The US Food and Drug Administration (FDA) is expanding its assessment of chemicals already present in the food supply, putting ingredient safety and regulatory monitoring firmly on the agenda for food manufacturers and procurement teams. Its review program covers selected food ingredients, color additives, food-contact substances and contaminants, with new scientific evidence helping determine which substances require closer examination.
For businesses that source food ingredients internationally, these reviews can influence purchasing decisions, product formulations, supplier qualification and access to the US market. An ingredient appearing on the FDA's review list does not automatically mean it is unsafe or prohibited. However, the review can signal that manufacturers should monitor regulatory developments and understand how potential decisions could affect their operations.
What the FDA's Food Chemical Safety Review Covers
The FDA evaluates chemicals used in food, substances that come into contact with food during packaging or processing and contaminants that may enter the supply chain. Each category presents different safety considerations, so companies need to understand the role a substance plays in their products before assessing the commercial implications of a review.
The program covers several groups:
Food ingredients: Substances added to food for a specific function, including ingredients assessed under the Generally Recognized as Safe (GRAS) framework.
Food and color additives: Materials used to achieve particular technological effects, such as preservation, processing or coloring.
Food-contact substances: Materials used in packaging, storage, processing equipment and other applications where substances may transfer into food.
Chemical contaminants: Unwanted substances that can enter food through environmental exposure, agricultural practices or processing conditions.
The regulatory status of each substance depends on its intended use, applicable authorization and conditions of use. Procurement teams should therefore evaluate the exact ingredient or material application rather than relying on a chemical name alone.
Why Previously Used Ingredients Face New Assessments
Food ingredients can remain in commercial use for years while scientific understanding continues to develop. New toxicological research, updated exposure estimates and findings from international scientific bodies can give regulators reasons to revisit earlier safety assessments.
The FDA may initiate a review after receiving a petition or request from an external stakeholder. It can also begin an assessment independently when new information raises questions that warrant further investigation.
Several developments can prompt closer examination:
New scientific findings: Research may identify potential health effects that earlier studies did not adequately address.
Changing exposure patterns: An ingredient's widespread use or higher consumption could change estimates of how much people encounter through their diets.
New information from other authorities: Findings from international regulators or scientific organizations can provide signals that justify further assessment.
Stakeholder concerns: Manufacturers, researchers, consumer organizations and other interested parties may submit information that encourages regulatory scrutiny.
A reassessment does not necessarily mean that earlier regulatory decisions were incorrect. Instead, it reflects the need to evaluate current evidence and determine whether existing conditions of use remain appropriate.
Which Ingredients Are Under FDA Review?
The FDA's published review list identifies selected substances that the agency is assessing and provides information about their review status. Its August 2025 update added several food preservatives, color additives and other substances, while also distinguishing lead associated with food-contact uses from lead considered as a contaminant.
Examples included in that update were:
Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT): Antioxidants used in certain food applications to help limit oxidation.
Azodicarbonamide (ADA): A dough-conditioning agent used in specified food applications.
FD&C Blue No. 1, Blue No. 2 and Green No. 3: Synthetic color additives used in authorized applications.
FD&C Red No. 40, Yellow No. 5 and Yellow No. 6: Color additives used in a range of food products.
Opiate alkaloids on poppy seeds: A contaminant-related issue included in the FDA's review program.
Phthalates, propylparaben and titanium dioxide: Substances for which the agency has continued assessment activities.
These examples illustrate the range of issues covered by the program, from ingredient functionality to color use and potential contamination. The current FDA list should serve as the reference point for the latest review status rather than an older news report or a supplier's general statement about regulatory compliance.
How the FDA Conducts Post-Market Safety Assessments
The FDA's post-market process helps the agency evaluate chemicals that are already present in food or used in food-contact applications. Its systematic approach moves from identifying potential concerns to prioritising substances, assessing scientific evidence and deciding whether regulatory action is appropriate.
The process generally follows four stages:
Signal identification and triage: The FDA reviews scientific studies, reported concerns, exposure information and other available evidence to identify substances that may warrant attention.
Prioritisation: The agency evaluates which substances need further assessment, taking account of potential hazards, exposure and other relevant factors.
Scientific assessment: Researchers examine available toxicological evidence, estimate dietary exposure and evaluate the potential risks associated with current uses. The FDA may also invite industry and public input through formal information requests and comment periods.
