In December 2024, the U.S. Food and Drug Administration (FDA) announced a significant update to its Final Ruling on the use of the claim “healthy” on food product labels. This change reflects the FDA’s commitment to promoting healthier eating habits and reducing chronic disease rates among Americans. This blog explores the key changes, their implications for food manufacturers, and how you can ensure compliance.

Background

The FDA first established the “healthy” label claim rules in 1994, setting conditions based on limits for total fat, saturated fat, cholesterol, and sodium, as well as minimum nutrient requirements for vitamin A, vitamin C, calcium, iron, protein, and fiber. However, these criteria often excluded nutrient-dense foods recommended by the Dietary Guidelines for Americans, such as nuts, seeds, and certain seafood.

The updated 2024 Final Ruling addresses these limitations by aligning with modern dietary science. It redefines the “healthy” claim criteria to better reflect foods that contribute to nutritious eating patterns.

What You Need to Know

Under the updated ruling, food products can bear the “healthy” label if they meet the following conditions:

1. Food Group Content: The product must contain a certain amount of food from at least one recommended food group or subgroup, such as fruits, vegetables, grains, low-fat dairy, or protein foods.
2. Nutrient Limits: The product must stay within specific limits for added sugars, saturated fat, and sodium. These limits vary depending on whether the product is an individual item, a mixed food, or a main meal/entire serving.

Examples of foods now eligible to use the “healthy” claim include:

• Vegetables, fruits, and whole grains
• Certain dairy products and protein sources like eggs, beans, and seafood
• Nut and seed products that meet nutrient requirements
• Plain water

However, some products that previously qualified as “healthy” may need re-evaluation due to stricter limits on sugar, saturated fat, and sodium.

How Can I Be Prepared?

Food manufacturers should review their product formulations and labeling practices to ensure compliance with the new criteria. Key steps include:

• Ingredient Review: Assess product ingredients to confirm they align with the recommended food groups and nutrient limits.
• Nutrient Analysis: Conduct a detailed analysis of added sugars, saturated fat, and sodium to ensure they fall within the allowable thresholds.
• Label Updates: Update packaging to reflect compliance with the revised “healthy” claim requirements.

Get Expert Advice

Navigating FDA labeling regulations can be complex, but dicentra is here to help. Our team of regulatory experts can evaluate your food products to determine eligibility for the “healthy” claim and guide you through the compliance process.

For more information, review the FDA’s Final Ruling here.

Ready to get started? Contact dicentra today to ensure your products meet the new FDA standards.