Harvard Law Analysis Warns Food Safety Preemption Bill Could Impact More Than Additives, Create Oversight Gaps
A new report from the Harvard Law School Food Law and Policy Clinic (FLPC) has analyzed the potential effects of the proposed FDA Review and Evaluation for Safe, Healthy, and Affordable Foods Act of 2026 (FRESH Act), warning that its broad federal preemption provision could dismantle state and local food safety laws without establishing equivalent federal requirements.
The report examined how the FRESH Act could affect the balance of food safety oversight among federal, state, and local jurisdictions. The authors asserted that, as drafted, the legislation could preempt state requirements covering areas beyond the food additive restrictions that have been a central focus of debate over the bill.
The FRESH Act was introduced by Representative Kat Cammack (Republican, Florida). The legislation would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to make several changes to FDA food oversight, including reforms to the Generally Recognized as Safe (GRAS) process, systematic post-market food chemical reviews, new infant and toddler food safety requirements, and expanded infant formula oversight.
A key provision would establish federal preemption over certain state food laws. According to FLPC, the bill's language would supersede state requirements or prohibitions related to the use, labeling, sale, or marketing of foods and food additives, as well as state labeling requirements conveying certain health or safety information.
FLPC Identifies State Food Safety Laws Potentially Affected by FRESH Act
FLPC's analysis found that the preemption provision would clearly or likely affect state and local requirements related to:
- Food additives and chemicals, including state additive bans and requirements for reporting GRAS substances not reviewed by FDA
- Food labeling and warnings, including restaurant allergen disclosures, menu labeling requirements, and rules for labeling plant-based and cell-cultivated proteins
- Chemical and biological contaminants, including requirements addressing heavy metals, PFAS in food packaging and food-contact materials, and contaminants in baby foods
- Retail food stores and foodservice establishments, including food codes, permitting, inspections, and restaurant grading requirements
- Cottage food and home kitchen operations
- Food manufacturing permits, licensing, and inspections, including requirements for smaller facilities exempt from certain federal Food Safety Modernization Act (FSMA) requirements.
Act Could Create Gaps in Food Safety Oversight Where No Federal Regulations Exist
Importantly, the authors said the FRESH Act would not condition federal preemption on the existence of a corresponding federal requirement. The report therefore warned that eliminating state requirements in areas with little or no equivalent federal regulation could create gaps in food safety oversight.
For example, state and local governments currently hold primary responsibility for regulating restaurants and many retail food establishments. FLPC noted that more than 3,000 state, local, and tribal agencies currently participate in retail and foodservice oversight, while FDA does not have direct jurisdiction over restaurants and most retail food settings. Shifting such responsibilities to FDA without providing corresponding resources or authority could weaken oversight, according to the report.
The report also raised concerns about legal remedies. Because the FDCA does not provide a private right of action, FLPC asserted that broad preemption could affect state consumer protection and tort claims currently available to consumers and state enforcement authorities.
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Federal Preemption Debate Continues
The appropriate balance between federal uniformity and state authority has been a central point of debate surrounding the FRESH Act.
During an April 29 Congressional hearing, Rep. Cammack argued that the growing patchwork of state food regulations and labeling requirements increases costs for consumers and fails to establish a uniform national food safety standard. Industry witnesses supported uniform federal ingredient and labeling requirements, while acknowledging that FDA would need sufficient resources and authority to implement science-based national standards.
Non-industry witnesses opposed broad preemption. Environmental Working Group Senior Vice President of Government Affairs Scott Faber argued that states have played an important role in addressing food chemicals when federal regulators have not acted.
Association of Food and Drug Officials (AFDO) Executive Director Steven Mandernach, J.D., took a more moderate position, stating that federal preemption should be applied carefully so that it strengthens rather than strains the state–federal food safety partnership.
FLPC's new analysis similarly emphasized the role states have historically played alongside federal regulators. The report characterized the U.S. food safety system as one of concurrent federal and state authority, with federal law establishing national requirements in some areas while states and localities retain primary or complementary authority in others.
The FRESH Act remains proposed legislation.
