Navigating New FDA Regulations: Why Food Traceability and EDI Matter More Than Ever 

The new U.S. administration is proposing changes to the food manufacturing industry as part of a sweeping effort to improve the health of American consumers. These reforms aim to remove synthetic additives, tighten safety regulations, and increase transparency across the food supply chain. 

The implications for food manufacturers are far-reaching. Reformulating products, adjusting supply chains, and ensuring compliance with new oversight rules will all require visibility, agility, and robust digital infrastructure. A key technology that can help food companies adapt to these changes is Electronic Data Interchange (EDI). In tandem with improved traceability systems, EDI can play a critical role in helping food manufacturers meet new standards and thrive in a more transparent, health-focused market. 

Food Dyes & GRAS Reform: What Is the New Administration Proposing? 

The administration’s agenda includes two headline initiatives that directly affect food manufacturers: 

1. Phasing out synthetic food dyes by the end of 2026 

2. Reforming the FDA’s GRAS (Generally Recognized as Safe) rule 

Synthetic Food Dyes: Under the proposed changes, food dyes such as Red 40, Yellow 5, and Blue 1 (derived from petroleum) would be banned from U.S. food products. These dyes have been linked to hyperactivity in children and are banned or restricted in other parts of the world, including the European Union. 

GRAS Reform: The administration also aims to overhaul the GRAS rule, which currently allows companies to self-certify the safety of food additives without FDA oversight. The proposed reform would require manufacturers to submit all new food ingredients for formal FDA review, increasing regulatory transparency and accountability. 

Together, these changes could create one of the most significant regulatory shifts in the U.S. food industry in decades. Failure to adhere to these proposed changes could lead to fines and civil penalties, product recalls, potential legal action from the FDA, and suspension of facility registration—which can halt operations altogether. 

What Do GRAS Changes Mean for Food Manufacturers? 

These proposed reforms mean more than eliminating a few artificial ingredients for food producers and brands. They will need to make strategic, operational, and logistical changes, including: 

1. Reformulating Products 

Food manufacturers will have to find natural alternatives to synthetic dyes. While many already use natural colors in products sold overseas, reformulating for the U.S. market involves rigorous testing for taste, appearance, shelf life, and safety. Even subtle ingredient changes can affect the final product’s stability, cost, or customer acceptance. 

2. Sourcing New Ingredients 

Natural colorants like beet juice, turmeric, or annatto may replace synthetic dyes, but these ingredients can be more expensive, less consistent in color, and harder to source at scale. That puts additional pressure on procurement and supply chain teams to secure high-quality, traceable alternatives. 

3. Complying with New Oversight Requirements 

If GRAS reform is implemented, manufacturers must provide more documentation about each ingredient’s safety and origin. They may also need to adjust their labeling, marketing claims, and product approvals. 

4. Updating Supply Chain Systems 

From R&D to labeling and distribution, product changes will cascade through multiple systems. Teams will need tools that offer visibility and control across the entire value chain. 

In short, food manufacturers will face higher product and data accuracy expectations. 

Why Traceability Will Be Key 

Traceability is the ability to track ingredients, products, and processes across the supply chain. As food manufacturers navigate the proposed reforms, traceability will become a cornerstone of compliance and operational success. 

Here’s how traceability will support food manufacturers: 

• Ingredient Origin Tracking: With stricter oversight on additives and dyes, manufacturers must verify where ingredients come from and how they were produced. 

• Batch and Lot Traceability: If a reformulated product causes issues, traceability allows companies to pinpoint affected batches and respond swiftly. 

• Regulatory Compliance: Traceability ensures the data needed to prove compliance is accurate, accessible, and auditable. 

• Consumer Trust: Consumers are demanding clean-label transparency. Traceability helps support marketing claims about natural, safe, and sustainably sourced ingredients. 

To build this level of visibility, manufacturers need digital tools that connect the dots from raw ingredients to finished goods. That’s where EDI comes in. 

The Role of EDI in Food Traceability and Compliance 

EDI enables manufacturers, suppliers, and retailers to exchange standardized business documents electronically. It is vital in enabling traceability, especially as food businesses face tighter oversight and accelerated timelines. 

Here’s how EDI supports traceability and compliance: 

• Real-Time Data Sharing: EDI enables companies to share accurate, structured data in real time. This includes documents like purchase orders (EDI 850), advance ship notices (EDI 856), and invoices (EDI 810 which help build a digital trail of every transaction and movement in the supply chain. 

• Consistent and Accurate Documentation: Because EDI uses standardized formats, it reduces the risk of human error and ensures that critical traceability data, such as lot numbers, expiration dates, and product descriptions, is consistently captured and transmitted. 

• Faster Recall and Risk Response: In the event of a quality or safety issue, EDI enables manufacturers to identify affected products quickly, notify partners, and initiate recalls. This minimizes brand damage and ensures consumer safety. 

• Improved Supply Chain Visibility: EDI integrates with other enterprise systems, such as ERP and warehouse management solutions, giving stakeholders a unified view of inventory, supplier performance, and ingredient traceability. 

• Simplified Regulatory Reporting: With more rigorous FDA oversight on the horizon, EDI can automate the flow of required documentation, making it easier to prepare for inspections, audits, and regulatory submissions. 

Preparing for What’s Ahead 

As the proposed food reforms take shape, manufacturers should start preparing now. Here are some steps companies can take to stay ahead: 

• Audit existing formulations for synthetic dyes and ingredients that may be affected by new rules. 

• Review traceability systems to ensure they can capture and report the necessary data. 

• Strengthen supplier relationships and sourcing strategies to secure natural, traceable ingredients. 

• Invest in EDI capabilities to streamline documentation, improve accuracy, and support real-time visibility. 

• Engage R&D, regulatory, and IT teams to align efforts and build a compliance-ready digital infrastructure. 

The food industry is on the verge of a major regulatory and consumer-driven transformation. The administration’s proposals to ban synthetic dyes and reform ingredient safety rules reflect growing concerns about food quality, transparency, and public health. 

With EDI and traceability working together, food businesses can confidently navigate reform, ensure compliance, and meet evolving consumer expectations. Now is the time to strengthen your digital foundation and take the lead in the next era of food manufacturing. 

If these proposed regulations will affect your business and you would like to speak with a TrueCommerce EDI expert, please contact us today.