The Department of Health and Human Services (HHS) announced the Food and Drug Administration’s (FDA) final “healthy” claims labeling rule (Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”) set to take effect to April 28, 2025. But HHS delayed the Final Rule, set to take effect February 28, 2025, in accordance with the Trump Administration’s Regulatory Freeze Pending Review Memorandum (Regulatory Freeze Memorandum or Memorandum), calling on federal agencies to consider postponing for 60 days from the date of the Memorandum the effective date for any rules published in the Federal Register in order to review and potentially reopen the rule for public comment and reconsideration of the underlying policy. While the notice did not address potential changes to the February 25, 2028, compliance date, Trump Administration policy and staffing shakeups could mean indefinite delays or even revisiting a rule that faced both vocal support and strong opposition.
The Final Rule
FDA undertook the rulemaking to address agency concerns regarding the misleading use of the term “healthy” and consumer confusion concerning what foods constitute a healthy diet. The FDA regulation of the term “healthy” on product labels is not new. Since 1994, the FDA recognized label claims that describe a food product as “healthy” as implicit claim that the nutrient content of the food may help consumers maintain healthy dietary practices. Through regulation of the term “healthy,” the FDA sought to encourage the consumption of certain food groups or food group equivalents and limit the consumption of some nutrients, including added sugar, sodium, and saturated fat to reduce the burden of diet-related chronic disease.
While the Agency’s efforts to improve transparency in food labeling and promote healthy eating were applauded, the Final Rule faced strong challenges from farmers and dairy producers to plant-based food and dietary supplement manufacturers with concerns that the Final Rule too narrowly defined “healthy” and excluded foods that provide nutritional benefits but fail to meet the criteria outlined in the rule. Some opponents cited concerns about the rule being “overly complicated” and so narrowly defined that it “…falls outside of FDA’s statutory authority…”
Will FDA’s Review Mean Delays or Another Bite at the Apple for the Controversial Policy?
The Memorandum is part of the Administration’s efforts to make sweeping organizational and policy changes at federal agencies, including the FDA, which could indefinitely delay the rule pending review and potential reconsideration.
The Memorandum, which calls on federal agencies to review affected rulemaking for “…any questions of fact, law, and policy that the rules may raise…,” comes at a time when the FDA is facing potentially historic cuts in staffing and funding that may impact the review timing and process. Should the FDA reopen the rulemaking process, the Final Rule would face strong opposition and an uncertain future.
The confirmation of RFK Jr. and congressional challenges to the Dietary Guidelines for Americans, upon which the rule was constructed, further obscure its path forward. The FDA directed the rulemaking at addressing “chronic disease,” a key tenet of RFK Jr.’s “Make America Healthy Again” (MAHA) platform. RFK Jr. has been a staunch opponent of “super processed” and “unhealthy” foods and their impacts on chronic disease. However, how the MAHA movement may impact the timing and outcome of the Final Rule is uncertain in light of opposition and operational and political shifts impacting FDA policy.
What Now for Affected Businesses and Industries?
For the businesses and industries impacted by the Final Rule, review presents the opportunity to revisit the rulemaking and work with the FDA to ensure the rule can serve to help promote healthy eating, while avoiding unintended consequences to consumers and industry. Companies should prepare for implementation and proactively engage the FDA and lawmakers to inform a thoughtful review of the Final Rule and the underlying policy.
For more information, please contact Ice Miller’s Advertising & Marketing Group or any member of Ice Miller’s Government Affairs & Regulatory Group
This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader’s specific circumstances.