Are your Labels in Compliance with FDA’s Nutrition and Supplement Facts Label Requirements?

The correct answers are a) and b). A slice of the cake is a discrete unit. The regulatory requirement is stated in 21 CFR 101.9(b)(2)(i). If a unit weighs more than 50 %, but less than 67 % of the reference amount, the manufacturer may declare one unit or two units as the serving size. Since the reference amount is 80 g, a unit – a slice – is 56% of the RACC, so the manufacturer could choose 1 slice or 2 slices as serving size.

The correct answers are a) and c). The “other ingredients” in a dietary supplement must follow the general requirements for the declaration of food ingredients in 21 CFR 101.4(a)(1). The requirement to declare the “other dietary ingredients” that are in a proprietary blend is stated in 21 CFR 101.36 (c)(2).

There is no requirement for the order of declaration of individual Non-(b)(2)-dietary ingredients. They are declared with their weight.

The correct answer is b). In 21 CFR 101.9(b)(12)(i) the regulation states “Products that are packaged and sold individually and that contain at least 200 percent and up to and including 300 percent of the applicable reference amount must provide an additional column within the Nutrition Facts label”. This means that the RACC has to be considered in relation to the net contents. The keyword is “contains”. The full tabular format is shown in the current regulation in 21 CFR 101.9(d)(11)(iii). It can be used when there is insufficient continuous vertical space (approximately 3 in). The simplified NF table display is explained in 21 CFR 101.9(f). It depends on formula and serving size and can be used when 8 of the following nutrients are present in insignificant amounts: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.