Nutrition Labeling on FDA-Regulated Products

Under NLEA all packaged food except those excepted in the Act1 must have nutrition labeling. NLEA also provides for voluntary nutrition information for fresh produce and seafood (21 U.S.C. §201). Specific nutrient content “facts” in a mandatory order are required in the Nutrition Facts box, as are specific label design elements (see Box 2-2). The product content of other nutrients specified by FDA may be voluntarily included in the box at the discretion of the manufacturer, but the order of the nutrients on the label must be maintained. If a manufacturer chooses to fortify a product with nutrients, then the content of those nutrients also must be included in the box. This is also true for nutrients about which manufacturers make health or nutrient content claims. The mandatory nutrient components in the Nutrition Facts box include those that scientists and health practitioners believed were important to the health of the American people based on the science available at the time NLEA was implemented.

FDA specifies that the Nutrition Facts box include all nutrients presented as % DVs (with the exception of sugars, monounsaturated fatty acids, polyunsaturated fatty acids, and soluble and insoluble fiber for which DVs have not been established) with the amount in grams or milligrams also included for specific nutrients. The % DV for protein is required only if a protein claim is made for the product or when the product is intended for infants or children under 4 years of age. On most larger food packages the box also must include a footnote that states that the % DVs are based on a 2,000-calorie diet. In addition it may include a statement of the calories provided per gram for fat, carbohydrate, and protein. Serving sizes, calculation of % DVs, and Nutrition Facts box format modifications are regulated by FDA and FSIS in a consistent manner. (For additional information about nutrition labeling, see CFSAN, 2003b; FDA, 1993a, 1999b; OPPD, 2003a.)

In 1999 FDA proposed to amend its regulations to require that the Nutrition Facts box include information about trans fatty acids


The food products specified by NLEA as exempt from food labeling include: food served for immediate consumption, ready-to-eat food not for immediate consumption that can be eaten when carried away, bulk-shipped food not for sale to consumers, medical food, food of no nutritional significance, food produced by small businesses (annual sales of not more than $500,000 if food is offered for sale or sales of food less than $50,000), and low-volume food products (fewer than 100,000 units of a product sold annually in the United States and less than 100 full-time equivalent employees of the firm).

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