This past February 25, America crossed the Rubicon into a new era with the Food and Drug Administration’s revised definition of what food manufacturers can label as “healthy.” 1
Except that manufacturers have three years to reach compliance. And that the U.S. Department of Health and Human Services, and the FDA itself, may well throw everything out the window once nominees of the new administration are approved. This may also affect rules surrounding front-of-package nutrition labeling, food additives and ultra-processed foods.
For now, the FDA’s new definition imposes stricter criteria that aim to better align food claims with current nutritional science and public health goals. As a result, many products – from fruit-flavored yogurt to fortified white bread to sweetened energy bars – can no longer be labeled as healthy if they exceed certain limits on saturated fat, sodium or added sugars. Meanwhile, some nutrient-rich items like salmon and almonds, as well as water, will now be eligible for the label, as fully outlined by the USDA’s Dietary Guidelines for Americans 2.
Health product labeling is a strong sales asset, one that can make a consumer’s hand pass over one item to choose another. In rising to this challenge, brands and marketers can benefit from a step-by-step guide to help navigate these changes and achieve food product compliance with the 2025 FDA Regulations:
Understand the Updated Criteria for “Healthy”
The FDA’s revised definition of “healthy” is based on what should be maximized in foods as well as what should be minimized. The best advice: Thoroughly review the USDA’s Dietary Guidelines for Americans to ensure adherence.
Nutrient Density: Foods must contain “meaningful” amounts of food group components recommended by the guidelines, such as fruits, vegetables, whole grains, low-fat dairy or lean proteins. For example:
- White bread must replace refined flour with at least 50% whole grain flour
- Frozen meals must include at least one full serving of vegetables like broccoli, spinach or bell peppers, and use lean proteins like grilled chicken or plant-based options (e.g., tofu or lentils)
- Sports drinks and flavored waters must include natural flavors, fortified with nutrients like potassium or vitamin D
Limits on Saturated Fat, Sodium and Added Sugars: Conversely, products must not exceed specific thresholds for these ingredients, which vary based on food categories. For example:
- Saturated fat is generally capped at 5% of the daily value (DV) per serving
- Sodium has a limit of 230 milligrams per serving
- Added sugars are allowed to a maximum of 2.5 grams per serving
Conduct a Nutritional Analysis of Existing Products
Before making any changes, food manufacturers must perform a complete nutritional analysis of their current product portfolio. Key actions include:
- Testing Nutritional Content: Use an accredited lab to verify the levels of saturated fat, sodium and added sugars in your products. These include FDA-recognized Certified Laboratories 3 and Eurofins Scientific 4
- Identifying Non-Compliant Products: Compare your products’ nutritional profiles against the FDA’s updated thresholds to determine which items no longer qualify as “healthy”
- Assessing Food Group Contributions: Ensure that your products contain sufficient quantities of recommended food groups
Reformulate Non-Compliant Products
For products that don’t meet the new criteria, look toward reformulation. This may take time so that it doesn’t compromise assets like taste, texture or shelf life, as fickle consumers might appreciate healthy yet still expect everything else. Consider:
- Replacing high-saturated-fat ingredients such as cream or butter with alternatives like unsaturated oils or plant-based options
- Experimenting with salt substitutes, flavor-enhancing herbs or spices to reduce sodium content without sacrificing taste
- Using natural sweeteners like fruit purees or low-calorie alternatives such as stevia to meet sugar thresholds
Revise Packaging and Labeling
Now we get to the desired results of all these efforts, flagging the health benefits of your products for consumers. Once your product meets the updated criteria, ensure that its packaging reflects compliance by:
- Updating the Nutrition Facts Panel: Include accurate and up-to-date information on saturated fat, sodium, added sugars and other ingredients
- Use the “Healthy” Claim Appropriately: Clearly and truthfully label products that qualify, adhering to FDA guidelines
- Add Educational Information: Consider including messages about the health benefits of your product’s key ingredients (e.g., “Rich in omega-3 fatty acids” for salmon)
Innovate with New Products
Every challenge presents an opportunity. And shifting government directives that may seem burdensome can motivate companies to innovate. Think about:
- Developing new healthy products from scratch, focusing on those that naturally meet the FDA criteria
- Exploring functional foods by incorporating ingredients with proven health benefits, such as probiotics, fiber or omega-3s, to appeal to health-conscious consumers
- Expanding plant-based offerings, tapping into the growing demand for meatless foods by offering nutrient-dense options made with legumes, nuts or seeds
Leverage Transparent Marketing
Transparency is critical to gaining consumer trust. A Deloitte study 5 found that consumers value straightforward language from companies, and that transparency is a key dimension of trust. In light of the FDA’s new healthy standards, use marketing strategies to highlight your compliance efforts:
- Communicate nutritional improvements to your products, promoting any changes made to reduce saturated fat, sodium or added sugars while emphasizing health benefits
- Educate consumers through your website, social media, advertising and packaging to explain what “healthy” means on your reformulated products
- Emphasize natural ingredients by highlighting the use of dense, whole-food nutrients that align with the FDA’s definition and improve consumer health
Monitor Regulatory Updates
As mentioned, the FDA is part of the U.S. government, which sways with the political winds. Its nutritional guidelines will continue to evolve, so manufacturers must stay informed:
- Subscribe to FDA alerts by signing up for updates on new agency decisions, food labeling regulations and compliance deadlines
- Engage with leading industry groups such as the Consumer Brands Association, Food Marketing Institute and International Food and Beverage Alliance to stay ahead of emerging trends and best practices
- Work with compliance consultants to ensure ongoing adherence to FDA rules
Key Takeaways
- On February 25, the FDA’s revised definition of what food manufacturers can label as “healthy” initially went into effect.
- Manufacturers have three years to achieve compliance, but this may be affected by the new presidential administration and new governance at the FDA.
- To get ready, manufacturers can take concrete steps such as thoroughly reviewing the updated FDA criteria, conducting a nutritional analysis of products, reformulating non-compliant products, revising packaging and labeling, and monitoring regulatory updates.
References
- FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers. FDA website. https://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers December 19, 2024
- USDA website. Dietary Guidelines for Americans. https://www.dietaryguidelines.gov/sites/default/files/2021-03/Dietary_Guidelines_for_Americans-2020-2025.pdf 2020-2025
- Certified Laboratories. https://certified-laboratories.com/nutritional-label/
- Eurofins Scientific. https://www.eurofinsus.com/food-testing/services/testing-services/nutrition-analysis/
- Deloitte website. Close the Trust Gap to Unlock Business Value and Improve Customer Engagement. https://www2.deloitte.com/content/dam/Deloitte/us/Documents/public-sector/close-the-trust-gap-to-improve-outcomes-and-improve-customer-engagement.pdf?utm_source=chatgpt.com October 2021
