The Food and Drug Administration last week issued guidance for industry that spelled out the agency’s policy for declaring small amounts of nutrients and dietary ingredients on nutrition labels. It finalizes without any content changes the draft guidance released by FDA in July 2015.
The guidance explains how FDA intends to exercise enforcement discretion when a conflict occurs between two items in Title 21 of the Code of Federal Regulations (21 CFR) and compliance with both is not possible.
The specific sections of the regulations that may be in conflict cover the methods of declaring mandatory and voluntary nutrients and the requirement that certain nutrients (vitamins, minerals, protein, total carbohydrates, polyunsaturated or monounsaturated fats, or dietary fiber) be at least 80 percent of the amount declared, while others (calories, total sugars, added sugars when the only source of sugars in the food is added sugars, total fat, saturated fat, trans fat, cholesterol or sodium) must be no more than 120 percent of the amount declared.
In many cases, the amount of a nutrient or dietary ingredient declared in nutrition labeling in accordance with 21 CFR 101.9(c)(1)-(8) will not conflict with the compliance requirements. However, based on the rounding requirements for nutrient declaration, FDA pointed out that certain small amounts of nutrients or dietary ingredients cannot be declared in accordance with both sections of 21 CFR 101.9. In these cases, FDA said, “We intend to consider the use of our 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).
As FDA indicated in the guidance, companies should use the appropriate means of declaration of nutrients as spelled out in 21 CFR 101.9(c)(1-8), including the rounding rules. In the case of a nutrient declaration that is declared correctly in line with 21 CFR 101.9(c) but deviates more than 20 percent from the printed declaration, FDA will use enforcement discretion.
Read “Guidance for Industry: FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.”
For more information, contact Michelle Matto, IDFA’s consultant on labeling and nutrition, at email@example.com.