FDA Regulations

Health claims are different from so-called "structure/function" claims, which also may appear on conventional food or dietary supplement labels. Manufacturers may make statements about a food substance's effect on the structure or function of the body--for example, "calcium builds strong bones." Unlike health claims, structure/function claims do not deal with disease risk reduction. Also, FDA does not pre-approve or authorize structure/function claims. Rather, when the manufacturer uses a structure/function claim, the company is responsible for making sure that the claim is truthful and not misleading.

Health claims can include implied claims, which indirectly assert a diet-disease relationship. Implied claims may appear in brand names (such as "Heart Healthy"), symbols (such as a heart-shaped logo), and vignettes when used with specific nutrient information. However, all labels bearing implied claims must also bear the full health claim.

Nutrition Labeling--Exemptions

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

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

Food produced by small businesses also may be exempt, under 1993 amendments to the NLEA. Businesses with fewer than 100 full-time equivalent employees may claim an exemption for food products that have U.S. sales of fewer than 100,000 units annually. Companies claiming this exemption must notify FDA that they meet the criteria before they begin marketing their products. U.S. companies, other than importers, with fewer than 10 full-time equivalent employees and selling fewer than 10,000 units of a food in a year also are exempt but do not need to notify FDA. Also exempt are retailers with annual gross sales in the United States of less than $500,000 or with annual gross sales of food to consumers in the United States of less than $50,000.

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