FDA GRAS Rule Under Scrutiny as RFK Jr. Targets Ultra-Processed Food Additive Oversight

A new federal health policy debate is intensifying after Robert F. Kennedy Jr. signaled plans to scrutinize the FDA’s long-standing “Generally Recognized as Safe” (GRAS) rule — a regulatory framework that allows food manufacturers to self-certify certain ingredients as safe without formal FDA approval. The move, reported February 16, 2026, places ultra-processed foods and food additive oversight at the center of the national health discussion.

The proposal could reshape how ingredients enter the U.S. food supply and reignite longstanding concerns about regulatory transparency and public health safeguards.

According to reporting published Feb. 16, Kennedy outlined an agenda focused on tightening oversight of ultra-processed foods, specifically calling attention to the FDA’s GRAS pathway. Under current rules, companies can determine that a food ingredient is “generally recognized as safe” based on scientific consensus and, in many cases, are not required to formally notify the FDA before bringing products to market.

Critics argue that the framework allows additives to enter the food supply without sufficient independent review. Kennedy suggested reforming or revisiting these rules as part of a broader strategy to address chronic disease and diet-related health issues in the U.S.

The GRAS rule has existed for decades and was initially designed to streamline approval for widely accepted substances such as salt or vinegar. However, public health advocates have long contended that the process has expanded beyond its original scope.

Why This Matters

1. Regulatory Oversight of Food Additives

The GRAS pathway allows manufacturers to convene their own expert panels to determine safety, often without mandatory FDA review. While companies can voluntarily notify the agency, notification is not required.

Public health groups have criticized this system for creating potential conflicts of interest and limiting federal oversight. Revisiting the GRAS framework could lead to:

• Mandatory FDA notification for new additives

• Increased transparency in safety determinations

• Expanded post-market surveillance of food ingredients

The FDA maintains that companies are legally responsible for ensuring the safety of ingredients added to food and that the agency can intervene if safety concerns arise.

2. Ultra-Processed Foods and Public Health

Ultra-processed foods — often high in refined sugars, additives, emulsifiers, and preservatives — have been increasingly linked in scientific literature to obesity, cardiovascular disease, and metabolic disorders.

Research funded by the National Institutes of Health has shown that diets high in ultra-processed foods can lead to increased calorie intake and weight gain compared to minimally processed diets, even when matched for nutrients.

If GRAS standards are revised, manufacturers of packaged and convenience foods could face additional regulatory scrutiny regarding additives used for flavoring, preservation, and texture.

3. Industry and Market Impact

Changes to GRAS rules would have significant implications for:

• Food manufacturers

• Ingredient suppliers

• Regulatory compliance teams

• Retail and consumer packaged goods companies

Mandatory FDA review for additives could lengthen product development timelines and increase compliance costs. Smaller manufacturers might face greater administrative burdens, while larger firms may need to reevaluate legacy ingredients previously self-certified as safe.

From a broader health market perspective, the debate also intersects with rising interest in “clean label” products and consumer demand for ingredient transparency.

Stricter GRAS oversight could lead to increased transparency about what ingredients are included in packaged foods.

Companies may face new regulatory hurdles if GRAS rules are revised or tightened.

Many advocacy organizations have long pushed for reform of the GRAS process and may view renewed scrutiny as an opportunity for systemic change.

The FDA could see expanded responsibilities if reforms require mandatory premarket reviews for food additives.

Public health researchers have previously warned that regulatory gaps in food additive oversight may limit the government’s ability to proactively prevent long-term health risks.

At the same time, food industry stakeholders argue that the GRAS system has functioned effectively for decades and that scientific consensus mechanisms provide sufficient safety assurance.

Any reform would likely require careful balancing of food safety, innovation, regulatory efficiency, and economic considerations.

While no formal regulatory proposal has yet been announced, policy discussions could lead to:

• Congressional hearings on food additive oversight

• FDA rulemaking proposals

• Expanded data requirements for ingredient safety determinations

Given rising national focus on chronic disease and diet-related health conditions, scrutiny of ultra-processed foods is likely to remain a prominent issue in 2026.

Food industry stakeholders and healthcare professionals should:

• Monitor FDA communications for potential GRAS rulemaking updates

• Review ingredient safety documentation and compliance processes

• Engage in public comment opportunities if regulatory proposals are introduced

As food regulation evolves, transparency and scientific rigor will remain central to shaping the future of the U.S. food supply.