FORMULA Act of 2026
- Sponsor
- Rep. Mast, Brian J. [R-FL-21]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jul 20, 2026
Bottom line
The FORMULA Act of 2026 aims to significantly enhance the safety of infant formula by establishing federal contaminant standards and increasing manufacturer accountability through mandatory testing and reporting.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish maximum permissible levels for a broad range of contaminants in infant formulas. It mandates that infant formula not complying with these levels be considered adulterated, requires manufacturers to conduct testing and maintain records, and includes provisions for annual reporting to Congress on compliance and contaminant levels.
Proponents argue
Proponents argue that this bill is a critical step to protect the health and neurodevelopment of infants by setting clear, science-based limits on harmful contaminants in infant formula. They contend it addresses a significant public health concern, provides regulatory clarity for manufacturers, and ensures greater transparency for parents regarding the safety of products intended for the most vulnerable population.
Opponents contend
Opponents might contend that while the goal of infant safety is paramount, the bill's broad scope and tight implementation timelines could impose substantial regulatory burdens and costs on infant formula manufacturers. They may argue this could lead to increased production costs, potentially higher prices for consumers, or even impact the availability of certain formulas if manufacturers struggle to meet new standards quickly, without sufficient time for research and development.
The bill is very short and clearly written, making it highly accessible for any reader to understand its core provisions and implications within a few minutes.
Section 2(a) amending 21 U.S.C. 350a(a)
Defining Adulterated Infant Formula
This provision expands the definition of 'adulterated infant formula' to include any formula that does not comply with the maximum permissible contaminant levels established by the Secretary of Health and Human Services. This means that if an infant formula exceeds these new limits, it will be considered unsafe and subject to regulatory action.
Supporters argue
Supporters argue this provision provides strong regulatory teeth, ensuring that infant formula exceeding established contaminant levels can be swiftly removed from the market, thereby directly protecting infant health.
Critics contend
Industry critics might argue that overly strict or rapidly implemented standards could lead to product shortages if manufacturers face challenges in immediate compliance, potentially harming consumers by limiting access to essential products.
Tradeoffs
The tension lies between ensuring the highest level of safety by deeming non-compliant products adulterated and the potential for market disruption if compliance is challenging for manufacturers.
Section 2(b) adding new subsection 412(n) to 21 U.S.C. 350a
Establishment of Maximum Permissible Contaminant Levels
This section directs the Secretary of Health and Human Services to establish, through regulation, maximum permissible levels for contaminants in infant formula. These levels must be set as close to the maximum contaminant level goal as feasible, considering the best available technology, treatment techniques, and cost. The Secretary must also consider specific factors like cumulative health impacts on infant neurodevelopment, contaminant prevalence, and bioaccumulation.
Section 2(b) adding new subsection 412(n)(4) to 21 U.S.C. 350a
Manufacturer Testing and Record-Keeping Requirements
The bill mandates that infant formula manufacturers conduct testing to ensure compliance with the newly established maximum permissible contaminant levels. Furthermore, manufacturers must maintain detailed records of this testing for at least two years beyond the shelf life of the infant formula and make these records available to the Secretary upon request.
Section 2(b) adding new subsection 412(n)(5) to 21 U.S.C. 350a
Broad Definition of 'Contaminant'
This section provides a comprehensive definition of 'contaminant' to include any physical, chemical, biological, or radiological substance or matter that is man-made or introduced into the environment via human activity. It specifically lists heavy metals, per- and polyfluoroalkyl substances (PFAS), phthalates, microplastics, synthetic pesticides, and biological toxins, including cyanotoxins associated with harmful algal blooms.
Section 2(b) adding new subsection 412(n)(6) to 21 U.S.C. 350a
Annual Report to Congress on Contaminant Levels and Violations
This provision requires the Secretary of Health and Human Services to include specific information in its annual report to Congress. This includes a list of any manufacturers found in violation of the maximum permissible contaminant levels, the specific concentrations of contaminants (including microplastics and cyanotoxins) detected during routine surveillance testing, and an assessment of progress towards achieving the lowest feasible levels for contaminants in the domestic supply chain.
Section 2(c)
Expedited Rulemaking and Implementation Timeline
This section mandates that the Secretary of Health and Human Services issue regulations to implement the new contaminant level requirements within 180 days of the Act's enactment. These regulations will then apply to infant formula manufactured 180 days after their issuance, creating a relatively swift timeline for both rulemaking and industry compliance.
The Secretary shall ensure contaminant levels are 'as close to the maximum contaminant level goal as is feasible with the use of the best available technology, treatment techniques, and other means which the Secretary finds are available, taking cost into consideration.'
Section 2(b), new subsection 412(n)(2) of the Federal Food, Drug, and Cosmetic Act
Why it matters:This phrasing is standard legislative practice for granting regulatory agencies discretion while setting parameters. It's not necessarily evasive but can be overlooked by a casual reader focusing on the mandate itself rather than the nuances of its implementation.
Case for: Supporters argue this language provides necessary flexibility for the Secretary to set ambitious yet achievable standards, balancing public health goals with practical and economic realities, ensuring regulations are both effective and sustainable.
Case against: Critics might argue that including 'taking cost into consideration' could allow for less stringent standards than scientifically optimal, potentially compromising infant health for economic convenience. The term 'feasible' also offers significant interpretive leeway.
Estimated impact: This clause will significantly influence the stringency of the final contaminant levels, impacting both the health protection afforded to infants and the financial burden on manufacturers.
The definition of 'contaminant' explicitly includes 'microplastics' and 'cyanotoxins associated with harmful algal blooms,' alongside heavy metals, PFAS, phthalates, and synthetic pesticides.
Section 2(b), new subsection 412(n)(5) of the Federal Food, Drug, and Cosmetic Act
Why it matters:This is standard practice for defining terms within legislation. However, the inclusion of microplastics and cyanotoxins is particularly forward-looking and significant, as these are emerging contaminants with less established regulatory frameworks compared to, for example, heavy metals.
Case for: Proponents argue that explicitly listing these emerging contaminants ensures the regulations are comprehensive and future-proof, addressing potential threats to infant health that might otherwise be overlooked by a more generic definition.
Case against: Manufacturers might argue that including contaminants like microplastics, for which standardized testing methods and clear health thresholds are still under scientific development, could create significant technical and financial challenges for compliance, potentially leading to regulatory uncertainty.
Estimated impact: This specific inclusion broadens the scope of required testing and research for manufacturers and regulators, potentially leading to groundbreaking standards for these emerging contaminants in infant formula.