FDA steps up scrutiny of food ingredients, additives and packaging: implications for companies operating in the U.S. market

The U.S. Food and Drug Administration has published the updated 2026 guidance agenda for its Human Foods Program, outlining the guidance documents under development and the priority areas of interest for the food sector. The document confirms an increasingly clear direction from U.S. regulators, with growing attention to ingredients, food and color additives, chemical contaminants and substances used in food contact materials.

For food companies exporting to the United States, as well as for importers, distributors, retailers and operators active in the U.S. market, regulatory compliance now requires a more detailed check not only of the finished product, but also of ingredients, additives, food contact substances and materials, labels and claims. The new FDA priorities point to a market in which formulations, packaging and supporting technical documentation may face closer scrutiny even after a product has entered the market.

A new phase for food chemical safety

In recent months, the FDA has strengthened its approach to food chemical safety, meaning the safety of chemical substances present in foods or used along the supply chain. The scope is broad: it includes ingredients, food additives, color additives, GRAS substances, food contact substances and materials, as well as contaminants that may enter the product through the environment, production process, packaging or transport.

The most significant change is the move towards a more structured control system after products have entered the market. The FDA has finalized a new systematic post-market assessment process, designed to identify, prioritize and reassess substances already present in the U.S. food supply when new information emerges on risk, exposure or conditions of use.

This means that a substance already authorized, used or considered safe in the past may come under review again if scientific knowledge, exposure levels, industrial uses or risk perceptions among authorities and consumers change.

FDA priorities for 2026

New guidance documents under development include caffeine content declarations for foods and beverages, questions and answers on the use of the "healthy" claim, updates to product categories in food facility registration and various guidance documents covering contaminants, additives, preventive controls and microbiological safety.

The section on chemical safety is particularly relevant for food companies. The FDA plans to move forward on several fronts: reform of the GRAS system, acronym for "Generally Recognized as Safe"; post-market reassessment of substances already present in the market; research on microplastics; reduction of exposure to contaminants such as arsenic, cadmium, lead and mercury in foods intended for infants and young children; assessment of PFAS and other contaminants; and the shift towards color additives from natural sources.

Post-market assessment: why it also matters for exporters

The new post-market assessment process does not concern U.S. companies only. It also affects foreign producers that sell in the United States, because imported foods must meet the same safety standards that apply to domestic products. For a European exporter, this means checking not only recipe compliance, but also the compliance of additives, flavorings, color additives, processing aids, new food ingredients and, where relevant, new dietary ingredients (NDIs), as well as packaging materials.

The FDA has clarified that including a substance on a review list does not automatically mean that its use is unsafe. It does, however, indicate that the agency is assessing whether new scientific information, new exposure data or changes in conditions of use may require further action. For companies, this creates a need to monitor regulatory updates more closely and to have solid technical data available.

The case of food contact substances

A concrete example concerns phthalates used in some food contact applications. In 2026, the FDA published a scientific assessment of the eight ortho-phthalates still authorized as plasticizers for food contact uses, with the aim of understanding whether some substances should be grouped for a future cumulative risk assessment.

This case is relevant because it shows that FDA scrutiny is not limited to the recipe of the food product. Food contact substances and materials, packaging, process components and other materials intended to come into contact with food can also become part of the safety assessment, especially when new scientific evidence or new exposure data suggest the need for reassessment.

GRAS, ingredients and technical documentation

Another central point concerns the GRAS system, meaning substances considered "Generally Recognized as Safe". According to the FDA, a regulatory proposal on the GRAS system is expected in 2026, with the aim of requiring companies to notify the agency of new substances they intend to use in foods by relying on this safety status.

This issue is highly relevant for functional ingredients, botanical extracts, new food ingredients, sweeteners, flavorings, color additives, additives and solutions developed for clean label, nutrition, wellness or high added-value products. Companies operating in the United States will therefore need to pay closer attention to the robustness of their safety assessments and to the availability of technical data showing in which products the substance may be used, in what quantities and for what technological or food-related function.

Labels and claims: focus on caffeine and "healthy"

The new topics included in the 2026 guidance agenda also cover caffeine content in foods and beverages and the use of the "healthy" claim. These are two areas with strong commercial impact, as they concern growing categories such as energy drinks, functional beverages, functional snacks, health-oriented products, protein foods and products intended for wellness-conscious consumers.

For producers, importers and retailers, product communication must be assessed carefully not only from a marketing point of view, but also from a regulatory perspective. Functional ingredients, nutrition claims, health-related claims, other product claims and labeling information must be consistent with FDA definitions and official guidance.

What companies should do

For companies that sell or intend to sell in the United States, the new FDA priorities suggest a more preventive approach to compliance. Checking the finished product is no longer enough: companies need to verify the full regulatory architecture of the product, from formulation and packaging to labeling and supporting technical documentation. In particular:

• verify ingredients, additives, flavorings, color additives and functional substances against the FDA framework;
• check that any GRAS substances are supported by adequate data consistent with the intended use;
• assess packaging and food contact substances and materials according to requirements for the U.S. market;
• monitor substances included in FDA post-market review lists;
• update technical specifications required from suppliers of ingredients, packaging and process materials;
• check labels, nutrition claims, health-related claims, other product claims and mandatory labeling information;
• maintain supporting technical documentation useful in the event of a request from importers, buyers, retailers or authorities.

Impact for importers, distributors and retail

U.S. importers, distributors and retailers are directly affected by this evolution. Companies bringing food products into the U.S. market must be able to rely on suppliers capable of documenting ingredients, additives, food contact substances and materials, labels and conditions of use. This applies in particular to innovative products, functional foods, beverages, infant and toddler foods, dietary supplements, packaged foods and private label products.

Greater FDA attention may translate into more detailed requests along the supply chain: updated technical sheets, declarations on food contact substances and materials, documentation on additives, label compliance and verification of substances under review. For buyers, compliance therefore becomes a supplier selection criterion, alongside price, quality, supply continuity and commercial positioning.