28 Aug 2015
FDA Issues Guidance on Declaring Small Amounts of Nutrients and Dietary Ingredients on Labels
The Food and Drug Administration has issued a draft guidance document outlining its current thinking on how manufacturers of conventional food and dietary supplements should determine the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount. This document does not establish legally enforceable responsibilities and should only be viewed as recommendations unless specific regulatory or statutory requirements are cited.
FDA regulations in 21 CFR 101.9 and 21 CFR 101.36 describe requirements for nutrition labelling in conventional foods and dietary supplements, respectively. The requirements for declaring the nutrient value in a serving of conventional food are in 21 CFR 101.9(c)(1)-(8). Certain dietary ingredients in dietary supplements are also required to be declared in accordance with these requirements. These dietary ingredients are listed in 21 CFR 101.36(b)(2) and are referred to as "(b)(2)-dietary ingredients." Unlike nutrients in conventional food, the (b)(2)-dietary ingredients can only be declared when they are present in dietary supplements in amounts that exceed the amount that can be declared as zero in nutrition labelling according to 21 CFR 101.9(c) (see 21 CFR 101.36(b)(2)(i)).
FDA regulations under 21 CFR 101.9(g)(4) and (5) describe compliance requirements for declaring nutrients and dietary ingredients in nutrition labelling. A conventional food or dietary supplement declaring the amount of a nutrient or dietary ingredient in its labelling is misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act if:
- the nutrient content of the composite of a vitamin, mineral, protein, total carbohydrate, dietary fibre, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium is below 80 percent of the value for that nutrient declared on the label; and/or
- the nutrient content of the composite of calories, sugars, total fat, saturated fat, trans fat, cholesterol or sodium is greater than 20 percent in excess for the value of that nutrient declared on the label.
In many cases the amount of a nutrient or (b)(2)-dietary ingredient declared in nutrition labelling in accordance with 21 CFR 101.9(c)(1)-(8) will not conflict with the compliance requirements. However, certain small amounts of nutrients or (b)(2)-dietary ingredients cannot be declared in accordance with both 21 CFR 101.9(c)(1)-(8) and the compliance requirements. In these cases, the amount declared in accordance with 21 CFR 101.9(c)(1)-(8) is below or above the level provided by the compliance requirements.
The FDA indicates that in such cases it intends to consider the use of enforcement discretion with respect to the compliance requirements and recommend that manufacturers declare nutrients and (b)(2)-dietary ingredients in accordance with 21 CFR 101.9(c)(1)-(8). The nutrition labelling requirements in 21 CFR 101.9(c)(1)-(8) specify the increments and units of measure for declaring nutrient values. However, 21 CFR 101.9(g)(4)(ii) and (5) do not specify the increments and units of measure required for declaring nutrient values. Instead these provisions provide acceptable levels of variance for declared values. The FDA considers it more practical and consistent for manufacturers to follow paragraph (c)(1)-(8) when a conflict occurs between 21 CFR 101.9(c)(1)-(8) and FDA compliance requirements. This policy applies the same requirements to all products in a consistent way.
The FDA will continue to consider the variability generally recognised for the analytical method used in the compliance requirements as well as the reasonable excesses and deficiencies of declared amounts acceptable within current good manufacturing practice. The agency is also considering whether changes to the nutrition labelling regulations are needed to address this issue.