Proposed FDA Update to Infant Formula Nutrient Standards Signals More Scrutiny of Manufacturers

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. on October 29, 2026, announced two U.S. Food and Drug Administration (FDA) actions targeting the safety and nutritional quality of infant formula sold in the U.S. FDA proposed a rule updating infant formula nutrient requirements – the initial phase of its first comprehensive nutrient review since 1998. FDA also released new chemical contaminant testing data through public tools available to parents, clinicians and, by extension, regulators and plaintiffs' counsel.

The actions are part of President Donald Trump's Operation Stork Speed and the broader Make America Healthy Again initiative. Secretary Kennedy said that "[p]arents deserve confidence in every bottle they feed their baby," and FDA Acting Commissioner Kyle Diamantas described the effort as "modernizing our nutritional requirements for infant formula for the first time in nearly three decades."

The initiative follows contamination concerns, recalls and production shutdowns that exposed the fragility of a highly concentrated U.S. formula supply and contributed to nationwide shortages. Although the initiative is framed as a public health measure, HHS' pledge to "hold infant formula manufacturers to rigorous scientific standards," combined with expanded testing and public disclosure, is likely to drive increased civil and criminal enforcement. These developments warrant close attention from in-house counsel, compliance leaders and quality assurance teams across the supply chain.

The Proposed Nutrient Rule

A Phased Review of All 30 Required Nutrients

FDA is reviewing the 30 nutrients currently required in infant formula in three phases, issuing evidence-based proposals for public comment as each phase is completed. Later phases will address the remaining required nutrients, potential new requirements and carbohydrate sources. FDA intends to issue a single final rule covering all three phases rather than finalizing each phase separately.

What the First Proposal Would Change

The first-phase proposed rule would:

• update requirements for iodine, manganese, vitamin A and vitamin D
• reaffirm existing requirements for chloride, potassium, selenium and sodium
• change units of measure for two nutrients
• solicit input on currently optional ingredients that manufacturers commonly add but that are not currently required; FDA cited evidence that arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine contribute to infant neurodevelopment

Comment Period

Comments are due February 26, 2027. Companies interested in submitting comments should contact Holland & Knight's White Collar Defense and Investigations Team. Our attorneys are available to help clients evaluate the proposal's impact on their products and operations, develop data-driven comments and guide them through each step of the submission process.

Contaminant Testing and Public Transparency

Latest Testing Results

FDA's latest testing found low or non-detectable levels of chemical contaminants in most samples, consistent with its earlier 2026 findings.

New Public Data Tools

FDA launched an Infant Formula Testing webpage and a Chemical Contaminants Dashboard that make the results publicly available.

Action Levels Under Development

FDA plans to establish action levels for chemical contaminants. Although the agency has not announced specific levels or timing, action levels would give regulators, litigants and prosecutors a concrete benchmark against which to measure products and lots.

Continued Monitoring and Agency Action

FDA will continue monitoring and "take action as appropriate." Manufacturers whose results diverge from FDA's findings should expect follow-up and, in serious cases, potential criminal referral.

Significance of the Announcement

A Higher and More Visible Compliance Bar

The proposed standards are the most significant change to infant formula requirements in nearly three decades. Under the Federal Food, Drug, and Cosmetic Act (FDCA), infant formula that lacks required nutrients or fails quality or manufacturing requirements is adulterated. Because adulteration is measured against those requirements, stricter specifications enlarge the universe of products that may be deemed adulterated, raising both the compliance bar and the civil and criminal enforcement exposure.

Criminal Exposure for Companies and Individuals

Beyond civil remedies such as warning letters, recalls, seizures and injunctions, the FDCA authorizes criminal prosecution, placing individual liberty – not merely corporate revenue – at risk. Charges rest on the prohibited acts in 21 U.S.C. § 331, which reach both the acts themselves and the causing of them. Most relevant here are introducing, adulterating, receiving and/or delivering adulterated or misbranded food in interstate commerce; failing to provide required infant formula notices, reports and records; failing to maintain required records; and refusing FDA inspection.

