The food system and supply chains continue to change and evolve at an accelerated pace. The Department of Health and Human Services (HHS), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) have taken a number of significant food safety regulatory actions in the first quarter of 2025, including announcing HHS’s intent to explore potential rulemaking to eliminate the self-affirmed Generally Recognized as Safe (GRAS) pathway and proposing to extend the compliance date for the Food Traceability Rule by 30 months.

The regulatory landscape is shifting, and regulatory changes continue to come fast and furious. The following recent actions (amongst others) have the potential to significantly impact food companies across the U.S.

Updated Allergen Guidance

On January 6, 2025, the FDA published a revised fifth edition of its food allergen guidance for industry, Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act. The guidance is intended to help the food industry meet requirements for accurately labeling FDA-regulated foods with the big 9 food allergens (i.e., milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame) to protect consumers with food allergies.

The guidance includes updates reflecting FDA’s current thinking on food allergen labeling topics, including the following:

• Information regarding sesame as a major food allergen.
• Expanded interpretations of milk and eggs as major food allergens to include milk from ruminant animals other than cows and eggs from birds other than chickens.
• Adjustments to remove certain tree nuts, including coconuts, from the list of major food allergens.

Companies should reference the updated guidance to ensure they understand these changes, accurately evaluate the food safety and allergen risks of their products, and update manufacturing and labeling practices to remain in compliance with food allergen labeling requirements.

Withdrawal of Salmonella Framework

On July 29, 2024, the USDA Food Safety and Inspection Service (FSIS) issued its proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. The proposed framework presented a systematic approach to addressing Salmonella contamination at the poultry slaughter and processing stages, including the first enforceable standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 CFU per gram/mL from entering the market. It also required poultry companies to establish microbial monitoring programs (MMPs) incorporating statistical process controls (SPCs) to identify and prevent pathogen contamination throughout the slaughter system. 

FSIS received over 7,000 public comments on the proposed framework and announced a Notice of Withdrawal on April 25, 2025, retracting the proposed rule and determination to allow the Agency to further assess its approach. FSIS cites the following areas as garnering the most comments—both positive and negative:

• FSIS’s legal authority to propose final product standards.
• Proposed Salmonella levels and serotypes for the final product standards.
• Proposed use of SPC monitoring.
• Scientific and technical information used to support the proposed framework.
• Potential economic impacts.
• Potential impacts on small poultry growers and processors.

The comments also suggested several alternative approaches to address Salmonella illnesses associated with poultry products. FSIS is taking all of this under advisement as it reassesses its approach to Salmonella and whether an update to the current standards is warranted.

Phasing Out Synthetic Dyes

HHS and FDA announced on April 23, 2025 that they are taking immediate action to phase out eight petroleum-based synthetic dyes in foods and to fast-track review and approval of natural alternatives. These dyes are found in hundreds of products, including candy, cereals, beverages, and even medications.

Many synthetic dyes currently used in the U.S. have been banned or restricted in the European Union since 2010. In November 2023, California became the first state in the U.S. to ban four food additives (Red No. 3, brominated vegetable oil, potassium bromate, and propylparaben) in foods sold in California through the California Food Safety Act, and in March 2025, West Viriginia signed one of the most comprehensive food dye bans into law. Now the FDA is taking the following significant actions to remove synthetic dyes from all U.S. products:

1. Establish a national standard and timeline for the food industry to transition from synthetic dyes to natural alternatives.
2. Revoke authorization of Citrus Red No. 2 and Orange B in the next few months.
3. Work with industry to remove the remaining six synthetic dyes from the food supply by the end of 2026. This includes FD&C Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2.
4. Fast-track authorization of four new natural color additives, including calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower, and accelerate review of others.
5. Partner with the National Institutes of Health (NIH) to further research how food additives impact children’s health.
6. Request food companies remove FD&C Red No. 3 sooner than the January 15, 2027 or January 18, 2028 deadlines established by FDA on January 15, 2025.

The FDA is planning to proceed without any statutory or regulatory changes, relying instead on the voluntary efforts of the food industry in complying. The Agency is taking steps to issue guidance and provide regulatory flexibility to industry to remove the synthetic dyes as quickly as possible from the market.

In most cases, companies will need to:

• Inventory existing products and their ingredients to determine which products use synthetic dyes.
• Reformulate affected products to use natural color alternatives, test new recipes, and, potentially, make other recipe changes.
• Identify and approve new suppliers of alternative ingredients.
• Update label design, adjust ingredient panels, and modify any relevant nutritional claims.

Stay Focused

Change is happening, and companies in the food industry need to pay attention and be prepared:

• Conduct a comprehensive food safety and quality gap assessment. Know your operations, inventory your ingredients, understand your supply chain. This assessment should be the starting point for understanding your regulatory and certification obligations and current compliance status—and for ensuring you are prepared to meet pending regulatory developments.
• Train your staff. Every change discussed above requires employee understanding. Train your team routinely on requirements, responsibilities, processes, expectations, etc.
• Seek third-party oversight. Having external experts periodically look inside your company can help determine regulatory applicability, provide an objective view of what is really going on, prepare for audits, and implement corrective/preventive actions that help ensure compliance. An outside expert can often provide the “big picture” view of what you have vs. what you need; how your plans, programs, and requirements intersect; and how you can best comply with changing requirements.