Risk management: The agency considers whether the findings justify regulatory measures, such as changing an authorisation, establishing limits for contaminants or pursuing other actions to protect public health.
The process can involve several rounds of evidence gathering and review. Its duration varies according to the substance, the complexity of the available evidence and competing regulatory priorities, so businesses should avoid assuming that every review will conclude within the same timeframe.
What an FDA Review Means for Food Manufacturers and Traders
A review listing creates a reason to monitor developments, not an automatic requirement to discontinue an ingredient. Businesses should distinguish between a substance under assessment, a final regulatory decision and a separate finding that a particular use lacks the required authorisation.
That distinction matters throughout international trade. A product may be commercially acceptable in one jurisdiction while its use in the United States requires a different authorisation or compliance assessment.
Manufacturers, importers and distributors should focus on three questions:
Is the intended use authorised? Confirm the applicable regulatory status, permitted applications and any restrictions relevant to the product.
Could the review affect the formulation? Identify whether the ingredient is essential to product performance or whether a technically suitable alternative exists.
What evidence can the supplier provide? Obtain specifications, identity and purity information, intended-use documentation and relevant safety data to support the company's assessment.
Procurement teams should also map the ingredients used across their product portfolios. This helps them identify where a regulatory change could affect multiple formulations, suppliers or customer contracts at the same time.
Managing Sourcing Risks and Supplier Documentation
Regulatory uncertainty can create commercial risks even before an authority reaches a final decision. Companies may face reformulation costs, qualification delays, revised customer requirements or the need to source alternative materials within a limited timeframe.
A structured supplier-management process can reduce these risks.
Start with traceability. Maintain an ingredient register that records the chemical or common name, supplier, manufacturer, country of origin, intended application and relevant regulatory documentation. Include food-contact materials where they form part of the packaging or processing chain.
Strengthen supplier communication. Ask suppliers to notify the procurement and quality teams when an ingredient's regulatory status changes or new safety documentation becomes available. Establish clear responsibilities for providing updated specifications and supporting technical information.
Assess alternatives before they become urgent. Where an ingredient has a critical functional role, evaluate potential substitutes for performance, compatibility, cost and regulatory suitability. A substitute should not enter production simply because it appears outside a review list. The proposed use must also meet applicable requirements.
Connect procurement with quality and regulatory teams. Purchasing decisions should reflect both commercial terms and compliance considerations. Shared review procedures help businesses respond consistently when a regulator publishes new findings or requests additional information.
These practices allow companies to manage risk without making premature decisions based solely on the announcement of a review.
How Food Businesses Can Monitor Regulatory Developments
The FDA publishes review information and related documents through its food chemical safety resources. Its review list provides information about assessment progress, relevant actions and opportunities for public input where applicable.
Procurement and compliance teams can establish a straightforward monitoring routine:
Check the official review list regularly. Compare new entries and status changes against the company's ingredient and packaging registers.
Review supporting documents. Read assessment updates, requests for information and notices of proposed or final action rather than relying only on headlines.
Track consultation deadlines. Where the FDA invites stakeholder submissions, determine whether the company has relevant technical or exposure information to contribute.
Record decisions internally. Document the review status, responsible team member, potential business impact and any follow-up required.
Coordinate international compliance checks. For products sold in several countries, compare applicable requirements across target markets instead of assuming that one regulator's position automatically determines another's.
A documented process also helps companies answer customer questions with current evidence. This becomes especially important when buyers request confirmation of ingredient status, packaging suitability or plans for managing a potential regulatory change.
What Procurement Teams Should Do Now
Food chemical safety reviews make regulatory awareness an important part of purchasing strategy. Companies that track official developments, maintain reliable supplier records and assess alternatives early can respond more effectively when a review progresses towards a final decision.
For procurement managers and chemical traders, the immediate priorities are practical:
Review ingredient and food-contact material inventories against the FDA's latest published list.
Confirm the regulatory basis for each intended use in products destined for the US market.
Request updated technical documentation from suppliers where gaps exist.
Evaluate supply continuity and alternative sourcing options for ingredients that perform critical functions.
Assign responsibility for monitoring regulatory updates and communicating relevant changes to quality, formulation and purchasing teams.
The key is to separate a review signal from a regulatory outcome. A clear understanding of the assessment process helps businesses make measured sourcing decisions, protect product continuity and respond to changing compliance requirements without unnecessary disruption.
SOURCE LINK: https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review
Titanium Dioxide CAS: 13463-67-7