FDA Proposes New Chemical Assessments Processes for Foods

Agency seeks feedback from the food industry on proposed risk assessment and corrective action processes for additives, food contact materials, and contaminants

Amid recent scrutiny around ingredients used by food manufacturers and substances that can be found in foods and related legislative actions, the Food and Drug Administration's new Human Foods Program is finalizing proposed enhancements for postmarket assessments of chemicals in food. FDA's current postmarket assessment efforts and processes are less defined. Based on legal and regulatory requirements, the food industry also has responsibility to perform postmarket monitoring and assessments for product safety.

FDA's actions follow 2023's California Food Safety Act, prohibiting the sale of food containing red dye 3, potassium bromate, propylparaben, and brominated vegetable oil - all of which are not approved for use in foods in the EU. The Toxic Free Food Act now being considered in the House of Representatives also proposes enhancing the safety assessment processes used to designate GRAS (generally recognized as safe) substances for use in the food supply.

In conjunction with a public meeting on Sept. 25, FDA released a discussion paper on the subject, outlining its development of a systematic process and soliciting feedback from the food manufacturing industry to facilitate refinements. The comment period is open until Dec. 6; comments can be submitted through regulations.gov, referencing Docket No. FDA-2024-N-3609.

Signal monitoring, triage, and assessment type determinations

Applicable to food and color additives, substances used in food contact materials, GRAS substances, and chemicals unintentionally present (such as environmental contaminants), FDA's proposed review process is to begin with these three steps.

1. Food Chemical Signal Monitoring: Identify new, relevant information on the use of or presence of food ingredients and substances through monitoring new submissions, scientific publications, international and U.S. regulatory activities, adverse event reports, news reports, social media, and other information.
2. Triage: Conduct preliminary quality and impact assessments of this new information to determine whether postmarket assessment is needed.
3. Fit-for-Purpose Decision: Based on the complexity of the assessment required, FDA will proceed to a Focused or Comprehensive Assessment, the latter for more complex assessments or those receiving a high degree of public interest.

Focused assessments

FDA's Focused Assessments are intended to be more limited in scope than Comprehensive Assessments. They would not require peer review or other external engagements. The typical Focused Assessment is estimated to be completed within 4 months to 1 year, unless risk management review and actions are warranted. FDA's Focused Assessments will proceed as follows.

1. Scope Formulation: Define the chemical substances at issue and establish the review's scope.
2. Risk Assessment: Conduct a scientific risk assessment to determine whether,
   1. New information suggests a possible safety concern for a chemical
   2. Substances intentionally added to food meet the standard of "reasonable certainty of no harm"
   3. Exposures exceed safe levels
   4. The information represents a possible public health concern
3. Risk Management Review: FDA subject matter experts conduct a risk management review to determine whether action is required to protect public health, including outlining possible mitigation strategies, identifying additional resource and research needs, and assessing the potential need for a Comprehensive Assessment.
4. Risk Management Communication and Action: FDA will communicate its conclusions and implement risk management actions.

Comprehensive assessments

More complex and resource intensive than Focused Assessments, Comprehensive Assessments may require years to conclude and would involve a team of FDA subject matter experts performing the following.

1. Prioritization: Prioritize chemicals, and their assessments, based on the agency's criteria.
2. Scope Formulation: Define the scope of the review in part through public engagement to identify new information, the chemical substances in question, and safety concerns that need to be addressed.
3. Risk Assessment: Conduct a scientific risk assessment, including characterization of adverse health effects, determination of anticipated dietary exposure, risk estimates for relevant populations, and identification of any additional research or data needed to support the assessment. This will allow the FDA to determine whether substances intentionally added to food meet the standard of "reasonable certainty of no harm," whether exposures exceed safe levels, or whether food contaminants require reduction measures and engage the public regarding their draft risk assessment.
4. Risk Management Review: Determine whether action is required to protect public health and the available options to do so, including associated health benefits and needed resources. The agency may collect new analytical or exposure data, conduct its own safety studies, or request new data from industry stakeholders.
5. Briefing for FDA Program Leadership: Brief members of the Human Foods Program on scientific conclusions, risk management options, and recommended actions.
6. Public Final Assessment and Risk Management Action: Following a possible public comment period and the public release of the final assessment, FDA will begin risk management actions, including but not limited to recall recommendations, enforcement actions, and regulatory measures.

Opportunity for food manufacturing stakeholder feedback

Now through the close of the comment period, Dec. 6, FDA is requesting input on the proposed processes for postmarket chemical assessments, including:

• The timing, nature, and frequency of engagement with the public
• The possible involvement of an advisory committee review
• The questions to be used by subject matter experts to determine whether to conduct Focused or Comprehensive Assessments
• The methods used to determine risk and chemical prioritization or ranking
• Whether the two-pronged approach of Focused and Comprehensive Assessments is appropriate or whether rationales for alternative processes should be considered

Food manufacturing stakeholders are encouraged to offer their feedback and input as regulations evolve in response to public health concerns.