A Guide to Food Labeling & Nutrition (#062071)

Section I. Course Objectives

Section II. Nutrition Labeling Education Act of 1990

      Exemptions & Variations

      Regulated Words

      Descriptors & Claims

Section III. Dietary Supplements Health & Education Act of 1994

Section IV. Restaurants & Fast Food Menus

Section V. Supermarket Tour

      Tour Guide Info

      Tour Participants Guide

Section VI. Additional Resources

Section VII. Appendix

      Glossary

Section VIII. Authors

Section IX. Footnotes

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Section I: Course Objectives

Introduction

A Guide to Food Labeling & Nutrition was developed to provide the dietetic professional with current information on food labeling requirements. Upon completing this course, you will be able to use nutrition labels to make quick, informed food choices that contribute to a healthy diet. In addition, the Supermarket Tour worksheets allow the practitioner to apply the information found on the food labels with the consumer in planning meals. Many consumers would like to know how to use this information more effectively and easily.

Supermarket Tour

One of the best ways to teach the consumer to apply the information contained on the new labels and in the Nutrition Facts is to lead a group of consumers through a supermarket. Products with declarations of "low fat" or a "good source" of a nutrient can be compared first hand to other products in the same line. The revised food labels are perfect nutrition education tools that as the nutrition and dietetics professional, you are the expert that consumers turn to for help in bridging the gap between knowledge and behavior. The supermarket tour was developed as a consumer friendly nutrition education tool to teach the tricks of the food trade right where comparisons can be made and examples using the real packaged product can be given.

Course Objectives

After completing this course, the nutrition and dietetics professional will be able to: 

  1. Explain the NLEA requirement for listing nutrition information on the food label.
  2. Define the term "Percentage of Daily Values"
  3. Describe the basis for the FDA's daily calorie recommendations
  4. Identify food label required components, exempt ions and variations
  5. Explain food label terms, regulated words, descriptors and claims
  6. Explain food label descriptors and claims
  7. Explain dietary supplement ingredients listing regulations
  8. Explain restaurant and fast food labeling requirements and the claims they can use to promote healthier menus
  9. Explain how to use food labels to compare products for a healthier diet
  10. Describe the current health status of the United States population
  11. Explain the effects of cholesterol
  12. Identify the 3 main types of fatty acids
  13. Explain the effects of Olestra and fat replacers

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Section II. Nutrition Labeling & Education Act of 1990 (NLEA)

New Food Labels

US Food & Drug Administration

Due to the new food label, grocery store aisles have become avenues to greater nutrition knowledge. In response to unclear labeling, frequent misuse of terms, and a nutrient data label that many thought was useless, the Federal Government mandated a change in food labels.  

The purpose of the Nutrition Labeling and Education Act of 1990 (NLEA) was to: 

The United States Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) established mandatory nutrition labeling for packaged foods on January 6, 1993. The regulations require most packaged foods to carry a nutrition label specifying the amounts of at least 14 required nutrients in amounts per serving and as the percentage of the daily values (except for energy from fat, sugars, and protein). The regulations also define descriptive terms for nutrient content and outline the allowable health claims about the relationship of nutrients or foods to diseases or conditions. The United States Department of Agriculture (USDA) is responsible for labeling meat and poultry and has developed regulations that are close to those written by the FDA.

The FDA conducts studies of food labels as a part of the monitoring of the nutritional status of the US population. Surveys of packaged food use helps the FDA make decisions about policy, additional regulations, and even economic impact. The survey from 1997 reflected the new laws, in effect since 1994. Results indicated that the new food label had been successful in increasing consumer use of the information contained on the label. In November 1995 more than half of the consumers surveyed indicated they were using quantitative information contained on the new label. Before the new label, only 20% of respondents reported using the label to help chose foods. The new label was reported being used to determine the level of a nutrient in the product, for assessing overall nutrient content of the food, and for comparing different food items.

Trans Fat Labeling

On July 9, 2003, FDA issued a regulation requiring manufacturers to list trans fatty acids, or trans fat, on the Nutrition Facts panel of foods and some dietary supplements. Under the new FDA regulations, by January 1, 2006, consumers will be able to find trans fat listed on food nutrition labels directly under the line for saturated fat.(1)  The new information is the first significant change on the Nutrition Facts panel since it was established in 1993.

With this rule, consumers have more information to make healthier food choices that could lower their consumption of trans fat as part of a heart-healthy diet. The new labeling reflects scientific evidence showing that consumption of trans fat, saturated fat and dietary cholesterol raises low-density lipoprotein (LDL) cholesterol ("bad" cholesterol) levels that increase the risk of coronary heart disease.

By providing more useful information to consumers seeking a healthy diet, the new labels are expected to reduce the costs of illness and disease for Americans. The FDA estimates that the changes in regulations will save between $900 million and $1.8 billion each year in medical costs, lost productivity and pain and suffering. The FDA also estimates that by 2009 (three years after the 2006 requirement) that trans fat labeling will have prevented from 600 to 1,200 cases of coronary heart disease and 250 to 500 deaths each year.

"We are empowering Americans to make healthier choices about the foods they eat," Secretary Thompson said. "By putting trans fat information on food labels, we are making it possible for consumers to make better educated choices to lower their intake of these unhealthy fats and cholesterol. It's just one more way we're helping consumers lead healthier lives."(2)

The additional information will give consumers a more complete picture of fat content in foods -- allowing them to choose foods low in trans fat, saturated fat and cholesterol, all of which are associated with an increased risk of heart disease. Reducing the intake of trans fat and saturated fats is recommended by the Federal Dietary Guidelines for Americans.

Trans fat occurs in foods when manufacturers use hydrogenation, a process in which hydrogen is added to vegetable oil in order to turn the oil into a more solid fat. Trans fat is often but not always found in the same foods as saturated fat, such as vegetable shortening, some margarines, crackers, candies, cookies, snack foods, fried foods, baked goods, salad dressings, and other processed foods made with partially hydrogenated vegetable oils. The chart below illustrates major food sources for trans fat and the percent of total trans fat intake from these food sources.

Major Food Sources of Trans Fat for American Adults (Average Daily Trans Fat Intake is 5.8 Grams or 2.6 Percent of Calories)

(Source: FDA, Questions and Answers about Trans Fat Nutrition Labeling, July 09, 2003)

The FDA is conducting research to determine how much trans fat is too much. However, it is true and accurate to say that the less saturated fat, trans fat and cholesterol consumed the better. Trans fat while pervasive in many of the foods we eat is not "essential" to any healthy diet.

Although some food products already list trans fat on the food label, food manufacturers have until Jan.1, 2006, to add it to the nutrition label. This phase-in period minimizes the need for multiple labeling changes and allows small businesses to use up current label inventories. The FDA will allow manufacturers to implement the change more quickly. PepsiCo said that it was one of the first companies to voluntarily label trans fat in its Frito-Lay chips, and that it was already moving towards eliminating trans fats entirely from its range of products. A switch to corn oil for its Doritos, Tostitos and Cheetos snacks meant that these brands were already trans-fat free, the company said.

In addition, dietary supplement manufacturers will now need to list trans fat, as well as saturated fat and cholesterol, on the Supplement Facts panel when their products contain more than trace amounts (0.5 gram) of trans fat. Examples of dietary supplements that may contain trans fat are energy and nutrition bars.

The FDA estimates that the average daily intake of trans fat in the U.S. population is about 5.8 grams or 2.6% of calories per day for individuals 20 years of age and older. On average, Americans consume approximately 4 to 5 times as much saturated fat as trans fat in their diet.

Nutrition Facts

The provisions of the Nutrition Labeling and Education Act of 1990 (NLEA) were put into practice in 1994 when the "Nutrition Facts" food label appeared. The most striking change on the new label is the appearance of the "Nutrition Facts" - a panel of nutrition data. (See Figure 1: Nutrition Facts) It contains mandatory and voluntary components in a specific order. The required nutrients were chosen because they address today's health concerns. Information is included on the basis of which foods will increase the total intake of certain nutrients and which will not. The order in which the components must appear reflects the priority of current dietary recommendations.

The Nutrition Facts panel has two parts: The main or top section (see #1-5 on the sample nutrition label below), which contains product-specific information (serving size, calories, and nutrient information) that varies with each food product; and the bottom part (see #6 on the sample nutrition label below), which contains a footnote. This footnote is only on larger packages and provides general dietary information about important nutrients.(3)

Figure 1: Nutrition Facts 

The list to the right of the following sample food label shows the mandatory (boldface) and voluntary components and the order in which they must appear on the nutrition panel.

Nutrition Pane

 

 

The following list shows the mandatory
food label components (in boldface)
and the voluntary components and
the order in which they must appear
on the nutrition panel.

-total calories
-calories from fat
-calories from saturated fat
-total fat
-saturated fat
-trans fat (1/1/2006)
-polyunsaturated fat
-monounsaturated fat
-cholesterol
-sodium
-potassium
-total carbohydrate
-dietary fiber
-soluable fiber
-insoluable fiber
-sugars
-sugar alcohol (i.e. xylitol and mannitol)
-other carobohydrates
-protein
-vitamin A
-percentage of vitamin A present
 as bega-carotene
-vitamin C
-calcium
-iron
-other essential vitamins and minerals

 

#1 Serving Size (#1 on sample label)

The first place to start when you look at the Nutrition Facts panel is the serving size and the number of servings in the package. Serving sizes are provided in familiar units, such as cups or pieces, followed by the metric amount, e.g., the number of grams. Serving sizes are based on the amount of food people typically eat, which makes them realistic and easy to compare to similar foods.

Pay attention to the serving size, including how many servings there are in the food package, and compare it to how much YOU actually eat. The size of the serving on the food package influences all the nutrient amounts listed on the top part of the label. In the sample label above, one serving of macaroni and cheese equals one cup. If you ate the whole package, you would eat two cups. That doubles the calories and other nutrient numbers, including the %Daily Values as shown below (see Calories and %Daily Value for more information).

The serving size, determined by FDA, is defined as that portion of food "customarily consumed per eating occasion". Usually it refers to the raw food, as purchased. According to the U.S. Department of Health and Human Services, examples of what constitutes a serving are:

What Counts as a Serving?

Grain Products Group (bread, cereal, rice, and pasta)

Vegetable Group

Fruit Group

Milk Group (milk, yogurt, and cheese)

Meat and Beans Group (meat, poultry, fish, dry beans, eggs, and nuts)

Some foods fit into more than one group. Dry beans, peas, and lentils can be counted as servings in either the meat and beans group or vegetable group. These "cross over" foods can be counted as servings from either one or the other group, but not both. Serving sizes indicated here are based on both suggested and usually consumed portions necessary to achieve adequate nutrient intake.(4)

# 2 Calories and Calories from Fat (#2 on sample label)

Calories provide a measure of how much energy you get from a serving of this food. The label also tells you how many of the calories in one serving come from fat. In the example, there are 250 calories in a serving of this macaroni and cheese.

Question: How many calories from fat are there in ONE serving (2 servings listed on label per package)?

Answer: 110 calories, which means almost half, come from fat. What if you ate the whole package content? Then, you would consume two servings, or 500 calories, and 220 would come from fat.

#3 & #4 The Nutrients (#3 and 4 on sample label)

Look at the top section in the sample nutrition label. It shows nutrients that are important for your health and separates them into two main groups:

Limit These Nutrients (#3 on sample label)

The nutrients listed first are the ones Americans generally eat in adequate amounts, or even too much. They are identified in yellow on the chart as Limit these Nutrients. Eating too much fat, saturated fat, trans fat, and cholesterol, or sodium may increase your risk of certain chronic diseases, like heart disease, some cancers, or high blood pressure. Eating too many calories is linked to overweight and obesity. The FDA recommends that individuals keep their intake of saturated fat, trans fats and cholesterol as low as possible as part of a nutritionally balanced diet.

Get Enough of These (#4 on sample label):

Americans often don't get enough dietary fiber, vitamin A, vitamin C, calcium, and iron in their diets. They are identified in blue on the chart as Get Enough of these Nutrients. Eating enough of these nutrients can improve your health and help reduce the risk of some diseases and conditions. For example, getting enough calcium can reduce the risk of osteoporosis, in which bones become brittle and break as one ages (see calcium example below).

#5 Percentage of Daily Values (#5 on sample label)

This part of the Nutrition Facts panel lists whether the nutrients (fat, sodium, fiber, etc) in a serving of food contribute a lot or a little to the total daily diet. By diet we mean all the different foods normally eaten in a day.



%DVs are based on recommendations for a 2,000 calorie diet. For labeling purposes, FDA set 2,000 calories as the reference amount for calculating %DVs. The %DV shows you the percent (or how much) of the recommended daily amount of a nutrient is in a serving of food. By using the %DV, you can tell if this amount is high or low. You, like most people, may not know how many calories you consume in a day. But you can still use the %DV as a frame of reference, whether or not you eat more or less than 2,000 calories each day.

The labels include a reference value termed Daily Value that is intended to prevent misinterpretations that arise with quantitative values. For example, a food with 140 milligrams (mg) sodium could be mistaken for a high sodium food because 140 is a relatively large number. In actuality, that amount represents less than 6% of the Daily Value for sodium, which is 2,400mg. (5)

All nutrients must be declared as Percentages of Daily Values (%Daily Value). The objective is to put a particular food into the context of a whole day's intake. "Daily Value" actually comprises two sets of dietary standards: the Daily Reference Values (DRV) and the Reference Daily Intake (RDI). However only the Daily Value term appears on the label.

