Our Food, Beverage & Agribusiness Team unpacks what companies need to know about the Food and Drug Administration’s final rule on “healthy” food labeling.
- To qualify as “healthy,” food products must contain a certain amount of food from at least one of the four food groups or subgroups
- "Healthy” food products must also meet sugar, saturated fat, and sodium limitations
- Food product labeling and packaging must comply with the new rule by February 25, 2028
In the final weeks of the Biden Administration, the Food and Drug Administration (FDA) published its final rule updating the regulatory definition for the implied nutrient content claim “healthy.” The final rule, published on December 27, 2024, will significantly change what products will qualify under the new definition. This change comes during a period of immense pressure from the plaintiffs’ bar in its focus on targeting allegedly deceptive labeling and marketing of processed foods.
As further covered in our advisory outlining the contours of the FDA’s proposed rule, the original definition of “healthy,” promulgated in 1994, “reflected an individual nutrient-centric approach” that – according to the FDA – no longer aligned with current nutrition science and federal dietary guidance. The FDA’s final rule instead focuses on “how nutrients in the food groups and subgroups may work together” and emphasizes nutrient-dense foods that are foundational to healthy dietary patterns. The FDA received approximately 400 comments in response to its proposed rule published on September 29, 2022 and made several changes in response to stakeholder comments to provide for more flexibility, which—according to FDA—will ultimately allow more foods to bear the “healthy” claim.
Final Rule: Key Requirements
The FDA has concluded that updating the criteria for making a “healthy” claim is necessary, “to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans.” To that end, according to the FDA, these requirements reflect the recommendations in federal dietary guidelines and focus on identifying nutrient-dense foods through a two-fold approach, considering (1) food groups; and (2) nutrients to limit.
Broadly, to meet the definition for “healthy,” food products need to meet two requirements:
- Contain a certain amount of food from at least one of the food groups or subgroups (e.g., vegetables, fruits, dairy, grains, protein foods, and oils).
- Meet limitations for added sugars, saturated fat, and sodium.
For (1), qualifying amounts of food from each food group are called “food group equivalents,” which are set out in the final rule. For (2), the limitations for added sugars, saturated fat, and sodium will depend on the type of food: individual food products (e.g., yogurt), mixed products (e.g., trail mix), or main dishes/meals (e.g., frozen salmon dinner). Those limitations are based on the applicable reference amount customarily consumed (RACC).
In a shift from its proposed rule, the final rule provides additional flexibility to industry, such as:
- Automatically qualifying individual foods or mixed products comprised of one or more of the following foods, with no other added ingredients (except for water): vegetable, fruit, whole grains, fat-free and low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts (including certain nut butters containing only nuts), and seeds.
- Automatically qualifying all water, tea, and coffee with less than 5 calories per RACC and per labeled serving.
The FDA is also requiring companies making a “healthy” claim to maintain records for a period of two years when the food group equivalent in the product is not apparent from the label.
What Regulated Industry Should Be Doing Now
Every food and beverage company should consider taking the following steps now:
- Evaluate food and beverage labels to determine whether these requirements are implicated and/or whether a “healthy” claim is of interest in the future. By including added sugar as a nutrient to limit and the concept of food groups and food group equivalents, the updated criteria significantly diverge from the current definition of “healthy,” so close consideration of these updated requirements will be necessary.
- Consider whether reformulation is appropriate based on the updated criteria.
- Monitor for any future developments. It remains to be seen whether the incoming Trump Administration will look to rework this final rule in view of its commitment to “Make America Healthy Again.” The 2025-2030 Dietary Guidelines, which informed the FDA’s final rule, are expected to be published in late 2025 and may impact what qualifies a food as “healthy.” The FDA’s final rule states that it will continue to update its regulations and policies as appropriate “to remain aligned with the most current nutrition science.”
Regulated entities have until February 25, 2028 to comply with these new requirements.
From a litigation perspective, the plaintiffs’ bar has continued to target “healthy” and other allegedly related claims and labeling graphics as not comporting with a consumer’s expectations of what it means for a food or beverage to be “healthy.” Importantly, industry successfully obtained preemption during the three-year compliance period of the final rule earlier this year. This win for the food and beverage industry will prevent plaintiffs from suing companies that market a product as “healthy” during the three-year compliance period if the product complies with either the current or the new definition of “healthy.” That said, preemption protection is unlikely to deter the plaintiffs’ bar from their continued focus on health-halo claims and related representations, so industry should continue to evaluate product labels and marketing claims.
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