Reprints of Federal Register documents on FDA's food labeling rules can be ordered by calling the National Technical Information Service at (703) 487-4650. Ask for #PB-93-139905. The cost is $91.

The Jan. 6 document also can be downloaded from the National Agricultural Library's electronic bulletin board, Agricultural Library Forum (ALF). The electronic bulletin board can be accessed 24 hours a day, seven days a week. The telephone numbers are (301) 504-6510, (301) 504-5111, (301) 504-5496, and (301) 504-5497. For assistance, call the FDA/USDA Food Labeling Education Information Center at (301) 504-5719.

The January and April 1993 documents also are included in the April 1, 1993, edition of the Code of Federal Regulations, which is available from the Government Printing Office (Title 21, Parts 100-169) for $21. This may be ordered by calling (202) 512-1800.

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