What guidance does FDA have for manufacturers of Butter?

Butter is defined in the standard provided by Act of Congress on March 4, 1923, as follows: "...butter' shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for". (21 U.S.C. 321 a)

Butter is examined for evidence of the use of dirty cream or milk and for mold which indicates the use of decomposed cream. Chemical additives and artificial flavor are not permitted.

FDA regulations in 21 CFR 101.67 provide for the use of nutrient content claims such as "light" or "reduced fat" in the labeling of butter under certain conditions. These conditions include the following: The product must contain cream or milk, or both, which may include milk constituents, such as whey and casein. Salt and safe and suitable colorings, nutrients, and bacterial cultures may be added to the product. The product may also contain minor amounts of safe and suitable nondairy ingredients to improve texture, prevent the product from separating into liquid and non-liquid parts (syneresis), add flavor, extend shelf life, improve appearance and add sweetness.

Water may be used to replace milk fat, but the amount of water in the product must be less than the amount of cream, milk, or milk constituents. The product may not be nutritionally inferior to regular butter. If significant differences in the performance characteristics of the product limit its uses as compared to regular butter, the difference must be explained on the label. For example, if the product is not suitable butter as an ingredient in baked goods, a statement such as "not recommended for baking purposes" must appear on the label of the reduced fat product.