Redefining “Healthy”: FDA Final Rule on Label Claims

The U.S. Food and Drug Administration (FDA) has finalized its long-anticipated update to the definition of “healthy” as it can appear on food labels. This rule reflects a shift toward a more holistic and evidence-based view of nutrition, moving away from outdated nutrient-based criteria and aligning more closely with the Dietary Guidelines for Americans. For food manufacturers, the revised definition introduces new regulatory standards but also offers an opportunity to reformulate and reposition products in ways that resonate with evolving consumer values and public health goals. 

What the New “Healthy” Rule Says 

Under the new rule, foods labeled as “healthy” must meet two core criteria. First, they must contain a meaningful amount of food from one or more of the recommended food groups, including fruits, vegetables, whole grains, dairy, or protein foods. Second, they must stay within specified limits for added sugars, saturated fat, and sodium. These limits are set based on a percentage of the Daily Value (DV) per Reference Amount Customarily Consumed (RACC). For instance, a product must not contain more than 5% DV of added sugars or saturated fat, and no more than 10% DV of sodium per serving. 

This approach marks a significant departure from the original 1994 definition, which primarily focused on limiting individual nutrients like total fat and cholesterol. The updated rule takes into account the overall nutrient profile and food group content, offering a more comprehensive measure of a food’s role in a healthy diet. 

What Qualifies and What Doesn’t 

Manufacturers must evaluate whether their products meet both the food group and nutrient requirements to use the “healthy” claim. This means calculating whether a food provides enough of a qualifying food group while ensuring that it stays below the specified thresholds for nutrients to limit. 

The FDA has also tailored the criteria for different product categories. For example, mixed dishes like grain bowls or frozen meals, beverages such as fruit drinks and dairy alternatives, and even composite snacks are evaluated under category-specific standards that consider their typical use and nutritional contribution. This flexibility supports more accurate assessments of foods that don’t fit neatly into one group. 

To use the “healthy” claim, foods must meet both food group and nutrient criteria: 

• Food Group Equivalents: These are based on the amounts recommended in the Dietary Guidelines. For example, breakfast cereal must contain a certain amount of whole grain per serving to qualify. 
• Nutrient Limits: 
• Added sugars: Must not exceed 5% of the DV per RACC (i.e., 2.5g or less per serving) 
• Sodium: Limited to 10% of the DV per RACC (i.e., 230mg or less per serving) 
• Saturated fat: Limited to 5% of the DV per RACC (i.e., 1g or less per serving) 

Practical Implications for Product Development 

The new rule provides manufacturers with clear guidelines for how to reformulate existing products or develop new ones that meet the “healthy” criteria. Reducing added sugars, lowering sodium, or increasing the inclusion of beneficial ingredients such as legumes, whole grains, or low-fat dairy can help products qualify under the updated definition. 

By treating the new rule as both a compliance mandate and a product development framework, manufacturers can position themselves to meet consumer expectations and regulatory standards simultaneously. 

Labeling and Marketing 

The FDA will monitor the use of the “healthy” claim to ensure it is applied accurately and in accordance with the new criteria. Manufacturers are responsible for ensuring all labeling, including front-of-package and marketing materials, accurately reflects the product's compliance. Manufacturers must be able to substantiate the claim through documented nutritional analysis and be prepared to update marketing materials and packaging as needed. 

Best practices include: 

• Clearly identifying qualifying ingredients and their amounts 
• Avoiding use of the “healthy” claim on products that meet only some, but not all, criteria 
• Keeping documentation and formulation details up to date in case of regulatory review 

Timeline and Compliance Considerations 

The final rule was published in 2024 and becomes effective 60 days after publication. The FDA has provided a three-year compliance period, giving manufacturers time to adjust formulations, review labels, and implement any necessary changes across their operations. 

During this transition period, companies are encouraged to conduct a comprehensive audit of current product lines, identify which products meet the new definition, and prioritize reformulation projects for those that fall short. Coordination between R&D, quality assurance, legal, and marketing teams will be key to a smooth and timely transition. 

Tools and Resources 

To support industry adoption of the rule, the FDA has published a variety of resources, including guidance documents, food group equivalents charts, and nutrient profile calculators. Many manufacturers may also choose to consult with third-party regulatory experts, registered dietitians, or labeling specialists to navigate the more technical aspects of the rule. 

• FDA’s nutrient database and food group equivalents guidance 
• Labeling software to calculate %DV values 
• Consultation with regulatory experts and registered dietitians 
• Trade associations and industry-specific guidance documents 

Turning Compliance into Competitive Advantage 

Looking forward, the updated “healthy” claim offers more than a compliance milestone; it provides an opportunity to differentiate products and brands in a crowded marketplace. Consumers are increasingly interested in making informed food choices, and clear, accurate claims that reflect meaningful nutrition can enhance brand credibility. Manufacturers who act early to adopt and promote products that meet the new criteria may gain a competitive edge and deepen consumer trust.