US Proposes GRAS Reform and Definition of Ultra-Processed Food

US Health Secretary Robert F. Kennedy Jr. has announced two food-policy initiatives under President Donald Trump’s Make America Healthy Again agenda. One would require manufacturers to notify the FDA about GRAS safety conclusions, while the other would establish the first standardized federal definition of ultra-processed food.

US Department of Health and Human Services Secretary Robert F. Kennedy Jr. has announced two proposed reforms intended to strengthen federal oversight of the food supply.
The first is an FDA proposal requiring manufacturers to report decisions that a substance used in human or animal food is Generally Recognized as Safe, commonly called GRAS. The second is a proposed federal definition of ultra-processed foods submitted by HHS and the US Department of Agriculture for final review.

“These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy,” Kennedy said.

Neither measure is final, and neither immediately changes food labels, manufacturing requirements or the products available to consumers.

FDA Would Make GRAS Notifications Mandatory

GRAS refers to an intended use of a food substance that qualified experts generally recognize as safe based on scientific evidence or, in certain cases, a history of common food use before 1958.

Under the existing framework, manufacturers can independently determine that an intended use qualifies as GRAS without notifying the FDA. Although the agency operates a voluntary notification programme, participation has not been compulsory.

The proposed rule would:

• Require manufacturers to notify the FDA about GRAS conclusions.
• Expand the public inventory of submitted GRAS notices.
• Give the FDA greater visibility into substances entering human and animal food.
• Support post-market safety monitoring and regulatory oversight.

The requirement would cover the conditions under which a substance is used, rather than declaring that an ingredient is universally safe for every purpose.

Notification Would Not Equal Premarket Approval

Mandatory notification would improve transparency, but it would not automatically subject every GRAS substance to the same premarket approval process required for conventional food additives.

Manufacturers could still reach GRAS conclusions, provided the intended use meets the legal standard. The principal change is that those conclusions and supporting information would have to be submitted to the FDA.

Therefore, the proposal should not yet be described as completely closing the GRAS exemption. Its effectiveness will depend on the information manufacturers must submit, the timing of notifications and the FDA’s capacity to examine potential safety concerns.

Existing Self-GRAS Uses Would Enter a Streamlined Process

The proposal would establish a time-limited, streamlined pathway for substances already marketed through previous industry self-GRAS conclusions.

Manufacturers could use this process to provide information about existing uses. The FDA says the resulting data would help it identify substances that may require priority post-market safety evaluation while limiting unnecessary regulatory burdens.

The proposal is open for public comment until December 9, 2026. Its requirements could be modified before any final rule is issued.

Federal Ultra-Processed Food Definition Moves Forward

HHS and USDA have also submitted what would become the federal government’s first standardized definition of ultra-processed food for final review.

The agencies previously sought information from researchers, health professionals, consumer groups, food manufacturers and members of the public. They said the absence of a uniform definition made it difficult to compare research and develop consistent nutrition policies across federal agencies.

However, the proposed definition’s wording has not been publicly released. The administration has also not provided a specific publication or implementation date.

Creating a Clear Definition of Ultra-Processed Food

Several research systems classify foods according to their ingredients, formulation and degree of industrial processing. However, there is no universally accepted definition.

An overly broad definition could place nutritionally different products in the same category, while a narrow definition might overlook processing methods or formulations associated with excessive sugar, sodium, saturated fat or energy intake.

A standardized definition could eventually support nutrition research, dietary guidance and food-policy decisions. It would not, by itself, prove that every product classified as ultra-processed is harmful.(1^✔ ✔Trusted Source
Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda

Go to source)

Research Links High UPF Intake to Health Risks

A randomized inpatient study found that participants consumed more calories and gained weight while following an ultra-processed diet than while eating an unprocessed diet matched for several nutrients.

A 2024 umbrella review also found that greater exposure to ultra-processed food was associated with several adverse health outcomes, particularly cardiometabolic conditions.(1^✔ ✔Trusted Source
Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda

Go to source)

However, much of the broader evidence is observational and cannot independently prove that processing caused every reported outcome.

A consistent federal definition could help researchers investigate which ingredients, processing methods and dietary patterns contribute most strongly to health risks.

Proposed Food Reforms Await Final Approval

The announcements represent developing policy rather than completed regulation. The GRAS measure remains a proposed rule, while the UPF definition is still under review and has not been published.

Consumers do not need to remove every processed food from their diets based on the announcement. Existing dietary advice continues to favor fruits, vegetables, whole grains, legumes, nuts and other nutrient-dense foods while limiting products high in added sugars, sodium and saturated fat.(1^✔ ✔Trusted Source
Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda

Go to source)

The reforms’ eventual public-health value will depend on their final wording, implementation, enforcement and use in future nutrition policy.

References:

1. Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda- (https://www.hhs.gov/press-room/hhs-announces-ultra-processed-foods-gras-reforms.html)

Source-Medindia