It's not hard to follow nutrition experts' advice for a healthy diet. Try to limit the total daily intake of fat, saturated fat, sodium, and cholesterol (shown in yellow on the chart) to less than 100%DV. Likewise, try to get enough essential nutrients like calcium, iron, and vitamins A and C as well as other components such as dietary fiber (shown in blue on the chart). Try to average 100% for each one of these nutrients each day.(6)

Quick Guide to %DV


This general guide tells you that 5%DV or less is low and 20%DV or more is high. This means that 5%DV or less is low for all nutrients, those you want to limit (e.g., fat, saturated fat, cholesterol, and sodium), and those that you want to consume in greater amounts (fiber, calcium, etc). As the Quick Guide shows, 20%DV or more is high for all nutrients.

Example: Look again at the amount of Total Fat in one serving listed on the sample nutrition label for macaroni and cheese.

Question: Is 18%DV contributing a lot or a little to your maximum fat limit of 100% DV?

Answer: You see that 18%DV, which is below 20%DV, is not yet high, but what if you ate the whole package (two servings)? You would double that amount, eating 36% (18% x 2) of your daily allowance for Total Fat. That amount, coming from just one food, would contribute a lot of fat to your daily diet. It would leave you 64% of your fat allowance (100%-36%=64%) for all of the other foods you eat that day, snacks and drinks included.

The %DV also makes it easy to make comparisons. You can compare one product or brand to a similar product. It's easy to see which one is higher or lower in a nutrient because the serving sizes are generally consistent for similar types of foods.

You can use the %DV to help you make dietary trade-offs with other foods throughout the day. When working with a consumer, it is important to point out that they don't have to give up a favorite food to eat a healthy diet. When a food they like is high in fat, balance it with foods that are low in fat at other times of the day. Also, pay attention to how much is eaten so that the total amount of fat for the day stays below 100%DV.

You can quickly distinguish one nutrient content claim from another, such as "reduced fat" vs. "light" or "nonfat." Just compare the %DVs for Total Fat in each food product to see which one is higher or lower in that nutrient--there is no need to memorize definitions. This works when comparing all nutrient content claims, e.g., less, light, low, free, more, high, etc.

Nutrients that Have No %DV

Trans Fats, Sugars, and Protein: do not list a %DV on the Nutrition Facts panel.


Trans Fat: Scientific reports link trans fat (and saturated fat) with raising LDL ("bad") blood cholesterol levels, both of which increase your risk of coronary heart disease, a leading cause of death in the US. But experts could not provide a reference value for trans fat nor any other information that FDA believes is sufficient to establish a Daily Value or %DV.

Sugars: No daily reference value has been established because no recommendations have been made for the total amount of sugars to eat in a day. Keep in mind, the sugars listed on the Nutrition Facts panel include naturally occurring sugars (like those in fruit and milk) as well as those added to a food or drink. Check the ingredient list for specifics on added sugars.

Protein: A %DV is required to be listed if a claim is made for protein, such as "high in protein". Otherwise, unless the food is meant for use by infants and children under 4 years old, none is needed. Current scientific evidence indicates that protein intake is not a public health concern for adults and children over 4 years of age.

To limit nutrients that have no %DV, like trans fat and sugars, compare the labels of similar products and choose the food with the lowest amount.

Calcium: Experts advise consumers to consume adequate amounts of calcium in their daily diet. This advice is given in milligrams (mg), but the Nutrition Facts panel only lists a %DV for calcium. The important thing is to look at the %DV for calcium on the food package so you know how much one serving contributes to the total amount you need. Remember, a food with 20%DV or more contributes a lot of calcium to your daily total, while one with 5%DV or less contributes a little.

#6 The Footnote, or lower part of the Nutrition Facts Panel (#6 on sample label)

Note the * used after the heading "%Daily Value" on the Nutrition Facts panel. It refers to the Footnote in the lower part of the nutrition label, which tells you that "%DVs are based on recommendations for a 2,000 calorie diet". This statement must be on all food labels. But the remaining information in the full footnote may not be on the package if the size of the label is too small. When the full footnote does appear, it will always be the same. It doesn't change from product to product, because it shows dietary advice for all Americans--it is not about a specific food product.

Example: look at the Total Fat information in the footnote. It tells you that if you eat a 2,000 calorie diet, you should eat less than 65g of fat in all the foods you eat in a day. By doing this, you will follow nutrition experts' advice to consume no more than 30 percent of your daily calories from fat. Because the DV for total fat is "less than 65g" this is the same thing as saying, to keep your total fat intake for the day below 100%DV.

Daily Reference Values (DRVs)(7)

Daily Reference Values (DRVs) have been established for nutrients for which no set of standards previously existed, such as fat and cholesterol, and sodium and potassium. The FDA daily guidelines, based upon a 2,000 calories a day, are as follows:

 (Source: US Food and Drug Administration)

For labeling purposes, 2000 calories has been established as the reference for calculating percent Daily Values. According to Paula Kurtzwell of the FDA, this level was chosen, in part, because many health experts say it approximates the maintenance calorie requirements of the group most often targeted for weight reduction: postmenopausal women. (8)

Not all people need 2,000 calories a day and some may need more while others need less. According to Virginia Wilkering, a registered dietitian in FDA's office of Food Labeling, "there are a variety of factors that need to be considered in determining the person's daily caloric intake. These factors include body size, age, height, weight, activity level and metabolism".(9)

(Source: National Academy of Science's Recommendations)

To determine the person's activity levels, the following examples can be applied: (10)

Whatever the calorie level, DRVs for the energy-producing nutrients are always calculated as follows: (11)

The DRVs for cholesterol, sodium, and potassium, which do not contribute to calories, remain the same whatever the calorie level.

Because of the links between certain nutrients and certain diseases, DRV's for some nutrients represent the uppermost limit that is considered desirable. Eating too much fat or cholesterol, for example, has been linked to an increased risk of heart disease. Too much sodium can heighten the risk of high blood pressure in some people.

Reference Daily Intake (RDI)

The RDI replaces the term "US RDA" which was introduced in 1973 as a label reference value for vitamins, minerals and protein in voluntary nutrition labeling. The name was changed to reduce the confusion that existed over "US RDA's", the values determined by the FDA and used on food labels, and "RDA's" (Recommended Dietary Allowances), the values determined by the National Academy of Sciences for various population groups and used by FDA to figure the US RDA's. (12)

Dietary Reference Intakes (DRI)

As if the above weren't confusing enough - Dietary Reference Intakes (DRIs) have been developed to replace and expand on the RDAs. They are a quantitative estimate of nutrient intakes for long term health, expanding on the past emphasis on preventing disease, by including emphasis on promoting health. The four primary uses of the DRIs are for assessing intakes for individuals, assessing intakes for population groups, planning diets for individuals, and planning diets for groups. There are four nutrient-based reference values contained in the term "DRIs", which are discussed below. DRIs have been developed for vitamins and minerals, with the DRIs for energy and the macronutrients expected in 2002.

1. The Recommended Dietary Allowance (RDA): The RDAs are the levels of intake of essential nutrients that are judged to be adequate to meet the known nutrient requirements of practically all healthy persons. They are based on estimates of nutrient requirements that are adjusted upward to allow for individual variability and to correct for bioavailability of nutrients. The allowance for energy is not adjusted upward, however, to prevent obesity in the person with average needs. The RDAs can be used to judge the adequacy of an individual's diet by comparing the average of the nutrient intake determined from a 2 week period to the RDAs for the individual's sex and age. The RDAs have been in use for more than 50 years and were revised periodically.

2. The Estimated Average Requirement (EAR): The EAR is the amount of a nutrient that is estimated to meet the nutrient requirement of half of the healthy individuals in a life stage and gender group. The nutrient requirement is defined as the lowest continuing intake of a nutrient that will maintain a defined level of nutritive in an individual. The RDA is set from the EAR, and cannot be set if no EAR can be determined. Specific criteria are used to set the EAR including health parameters such as disease risk reduction. The EAR are used to assess individual's diets and to plan menus for individuals and groups.

3. The Adequate Intake (AI): When there is sufficient evidence to calculate an EAR, an AI is set and used as a goal for the nutrient intake, rather than an RDA. The AI is based on observed or experimentally determined estimates of nutrient intakes by a group of healthy people. The AI is set at the level that appears to maintain an acceptable level of health or growth. An example is the AI for young infants, which is based on the daily mean nutrient intake supplied by human breast milk.

4. The Tolerable Upper Intake Levels (UL): the UL is the highest level of daily nutrient intake that is likely to pose no risks of adverse health effects to almost all individuals in the general population. This category is not a suggestion of a recommended level of intake. It was developed to provide guidance to those individuals who may be ingesting high levels of nutrients due to daily use of dietary supplements, and the increased use of fortified foods in the marketplace. For each nutrient that lists a UL, the source of the nutrient (water, food, and supplement) that contributes to the total intake and may be associated with an adverse effect is given. For many nutrients there may not be adequate evidence to develop a UL and therefore there is no UL given. This should not be taken as evidence that no adverse effect may be associated with high levels of intake.

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Exemptions & Variations

Raw Foods: Fruits, Vegetables & Fish

Voluntary programs offering nutrition information at "point of purchase" were set up for many raw foods. Raw foods do not usually lend themselves to individual labeling since they are not usually pre-packaged. Retailers are able to display nutrition information on large placards, in consumer pamphlets or brochures that are easily available in the same department as the food item. However, when appropriate, the information can appear on a sticker that can adhere to the item, as with a sticker that adheres to a banana. (13)

According to the FDA, the most common Fruits, Vegetables and Fish sold raw are: (14)

(Source: U.S. Food and Drug Administration)

Raw Foods: Meat

The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) has established a voluntary nutrition information program for 45 of the best-selling cuts of raw meat and poultry. Similar to FDA's voluntary point-of-purchase nutrition information program for raw fish and produce, FSIS' program calls for "significant" compliance by grocers. Like FDA's program, FSIS' voluntary program targets a select group of foods--major cuts of raw single-ingredient meat and poultry products. And, similar to the FDA's, FSIS' program allows nutrition information to be presented on posters, in brochures and other point-of-purchase materials--as long as they are near the food. Information also can be provided on the package label. To meet FSIS guidelines, point-of-purchase nutrition information for raw meats and poultry must include the following: (15)

Optional information includes:

Major meat and poultry cuts are: (15)

In 1997, the FSIS proposed nutrient labels be required on packages of raw ground or chopped meat. The FSIS, from data collection, determined that information available to the consumer as "point of purchase" information did not provide enough information about certain parameters. One parameter that the FSIS specifically felt the consumer would benefit from knowing is the fat content of the meat. By providing the percentage fat in the ground or chopped meat directly on the package, the consumer could be made aware of an important aspect of meat. Being able to identify fat content in foods from the labels is one of the most often reported benefits of the new food label.

Age Categories

Variations in the format of the nutrition panel are mandatory for labels of foods for children under the age of 2. Information is omitted for saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, calories from fat, and calories from saturated fat to prevent parents from wrongly assuming that infants and toddlers should restrict their fat intake. Infant formula, also, has special labeling rules under the Infant Formula Act of 1980.

Labels of foods for children under 4 may not include the percent Daily Values for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber. However they may include percent Daily Values for protein, vitamins and minerals.

Simplified Labels

Foods that contain insignificant amounts of seven or more of the mandatory nutrients and total calories qualify for a simplified label format. However, the following components still must be listed, even if in insignificant amounts:

"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 gram". Packaging for foods for children under age 2, can display the simplified format and may be used if the product contains insignificant amounts of six or more of the following:

Packaging

Some food packaging demands a format modification depending on size or shape. For small packages (less than 12 square inches), regulations state that labeling is not mandatory unless a statement is made concerning the nutrient content of the item or a health claim is made. Then the label must include an address or telephone number for consumers to obtain the referenced nutrition information. Some of the options food packagers with small packages can use include: (16)

Dual Declaration

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 reflecting the numbers for the prepared product. (17)

Aggregate Display

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

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Regulated Words

Not Just Advertising

Until the passage of the NLEA, many words commonly used to promote food products such as "low" and "Fat free" were more marketing hype science. The public has been misled with products like "light" vegetable oil that was light in color and the "lite" cheesecake that was just light in texture. The regulations spell out which nutrient content claims are allowed and under what circumstances that can be used. (18)

Extra Lean

"Extra lean" means the food has less than 5mg of fat, less than 2g of saturated fat, and less than 95mg of cholesterol per 3 ounce serving. Examples of "extra lean" foods are haddock, swordfish, clams, and deer.

% Fat Free

A product bearing the claim of "'x' percent fat free" must meet the definitions for low fat. In addition, the claim must accurately reflect the amount of fat present in 100g of the food, e.g. if a food contains 2.5g of fat per 50g, the claim must be "95% fat free"

Free

This term can be used when 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 0.5g per serving. Synonyms for "free" include "without", "no", "zero", "negligible source of", and "dietarily insignificant source of".

Because it may be virtually impossible to measure below a certain amount, the regulations allow a fat-free claim on foods with less than 0.5g of fat per serving. An amount that they argue is physiologically insignificant even if a person eats several servings. Consumers need to be aware that the food isn't truly "fat-free" and fat calories may add up if enough of the food is eaten.

Fresh

The FDA has issued a regulation for the term "fresh", even though it is not included in the mandates by the Nutrition Labeling and Education Act of 1990. Under this regulation, "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.

