US health officials have proposed a major change to the way new ingredients and additives are introduced into processed and packaged foods, seeking to close regulatory loophole.
Under the proposal announced on Monday (August 10), food manufacturers would have to notify the Food and Drug Administration (FDA) before introducing new ingredients through the “generally recognized as safe” (GRAS) pathway. Companies would also have to provide documentation explaining why they believe the ingredient is safe.
The proposal is part of Health Secretary Robert F. Kennedy Jr.’s broader push to increase scrutiny of food additives, artificial colours and highly processed foods.
But the proposed changes do not mean that the FDA would automatically review or approve every new food ingredient.
What is the FDA proposing?
Currently, companies can determine for themselves that an ingredient is “generally recognized as safe,” or GRAS, based on scientific evidence and expert consensus.
Although some companies voluntarily notify the FDA about such determinations, they are not generally required to do so.
Under the proposed rule, manufacturers using this pathway would have to:
-Notify the FDA before introducing a new ingredient.
-Submit the scientific basis for their conclusion that the ingredient is safe.
-Give regulators greater visibility into ingredients entering the food supply.
-Allow the FDA to investigate submissions if it identifies potential safety concerns.
Acting FDA Commissioner Kyle Diamantas said the mandatory notification system would address what he described as a long-standing information gap.
“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” Diamantas said.
The FDA plans to accept public comments on the proposal for 120 days.
Will the FDA approve every new ingredient?
No.
This is one of the most important points about the proposed rule.
The FDA says the proposal would create a mandatory notification system, but it would not require the agency to formally review and approve every ingredient before it enters the food supply.
Diamantas said Congress would need to give the FDA additional authority to require mandatory reviews.
“What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility,” he said.
Under the proposal, the FDA would aim to review new ingredient submissions within 180 days.
If regulators identify concerns, they could seek additional information from manufacturers or ask a company to delay introducing the ingredient.
What is the GRAS loophole?
The controversy centres on the GRAS exemption.
Food ingredients intentionally added to products generally have to undergo regulatory review unless they are considered safe under an exemption recognised in federal food law.
For decades, the FDA played a direct role in overseeing the GRAS process. But beginning in 1997, the agency allowed companies to independently determine that an ingredient qualified as GRAS based on publicly available scientific information and the consensus of qualified experts.
This meant manufacturers could make their own safety determinations without necessarily informing the FDA.
Consumer and public-health groups have criticised the system, arguing that it allowed thousands of ingredients to enter the US food supply without independent FDA assessment.
How many additives are used in US food?
Consumer advocates estimate that roughly 10,000 additives are allowed in US food.
These include substances used for purposes such as:
Preserving food
Improving texture
Thickening products
Maintaining colour
Enhancing flavour
Processing and packaging
The proposed notification system could give the FDA a clearer picture of which ingredients companies are using and the scientific evidence behind their safety determinations.
However, former FDA food-program director Susan Mayne cautioned that the proposal would not mean every ingredient is independently reviewed.
“This is a reasonable first step towards a more complete inventory,” Mayne said.
She added that most self-affirmed GRAS ingredients would still not be reviewed by the FDA and that food safety would continue to be handled on a risk-based approach.
FDA to publish list of submitted ingredients
The FDA also plans to publish a list of ingredients submitted by companies under the new system.
But appearing on that list would not mean the FDA has determined that an ingredient is safe.
Mayne warned consumers against interpreting inclusion on the list as an official safety endorsement.
That distinction could become important if the proposed system results in a large public database of food ingredients.
What about ultraprocessed foods?
The FDA also announced separately that it has completed work on the federal government’s first definition of “ultraprocessed food.”
However, the agency did not release the proposed definition. Instead, it submitted the language to the White House for further review.
Ultraprocessed foods generally include products made using industrial processing and ingredients such as additives, preservatives and colours that are not typically found in home kitchens.
Examples include:
Sugary cereals
Soft drinks
Chips
Frozen pizzas
Other highly processed packaged foods
An official government definition could eventually influence research, dietary guidance and potentially future policies such as warning labels or restrictions.
Why is defining ultraprocessed food difficult?
Scientists have been debating how to classify processed foods for years.
One challenge is that processing does not automatically make a food unhealthy.
Foods such as whole-grain bread, yogurt and granola can undergo significant processing while still offering nutritional benefits.
Some proposed classification systems therefore include exceptions for processed foods that meet certain nutritional standards.
A government definition would need to distinguish between foods that are heavily processed and foods that may be highly processed but still nutritionally beneficial.
Kennedy’s broader food policy push
The proposals are part of Kennedy’s broader agenda to increase scrutiny of artificial colours, additives and highly processed foods.
Kennedy said the two initiatives would change how the federal government oversees food ingredients and understands what Americans eat.
“These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat,” Kennedy said.
He also said the Trump administration would seek additional authority from Congress to strengthen the FDA’s ability to regulate ingredients.
“Congress needs to give FDA the additional tools it needs to keep pace with the changing food supply and protect the American people,” Kennedy said.
