The process documents make clear that FDA plans to work swiftly to prioritize chemicals for assessment, conduct post-market assessments and take regulatory action.

In light of this more proactive review framework, food manufacturers, ingredient suppliers and others in the supply chain should consider steps now to position themselves to participate in FDA’s administrative process and mitigate potential regulatory, commercial and litigation risks arising from FDA’s actions.

With the program announcement, FDA released the Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food, which outlines the process the agency will use to identify and assess the food additives as well as the procedures for conducting the post-market assessments.

FDA also published the Tool for the Prioritization of Food Chemicals for Post-Market Assessment, which describes the methodology for identifying substances that present the greatest potential risk to public health.

Developed following extensive public input, these documents are designed to support FDA’s ability to prioritize post-market assessments and take action when the agency deems it necessary.

The framework establishes a three-step process for selecting ingredients for post-market review: signal detection, triage and prioritization.

FDA will utilize an AI platform, Warp Intelligent Learning EnginE or WILEE, to analyze publicly available data, including scientific literature, international regulatory actions, trade group materials, press reports and internet sources, alongside information received through existing regulatory pathways.

Ingredients selected for assessment are evaluated using a prioritization tool that considers factors such as toxicity, changes in exposure, impacts on susceptible populations and new scientific information. FDA will publish an annual post-market work plan identifying the selected ingredients for assessment and solicit public input and data through Federal Register notices, with comment periods being limited to 60 days without extensions.

FDA then will determine whether regulatory or other risk management actions are appropriate and take such actions consistent with applicable laws and regulations, which may require hearings or other administrative processes.

Implications for the industry

FDA’s new approach to post-market review introduces both strategic opportunities and material risks for food manufacturers, ingredient suppliers, contract manufacturers, retailers and others in the food supply chain.

Companies must be aware of and take into consideration the following:

Heightened Regulatory Scrutiny: FDA’s increased focus on post-market reassessment requires companies to adopt active and continuous monitoring practices and proactive defensive strategies rather than relying on static regulatory clearances (e.g., GRAS conclusions or food additive approvals). Companies should understand the vulnerabilities in their portfolios and closely monitor global food regulatory trends and actions as they may provide an early warning signal of the substances that FDA may be most likely to target.

The current absence of permanent leadership at FDA may provide an opportunity for the Secretary of Health and Human Services to become more involved in decisions around additional restrictions for food.

Disruptions to Supply Chain: Post-market review introduces uncertainty that can impact the supply chain. Even absent formal regulatory action, the designation of an ingredient for review on the annual list can trigger de facto market withdrawal pressures, particularly from retailers or downstream customers sensitive to reputational risk.

Suppliers may face contractual instability, including reformulation demands, specification changes, shortages of ingredients or accelerated phase-outs. Companies should anticipate the need for dual sourcing strategies or prequalified alternative ingredients, particularly for substances with limited substitutes or complex functional roles (e.g., emulsifiers, preservatives).

Litigation: While being on the FDA post-market assessment list does not mean that an ingredient is unsafe, post-market review activity is likely to be leveraged by private plaintiffs and state regulators to increase the risk of litigation before any formal conclusions about safety. Companies should consider taking steps to prepare for and mitigate these risks.

Expanded Role for Public Comment and Stakeholder Engagement: FDA’s process creates meaningful opportunities for industry to provide scientific information and shape the narrative both at the agency and in social media more generally. Companies should be prepared to respond to FDA information requests with high-quality scientific data, including toxicology, exposure modeling and use-level information.

Companies may also want to consider increasing their participation in trade associations and consortia, which may play a critical role in data generation and coordinated advocacy.

Post-market assessments kick-off

FDA’s approach to assessing ADA and BHT will be a roadmap for things to come. So closely following the proceedings and commenting on the process, even if a company does not have a specific interest in either of these two substances, should be strongly considered.

For both substances FDA is requesting information on uses, use levels, dietary exposure and safety data on use of substances. Comments are due July 13.

The new post-market assessment program marks a significant shift in how FDA intends to police the food supply. These changes will be disruptive to food manufacturers and suppliers and will create the immediate need for ongoing monitoring of food science literature and global food regulatory trends and in some cases creative solutions for ingredient substitutions and supply chains.

Companies should consider strategies for minimizing potential increased litigation and reputational risk from FDA review decisions.

Kathleen Sanzo and Franco Corrado are partners and Ariel Seeley is of counsel at law firm Morgan Lewis. This is from the firm’s blog Well Done.