FDA has published Federal Register notice of a draft guidance document, entitled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry” (July 2015).
Issuance of the draft guidance for industry was deemed necessary because declaring small amounts of nutrients and dietary ingredients in the nutrition labeling of, respectively, conventional foods and dietary supplements may result in a conflict between 21 C.F.R. § 101.9(c)(1) through (8) and 21 C.F.R. § 101.9(g)(4)(ii) and (g)(5). Paragraphs (c)(1) through (c)(8) identify the nutrients to be declared on the Nutrition Facts label of a conventional food, and how their quantitative amounts must be rounded and declared. Paragraphs (g)(4)(ii) and (g)(5), dealing with nutrition labeling compliance, provide:
(4) A food with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be deemed to be misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) unless it meets the following requirements:
* * *
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.
(5) A food with a label declaration of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium shall be deemed to be misbranded under section 403(a) of the act if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls above this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.
FDA’s regulation governing Supplement Facts labels on dietary supplements, 21 C.F.R. § 101.36, cross-references these paragraphs.
The draft guidance for industry provides examples of situations in which the nutrition labeling provisions conflict. For example, if a food contains 0.70 g of saturated fat per serving, this amount would be declared as 0.5 g under § 101.9(c)(2)(i), but this declaration would not comply with § 101.9(g)(5) because 0.70 g is more than 20 percent in excess of 0.5 g. In such circumstances, FDA recommends that manufacturers declare nutrients and dietary ingredients in accordance with § 101.9(c)(1) through (8). If the draft guidance is finalized, FDA intends to consider the use of enforcement discretion with respect to the compliance requirements in § 101.9(g)(4)(ii) and (g)(5) when a conflict exists with § 101.9(c)(1) through (8). FDA is also considering whether there should be changes to the nutrition labeling regulations to address this issue.
The draft guidance for industry, when finalized, will explain to manufacturers of conventional foods and dietary supplements FDA’s policy on determining the amount to declare on the nutrition label for nutrients and dietary ingredients that are present in a small amount. While comments on a guidance document generally may be submitted at any time, to be considered by FDA in finalizing this guidance for industry, comments must be submitted by September 28, 2015.
