Dietary Guidance Statements are statements that state or imply a food may contribute to a particular diet pattern. FDA released a draft guidance detailing the agency’s current thoughts on these types of statements; though not binding, the guidance provides FDA’s considerations when determining if a label is misleading. The complete draft guidance is available on the FDA website.
FDA states that Dietary Guidance Statements are not nutrient content claims (and are therefore not subject to the regulations applicable to nutrient content claims). These statements must focus on the food or food group’s contribution to or maintenance of a nutritious dietary pattern, and cannot include references to or implications of disease risk reduction or treatment. Claims that a food or food group treat or prevent a disease would be considered health claims and would be subject to FDA’s regulations and review.
Dietary Guidance Statements should be based on a consensus report produced by a group of experts that reflects the current thinking of the scientific community. Companies can rely on the Dietary Guidelines published by FDA and USDA as a consensus report to support a Dietary Guidance Statement. Dietary Guidance Statements should reflect the key or principal recommendations provided in the consensus report.
When a Dietary Guidance Statement is used on an individual food or a food representing one food group, FDA expects the product will provide at least 1/4 of the daily recommended amount of that food group. When foods composed of multiple food groups use a Dietary Guidance Statement, foods must provide specified amounts of the food groups.
In addition, FDA is recommending foods with Dietary Guidance Statements comply with nutrient limits. Specifically, FDA proposed nutrient levels for saturated fat, sodium and added sugars. Individual foods with Statements should not contain more than 10% of the Daily Value (DV) of saturated fat per RACC, no more than 15% DV sodium, and no more than 10% DV added sugars. Main dish products should not exceed 30% DV saturated fat and sodium, and 20% DV added sugars per RACC; meal products should not exceed 40% DV saturated fat and sodium and 30% DV added sugars per RACC.
Certain exceptions from the nutrient limits were proposed for foods that are nutrient dense; for example, saturated fat from unsalted nuts and seeds would not be considered when evaluating if a food meets the proposed nutrient levels. In addition, where a food exceeds the nutrient limits but is otherwise recommended as part of a nutritious dietary pattern, disclosure statements can be used when a Dietary Guidance Statement is used. For example, if a product exceeds the added sugar nutrient limit, a statement disclosing the amount of added sugar in a serving or directing the consumer to the Nutrition Facts would be appropriate.
Comments on the draft guidance can be submitted on regulations.gov until June 26, 2023.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.