What are FDA requirements for Foods for Special Dietary Use?

Section 403(j) of the Federal Food, Drug, and Cosmetic Act classes a food as misbranded: "If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary of Health and Human Services determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses."

Section 411(c)(3) of the Federal Food, Drug, and Cosmetic Act defines "special dietary use" as " a particular use for which a food purports or is represented to be used, including but not limited to the following:

1. Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the conditions of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium.

2. Supplying a vitamin, mineral, or other ingredient for use by humans to supplement the diet by increasing the total dietary intake.

3. Supplying a special dietary need by reason of being a food for use as the sole item of the diet. Regulations (21 CFR 105) under this section of the Federal Food, Drug, and Cosmetic Act prescribe appropriate information and statements which must be given on the labels of foods in this class.