“Healthy” has evolved. The U.S. Food and Drug Administration (FDA) has officially implemented the long-anticipated rule redefining the criteria for when a food product may be labeled as “healthy.” This final rule, which took effect in April, marks the first significant update to the “healthy” claim since the 1990s and reflects the latest updates in modern nutrition science and dietary guidelines. Stakeholders should take note of the sweeping implications this rule has on labeling practices, compliance obligations, and marketing strategies, and, to the extent they have not already, should ensure compliance and reduce the risk of costly litigation or enforcement.
Why redefine “healthy”?
The FDA’s move to revise the definition stems from growing concerns over outdated nutrition standards. The prior rule, established in 1994, focused heavily on what are now controversial or outdated approaches to nutrition, such as limiting total fat without distinguishing between types of fat (e.g., saturated vs. unsaturated), and allowing products such as sugary granola or breakfast cereals to bear the “healthy” label if they met certain vitamin or mineral content thresholds. Over the years, both scientific understanding and public health policy have shifted to emphasize nutrient quality and dietary patterns over individual nutrient quantities.
Key provisions of the final rule
Under the FDA’s final rule, the use of the “healthy” claim on food labels will now require products to:
- Contain a meaningful amount of food from at least one of the recommended food groups (e.g., fruits, vegetables, dairy, whole grains, or protein) as defined by the Dietary Guidelines for Americans.
- Meet updated limits on saturated fat, sodium, and added sugars. These limits are tailored based on the specific food category. For instance, the sodium threshold for individual food items is now capped at 230 mg per serving.
- Align with modern nutritional science, prioritizing whole foods and limiting added sugars – an area previously underregulated in the context of “healthy” labeling.
Importantly, the rule creates an opportunity for some previously ineligible products to begin using the “healthy” claim, including avocados, higher-fat fish such as salmon, olive oil, and some nuts and seeds. The rule also disqualifies some foods that meet nutrient thresholds through fortification alone but may otherwise be nutritionally poor (e.g., sugary cereals with added vitamins). This is a shift from the past, when such products could technically meet the “healthy” standard.
Implications for the food and beverage industry
With this rule comes a variety of implications and considerations for stakeholders across the food and beverage industry, including:
- New marketing opportunities: Companies should examine whether previously ineligible products can now make “healthy” claims under the revised framework.
- Strategic product reformulation: Brands may opt to reformulate products to meet the new requirements – particularly those that rely on “healthy” as a key marketing claim.
- Increased scrutiny and litigation risk: With the new definition, plaintiffs’ attorneys are likely to bring false advertising claims against products that previously qualified as “healthy” but no longer meet the updated criteria.
- Labeling revisions: Companies currently using “healthy” claims under the old standard will need to reassess their packaging, reformulate products if necessary, and update marketing materials to mitigate risk.
Final thoughts
The FDA’s new definition of “healthy” is a landmark regulatory development aimed at aligning food labeling with the latest nutritional science. For some food companies, the revised definition of “healthy” presents a business opportunity to break into markets previously beyond reach. For others, it is not just a labeling issue; it is a strategic business concern with legal implications. Staying ahead of risk and understanding the broader regulatory landscape will be critical in avoiding costly pitfalls. Reed Smith is prepared to offer guidance and assist clients through these changes with our broad range of experience across the industry.
Client Alert 2025-142
