After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”” (Final Rule) that updates the definition for “healthy” food marketing claims “…to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines).” The rule is set to take effect February 25, 2025, with a compliance date of February 25, 2028. However, major federal agency shake-ups, the confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services (HHS), and calls from Congress to revisit the dietary guidelines could mean delayed implementation of the rule, or even a reexamination of the rule itself.
The Final Rule
FDA regulation of the term “healthy” on product labels is not new. Since 1994, the FDA has recognized label claims describing a food product as “healthy” as an implicit claim that the nutrient content of the food may help consumers maintain healthy dietary practices. Through regulation of the term “healthy,” the FDA seeks to encourage the consumption of certain food groups or food group equivalents (FGE) and limit the consumption of some nutrients, including added sugar, sodium, and saturated fat (Nutrients to Limit or NTL) in an effort to reduce the burden of diet-related chronic disease.
The Final Rule seeks to address Agency concerns regarding misleading use of the term “healthy” and consumer confusion concerning what foods constitute a healthy diet. The Final Rule also responds to concerns from consumers and food producers, including that the previous rule defined “healthy” too narrowly and lacked adequate consideration of varied cultural standards of what is healthy. Stakeholder responses indicate that concerns remain, including those regarding limits on “healthy fats,” sodium limits in dairy and meat products, and disadvantages to plant-based products.
The Final Rule –
- Establishes parameters for use of the term “healthy” and derivative terms as an implied nutrient content claim on food labels and labeling;
- Establishes a framework for claim regulation based on food groups and NTL; and
- Establishes that “food group,” for the purpose of the “healthy” claim, refers to the groups of foods recommended in the Dietary Guidelines for Americans, 2020–2025 (for adults and children two years of age and older) (Dietary Guidelines).
To carry the voluntary claim, the food must:
- Contain a minimum amount of a food or FGE from one or more food groups or subgroups recommended by the Dietary Guidelines. Based on food groups, the Final Rule does not currently allow for “healthy” claims based on amounts of a recommended nutrient like protein or fiber; and
- Adhere to specified limits for saturated fat, sodium, and added sugar.
Trump Regulatory Freeze and Agency Shakeups May Lead to Delays or Changes to the Final Rule
President Trump’s Regulatory Freeze Pending Review Memorandum (Regulatory Freeze Memorandum or Memorandum) and sweeping actions aimed at increasing federal government efficiency could mean delays and changes to the Final Rule and its implementation. The Regulatory Freeze Memorandum called on federal agencies to consider postponing the effective date for any rules published in the Federal Register for 60 days from the date of the Memorandum in order to review the postponed rules and consider reopening the public comment period and reevaluating the rule pending the additional petitions it receives.
The Memorandum comes at a time the FDA and other federal agencies are facing potentially historic shifts in staffing and funding that may impact a review of “…any questions of fact, law, and policy that the rules may raise…” or a new public comment period and reconsideration of the rule, as recommended under the Memorandum.
Changes in HHS Leadership and Calls from Congress Create Uncertainty for the Future of the Rule
With the confirmation of RFK Jr. and Republican members of Congress questioning the transparency of the development of the underlying Dietary Guidelines, the outcome of any regulatory review is uncertain. The FDA framed the rulemaking as directed at addressing “chronic disease,” a key tenet of RFK Jr.’s Make America Healthy Again platform. RFK Jr. has been a staunch opponent of “super processed” and “unhealthy” foods and their impact on chronic disease. However, given the regulatory freeze, how RFK Jr.’s stance might impact the Final Rule amidst potential political and operational pressures remains to be seen.
Navigating the Uncertainty
The industry can navigate this uncertainty by preparing for implementation and affirmatively seeking ways to engage the FDA and lawmakers to address remaining concerns regarding the Final Rule, implementation, and the underlying policy. Whether seeking to implement Final Rule-compliant marketing and advertising policies, or exploring ways to engage the FDA and lawmakers to call for its reexamination, companies must ensure they have experienced legal and government affairs professionals to guide them through points of fact, law, and policy underlying the Final Rule that will shape implementation and potential opportunities to engage.