Good Source

Products cannot claim to be made with an ingredient known to be a good source of that ingredient without containing 10 - 19% of the Daily Value of that ingredient.

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% of one or more 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% of two or three of these vitamins or minerals or of protein, fiber, in addition to meeting the other criteria. There must be no more than 480mg of sodium per serving. After January 1, 1998, the sodium limit for FDA-regulated foods will drop to 360mg per serving for individual foods and 480mg per serving for meal-type products that carry the "healthy" claims.

High

The food must contain 20% or more of the Daily Value for that nutrient in a serving. Synonyms include rich in and excellent source.

Lean

"Lean" and "Extra-lean" can be used to describe the fat content of meat, poultry, seafood, and game meats. "Lean" means the food has less than 10g of fat, less than 4g of saturated fat, and less than 95mg of cholesterol per serving (per 100g or a 3 ounce serving.) Some "lean" foods are Spanish mackerel, bluefin tuna, and domesticated rabbit./P>

Less

The food, whether altered or not, must contain 25% less of a nutrient or of calories than the reference food, e.g. pretzels that have 25% less fat than potato chips can carry a less claim. Fewer is an acceptable synonym. 

Light

This descriptor has two meanings: First, the 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% of the fat. Second, that the sodium content of a low-calorie, low-fat food has been reduced by 50%. It can still be used to describe such properties as texture and color, as long as the label explains the intent, e.g. "light brown sugar" and "light and fluffy".

Low

This term can be used on foods that can be eaten in large amounts without exceeding the Daily Value for one or more of these nutrients: fat, saturated fat, cholesterol, sodium, and calories. Synonyms include "little", "few", "contains a small amount of", and "low source of".

More

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

Nutritionally Altered/P>

The product must contain at least one-third fewer calories or half the fat of the reference food. If the food derives 50% or more of its calories from fat, the reduction must be 50% of the fat.

Reduced

To qualify as "reduced", a nutritionally altered product must contain at least 25% of a nutrient or of calories than the regular, or reference, product; However, a reduced claim cannot be made on a produ;

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Food Label Descriptors & Claims

Nutrient Content Descriptors

The regulations spell out what terms may be used to describe the level of a nutrient in a food and how those terms can be used. There are restrictions on both relative claims and the reference food. A relative claim must include the percent difference and the identity of the reference food. Reference foods for "light" and "reduced" claims must be similar to the product bearing the claim, e.g. reduced fat potato chips compared with regular potato chips. Claims that wrongfully imply a food contains or does not contain a meaningful level of a nutrient are prohibited. (19)

Standards of Identity

"Standards of identity" define a food's composition and specify the ingredients it must contain. The government originally developed standardized recipes for such foods as dairy products, mayonnaise, ketchup, jelly, and orange juice to protect consumers from economic deception. Previously exempt "standardized foods" must now list all ingredients.  

Some standards of identity requires the food to contain large amounts of nutrients that many consumers would like to avoid. For example, the standard for sour cream requires that the food contain 18% fat and the standard for mozzarella cheese requires that it be 45% fat. Before the new regulations, "reduced fat" sour cream or mozzarella cheese were required to have their own standard of identity or be called "imitation" or "substitute", names that consumers may perceive as negative. The new regulations allow manufacturers to reduce the fat content of such products and call them "low fat" or "light", as appropriate, as long as the food is still nutritionally equivalent to the regular version. For example, sour cream can be called "light" as long as its fat content is reduced to 9% and it has vitamin A added to replace the amount lost when the fat was removed. If the company decides not to add the vitamin A, it must call the product "imitation light sour cream".  

Additives

Food labels are also required to list FDA-certified color additives by name as a help to consumers who may be allergic to specific additives, or who avoid substances for religious or cultural reasons. "Artificial colors" listed on the label defines the use of colors that are exempt from certification by the FDA and include caramel, paprika, and beet juice.

A food label may read "nondairy" even though it may contain a milk derivative called caseinate, to which some consumers are sensitive. Also, consumers will now be informed as to which foods contain protein hydrolysates. Hydrolyzed proteins (proteins broken down by acid or enzymes into amino acids) are added to foods to serve various functions. They can be used as leavening agents, stabilizers (to impart body or improve consistency, for example), thickeners, flavorings, flavor enhancers, and as a nutrient (protein source), to name a few uses.

Age

The FDA is not allowing nutrient content claims of foods for infants and children under 2, unless explicit permission has been given. The FDA allows manufacturers to use the terms "unsweetened" and "unsalted" on these foods because these claims are considered to be about taste rather than nutrient content. However, current dietary guidelines do not call for limiting salt or sugar in the diets of children under 2. Therefore FDA will not allow phrases that imply low or reduced amounts of sodium and calories, such as "no salt added" and "no sugar added", on these types of foods.

Implied Claims

Implied 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 of a "good source" of fiber.

Health Claims

Planning a healthier diet is made easier when a food package claims a relationship between that food or a nutrient in that food and the risk of a disease or health-related condition. The claim must meet the requirements for authorized health claims, must state that other factors play a role in that disease, and 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. (20)

According to the law, a "health claim" is any claim on the package label or other labeling (such as an advertisement) of a food, including fish and game meats, that characterizes the relationship of any nutrient or other substance in the food to a disease or health-related condition. Health claims include implied claims, which indirectly assert a relationship. An implied claim may appear as a symbol (such as heart shaped logos), or as third party references, such as "The National Cancer Institute recommends a high-fiber diet."

Claims about general health or food classes are not health claims, e.g. "Eat five servings of fruit and vegetables a day for good health." This regulation does not cover nutrient-deficiency diseases - such as scurvy, caused by a lack of vitamin C.

Health claims do not apply to:

To qualify for labeling with a health claim, foods must contain either:

The foods must make a contribution to the diet of at least 10% of the Daily Value of one or more of the nutrients vitamin A, vitamin C, iron, calcium, protein, or fiber. These nutrients must occur naturally in the food.

The food bearing a health claim must not contain any nutrient or food substance in an amount that increases the risk of a disease or health condition. Because dietary guidance calls for people to limit intake of fat, saturated fat, cholesterol, and sodium, FDA identified these substances as risk nutrients and set disqualifying levels per serving and per reference amount, as well as, when a food has a small reference amount (30g or 2 tablespoons or less) per 50g of the food. Foods bearing health claims must contain 20% or less of the Daily Value of fat (13g), saturated fat (4g), cholesterol (60mg), and sodium (480mg).

For example, whole milk, which is high in calcium, may not bear a calcium-osteoporosis claim because its fat content exceeds the disqualifying levels, as excess fat increases the risk of cancer and heart disease.

Main dish products (as defined as 6 ounces or more, with not less than 40g of 2 foods from 2 or more of the 4 food groups) and meal products (10 ounces or more, with not less than 40g of three or more foods from 2 or more food groups) may not bear claims if they contain, respectively, 30 - 40% or more of the Daily Value for a disqualifying nutrient. FDA may, by regulation, permit a claim on food that contains a nutrient in amounts that exceed the disqualifying level if the agency finds that the claim will help consumers maintain a healthy diet, and the labeling discloses the presence of the nutrient at that level. No such exceptions have yet been made.

Every statement, phrase or symbol on a food label must be truthful and not misleading. Because many factors affect disease development, it would be misleading to overemphasize the role of the food substance claim, such as indicating it will prevent the disease. Claims that a substance will prevent a disease are drug claims.

Nutrient-Disease Relationship Claims

The following nutrient disease relationship claims and rules for their use are: (21)

Misleading Food Labels

An important element in making food choices is to compare the labels of similar items. Even then there are different ways that the information on the food labels may be misleading.

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Section III: Dietary Supplements Health & Education Act of 1994 (DSHEA)

Dietary Supplements Labeling

For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions. (22)

On July 9, 2003, FDA issued a regulation requiring manufacturers to list trans fatty acids, or trans fat, on the Nutrition Facts panel of foods and some dietary supplements. Under the new FDA regulations, by Jan. 1, 2006, dietary supplement manufacturers will now need to list trans fat, as well as saturated fat and cholesterol, on the Supplement Facts panel when their products contain more than trace amounts (0.5 gram) of trans fat. Examples of dietary supplements that may contain trans fat are energy and nutrition bars.

The DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress's intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.

The dietary supplement industry is among the world's fastest growing industries. Supplement sales are reported to have reached $17.1 billion in 2000. Consumer spending in this area nearly doubled from 1994 to 2000 and spending continues to grow at a rate of more than 10% per year. A recent survey by PREVENTION Magazine found that over 158 million consumers use dietary supplements. They use them in an effort to achieve self-care goals and as a means of ensuring good health. They also use them for "medicinal" purposes such as treating and preventing various illnesses, colds, and flu. Over time, the market for these supplements likely will grow due to factors such as the aging of the baby-boom generation, increased interest in self-sufficiency, and advances in science that are uncovering new relationships between diet and disease.(23)

But with the growing use of dietary supplements comes increased risks of fraud and consumer injury. Promotions for fraudulent products appear regularly in newspaper and magazine ads and in television "infomercials." They accompany products sold in stores and through mail-order catalogs. The Internet provides myriad opportunities for deception and, because it is a worldwide communications system, U.S. citizens are susceptible to fraud from sources outside this country.

This wave of promotions leads many consumers to buy fraudulent health products. Hoping to cure illness or improve their appearance, consumers often fall victim to products and devices that cheat them out of their money and steer them away from proven treatments. These fraudulent products pose specific dangers including:

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Dietary Supplement Definition

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.(24)

A "dietary supplement":(25)

Ingredient & Nutrition Information

Labels must provide nutrition labeling. This labeling must first list dietary ingredients present in "significant amounts" for which FDA has established daily consumption recommendations, followed by dietary ingredients with no daily intake recommendations.

Dietary supplement products must also provide ingredient labeling. However, if an ingredient is listed in the nutrition labeling, (which appears first on the label), it need not appear in the statement of ingredients. Labeling must include the name and quantity of each dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (excluding inert ingredients) in the blend. Products containing herbal and botanical ingredients must state the part of the plant from which the ingredient is derived.

Nutritional Support Statements

The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim "cures cancer" or "treats arthritis". Appropriate health claims may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases - as long as these statements disclose the prevalence of the disease in the United States.

In-Store Literature

The DSHEA provides that retail outlets may make available "third party" materials to help inform consumers about any health-related benefits of dietary supplements. These materials cannot be false or misleading; cannot promote a specific supplement brand; must be displayed with other similar materials to present a balanced view; must be displayed separate from other supplements; and may not have other information attached. (26)

Dietary Supplement Enforcement

The 2002 Dietary Supplement Enforcement Report highlights the FDA's actions to enforce DSHEA. In fiscal year 2002, FDA took numerous actions to protect the health of consumers and to help ensure a level field for legitimate dietary supplement manufacturers and marketers.

Following are highlights of the measures FDA took last year:

FDA coordinated many of its efforts with other state and federal law enforcement agencies. FDA also used its Web site to provide truthful and reliable dietary supplement information for consumers and to provide industry with guidance on permissible practices under DSHEA.

Looking ahead, FDA will intensify its work to meet the goal set by its January 2000 dietary supplement enforcement program: to have a "regulatory program that fully implements [DSHEA], thereby providing consumers with a high level of confidence in . . . dietary supplements." A key part of this program will be enforcement action ranging from seizures and injunctions to, where appropriate criminal prosecutions. Based on its experience in this area, FDA has targeted certain "problem" products for close attention, including treatments for life-threatening diseases, treatments for diseases that afflict children (e.g., autism and behavioral disorders), weight loss products, and supplements marketed to smokers and drinkers.

FDA intends to continue considering the exercise of enforcement discretion for dietary supplement health claims in appropriate circumstances, and it intends to expand the exercise of enforcement discretion to conventional food health claims under the same circumstances. Specifically, the agency will consider exercising enforcement discretion for a health claim that is not the subject of an authorizing regulation under the following circumstances:(27)

(1) The claim is the subject of a health claim petition that meets the requirements of 21 CFR 101.70 and has been filed for comprehensive review under 21 CFR 101.70(j)(2);

(2) The scientific evidence in support of the claim outweighs the scientific evidence against the claim, the claim is appropriately qualified, and all statements in the claim are consistent with the weight of the scientific evidence;

(3) Consumer health and safety are not threatened; and

(4) The claim meets the general requirements for health claims in 21 CFR 101.14, except for the requirement that the evidence supporting the claim meet the significant scientific agreement standard and the requirement that the claim be made in accordance with an authorizing regulation.

In recent years, because of adverse effects including deaths from herbal supplements, the FDA has been receiving more and more criticism for not monitoring the safety of dietary supplements, specifically the herbal products. Funding for studies to determine both the efficacy and the safety of dietary supplements has increased, coming from both the National Institutes of Health, other federal agencies, and medical departments at universities. Similar to the mandatory reporting by drug makers of their adverse events, the FDA has asked for reporting of adverse events by the supplement industry. The FDA receives adverse event reports already from consumers and health care workers. Whatever the decision by the government as to how and when to regulate the supplement industry, consumers would be wise to share with their health care providers any dietary supplements that they are taking in case of adverse interactions between the components.

