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The Food and Drug Administration (FDA) is proposing a rule change to require food companies to notify regulators before introducing ingredients or additives into processed or packaged foods, according to federal health leaders.
Under the rule, companies would have to submit a safety rationale for new ingredients.
“The proposal would change a decades-old policy that advocates have called a regulatory loophole, blaming it for allowing thousands of unvetted ingredients into the U.S. food supply,” according to the Associated Press.
You can submit a public comment crafted by Salud America! to provide feedback on FDA’s plan to tighten restrictions on new food additives and ingredients.
Comments are due Dec. 9, 2026.
Submit This Model Comment on Food Additives and Ingredients
FDA leaders,
As you know, food is an important part of health for our families and nation.
Yet many Americans are uncertain of the health and safety of the over 10,000 preservatives, thickeners, and other additives allowed in our food supply.
This is because the FDA has allowed food companies to self-certify that additives and ingredients as “generally recognized as safe” (GRAS).
The proposed rule would add a layer of safety by requiring companies to provide documentation of how they arrived at determining any new additives are GRAS, giving regulators a chance to review.
We need clarity on the safety of ingredients that are in the foods we eat because many families, including Latinos, already struggle with poor nutrition (https://bit.ly/4wCb7kX) and less access to sources of healthy food, such as grocery stores and farmer’s markets (https://bit.ly/2gFGA25). This results in high rates of obesity and disease (https://bit.ly/4ih7IS2).
We support efforts to give families and communities greater understanding of the additives and ingredients in our food.
Thank you.
Why Is This Rule Change Needed for Food Additives and Ingredients?
In the United States, about 10,000 additives are allowed in food, including preservatives, thickeners, and packaging ingredients, according to the Associated Press.
Many ingredients are “generally recognized as safe” (GRAS).
Congress established the GRAS exemption in 1958, allowing manufacturers to reach their own conclusions that certain substances are generally recognized as safe under the conditions of their intended use.
“Originally understood to cover common ingredients such as vinegar and flour, the GRAS exemption evolved over subsequent decades,” according to Holland and Knight.
Food companies have not been required to notify the agency when making these determinations about substances generally recognized as safe.
“This has drawn fire from some consumer groups who believe that food industries may abuse this allowance and use ingredients with potentially harmful health effects that are submitted under the GRAS classification,” according to Harvard nutrition experts.
What Does the Rule Change Mean for Food Additives and Ingredients?
The proposed rule change would make GRAS notifications mandatory among food companies, giving regulators 180 days to review new ingredients and additives.
The change also would expand the public-facing inventory of submitted notices.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” said acting FDA Commissioner Kyle Diamantas.
For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited streamlined submission pathway that would allow manufacturers to provide the FDA with information about existing uses.
“This enables the agency to prioritize post-market safety evaluations while minimizing unnecessary regulatory burden,” according to federal health leaders.
What Happens Next for Food Additives and Ingredients?
Comments on the proposed rule change are due Dec. 9, 2026.
Following the deadline, public comments will be reviewed and deliberated upon by the FDA before a final rule is issued.
Public input is critical because it gives federal officials information about the potential impact of a proposed regulation, according to Unidos US. Participating in the rulemaking process allows you to shape federal programs and the rules that govern.
By The Numbers
50
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of big U.S cities have a local board of health