Liability under the FDCA is strict. Any violation is a misdemeanor punishable by up to one year of imprisonment, without proof of knowledge or intent. A repeat offense, or one committed with intent to defraud or mislead (which courts have held requires conduct designed to evade regulatory scrutiny), is a felony punishable by up to three years. Maximum fines are $100,000 for individuals and $200,000 for organizations for misdemeanors, and $250,000 and $500,000, respectively, for felonies or misdemeanors resulting in death. Under the responsible corporate officer doctrine, liability reaches anyone with a responsible share in the violation, and an officer may be convicted if he or she had authority to prevent or promptly correct the violation and failed to do so. Defenses are narrow, and courts have upheld prison sentences for officers convicted only of misdemeanors. If and when the proposed rule is finalized, this liability will extend to violations of its new, heightened standards.

An Aggressive Enforcement Backdrop

FDCA enforcement is also intensifying. On October 1, 2026, the U.S. Department of Justice's (DOJ) National Fraud Enforcement Division (NFED) issued Directive 26-12, which targets fraudulent FDCA violations without specifying which ones, suggesting that any violation may draw scrutiny and making joint or DOJ-led prosecutions more likely. An August 31, 2026, memorandum of understanding between FDA and the U.S. Securities and Exchange Commission (SEC) further signals multi-agency enforcement.

NFED is also expanding its case pipeline. Its Fraud Whistleblower Incentive Program (WHIP), announced October 20, 2026, pays $10,000 to $30,000 once criminal charges are filed for tips involving fraud on programs administered by the U.S. Department of Agriculture and HHS, among others. Because federal nutrition programs purchase infant formula in significant volume, formula companies should expect more matters to reach the government through insiders. In light of these developments, formula companies should ensure that they maintain an effective compliance program, including internal reporting channels that allow issues to be addressed before they reach the government.

Public Data as a Litigation and Investigation Road Map

The dashboard puts product-level data in the hands of consumers, plaintiffs' firms, state attorneys general, journalists and potential whistleblowers. Even low results may fuel class actions and false advertising claims, particularly challenges to purity marketing, and FDA's ARA, DHA and L-carnitine inquiry may invite scrutiny of neurodevelopmental claims. Prosecutors may likewise use divergent results to identify targets for investigation.

A Prolonged Period of Regulatory Uncertainty

Until all three phases are proposed and finalized, companies must plan reformulation, revalidation and relabeling against a moving target while complying with current requirements.

Key Takeaways

• Consider Engaging in the Rulemaking: If you have an interest in shaping the final rule, consider submitting data-driven comments by February 26, 2027, that address the proposed nutrient requirements, feasibility and compliance timelines.
• Confirm Whether This Will Impact Your Product: Compare current specifications against the proposed iodine, manganese, vitamin A and vitamin D requirements and plan for reformulation, revalidation and relabeling.
• Benchmark Contaminant Testing: Compare internal and supplier results against FDA's published data before regulators, prosecutors, litigants or the public do.
• Review Labeling and Marketing Claims: Confirm that nutrient, neurodevelopmental, purity and safety claims are substantiated, particularly in light of FDA's public contaminant data and its ARA, DHA and L-carnitine inquiry, which may fuel false advertising challenges.
• Strengthen Compliance and Internal Reporting: Maintain an effective compliance program and promptly investigate out-of-specification results, complaints and employee concerns so the company can remediate before insiders, now incentivized by whistleblower rewards, take them to the government.
• Prepare for Possible Agency Follow-Up: Establish protocols for responding to FDA follow-up and inspections and to inquiries from DOJ, SEC and other federal regulators, recognizing that refusing an FDA inspection is itself a prohibited act.
• Engage Experienced Counsel Early: Retain counsel experienced in FDA regulatory, white collar and litigation matters to assess regulatory, criminal and civil exposure under privilege.

Stricter standards, strict criminal liability, intensified DOJ enforcement and expanded whistleblower incentives mean that companies and their officers across the infant formula supply chain now face heightened legal risk.

Holland & Knight's White Collar Defense and Investigations Team continues to monitor developments regarding FDA's infant formula rulemaking and related enforcement. Our attorneys regularly counsel companies and individuals on government investigations, FDA compliance and whistleblower matters. For additional information or questions, please contact the authors or another member of the team.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.