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Section IV: Restaurants & Fast Food Menus 

Nutrition & Education Act of 1990 (NLEA) 

As of May 2, 1997, Food and Drug Administration regulations, published in the Aug. 2, 1996, Federal Register, applied the Nutrition Labeling and Education Act (NLEA) of 1990 to restaurant menu items that carry a claim about the food's nutritional content or health benefits. (28)

Under NLEA, FDA established regulations mandating specific nutrition information on the labels of most store-bought products and set up criteria under which nutrient and health claims can be used in food labeling. Claims like these that appear on signs or placards in most restaurants have been covered by the requirements of the food labeling regulations since 1994.

The new menu regulations affect all eating establishments--whether a small-town corner tavern or a big-city four-star restaurant, a grocery store deli or a deli that delivers. All will have to follow requirements for nutrition and health claims for menu items that bear a claim and give customers the appropriate nutrition information for these items when requested. 

"The idea is for the claims to mean the same thing wherever they show up--on food labels in the store or on menus in a restaurant," said Michelle Smith, a food technologist in FDA's Office of Food Labeling.(29)

Eating Out in the 1990's

According to Smith, nutrition and health claims on menus can help people better understand the role of diet in health and choose restaurant foods that contribute to a healthy diet.

This is important, considering that more and more Americans are eating their meals outside the home. According to the National Restaurant Association in 2002, restaurants accounted for 46.1% of American dollars spent on food, up from 25% in 1970.(30)  In the Associations Restaurant Spending-2000, the typical American household spent an average of $2,137 on food away from home in 2000 and restaurant-industry sales are projected to reach a record $426.1 billion in 2003. On a typical day in 2003, the restaurant industry will post average sales of nearly $1.2 billion.(31

In the association's report, Tableservice Restaurant Trends-- more than half of consumers 35 and older and 2 out of 5 consumers 18 to 34 look for lower fat menu options when eating out. Also, restaurateurs report that their customers are increasingly requesting meatless dishes.

The frequency with which eating establishments have been catering to these preferences by making claims about menu items is not well known. In its final rule on claims for restaurant foods, FDA cited information from the National Restaurant Association's annual menu contest, in which the group found that 89 percent of all printed menu entries had at least one nutritional or health claim. But it is not known how representative this number is for menu practices across the country. (32)

In 1996, after a federal district court ordered FDA to include menu claims under food labeling regulations, Bruce Silverglade, legal director for the Center for Science in the Public Interest, said in a press statement: "For years, many restaurant menus have made misleading health and nutrition claims from 'low fat' claims for high-fat desserts to claims that foods flavored with Chinese herbs will lower blood pressure and improve vision. A restaurant menu should not be a work of fiction." (CSPI and another public advocacy group, Public Citizen, filed suit in 1993 against the government for excluding menu claims from the labeling regulations.)

Look to the Menu

FDA's regulations permit restaurants to promote their healthier menu fare using the following:

Consumers can use these claims to spot foods that may be more healthful for them. They also can look for statements giving what FDA considers general dietary guidance. For example, the salad section may start with the message "Eating five fruits and vegetables a day is an important part of a healthy diet." This statement would refer to the National Cancer Institute's recommendation that Americans eat more fruits and vegetables to help reduce their risk of cancer and heart disease.

Restaurants do not have to provide nutrition information about foods that do not bear nutrient content or health claims or that are referred to in general dietary guidance messages. However, restaurateurs need to be careful that the general guidance they provide on the menu doesn't turn into a claim, such as "Fruits and vegetables can help reduce the risk of cancer." This, then, would require the item to meet FDA's nutrition information and claims' requirements.

Claims that promote a nutrient or health benefit must meet certain criteria established by FDA and the U.S. Department of Agriculture; for example, the food must provide a requisite amount of the nutrient or nutrients referred to in the claim. In addition, a menu item carrying a health claim must provide significant amounts of one or more of six key nutrients, such as vitamin C, iron or fiber, and cannot contain a food substance at a level that increases the risk of a disease or health condition. For example, a restaurant meal that contains 26 grams of fat (40 percent of the Daily Value for fat) or 960 milligrams of sodium (40 percent of the Daily Value for sodium) is disqualified from making a heart-healthy claim.

These same rules apply to claims used in the labeling of commercial food products. However, the requirements for further information differ between restaurant and commercially manufactured foods.

To meet FDA's criteria, food manufacturers may choose to do chemical analyses to determine the nutritional value of their products. The criteria for menu items are more flexible, and, under FDA's requirements, restaurants may back up their claims with any "reasonable" base, such as databases, cookbooks, or other secondhand sources that provide nutrition information.

Also, restaurants do not have to provide the standard nutrition information profile and more exacting nutrient content values required in the Nutrition Facts panel of packaged foods. Instead, restaurants can present the information in any format desired, and they have to provide only information about the nutrient or nutrients that the claim is referring to. They can say simply that the amount of the nutrient in question does not exceed the limit imposed by FDA--for example, "This low-fat restaurant dish provides no more than 5 grams of fat per serving."

"It should be accurate," FDA's Smith said, "but not necessarily precise."

Although nutrition information is not required to appear on the menu, it must be made available to consumers when they request it. Restaurants can present it in a printed format--such as a notebook--or by having the staff recite it.

FDA is granting restaurants more flexibility because they don't produce foods according to the more exacting standards that food manufacturers follow, Smith said. She notes that restaurants change their menus frequently and produce smaller quantities than commercial food operations. And restaurant products often vary, depending on the type of ingredients available.

"A commercial operation has more stability than a restaurant," she said. "It would be an unreasonable burden to require restaurants to follow the same labeling regulations for packaged foods."

However, restaurants are under increasing pressures from state legislatures and others to include nutritional information on their menus. In Maine and New York, the Wall Street Journal reports that the legislatures are preparing to introduce bills that would force restaurants to make the same disclosures as are currently required on all grocery stores packaged food items. The Restaurant Association says it is impractical because 70% of the restaurant customers order custom meals.

Much of the enforcement of the menu claims' regulations will likely be provided by state and local public health departments. The reason, Smith said, is that state and local health departments have direct jurisdiction over restaurants, including monitoring their food safety and sanitation practices, and regularly visit them to ensure compliance with various federal and state laws. Also, she said, FDA doesn't have the resources.

Menus Nutrient Claims

Low sodium, Low fat, Low cholesterol

These claims mean the item contains low amounts of these nutrients.

Light

Means the item has fewer calories and less fat than the food to which it's being compared. (Restaurants may continue to use the term "light" for reasons other than as a nutrient content claim--for example, "lighter fare" to mean the dishes contain smaller portions. However, its meaning must be clarified on the menu.)

Healthy

Means the item is low in fat and saturated fat, has limited amounts of cholesterol and sodium, and provides significant amounts of one or more of the key nutrients vitamins A and C, iron, calcium, protein, or fiber.

Health Claims

Heart Healthy has two possible meanings: (33)

  1. The item is low in saturated fat, cholesterol and fat and provides without fortification significant amounts of one or more of six key nutrients. This claim will indicate that a diet low in saturated fat and cholesterol may reduce the risk of heart disease.
  2. The item is low in saturated fat, cholesterol, and fat, provides without fortification significant amounts of one or more of six key nutrients, and is a significant source of soluble fiber (found in fruits, vegetables and grain products). This claim will indicate that a diet low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of fiber (particularly soluble fiber) may reduce the risk of heart disease.

Fast Food Nutrition Example

One major sandwich shop franchise has published their nutrition information on their paper napkins. They also list the relative nutritional content of hamburgers from 2 of the leading hamburger chains. This is a good example of how a fast food chain can use the required nutritional listings as a competitive edge by promoting their sandwiches as having fewer calories.

Menu Regulation Progress

The requirement of Restaurants to implement the Nutrition Labeling and Education Act (NLEA), became official on May 2, 1997 and was a direct response to the lawsuit filed by 2 consumer groups.

1990

Congress passes the Nutrition Labeling and Education Act (NLEA), which makes nutrition information mandatory for most foods. Among the few foods exempted were restaurant items--unless they carried a nutrient or health claim.

January 1993

FDA issues regulations under NLEA that require restaurants to comply with regulations for nutrient and health claims that appear on signs and placards. Menu claims are exempt.

March 1993

Two consumer advocacy groups, Public Citizen Inc. and Center for Science in the Public Interest, file suit against the Department of Health and Human Services and FDA, charging that the menu exemption violates NLEA and the Administrative Procedure Act.

June 1993

FDA proposes to require that menu items about which claims are made be subject to the nutrient and health claims' regulations.

June 1996

Because FDA failed to finalize its June 1993 proposal, the U.S. District Court in Washington, D.C., rules that Congress intended restaurant menus to be covered by NLEA and orders FDA to amend its nutrition labeling and claims' regulations to include menu items about which claims are made.

August 1996

FDA issues a final rule removing the restaurant menu exemption and establishing criteria under which restaurants must provide nutrition information for menu items.

May 2, 1997

FDA's regulations for nutrition labeling of restaurant menu items that bear a claim take effect.

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Section V. The Supermarket Tour

Tour Guide Information

Tour Overview

What follows is specific information on store aisles and products that illustrate the new label in action - the Nutrition Facts from products can be used to compare which product is the best buy for the nutrient, descriptors on the front of labels can be scrutinized to determine whether it is a true reflection of the product, and general statements that food professionals may know about foods and the general population may not but could benefit from.

Every tour turns out differently depending on the individuals and their needs as well as the professional's own personal interest. Begin with the following worksheets as examples and customize the information for your tour.

The tour guide should have planned comments to make throughout the store, but questions should not be discouraged. Of course, it is for the consumers' benefit that the tour was created, and they will let you know what they need explained.

Supermarket Sleuth

Supermarkets can be confusing places when you recognize that there are thousands of products on the shelves that are vying for the consumers' attention. The consumer's first impression of the product from its food label and its place on the grocery shelf is important. There are some clues to help the consumer make smart shopping decisions. General points to make at the beginning and during the supermarket tour are given below, with specifics to each aisle following. The NLEA, like most government documents, is long, wordy, specific, and detailed, and likely to lose consumers' attention should they be advised to read through it. Instead, the nutrition and dietetics professional can translate the law into friendly bites of information, applying the essentials to the real world task of grocery shopping.

The "tour" can just as easily be held in a classroom or auditorium with slides or overheads of labels and photos of products in advertising or magazines. There is less to work with, but the same information can be shared with a larger group.

Topics for Group Discussion

Additional topics that the tour guide may want to discuss with the supermarket tour participants are:

1. NLEA Benefits

The NLEA provides 4 main benefits to the consumer with the new labeling:

  1. Nutrition Facts have an easy to read format using standardize serving sizes that enable consumers to make nutritional comparisons between products;
  2. Nutrition Facts contain information on the amount per serving of total fat, saturated fat, cholesterol, sodium, dietary fiber and other nutrients that are of major concern to today's consumer;
  3. Food Labels use 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;
  4. Food Labels can make claims about the relationship between a nutrient or food and a disease or health related condition such as calcium and osteoporosis.

2. US Department of Health and Human Services Dietary Guidelines

The Dietary Guidelines, developed by the Department of Health and Human Services and the U.S. Department of Agriculture, represent the best, most current advice for healthy Americans 2 years and older. They reflect recommendations of health and nutrition experts, who agree that enough is known about the effect of diet on health to encourage certain eating practices. (34) The seven Dietary Guidelines are:

  1. Eat a variety of foods to get the energy (calories), protein, vitamins, minerals, and fiber you need for good health.
  2. Maintain a healthy weight to reduce your chances of having high blood pressure, heart disease, a stroke, certain cancers, and the most common kind of diabetes.
  3. Choose a diet low in fat, saturated fat, and cholesterol to reduce your risk of heart disease and certain types of cancer. Because fat contains more than twice the calories of an equal amount of carbohydrates or protein, a diet low in fat can help you maintain a healthy weight.
  4. Choose a diet with plenty of vegetables, fruits, and grain products that provide needed vitamins, minerals, fiber, and complex carbohydrates. They are generally lower in fat.
  5. Use sugars only in moderation. A diet with lots of sugars has too many calories and too few nutrients for most people and can contribute to tooth decay.
  6. Use salt and other forms of sodium only in moderation to help reduce your risk of high blood pressure.
  7. If you drink alcoholic beverages, do so in moderation. Alcoholic beverages supply calories, but little or no nutrients. Drinking alcohol is also the cause of many health problems and accidents and can lead to addiction.

3. Calories

Check the bottom of the Nutrition Facts for the calories per gram for the three macronutrients. Recognize that calories from fat are "expensive" in the sense that they contain twice the amount of calories for the same unit measure as either carbohydrate or protein. Carbohydrate and protein provide 4 calories per gram while fat provides 9 calories per gram.

Reading from the top down in the Nutrition Facts, notice that the calories from fat are listed on the same line with the total calories based on the serving size. You may notice that the calories from fat are not exactly 9 times the grams of fat listed on the line below that, but it is usually close.

Don't be fooled by a listing of '0' for fat calories or grams in the Nutrition Facts. If the serving size for the food would only contribute a small (physiologically unimportant) amount, the label can list '0'. However, if you eat many times the serving size, the 'small amount' may add up to many calories from fat. This can be a hidden source of fat calories for people. If you are concerned with fat grams or calories consider that when an item declares itself to be 'fat-free', the serving size contains .5 grams or 4-5 calories from fat. Check the ingredient list for fat in the food to verify if there is additional fat you need to include in your calculations.

Because fat contains more calories than protein or carbohydrate it becomes an area of adjustment in the diet, either for those needing to gain weight (eat fat laden food) or for those needing to lose weight (eat foods without added fat fried or cooked in fat.)

