Health Claims

As part of the Nutrition Labeling and Education Act of 1990 (NLEA), the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) implemented regulations defining what terms may be used to describe the level of a nutrient in a food, as well as what claims could be made about the relationship between a nutrient or a food and the risk of a disease or health-related condition. Prior to the implementation of these regulations, there were no guidelines for food manufacturers to use when making statements about the nutritional value of a food product. Consequently, consumers had difficulty comparing foods based solely on the nutritional content of the products. The NLEA served to level the playing field for manufacturers of nutritionally focused food products by providing a consistent definition of claims to assist consumers when shopping for food products.

Nutrient Content Claims

Nutrient content claims, such as "high in calcium" or "lite," are a form of advertising used to highlight the levels of key nutrients, cholesterol, fiber, or calories in the products being labeled. The claim is usually placed on the front side of the package so it is visible to the shopper wanting to make quick comparisons among food products. As a result of NLEA, the FDA strictly regulates nutrient content claims. The regulations spell out which nutrient content claims are allowed and under what circumstances they can be used. There are eleven core terms: "free," "low," "lean," "extra lean," "high," "good source," "reduced," "less," "light," "fewer," and "more." In addition, there is a multitude of synonyms that may be used for each of these terms.

"Healthy"

Food labeling regulations allow manufacturers to make a "healthy" claim on the label. Due to the types of foods that are regulated by each agency, however, the FDA's definition of "healthy" is different from the USDA's definition. Under the FDA, "healthy" may be used if the food is low in fat and saturated fat and has a limited amount of sodium and cholesterol. In addition, single-item foods must provide at least 10 percent of one or more of vitamin A, vitamin C, iron, calcium, protein, and fiber. Raw, canned, or frozen fruits and vegetables and certain cereal-grain products do not necessarily need to meet this criteria. These foods can be labeled "healthy" if they do not contain ingredients that change the nutritional profile and, in the case of enriched grain products, if they conform to the standards of identity, which call for certain required ingredients (vitamins, minerals, protein, or fiber). Meal-type products (those large enough to be considered a meal [6 ounces]) must provide 10 percent of the Daily Value of two or three of these ingredients, in addition to meeting the other criteria. The sodium content cannot exceed 360 mg (milligrams) for individual foods and 480 mg for meal-type foods.

Health Claims

Health claims describe a relationship between a food substance and a disease or health-related condition. Due to the nature of such claims and the complexity of the science upon which such claims are made, the FDA carefully regulates health claims. Under the provisions of NLEA, the FDA has approved twelve specific health claims, and also provided a framework for additional specific claims to be approved as nutritional science evolves. Since NLEA, other processes have been established that allow food manufacturers a more efficient process to obtain approval for making a health claim. The Food and Drug Administration Modernization Act (FDAMA) was passed in 1997. Under FDAMA, upon successful submission of a "notification," a health claim may be made for a food based on an authoritative statement

NUTRIENT CONTENT CLAIMS

of a scientific body of the U.S. government or the National Academy of Sciences. The passage of this law has provided an opportunity for additional health claims, and for food manufacturers to efficiently communicate to consumers information about the relationship between foods and health.

General requirements for making a health claim.

All products carrying a health claim must meet general requirements for levels of nutrients that may be associated with the risk of chronic disease. Food products with high levels of total fat, saturated fat, cholesterol, or sodium are not allowed to make a health claim. For individual foods, these levels are 13 grams of fat, 4 grams of saturated fat, 60 mg of cholesterol, and 480 mg of sodium per standardized serving. For meal products, the levels are 26 grams of fat, 8 grams of saturated fat, 120 mg of cholesterol, and 960 mg of sodium per label serving size. The levels for a main dish product are 19.5 grams of fat, 6 grams of saturated fat, 90 mg of cholesterol, and 720 mg of sodium per label serving size.

Types of health claims.

Health claims can be made through third-party references (such as the National Cancer Institute), statements, symbols (such as a heart), and vignettes or descriptions. In all cases, the claim must meet the requirements for authorized health claims. The claim cannot state the degree of risk reduction and can only use "may" or "might" in discussing the food–disease relationship and it must indicate other factors that play a role in the specified disease. The claim must also be presented in relationship to the overall diet. For example, it might say: "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease."

Nutrition is a dynamic science. FDA and USDA food-labeling regulations are designed to be flexible enough to evolve with the science, yet they also provide the consistency consumers need to make sound food choices in the supermarket. Through NLEA, food manufacturers have an equal opportunity by which to market food products. Additionally, consumers have credible food labels so they make informed food choices based on the nutritional attributes of a food product.

Karen Hare