The FDA publishes the agenda for the FDA Foods Programme

If you export to the US or manufacture your products for that market, you should take into account the new roadmap proposed by the FDA Foods Programme.

These guidelines detail which regulations will be updated in the Federal Register in the coming months and years. For companies in the sector, this provides a roadmap that allows them to anticipate impacts on formulas, labelling, requests for additives or colourings and, in the area of supplements, the limits for each category.

The list originates from the federal Unified Agenda (OIRA/OMB), which is updated twice a year. Although these updates are not fixed in the calendar, they do provide a reliable roadmap for prioritising projects and coordinating windows of change, thereby avoiding last-minute emergencies.

Updates for the years 2025–2027 of the FDA Foods Programme

Viewing the FDA Foods Programme’s list of regulations under development as ‘something distant’ is one of the biggest risks a company can take. When one of the rules moves from proposal to final status, it is often too late to reformulate, reprint or renegotiate with distributors. Failure to address this issue in a timely manner can result in poor-quality products, losses due to obsolete packaging, customs blockages, or warning notices. In short, the risk is not only legal, but can also become operational, commercial, and, of course, reputational. Some of the most likely risks are as follows:

• Definitions and category boundaries.
  — GRAS (Generally Recognised As Safe): Information provided as ‘generally recognised as safe’ may cast doubt on the transparency required of a company of your nature. The changes here affect how you justify the safety of ingredients and the monitoring of notifications.
  — Food supplements: The regulation will clarify when an ingredient is not excluded from the legal definition of a food supplement. This imposes clear boundaries between what is a supplement and other categories, with particular emphasis on botanical-based compounds, extracts and compounds with pharmaceutical use.
• Reformulation and standards.
  — Enabling the use of salt substitutes in food opens the door to reducing sodium without conflicting with different regulations. This would involve reviewing formulations, labelling and claims such as ‘reduced sodium’.
  — Adapting the front-of-pack (FOP). A nutritional labelling system on the front of the packaging would have an impact on design, visual hierarchy and positioning with other brands or logos.
  — For dairy and canned products, changes are needed, such as recognising ultra-filtered milk in certain cheeses or updating the standard for canned tuna. This would affect production costs, yields and quality departments.
• Application procedures (additives and colourings).
  Adjustments to formal and technical requirements for applications may result in new file formats, deadlines, and criteria. This may affect your workflow in the innovation chain and coordination with intellectual property services and publication timing.
• Background signal: system reorganisation.
  Everything continues to move forward as the FDA Foods Programme is consolidated and the most important documents are published by risk area (contaminants, nutrition, labelling, supply chain safety). The message to operators is clear: specific rules that may change must be taken into account, adapting to a system that seeks greater predictability and transparency.

Prepare your company for the latest developments in the FDA Foods Programme

Your company can anticipate the various changes by drawing up a simple plan identifying both those responsible for the actions and the deadlines for action. It is advisable to start by reviewing what affects each product family and prioritising critical issues, such as labelling reviews. It will also help to have an updated technical report with reformulations and packaging designs. With regard to logistics, it is advisable to inform suppliers and manufacturers of your company’s new requirements. With these small changes, the FDA’s regulatory calendar will go from being a problem to an opportunity. Here are some of the changes you could start implementing in your company:

1. Develop an impact map by product families. For each section, determine what phase, target date and type of impact it will have. Correctly define the category, labelling, standards, requests and reformulation of your products. In addition, it is recommended to identify dependencies (laboratories, suppliers, design agencies, regulatory consultants) and assess the risk and return to check whether it is optimal to make these changes or not.
2. Prioritise deadlines. Schedule all potential changes, organising them into different categories based on their urgency or importance.
3. Develop an updated technical dossier. Adapt or develop from scratch an up-to-date technical report for all your projects, including product specifications, packaging designs and legal requirements.
4. Design the first packaging prototypes. Explore as soon as you can the different ways in which you are going to present your products, both the physical format itself and the labelling, and always have them available for last-minute changes.
5. Do not forget the supply chain. Confirm suppliers’ capacity in the event of changes to requests.
6. Internal regime. Assign responsibilities by topic with clear KPIs, such as dossier preparation, reformulation/labelling, transition plan personnel, etc.
7. Training and commercial narrative. Update sales forecasts objectively.

How to use the calendar to your advantage

EBetween 2025 and 2027, there will be various changes that companies must take into account. For the United States, sodium reformulation, modification of identity standards, and front-of-package labelling updates will be some of the changes on the horizon. Companies that anticipate these changes and meet the deadlines with their ‘homework done’ will set trends and achieve better positioning in both the market and with consumers.

As always, if you would like us to review and audit all these changes, prioritise modifications and design a 2025–2027 plan for labelling, reformulation, files and printing timings, LegaleGo Regulatory Affairs can assist you with implementation and development. As always, if you would like us to review and conduct an audit of all these changes, prioritise modifications and design a 2025–2027 plan for labelling, reformulation, dossiers and printing timings, LegaleGo Regulatory Affairs can assist you with the implementation and development. As always, if you would like us to review and audit all these changes, prioritise modifications and design a 2025–2027 plan for labelling, reformulation, dossiers and printing timings, LegaleGo Regulatory Affairs can assist you with the implementation and development.