Fat has many functions in foods- it provides a texture and 'mouth-feel' that we have come to enjoy. It provides taste, moistens foods, helps blend flavor and it carries fat-soluble vitamins. Unfortunately for most Americans, it is hard to give up. There is a market for fat replacement that would provide all of the functions listed above, but provide no calories. Read Appendix B and C for additional information on cholesterol, fat and fat replacers such as Olestra.

Getting Started

To begin the supermarket tour the guide can stress to the participants that:

  1. They should never go food shopping hungry
  2. Try to go alone or at least without children, they may prompt them to buy "treats"
  3. Never go without a list. The list is most helpful when the list maker has planned a week or so of menus against the store's advertisements of sales and good buys. Coupons that were clipped earlier in the week are most helpful if paperclipped to the list, or write the list on a used envelope that can hold the coupons until their time comes.

Some additional points to discuss for the supermarket tour participants when they are in the store include:

  1. By shopping along the perimeter of the store as much as possible, they are usually shopping in the area of less processed, fresher foods. Generally inside the aisles is where the boxes and cans and bottles of many-ingredient foods are kept.
  2. When shopping in an aisle, beware of products at eye-level. These are usually the high fat, high profit items that encourage impulse buying.
  3. Check the expiration date and the sell-by date and choose the date the furthest in the future.

Beginning the tour in the produce aisle is refreshing and is an opportunity to play a "waiting game". The tour guide can ask participants to spot a fruit or vegetable that they aren't familiar with and share their newly found item with the group. Once everyone has assembled, the tour guide show begin the "Supermarket Tour".

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Supermarket Tour Participants Guide 

Food Labels

Each product contains a Food Label that will allow you to analyze the nutritional ingredients so that you can make intelligent choices in the foods that you select. This Supermarket Tour will serve as a starting point for your greater understanding of the many choices that you are faced with in planning meals.

The new food label can be found on the food packaging as "Nutrition Facts". The US Food and Drug Administration requires that the labels have the following format:

 
The top section of the label lists the
serving sizes,ingredients and nutritional
information.  You will see both an absolute
number such as "Total Fat 3 grams" and a
"% of Daily Value".  The "% of Daily Value"
shows how much of your daily-recommended
nutritional intake the ingredient contributes
based upon a daily diet of 2,000 calories.
 
 
 
 
 
 
 
 
 
 
 
 
Many labels will also include the bottom
section, which shows the Percent of Daily
Values recommended for a 2,000 and a 2,500
daily calorie diet.  Your personal daily
calorie diet will depend upon many factors
such as age and level of physical
exercise.
 

Supermarket Worksheets

The following worksheets have been provided to assist you in analyzing and discussing the products' ingredients based upon the nutritional levels. As you visit each aisle, review the additional nutrition tips.(35)

Produce

Nutritional Benefits

Serving Size for Raw Produce

The serving size can vary depending on what is appropriate for the product:

Nutrition Labels

Nutrition labels here will be found posted above the items or the information provided in a brochure and will include the following information:

Questions

1. Select one of your favorite fruits and vegetables. Complete the following chart with the nutritional information for each item:

2. Where did you find the answers for question #1?_______________________________

3. Which fruits & vegetables were unfamiliar to you? ______________________________

4. How would you know how to cook or serve them? _____________________________

5. Compare the price and ingredients list for a raw vegetable versus canned (such as carrots or beans): _____________________________________________________________________________________________________________________________________________________________________________________________________________________

Salad Bar/Deli

Salad Bar

Questions

1. Compare cost per pound of cleaned and trimmed vegetables to the equivalent fresh vegetables in the produce aisle. How does the price per pound compare? ________________________________________________________________

2. Compare the cost per pound of cleaned and trimmed fruit to the equivalent fresh fruit in the produce aisle. How does the price per pound compare?___________________________

3. Would you buy the salad bar ready to eat vegetable and fruits versus the produce aisle selections?___________________________________________________________

Deli

Questions

1. How many calories are there in a serving of: Potato Salad? ______ Pasta Salad? _______

2. Is the Potato Salad serving size on the Food Label your normal portion? _________

3. How many calories do you estimate are in your normal serving size of Potato Salad? _____________________

4. Select any package of pre-packaged meat. How many calories are there in a serving? ________________

5. What is the total number of calories if you add your answers for question #3 and #4 together?_______

6. If your goal is to consume 2,000 calories (or less) daily, how many calories can you consume for the remainder of the day after subtracting the answer to question #5 from 2,000 calories? _________________________________

Meat & Poultry

Nutrition Labels

Since July 1994, the USDA has encouraged retailers to provide point of purchase information for raw meat and poultry. The information must include the following:

Buying Beef or Pork

Visually judge cuts of meat for fat content (the marbling.)

Buying Chicken and Turkey

Most of the time, skinless chicken and turkey are lower fat choices compared to beef and pork.

Questions

1. Complete the following chart based upon the food label for the following items:

2. Which of these Franks has the least calories from fat? ___________________________

3. Look at the various ways you can buy Chicken - whole, cut up, boned, skinless, prepared with a sauce or grilled. Compare prices for serving per portions of meat. Which choice would you select?_________________

4. Look at the various cuts of Meat - regular ground, tenderloin steak, rib steak or rib roast. Compare the prices for per serving portions of meat. Which would you select for low fat content? ________________________

Dairy Case

Low Calorie Substitutions

Cheese

Sugars on Food Label

Questions

1. What important nutrients do dairy products provide? ____________________________

2. Enter the quantities listed on the milk food labels for:

3. Is 2% milk really much of a fat and calorie saver compared to Whole milk? ____________

4. What added bonus do you get when you drink milk?_________________

5. How much milk do you need to fulfill your daily calcium requirement? _______________

6. How many calories are there in serving of cottage cheese?________________________

7. Compare a package of American Singles cheese and its ingredients with one whole fat cheese that you may like such as Baby Gouda & one low-fat or no-fat cheese. Which has the most total fat?____________

(Cheese: remember to compare the product taste and melting ability in comparing your dietary selections)

Packaged Products

Nutrition Tips

Questions

1. Analyze canned and packaged soups. Compare the serving sizes, sodium per serving and the ingredients list. Which soups have the lowest sodium content? _____________________

2. Compare a bag of Fritos and Potato Chips.

3. Analyze cookies and snack cakes. Compare a product like Little Debbie Snack cakes with Oatmeal Lights and Oatmeal Cream Pies.

4. Compare different brands of popcorn - microwave and non-microwave. How many calories are in your normal serving? ________________________

 Bread, Crackers & Cereal

Nutrition Tips

Bread

Cereal

Crackers

Questions 

1. Which loaf of bread has the highest fiber content? __________ Is it "whole wheat"? ______

2. Complete the following chart for bread.

3. Analyze the various claims being made on bread packaging. Is "natural", "low fat" and "enriched" substantiated on the food label? ____________________________________

4. Complete the following chart for breakfast cereals for the unprepared

Frozen Dinners & Entrees 

Nutrition Tips

Questions

1. Enter the ingredients for a "low" fat frozen dinner with a standard frozen dinner. Is the "low" fat really a calorie and fat saver? ________________________________________

2. Is the serving size adequate for you? _____________________

3. Using the frozen food dinners in question #1, complete the following chart. How much are you paying for each serving? _________________________________________________

4. Is the meal balanced? ______ What else would you eat with the meal to improve the daily value?_______________________________________________________________

Fats, Oils & Dressings

Nutrition Tips

Questions

1. Complete the following chart for butter and margarine.

2. Complete the following chart comparing cooking oils.

3. Complete the following chart comparing fat free mayonnaise and regular mayonnaise.

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Section IV: Additional Resources

American Dietetic Association,120 South Riverside Plaza, Suite 2000, Chicago, IL 60606-6995 800/877-1600  http://www.eatright.org

Cancer Information Service, Office of Cancer Communications, National Cancer Institute, Building 31, Room 10A16, 9000 Rockville Pike, Bethesda, MD 20892.

Center for Food Safety and Applied Nutrition, FDA, 5100 Paint Branch Parkway, College Park, MD 20740-3835 http://vm.cfsan.fda.gov

Center for Nutrition Policy and Promotion, USDA, 1120 20th Street, NW, Suite 200 North Lobby, Washington, DC 20036.

Food and Nutrition Information Center, USDA/National Agricultural Library, Room 304, 10301 Baltimore Boulevard, Beltsville, MD 20705-2351. E-mail: fnic@nalusda.gov

National Heart, Lung, and Blood Institute Information Center, P.O. Box 30105, Bethesda, MD 20824-0105. Gopher: gopher://gopher.nhlbi.nih.gov/ E-mail: nhlbic@dgs.dgysys.com

National Institute on Aging Information Center, Building 31, Room 5C27, National Institutes of Health, Bethesda, MD 20892.

National Institute on Alcohol Abuse and Alcoholism, 600 Executive Boulevard, Suite 409, Bethesda, MD 20892-7003.

Office of Food Labeling, Food and Drug Administration (HFS-150), 200 C Street, SW, Washington, DC 20204.

Weight-Control Information Network (WIN) of the National Institute of Diabetes and Digestive and Kidney Diseases, 1 WIN WAY, Bethesda, MD 20892

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Section VII: Appendix

Appendix A: Health, United States, 2002 (36)

Health, United States, 2002 is the 26th report on the health status of the Nation, and is submitted by the Secretary of the Department of Health and Human Services to the President and Congress of the United States in compliance with Section 308 of the Public Health Service Act. This report was compiled by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). The National Committee on Vital and Health Statistics served in a review capacity. The Health, United States series presents national trends in health statistics.

The Following are Highlights of Health Status and Determinants

Population Characteristics

Important changes in the U.S. population will shape future efforts to improve health and health care. Two major changes in the demographic characteristics of the U.S. population are the growth of the elderly population and the increasing racial and ethnic diversity of the Nation.

From 1950 to 2000 the proportion of the population that is elderly rose from 8 to 12 percent. By 2050 it is projected that one in five Americans will be 65 years of age or over.

The racial and ethnic composition of the Nation has changed over time. The Hispanic population and the Asian and Pacific Islander population have grown more rapidly than other racial and ethnic groups in recent decades. In 2000 more than 12 percent of the U.S. population identified themselves as Hispanic and almost 4 percent as Asian or Pacific Islander.

In 2000 the percent of Americans living in poverty dropped to 11.3 percent overall. However, the poverty rate differs significantly among population subgroups. More than one-quarter of black and Hispanic children lived in poor families in 2000.

Fertility

Birth rates for teens have continued to decline, while birth rates for women 20-44 years of age increased in 2000. The overall fertility rate increased for the third year in 2000 after dropping each year during 1990-97.

The birth rate for teenagers declined for the ninth consecutive year in 2000, to 48.5 births per 1,000 women aged 15-19 years, an all-time low for the Nation. Between 1991 and 2000 the teen birth rate declined more for 15-17 year olds than for 18-19 year olds (by 29 percent compared with 16 percent) (table 3).

The birth rate for unmarried women increased 2 percent in 2000 to 45.2 births per 1,000 unmarried women ages 15-44 years, but was still 4 percent below its high in 1994. The birth rate for unmarried black women increased slightly in 2000 to 72.5 per 1,000, after having declined steadily over the past decade, and the birth rate for unmarried Hispanic women increased for the second year to 97.3 per 1,000.

Health Behaviors and Risk Factors

Health behaviors and risk factors have a significant effect on health outcomes. Cigarette smoking increases the risk of lung cancer, heart disease, emphysema, and other respiratory diseases. Overweight and obesity increase the risk of death and disease as well as the severity of disease. Regular physical activity reduces mortality, lessens the risk of disease, and enhances physical functioning. Heavy and chronic use of alcohol and use of illicit drugs increase the risk of disease and injuries. Environmental exposures also affect health. For example, poor air quality contributes to respiratory illness, cardiovascular disease, and cancer.

Since 1990 the percent of adults who smoke cigarettes has declined only slightly. In 2000, 26 percent of men and 21 percent of women were smokers. Cigarette smoking by adults is strongly associated with educational attainment. Adults with less than a high school education were almost three times as likely to smoke as those with a bachelor's degree or more education in 2000.

The percent of high school students who smoke cigarettes increased in the early 1990s. Since 1997 the percent of students who smoke has declined. In 2001, 29 percent of high school students reported smoking during the past month.

Cigarette smoking during pregnancy is a risk factor for poor birth outcomes such as low birthweight and infant death. In 2000 the proportion of mothers who smoked cigarettes during pregnancy declined to 12 percent, down from 20 percent in 1989. Smoking rates for mothers ages 18-19 years decreased in 2000, after increasing each year since 1995. Mothers in this age group remained more likely to smoke during pregnancy than mothers at other ages.

The prevalence of overweight and obesity among adults has increased substantially since 1976-80. In 1999 an estimated 61 percent of adults 20-74 years of age were overweight with 27 percent obese, based on preliminary data.

The prevalence of overweight among children and adolescents rose from 1976-80 to 1999. In 1999 an estimated 13 percent of children 6-11 years of age and 14 percent of adolescents 12-19 years of age were overweight, based on preliminary data.

Almost 40 percent of adults reported that they did not engage in physical activity during leisure time in 2000. The percent of adults who were physically inactive increased with age, and at most ages women were more likely to be inactive than men.

