On July 1, the U.S. Food and Drug Administration released yet another clarification on its food and dietary supplement labeling policies by way of guidance for industry on declaring small amounts of nutrients and dietary ingredients on nutrition labels.
The guidance narrowly focuses on how FDA would exercise enforcement discretion when a conflict occurs between complying with the requirements for declaring the nutrient value in a serving of food or dietary supplement (21 C.F.R. § 101.9(c)(1)-(8)) and the compliance requirements for declaring nutrients and dietary ingredients in nutrition labeling (21 C.F.R. § 101.9(g)(4)-(5)). While in most cases the regulatory requirements do not conflict, in some cases, certain small amounts of nutrients or dietary ingredients cannot be stated in accordance with both the declaration and compliance regulations. In these cases, the guidance recommends that manufacturers declare the amounts in accordance with the declaration regulations rather than the compliance regulations.
Food and dietary supplement manufacturers should continue to watch FDA, which is expected to finalize gluten-free claims and address claims based on the Nutrition Facts and Serving Size Rules in future rulemaking.