Understanding Claims on Food Packages

Nutrient Content Claims

A nutrient content claim (NCC), often found on the front of a food package, indicates the amount of a nutrient a product contains. The Nutrition labeling and Education Act (NLEA) and FDA have created definitions for and allowed use of terms including “low-fat”, “sodium free”, and “good source” on food packages as a tool to help consumers make more healthful food selections based on their individual needs and preferences.

A disclosure statement must be made on products that contain an NCC if they contain nutrients in the following amounts (per serving or per 50 grams, or 2 ounces of the product if it comes in a small package) because these amounts can increase the risk f a diet-related disease or condition:

• Total fat – Greater than 13 grams
• Saturated fat – Greater than 4 grams
• Cholesterol – Greater than 60 milligrams
• Sodium – Greater than 480 milligrams

A meal-type product (a product that weights between 6 and 12 ounces per serving and contains ingredients from two or more of four specified food groups) needs a disclosure statement if, per labeled serving, it contains more than 26 gram of fat, 8 grams of saturated fat, 120 milligrams of cholesterol, or 960 milligram so sodium. Similarly, a main dish product (a product that weights at least 6 ounces and contains at least two different foods from at least two of four specified food groups) must bear a disclosure statement if it contains (per labeled serving) more than 19.5 grams of fat, 6.0 grams of saturated fat, 90 milligrams of cholesterol, or 720 milligrams of sodium.

A manufacturer can also make a claim about a nutrient that has no established DV as long as it simply states the amount of that nutrient per labeled serving (and not the level of the nutrient in the product). For example, “x grams of omega-3 fatty acids” can be made and placed somewhere on the food package (but not on the nutrition facts panel).

Health Claims

Health claims are statements on food packages that associate a particular food (or substance or nutrient in that food) with a reduction in a diet-related disease or condition (but not the treatment, diagnosis, cure, or mitigation of a disease or condition). Health claims must be supported by scientifically valid evidence and must include an amount of the particular nutrient or food that is directly associated with the diet-related disease or condition.

The FDA reviews and evaluates all health claims and authorizes their use on food packages only if there is “significant scientific agreement” supporting the particular health claim. Thus far, the following health claims have been approved by the FDA (an example of how that claim may be stated on food package is provided for each):

• Calcium and osteoporosis – Adequate calcium and regular exercise may reduce the risk of osteoporosis.
• Sodium and hypertension – Low-sodium diets may reduce the risk of hypertension.
• Dietary fat and cancer – A diet low in total fat may reduce the risk of some cancers.
• Dietary saturated fat and cholesterol and risk of coronary heart disease – Diets low in saturated fat and cholesterol may reduce the risk of coronary heart disease.
• Fiber-containing grain products, fruits, and vegetables and cancer – Low-fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer.
• Fruits and vegetables and cancer – Low-fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, or vitamin C) or other vitamins may reduce the risk of some types of cancer.
• Folate and neural tube defects – Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect.
• Sugar alcohols and dental caries – Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay. (Small packages can simply state “Does not promote tooth decay”).
• Soluble fiber from certain foods and risk of coronary heart disease – soluble fiber from [name of fiber source and, if desired, food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food product] supplies [x grams] of the [necessary daily dietary intake for the benefit] should fiber from [name of soluble fiber source] necessary per day to have this effect.
• Foods that contain fiber from psyllium and risk of heart disease – Diets low in saturated fat and cholesterol that include soluble fiber from psyllium seed husk may reduce the risk of heart disease.
• Soy protein and risk of coronary heart disease – 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x grams] of soy protein. Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides [x grams] of soy protein.
• Plant sterol/stanol esters and risk of coronary heart disease – Foods containing at least 0.65 gram per of vegetable oil sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. A serving of [name of food] supplies [x grams] of vegetable oil sterol esters. Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals can reduce the risk of heart disease. A serving of [name of food] supplies [x grams] of plant stanol esters.

Some health claims are authorized based on an authoritative statement by the FDA’s Modernization Act (FDAMA) health claims. These include the following:

• Whole grain foods and risk of heart disease and certain cancers – Diets rich in whole grain foods and other plant foods and that are low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers.
• Potassium and the risk of high blood pressure and stroke – Diets containing foods that are a good source of potassium and that are also low in sodium may reduce the risk of high blood pressure and stroke.
• Fluoridated water and reduced risk of dental caries – Drinking fluoridated water may reduce the risk of dental caries or tooth decay.

Qualified Health Claims

Qualified health claims (QHCs) can be made for conventional foods as well as dietary supplements although there is some scientific support for these claims, they have not yet reached “significant scientific agreement”. Here’s an example of what a QHC on a food package can look like:

• Scientific evidence suggest but does not prove that eating 1 ½ ounces of nuts as part of a diet low in saturated fat and cholesterol can reduce risk of hert disease.
• Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of the food] provides [x grams] of EPA and DHA omega-3 fatty acids.

Structure / Function Claims

Structure / function claims describe the effect of a food or food component on body structures or functions without making reference to a disease. Here are a few examples of structure/function claims:

• “…helps promote immune health”
• “…is an energizer”
• “Calcium builds strong bones”
• “Fiber maintains bowel regularity”

Structure/function claims do not need FDA review or approval, but if used, they must be truthful and not misleading.

Dietary Guidance Statements

Although they’re not considered health claims, dietary guidance statements that are scientifically sound and not misleading can appear on food packages. These types of statements refer to broad classes of foods (rather than a specific food or substance to in health claims) and have scientific support. Here are two examples of a dietary guidance statement:

• “Consuming at least 3 or more ounce-equivalents of whole grains per day can reduce the risk of several chronic diseases”
• “Carrots are good for your health”
• “Calcium is good for you”

Although dietary guidance statements can appear on food packages without FDA approval, they may be reviewed by the FDA at a later point to ensure they’re truthful and not misleading.

A disclosure statement is a statement that calls the consumer’s attention to one or more nutrients in the food that may increases the risk of a disease or health-related condition that is diet related; it’s required when a nutrient in a food exceeds certain prescribed levels.

Dietary guidance statements are statements made on food packages that either associate a class of foods (such as whole grains) to a diet-related disease or condition or refer to a specific food or food component without referring to a disease or health-related condition. They are not health claims and are not subject to approval by the FDA before they can be used.