Among current drinkers, 43 percent of men and 19 percent of women reported drinking five or more alcoholic drinks in a day on at least one-day in the past year in 2000. This level of alcohol consumption was most common among young adults 18-24 years of age.

The prevalence of illicit drug use within the past 30 days among youths 12-17 years of age remained essentially unchanged between 1999 and 2000 at about 10 percent. The percent of youths reporting illicit drug use increased with age, ranging from 3 percent among those 12-13 years to over 16 percent among those 16-17 years in 2000.

The number of cocaine-related emergency department episodes per 100,000 population for persons 35 years and over increased steadily throughout the 1990s to 68 per 100,000 in 2000. Among those 26-34 years, the age group with the highest episode rate, the 2000 rate (155 per 100,000) declined for the second year in a row. The same patient may be involved in multiple drug-related episodes.

In 2000 about one-half of substance abuse clients in specialty treatment units were receiving treatment for both alcoholism and drug abuse.

The presence of unacceptable levels of ground-level ozone is the largest source of air pollution. In 2000 approximately 42 percent of the U.S. population lived in areas designated as nonattainment areas for established health-based standards for ozone.

Morbidity

Limitation of activity due to chronic health conditions and self-assessed (or family member-assessed) health status are two summary measures of morbidity presented in this report. Additional measures of morbidity that are presented include the incidence of specific diseases, injury-related emergency department use, and suicide attempts.

Limitation of activity due to chronic health conditions occurs about twice as often among boys as girls and is significantly higher among school-age children than preschoolers. Among children 5-17 years, 9 percent of boys and 5 percent of girls had an activity limitation in 1998-2000 with the majority classified as having a limitation based on participation in special education.

Limitations in handling personal care needs such as bathing (activities of daily living or ADLs) and routine needs such as shopping (instrumental activities of daily living or IADLs) increase sharply with age among the noninstitutionalized population. Among adults 75 years of age and over, nearly 10 percent reported ADL limitations and nearly 20 percent reported IADL limitations in 1998-2000.

The relative importance of different chronic conditions as causes of activity limitation differs by age. Among younger adults 18-44 years the most frequently mentioned chronic conditions causing limitations were arthritis and other musculoskeletal conditions and mental illness in 1998-2000. Among adults 45 years of age and older arthritis and other musculoskeletal conditions and heart and other circulatory conditions outranked other conditions as causes of activity limitation.

The percent of noninstitutionalized adults reporting fair or poor health increases substantially through middle and old age. In 2000 about 1 in 10 persons 45-54 years of age reported fair or poor health status compared with 1 in 5 persons ages 55-64 years, 1 in 4 persons ages 65-74 years, and 1 in 3 persons 75 years of age and older.

Of the more than 40,000 new AIDS cases in 2000, 3 out of 4 were male. New AIDS cases dropped more for men than for women in 2000. Among males 13 years of age and over, 11 percent fewer new AIDS cases were reported in 2000 than in 1999 while among females in the same age group, 4 percent fewer cases were reported.

Incidence rates for all cancers combined declined in the 1990s for males but not for females. Between 1990 and 1998 age-adjusted cancer incidence rates declined on average more than 2 percent per year for non-Hispanic white males and Hispanic males and almost 2 percent for black males. Although there was no significant change in cancer incidence for females overall, among Hispanic females rates decreased on average 1 percent per year, and among Asian or Pacific Islander females rates increased almost 1 percent per year.

The most frequently diagnosed cancer sites in males are prostate, followed by lung and bronchus and colon and rectum. Cancer incidence at these sites is higher for black males than for males of other racial and ethnic groups. In 1998 age-adjusted cancer incidence rates for black males exceeded those for white males by 64 percent for prostate, 43 percent for lung and bronchus, and 11 percent for colon and rectum.

Breast cancer is the most frequently diagnosed cancer among females. Breast cancer incidence is higher for non-Hispanic white females than for females in other racial and ethnic groups. In 1998 age-adjusted breast cancer incidence rates for non-Hispanic white females exceeded those for black females by 27 percent, for Asian or Pacific Islander females by 46 percent, and for Hispanic females by 78 percent.

Mortality Trends

Life expectancy and infant mortality are measures often used to gauge the overall health of a population. Over the past 50 years overall mortality has declined substantially among Americans of all ages.

In 2000 life expectancy at birth for the total population reached a record high of 76.9 years, based on preliminary data. In 1999 life expectancy was 76.7 years.

During the 20th century life expectancy at birth increased from 48 to 74 years for males and from 51 to 79 years for females. Life expectancy at age 65 rose from 12 to 16 years for men and from 12 to 19 years for women.

In 2000 the infant mortality rate declined to a record low of 6.9 infant deaths per 1,000 live births, based on preliminary data. In 1999 the infant mortality rate was 7.1 per 1,000 (table 23). Between 1950 and 1999 the infant mortality rate declined by about 75 percent. Substantial declines occurred in mortality during the first month of life (neonatal) as well as after the first month of life (postneonatal).

Since 1950 mortality among children and young adults (ages 1-24 years) has declined by more than one-half. Overall mortality at ages 1-24 years has declined, in part, due to decreases in death rates for unintentional injuries, cancer, heart disease, and infectious diseases. Homicide and suicide rates generally increased over this period, but have declined since the mid-1990s.

Between 1950 and 1999 mortality among adults 25-44 years declined by more than 40 percent overall. Death rates for unintentional injuries, cancer, heart disease, and tuberculosis decreased substantially during this period. Suicide rates rose through 1980 and have since declined slightly. HIV disease was the leading cause of death in this age group in the mid-1990s; with decreasing HIV disease death rates, it dropped to the fifth leading cause of death in 1999.

Since 1950 mortality among adults 45-64 years has decreased by nearly 50 percent overall. During this period death rates for heart disease, stroke, and unintentional injury decreased while cancer mortality rose slowly through the 1980s and then declined. Cancer is the leading cause of death for 45-64 year olds, accounting for more than one-third of deaths in this age group in 1999.

During the past 50 years mortality among elderly persons 65 years of age and over has dropped by about one-third. During this period death rates for heart disease and stroke have declined sharply while the death rate for cancer rose until 1995 and has since decreased slightly.

Disparities in Mortality

Despite overall declines in mortality, racial and ethnic disparities as well as gender disparities in mortality persist. The gap in life expectancy between the sexes and between the black and white populations has been narrowing.

Infant mortality rates have declined for all racial and ethnic groups, but large disparities remain. In 1997-99 the infant mortality rate was highest for infants of non-Hispanic black mothers (13.9 deaths per 1,000 live births) and lowest for infants of Chinese mothers (3.3 per 1,000 live births).

Infant mortality increases as mother's level of education decreases. In 1999 the mortality rate for infants of mothers with less than 12 years of education was 57 percent higher than for infants of mothers with 13 or more years of education. This disparity was more marked among non-Hispanic white infants, for whom mortality among infants of mothers with less than a high school education was more than twice that for infants of mothers with more than a high school education.

Life expectancy at birth increased more for males than for females between 1990 and 2000, reducing the difference in life expectancy between the sexes. The difference in life expectancy between males and females narrowed from 7 years in 1990 to 5.5 years in 1999 and 5.4 years in 2000 (preliminary data).

During the 1990s mortality from lung cancer declined for men and increased for women. Although these trends reduced the sex differential for this cause of death, the age-adjusted death rate for lung cancer was still 89 percent higher for men than for women in 1999 and 84 percent higher in 2000 (preliminary data).

Between 1990 and 2000 life expectancy at birth increased more for the black than for the white population, thereby narrowing the gap in life expectancy between these two racial groups. In 1990 life expectancy at birth was 7 years longer for the white than for the black population. By 1999 the difference had narrowed to 5.9 years and by 2000, to 5.6 years (preliminary data).

Overall mortality was one-third higher for black Americans than for white Americans in 1999, compared with 37 percent higher in 1990. In 1999 age-adjusted death rates for the black population exceeded those for the white population by 38 percent for stroke, 28 percent for heart disease, 27 percent for cancer, and more than 700 percent for HIV disease.

Appendix B: A Consumer's Guide to Fats

U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition

FDA Consumer., May 1994; Revised November 1994, January 1996, and 1999

by Eleanor Mayfield

Once upon a time, we didn't know anything about fat except that it made foods tastier. We cooked our food in lard or shortening. We spread butter on our breakfast toast and plopped sour cream on our baked potatoes. Farmers bred their animals to produce milk with high butterfat content and meat "marbled" with fat because that was what most people wanted to eat.

But ever since word got out that diets high in fat are related to heart disease, things have become more complicated. Experts tell us there are several different kinds of fat, some of them worse for us than others. In addition to saturated, monounsaturated and polyunsaturated fats, there are triglycerides, trans fatty acids, and omega 3 and omega 6 fatty acids.

Most people have learned something about cholesterol, and many of us have been to the doctor for a blood test to learn our cholesterol "number." Now, however, it turns out that there's more than one kind of cholesterol, too.

Almost every day there are newspaper reports of new studies or recommendations about what to eat or what not to eat: Lard is bad, olive oil is good, margarine is better for you than butter-then again, maybe it's not.

Amid the welter of confusing terms and conflicting details, consumers are often baffled about how to improve their diets. Clearly, though, consumers are interested in obtaining this information. In a poll conducted by Nielsen Marketing Research, people were asked to select the food qualities that were "very important" to them, and knowing which foods were low in fat and cholesterol ranked highest:

Percentage of people who said these food qualities were "very important" to them:

FDA regulations enable consumers to see clearly on a food product's label how much and what kind of fat the product contains.

Fats & Fatty Acids

Fats are a group of chemical compounds that contain fatty acids. Energy is stored in the body mostly in the form of fat. Fat is needed in the diet to supply essential fatty acids, substances essential for growth but not produced by the body itself.

There are three main types of fatty acids: saturated, monounsaturated and polyunsaturated. All fatty acids are molecules composed mostly of carbon and hydrogen atoms. A saturated fatty acid has the maximum possible number of hydrogen atoms attached to every carbon atom. It is therefore said to be "saturated" with hydrogen atoms.

Some fatty acids are missing one pair of hydrogen atoms in the middle of the molecule. This gap is called an "unsaturation" and the fatty acid is said to be "monounsaturated" because it has one gap. Fatty acids that are missing more than one pair of hydrogen atoms are called "polyunsaturated."

Saturated fats (which contain saturated fatty acids) are mostly found in foods of animal origin. Monounsaturated and polyunsaturated fats (which contain monounsaturated and polyunsaturated fatty acids) are mostly found in foods of plant origin and some seafoods. Polyunsaturated fatty acids are of two kinds, omega-3 or omega-6. Scientists tell them apart by where in the molecule the "unsaturations," or missing hydrogen atoms, occur.

Recently a new term has been added to the fat lexicon: trans fatty acids. These are byproducts of partial hydrogenation, a process in which some of the missing hydrogen atoms are put back into polyunsaturated fats. "Partially hydrogenated vegetable oils," such as vegetable shortening and margarine, are solid at room temperature.

Cholesterol

Cholesterol is sort of a "cousin" of fat. Both fat and cholesterol belong to a larger family of chemical compounds called lipids. All the cholesterol the body needs is made by the liver. It is used to build cell membranes and brain and nerve tissues. Cholesterol also helps the body produce steroid hormones needed for body regulation, including processing food, and bile acids needed for digestion.

People don't need to consume dietary cholesterol because the body can make enough cholesterol for its needs. But the typical U.S. diet contains substantial amounts of cholesterol, found in foods such as egg yolks, liver, meat, some shellfish, and whole-milk dairy products. Only foods of animal origin contain cholesterol.

Cholesterol is transported in the bloodstream in large molecules of fat and protein called lipoproteins. Cholesterol carried in low- density lipoproteins is called LDL-cholesterol; most cholesterol is of this type. Cholesterol carried in high-density lipoproteins is called HDL-cholesterol. (See "Fat Words.")

A person's cholesterol "number" refers to the total amount of cholesterol in the blood. Cholesterol is measured in milligrams per deciliter (mg/dl) of blood. (A deciliter is a tenth of a liter.) Doctors recommend that total blood cholesterol be kept below 200 mg/dl. The average level in adults in this country is 205 to 215 mg/dl. Studies in the United States and other countries have consistently shown that total cholesterol levels above 200 to 220 mg/dl are linked with an increased risk of coronary heart disease.

LDL-cholesterol and HDL-cholesterol act differently in the body. A high level of LDL-cholesterol in the blood increases the risk of fatty deposits forming in the arteries, which in turn increases the risk of a heart attack. Thus, LDL-cholesterol has been dubbed "bad" cholesterol.

On the other hand, an elevated level of HDL-cholesterol seems to have a protective effect against heart disease. For this reason, HDL- cholesterol is often called "good" cholesterol.

In 1992, a panel of medical experts convened by the National Institutes of Health (NIH) recommended that individuals should have their level of HDL-cholesterol checked along with their total cholesterol.

According to the National Heart, Lung, and Blood Institute (NHLBI), a component of NIH, a healthy person who is not at high risk for heart disease and whose total cholesterol level is in the normal range (around 200 mg/dl) should have an HDL-cholesterol level of more than 35 mg/dl. NHLBI also says that a LDL-cholesterol level of less than 130 mg/dl is "desirable" to minimize the risk of heart disease.

Some very recent studies have suggested that LDL-cholesterol is more likely to cause fatty deposits in the arteries if it has been through a chemical change known as oxidation. However, these findings are not accepted by all scientists. The NIH panel also advised that individuals with high total cholesterol or other risk factors for coronary heart disease should have their triglyceride levels checked along with their HDL-cholesterol levels.

Triglycerides and VLDL;

Triglyceride is another form in which fat is transported through the blood to the body tissues. Most of the body's stored fat is in the form of triglycerides. Another lipoprotein--very low-density lipoprotein, or VLDL--has the job of carrying triglycerides in the blood. NHLBI considers a triglyceride level below 250 mg/dl to be normal.

It is not clear whether high levels of triglycerides alone increase an individual's risk of heart disease. However, they may be an important clue that someone is at risk of heart disease for other reasons. Many people who have elevated triglycerides also have high LDL- cholesterol or low HDL-cholesterol. People with diabetes or kidney disease--two conditions that increase the risk of heart disease--are also prone to high triglycerides.

Dietary Fat & Cholesterol Levels

Many people are confused about the effect of dietary fats on cholesterol levels. At first glance, it seems reasonable to think that eating less cholesterol would reduce a person's cholesterol level. In fact, eating less cholesterol has less effect on blood cholesterol levels than eating less saturated fat. However, some studies have found that eating cholesterol increases the risk of heart disease even if it doesn't increase blood cholesterol levels.

Another misconception is that people can improve their cholesterol numbers by eating "good" cholesterol. In food, all cholesterol is the same. In the blood, whether cholesterol is "good" or "bad" depends on the type of lipoprotein that's carrying it.

Polyunsaturated and monounsaturated fats do not promote the formation of artery-clogging fatty deposits the way saturated fats do. Some studies show that eating foods that contain these fats can reduce levels of LDL-cholesterol in the blood. Polyunsaturated fats, such as safflower and corn oil, tend to lower both HDL- and LDL-cholesterol. Edible oils rich in monounsaturated fats, such as olive and canola oil, however, tend to lower LDL-cholesterol without affecting HDL levels.

How Do We Know Fat's a Problem?

In 1908, scientists first observed that rabbits fed a diet of meat, whole milk, and eggs developed fatty deposits on the walls of their arteries that constricted the flow of blood. Narrowing of the arteries by these fatty deposits is called atherosclerosis. It is a slowly progressing disease that can begin early in life but not show symptoms for many years. In 1913, scientists identified the substance responsible for the fatty deposits in the rabbits' arteries as cholesterol.

In 1916, Cornelius de Langen, a Dutch physician working in Java, Indonesia, noticed that native Indonesians had much lower rates of heart disease than Dutch colonists living on the island. He reported this finding to a medical journal, speculating that the Indonesians' healthy hearts were linked with their low levels of blood cholesterol.

De Langen also noticed that both blood cholesterol levels and rates of heart disease soared among Indonesians who abandoned their native diet of mostly plant foods and ate a typical Dutch diet containing a lot of meat and dairy products. This was the first recorded suggestion that diet, cholesterol levels, and heart disease were related in humans. But de Langen's observations lay unnoticed in an obscure medical journal for more than 40 years.

After World War II, medical researchers in Scandinavia noticed that deaths from heart disease had declined dramatically during the war, when food was rationed and meat, dairy products, and eggs were scarce. At about the same time, other researchers found that people who suffered heart attacks had higher levels of blood cholesterol than people who did not have heart attacks.

Since then, a large body of scientific evidence has been gathered linking high blood cholesterol and a diet high in animal fats with an elevated risk of heart attack. In countries where the average person's blood cholesterol level is less than 180 mg/dl, very few people develop atherosclerosis or have heart attacks. In many countries where a lot of people have blood cholesterol levels above 220 mg/dl, such as the United States, heart disease is the leading cause of death.

High rates of heart disease are commonly found in countries where the diet is heavy with meat and dairy products containing a lot of saturated fats. However, high-fat diets and high rates of heart disease don't inevitably go hand-in-hand.

Learning from Other Cultures

People living on the Greek island of Crete have very low rates of heart disease even though their diet is high in fat. Most of their dietary fat comes from olive oil, a monounsaturated fat that tends to lower levels of "bad" LDL-cholesterol and maintain levels of "good" HDL- cholesterol.

The Inuit, or Eskimo, people of Alaska and Greenland also are relatively free of heart disease despite a high-fat, high-cholesterol diet. The staple food in their diet is fish rich in omega-3 polyunsaturated fatty acids.

Some research has shown that omega-3 fatty acids, found in fish such as salmon and mackerel as well as in soybean and canola oil, lower both LDL-cholesterol and triglyceride levels in the blood. Some nutrition experts recommend eating fish once or twice a week to reduce heart disease risk. However, dietary supplements containing concentrated fish oil are not recommended because there is insufficient evidence that they are beneficial and little is known about their long-term effects.

Omega-6 polyunsaturated fatty acids have also been found in some studies to reduce both LDL-and HDL-cholesterol levels in the blood. Linoleic acid, an essential nutrient (one that the body cannot make for itself) and a component of corn, soybean and safflower oil, is an omega-6 fatty acid.

At one time, many nutrition experts recommended increasing consumption of monounsaturated and polyunsaturated fats because of their cholesterol-lowering effects. Now, however, the advice is simply to reduce dietary intake of all types of fat. (Infants and young children, however, should not restrict dietary fat.

The available information on fats may be voluminous and is sometimes confusing. But sorting through the information becomes easier once you know the terms and some of the history.

The "bottom line" is actually quite simple, according to John E. Vanderveen, Ph.D., director of the Office of Plant and Dairy Foods and Beverages in FDA's Center for Food Safety and Applied Nutrition. "What we should be doing is removing as much of the saturated fat from our diet as we can. We need to select foods that are lower in total fat and especially in saturated fat." In a nutshell, that means eating fewer foods of animal origin, such as meat and whole-milk dairy products, and more plant foods such as vegetables and grains.

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Fat Words- Glossary

Here are brief definitions of the key terms important to an understanding of the role of fat in the diet.

Cholesterol: A chemical compound manufactured in the body. It is used to build cell membranes and brain and nerve tissues. Cholesterol also helps the body make steroid hormones and bile acids.

Dietary cholesterol: Cholesterol found in animal products that are part of the human diet. Egg yolks, liver, meat, some shellfish, and whole- milk dairy products are all sources of dietary cholesterol.

Fatty acid: A molecule composed mostly of carbon and hydrogen atoms. Fatty acids are the building blocks of fats.

Fat: A chemical compound containing one or more fatty acids. Fat is one of the three main constituents of food (the others are protein and carbohydrate). It is also the principal form in which energy is stored in the body.;

Hydrogenated fat: A fat that has been chemically altered by the addition of hydrogen atoms (see trans fatty acid). Vegetable oil and margarine are hydrogenated fats.

Lipid: A chemical compound characterized by the fact that it is insoluble in water. Both fat and cholesterol are members of the lipid family.

Lipoprotein: A chemical compound made of fat and protein. Lipoproteins that have more fat than protein are called low-density lipoproteins (LDLs). Lipoproteins that have more protein than fat are called high- density lipoproteins (HDLs). Lipoproteins are found in the blood, where their main function is to carry cholesterol.

Monounsaturated fatty acid: A fatty acid that is missing one pair of hydrogen atoms in the middle of the molecule. The gap is called an "unsaturation." Monounsaturated fatty acids are found mostly in plant and seafoods.

Monounsaturated fat: A fat made of monounsaturated fatty acids. Olive oil and canola oil are monounsaturated fats. Monounsaturated fats tend to lower levels of LDL-cholesterol in the blood.

Polyunsaturated fatty acid: A fatty acid that is missing more than one pair of hydrogen atoms. Polyunsaturated fatty acids are mostly found in plant and seafoods.

Polyunsaturated fat: A fat made of polyunsaturated fatty acids. Safflower oil and corn oil are polyunsaturated fats. Polyunsaturated fats tend to lower levels of both HDL-cholesterol and LDL-cholesterol in the blood.

Saturated fatty acid: A fatty acid that has the maximum possible number of hydrogen atoms attached to every carbon atom. It is said to be "saturated" with hydrogen atoms. Saturated fatty acids are mostly found in animal products such as meat and whole milk. Saturated fat: A fat made of saturated fatty acids. Butter and lard are saturated fats. Saturated fats tend to raise levels of LDL-cholesterol ("bad" cholesterol) in the blood. Elevated levels of LDL-cholesterol are associated with heart disease.

Trans fatty acid: A polyunsaturated fatty acid in which some of the missing hydrogen atoms have been put back in a chemical process called hydrogenation. Trans fatty acids are the building blocks of hydrogenated fats.

Government Advice

Dietary guidelines endorsed by the U.S. Department of Agriculture and the U.S. Department of

Health and Human Services advise consumers to:

Appendix C: Taking the Fat Out of Food

U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, by Paula Kurtzweil

Food manufacturers are making it easier for fat-conscious consumers to have their cake and eat it, too--and their cheeses, chips, chocolate, cookies, ice cream, salad dressings, and various other foods that are now available in lower fat versions.

These products can help adult consumers reduce their fat intakes to recommended levels while allowing them to enjoy foods traditionally high in fat. A diet high in fat can contribute to heart disease and some forms of cancer and, because fats are calorie-dense, to excessive body weight.

A host of fat substitutes that replaces most, if not all, of the fat in a food, makes these lower fat foods possible. Most of these fat replacers are ingredients already approved by the Food and Drug Administration for other uses in food. For instance, starches and gums are approved as thickeners and stabilizers. New compounds, such as olestra, have undergone or will undergo close scrutiny by FDA to assess their safety.

In theory, the perfect fat replacer is one that contributes everything fat does in a food but without the calories, saturated fat, and cholesterol. The question remains: Can fat-reduced products actually reduce people's overall calorie intake and have a significant impact on their total fat intake?

Fat in the Diet

Fat is a difficult substance to replace because it has many important functions. A major nutrient, it is important for proper growth and development and maintenance of good health. Fats carry the fat-soluble vitamins A, D, E, and K and aid their absorption in the intestine. They are the only source of the essential fatty acids linoleic and linolenic acids. They are an important source of calories for many adults and for infants and toddlers, who have the highest energy needs per kilogram of body weight of any age group. Fat provides 9 calories per gram, compared with 4 calories per gram for protein and carbohydrates.

As a food ingredient, fat is important in food preparation and consumption because it gives taste, consistency, stability, and palatability to foods and helps us feel full so we stop eating.

But there are limits on the amount we should eat because of fats' link to heart disease, cancer and overweight. The Dietary Guidelines for Americans recommend limiting total fat intake to no more than 30 percent of calories and saturated fat to no more than 10 percent. Cholesterol intake should be limited to no more than 300 milligrams a day. Saturated fat and cholesterol are the substances in fat that contribute to the formation of plaque, which clogs arteries, leading to heart disease.

Americans appear to be heeding the experts' advice because, according to a 1995 annual survey by the Food Marketing Institute--an organization of grocery retailers and wholesalers--65 percent of the consumers surveyed--the highest level to date--rated fat as their No. 1 nutrition concern. More than three-fourths of the consumers said they stopped buying a specific food because of the amount of fat listed on the nutrition label.

A 1995 survey by the Calorie Control Council--an international association of manufacturers of low-calorie, low-fat, and diet foods and beverages--found that 72 percent of respondents who said they look for "light" foods said they are most attracted to food products claiming to be "reduced in fat."

Manufacturers are responding by adding more and more reduced-fat foods to their product lines. That corresponds to the Department of Health and Human Services' Healthy People 2000 goal of increasing to 5,000 from 2,500 in 1986 the number of brand items reduced in fat and saturated fat.

Regulation

Fat replacers can help reduce a food's fat and calorie levels while maintaining some of the desirable qualities fat brings to food, such as "mouth feel," texture and flavor. Under FDA regulations, fat replacers usually fall into one of two categories: food additives or "generally recognized as safe" (GRAS) substances. Each has its own set of regulatory requirements.

Food additives must be evaluated for safety and approved by FDA before they can be marketed. They include substances with no proven track record of safety; scientists just don't know that much about their use in food. Examples of food additives are polydextrose, carrageenan and olestra, which are used as fat replacers.

Manufacturers of food additives must test their products, submit the results to FDA for review, and await agency approval before using them in food. GRAS substances, on the other hand, do not have to undergo rigorous testing before they are used in foods because they are generally recognized as safe by knowledgeable scientists, usually because of the substances' long history of safe use in foods. Many GRAS substances are similar to substances already in food. Examples of GRAS substances used as fat replacers are cellulose gel, dextrins, guar gum, and gum arabic.

Sources

Fat replacers may be carbohydrate- protein- or fat-based substances.

The first to hit the market used carbohydrate as the main ingredient. Avicel, for example, is a cellulose gel introduced in the mid-1960s as a food stabilizer. Carrageenan, a seaweed derivative, was approved for use as an emulsifier, stabilizer and thickener in food in 1961. Its use as a fat replacer became popular in the early 1990s. Litesse (polydextrose) came on the market in 1981 as a humectant, which helps retain moisture. Others in this category include dextrins, maltodextrins, fiber, gums, starch, and modified food starch. FDA has affirmed many carbohydrate-based fat replacers as GRAS.

Although their original intent was to perform certain technical functions in food that would improve overall quality, some carbohydrate-based fat replacers are now used specifically to reduce a food's calorie content. They provide from zero to 4 calories per gram. They are used in a variety of foods, including dairy-type products, sauces, frozen desserts, salad dressings, processed meats, baked goods, spreads, chewing gum, and sweets.

Protein-based fat substitutes came along in the early 1990s. These and fat-based replacers were designed specifically to replace fat in foods.

One form, Microparticulated Protein Product (MPP), such as Simplesse and Trailblazer, is made from whey protein or milk and egg protein. These fat replacers provide 1 to 4 calories per gram, depending on their water content, and are approved for use in frozen dessert-type foods. FDA has agreed that whey-based MPP conforms to FDA's definition of whey protein concentrate, such as the fat replacer Dairy-Lo, a GRAS substance. Therefore, whey-based MPP can be used in other foods, including reduced-fat versions of butter, sour cream, cheese, yogurt, salad dressing, margarine, mayonnaise, baked goods, coffee creamer, soups, and sauces.

Another type of protein-based fat replacers, called protein blends, combine animal or vegetable protein, gums, food starch, and water. They are made with FDA-approved ingredients and are used in frozen desserts and baked goods.

Olestra

Olestra is an example of a fat-based fat replacer. FDA approved olestra (brand name Olean), made by Procter & Gamble Co. of Cincinnati, in January 1996, for use in preparing potato chips, crackers, tortilla chips, and other savory snacks. Procter & Gamble said it expected to begin test-marketing olestra-containing products in 1996.

Olestra has properties similar to those of naturally occurring fat, but it provides zero calories and no fat. That's because olestra is undigestible. It passes through the digestive tract but is not absorbed into the body. This is due to its unique configuration: a center unit of sucrose (sugar) with six, seven or eight fatty acids attached.

Olestra's configuration also makes it possible for the substance to be exposed to high temperatures, such as frying--a quality most other fat replacers lack.

As promising as olestra sounds, it does have some drawbacks. Studies show that it may cause intestinal cramps and loose stools in some individuals.

Also, according to clinical tests, olestra reduces the absorption of fat-soluble nutrients, such as vitamins A, D, E, and K and carotenoids, from foods eaten at the same time as olestra-containing products. Tests by Procter & Gamble show that no reduction in absorption of fat-soluble vitamins will occur when proper levels of vitamins are added for compensation to olestra-containing foods.

To address these concerns, FDA approved olestra on conditions that vitamins A, D, E, and K be added to olestra-containing foods and that Procter & Gamble continue studies on consumption and long-term effects of olestra. That requirement will continue, but packages no longer will have to disclose why the vitamins are being added.

When originally approved in 1996, the FDA, to provide consumers with information about olestra's possible effects, that the following interim labeling statement appear on products made with 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." FDA invited public comment on the need for such a label statement and on the statement's adequacy and clarity.

On August 1, 2003, the Food and Drug Administration lifted this warning, concluding that if the zero-calorie fat substitute has any stomach-troubling effect, it's mild and rare.

FDA said it was convinced by a study that tracked how 3,000 people felt after eating chips during a six-week period. Half ate chips with olestra, and half ate chips they thought contained olestra but really didn't. The olestra eaters had only slightly more frequent bowel movements than the people who ate full-fat chips..

Of more concern to FDA were that people had falsely attributed serious health problems to olestra because of the warning label. Some people blamed olestra for abdominal pain but it that turned out they had appendicitis and others who had weeks of diarrhea due to intestinal viruses.

Some people might experience mild abdominal discomfort after eating olestra, just as some people do after eating high-fiber fruit. The FDA's position is that fruit doesn't bear a warning label, and now olestra won't either.

Other Replacers

Some other fat-based replacers are being considered or developed: Salatrim (which stands for short and long-chain acid triglyceride molecules) is the generic name for a family of reduced-calorie fats that are only partially absorbed in the body. Salatrim provides 5 calories per gram. A petition seeking FDA's affirmation that Salatrim is GRAS was filed in June 1994. An example of its use is in Hershey Co.'s reduced-fat baking chips, semi-sweet chocolate flavor.

Caprenin, another Procter & Gamble product, is a 5-calorie-per-gram fat substitute for cocoa butter in candy bars. A petition seeking FDA's affirmation that Caprenin is GRAS was filed in 1991.

Emulsifiers are fat-based substances that are used with water to replace all or part of the shortening content in cake mixes, cookies, icings, and vegetable dairy products. They give the same calories as fat but less is used, resulting in fat and calorie reductions.

Other fat replacers are being developed, according to the Calorie Control Council and other organizations. They include DDM (dialkyl dihexadecylmalonate), a fat-based substance that is not absorbed into the body and can be used in frying and baking. Frito-Lay Inc. has been studying this fat substitute since 1986, although it has not yet petitioned FDA for approval. Also on the horizon is a fat substitute made by combining starches or gums with small amounts of oil. Opta Food Ingredients Inc. received an exclusive license from the U.S. Department of Agriculture last February for the process, called Fantesk. This fat replacer would give foods the taste and texture of regular fat but provide less than 0.5 grams of fat per serving.

Reducing Dietary Fat

Can these fat replacers help consumers make positive dietary changes? Can they help those who are overweight lose weight?

It may be too early to say, and studies to date give varying answers. For example, in a study of lean non-dieting men, one group ate breakfasts of conventional fat foods, while the other ate olestra-containing foods. Those who ate the olestra-containing foods made up their usual daily calorie intake by eating more carbohydrate-containing foods. The study, sponsored partly by Procter & Gamble and published in a 1992 issue of the American Journal of Clinical Nutrition (Volume 56), suggested that a diet of reduced-fat foods can help reduce fat intake without affecting total calories.

Fat intake also was decreased in a study of 96 men and women "habitual snackers." One group was fed potato chips prepared with olestra, while the rest ate potato chips prepared with conventional frying oil. The group fed olestra chips ate on average 29 grams less fat and 270 fewer calories a day than those fed regular chips--even though those who knew they were eating fat-free chips ate 10 grams of chips more than those who ate regular chips. This study, done at Pennsylvania State University, also was partly sponsored by Procter & Gamble.

A possible concern about fat replacers is: Can foods claiming to be reduced in fat inadvertently influence people to eat more? Another study at Pennsylvania State University suggests they might. In this study, women were fed the same yogurt labeled either "high-fat" or "low-fat." The group fed the low-fat-labeled version ate more in a lunch that followed the yogurt than the group eating the high-fat-labeled yogurt. As a result, the group eating what they thought was low-fat yogurt took in more calories than the other group.

"It appeared that these women regarded the low-fat label as a license to overeat," wrote Debra Miller, a doctoral student in biobehavioral health and nutrition at Pennsylvania State, in an article she prepared for Weight Control Digest.

Still, reduced fat foods appear to be an important part of a fat-reduction diet, according to a study involving the Women's Health Trial. The study, designed to determine the role of low-fat diets in the prevention of breast cancer, found that eating "specially manufactured" low-fat foods was one of the most easily adopted dietary practices for those who received prior dietary instruction. Avoiding meats and giving up fats as flavorings (for example, eating bread without butter or margarine) were among the most difficult practices to adopt.

In using reduced-fat foods, the American Dietetic Association cautions consumers to realize that fat-free doesn't mean calorie-free. The calories lost in removing regular fat from a food can be regained through sugars added for palatability, as well as fat replacers, many of which provide calories, too. Consumers should refer to the Nutrition Facts panel on the food label to compare calories and other nutrition information between fat-reduced and regular-fat foods./P>

Many nutrition experts agree that, used properly, fat replacers can play an important role in improving adult Americans' diets. But, as with any diet or food, they emphasize variety and moderation to ensure a healthy intake.

"These [fat replacers] are truly innovative ideas," said Dennis Gordon, Ph.D., a food scientist at North Dakota State University, Columbia. "But they shouldn't be looked at as a total panacea. [The advice] is the same as with anything: Be prudent."

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Section VIII. Author Information

About the Author:

CAROLE S. MACKEY, MS, RD, LD. Carole is a Registered Dietitian in the Tampa Bay area. She surveys Long Term Care Facilities for the Agency for Health Care Administration to insure compliance with state and federal guidelines. Carole wrote the chapter Nutrition Assessment and Support in the Florida Dietetic Association Handbook of Medical Nutrition Therapy: The Florida Diet Manual.

She provides consultation to Home Care Companies and Educational Agencies and teaches the weight loss program "Chose to Lose". Carole developed the Nutrition Component to the AIDS Program at Bronx-Lebanon Hospital Center, a teaching facility and recipient of local, state, and federal funding as a provider of health care to HIV infected individuals in South Bronx, New York. She is a member of the American Dietetic Association, the American Society for Parenteral and Enteral Nutrition, and is the former President of the Tampa Dietetic Association.

This publication is designed for educational purposes only. Vantage Professional Education is not engaged in rendering medical advice or professional services. Any medical or other decisions should be made in consultation with your doctors. Vantage Professional Education will not be liable for any complications, injuries or other medical accidents arising from or in connection with the use of the subject matter covered.

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Section VIII. Footnotes

1. Federal Register, Volume 68, Number 133, Rules and Regulations,
Page 41433-41506, Food Labeling: Trans Fatty Acids in Nutrition Labeling,
Nutrient Content Claims, and Health Claims [Website] July 11, 2003.
http://www.cfsan.fda.gov/~lrd/fr03711a.html
2. US Food and Drug Administration, HHS To Require Food
Labels To Include Trans Fat Contents [Website] July 9, 2003.
http://www.hhs.gov/news/press/2003pres/20030709.html
3. US Food and Drug Administration, Center for Food Safety and
Applied Nutrition, "Guidance on How to Understand and Use the Nutrition
Facts Panel on Food Labels", June 2003.
4. US Department of Health and Human Services; Nutrition Your Health:
Dietary Guidelines For Americans; Fourth Edition;1995
5. Guide to Nutritional Labeling and Education Act (NLEA) Requirements;
21 CFR 101.9.c(7)&(8)&(9)
6. US Food and Drug Administration, Center for Food Safety and Applied
Nutrition, "Guidance on How to Understand and Use the Nutrition Facts
Panel on Food Labels", June 2003.
7. Guide to Nutritional Labeling and Education Act (NLEA) Requirements;
21 CFR 101.9.c(7)&(8)&(9)
8. Kurtzwell, Paula; Food and Drug Administration- 'Daily Values'
Encourage Healthy Diet; 1993
9. Food and Drug Administraion; Counting Calories; 1997
10. Food and Drug Administration; Counting Calories;1997
11. Kurtzwell, Paula; Food and Drug Administration- 'Daily Values'
Encourage Healthy Diet; 1993
12. U.S. Food and Drug Administration-The New Food Label;May 1995
13. Guide to Nutritional Labeling and Education Act (NLEA) Requirements;
21 CFR 101.9(j)(8)
14. Kurtzwell, Paula;Food and Drug Administration- Nutritional Info
Available for Raw Fruits, Vegetables, Fish;1993
15. Kurtzwell, Paula; Food and Drug Administration; A Serving of Nutrition
Info at the Meat Counter;1993
16. Guide to Nutritional Labeling and Education Act (NLEA) Requirements;
21 CFR 101.9.(j)(13)
17. Guide to Nutritional Labeling and Education Act (NLEA) Requirements;
21 CFR 101.9(b)(10)(ii)
18. Stehlin, Dori; The Food and Drug Administration- A Little "Lite" Reading, 1993 
19. U.S. Food and Drug Administration-The New Food Label;May 1995
20. Guide to Nutritional Labeling and Education Act (NLEA)
Requirements;21 CFR 14
21. U.S. Food and Drug Administration-The New Food Label; May 1995
22. U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition;
Dietary Supplement Health and Education Act of 1994; December 1, 1995
23. U.S. Food and Drug Administration, 2002 Dietary Supplement
Enforcement Report, 2002
24. U S. Food and Drug Administration, Center for Food Safety and Applied
Nutrition. Overview of
Dietary Supplement, January 3, 2001.
25. U.S. Food and Drug Administration, Center for Food Safety and Applied
Nutrition; Dietary
Supplement Health and Education Act of 1994.
26. U.S. Food and Drug Administration, Center for Food Safety and Applied
Nutrition; Dietary
Supplement Health and Education Act of 1994.
27. U. S. Food and Drug Administration, Center for Food Safety and Applied
Nutrition Office of Nutritional
Products, Labeling and Dietary Supplements,Guidance for Industry Qualified Health Claims in the
Labeling of Conventional Foods and Dietary Supplements, December 18, 2002.
28. Kurtzwell, Paula;Food and Drug Administration-Today's Special: Nutrition Information;1997
29. Kurtzwell, Paula;Food and Drug Administration-Today's Special: Nutrition Information;1997
30. Shirley Leung, Eateries Pressed for Nutrition Date, The Wall Street Journal,
Thursday, February 13, 2003;A3
31. National Restaurant Association's 2003 Restaurant Industry Forecast
32. Kurtzwell, Paula;Food and Drug Administration-Today's Special: Nutrition Information;1997
33. Kurtzwell, Paula;Food and Drug Administration-Today's Special: Nutrition Information;1997
34. U.S. Department of Health and Human Services;Dietary Guideline 
35. U.S. Food and Drug Administration Examples of Revised Nutrition Facts Panel
Listing Trans Fat [Website] September 4, 2003. http://www.cfsan.fda.gov/~dms/labtr.html
36. National Center for Health Statistics. Health, United States,
2002 With Chartbook on Trends in the Health of Americans.Hyattsville, Maryland: 2002.

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