US FDA Proposes New Food Safety Rule To Track New Ingredients and Additives
The US FDA has proposed requiring food manufacturers to notify regulators when they determine new ingredients or additives are 'generally recognised as safe' (GRAS). The move would give the agency greater visibility into ingredients entering the food supply. Separately, federal officials have completed a proposed definition of ultra-processed food and sent it to the White House for review.
US health officials on Monday, August 10, proposed requiring food manufacturers to notify the Food and Drug Administration before introducing new ingredients or additives that they determine are “generally recognised as safe”, or GRAS. The proposed change would give regulators greater visibility into ingredients entering the US food supply, while companies would still be responsible for providing the scientific basis for their safety conclusions.
The proposal would change a decades-old system that consumer advocates have criticised as a regulatory loophole. Under the current framework, companies can determine themselves that an ingredient is GRAS based on scientific evidence and expert consensus, without being required to notify the FDA, although many companies voluntarily do so. Why the US FDA Flagged 3 Indian Supplements Over Unapproved S*xual Performance Claims.
FDA Seeks Greater Oversight of Food Ingredients
Under the proposed rule, manufacturers would have to document and submit their safety findings when using the GRAS pathway. The FDA would then have an opportunity to review the information and investigate if regulators identify potential safety concerns.
“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” acting FDA Commissioner Kyle Diamantas told reporters on Monday, August 10. FDA Approves First-of-Its-Kind Cholesterol Pill Lipfendra for Heart Patients, Alternative to Costly Injections.
The FDA will accept public comments on the proposal for 120 days. The agency says the move is intended to increase transparency and consumer confidence in the food supply.
The proposal would not require every new ingredient to undergo a full FDA review. Diamantas said such a requirement would require Congress to change the agency's statutory authority.
“What we’re doing is requiring companies that utilise the pathway to notify us of their conclusions so that we have greater visibility into those conclusions and consumers have awareness,” Diamantas said.
What Is the GRAS Rule?
GRAS stands for “Generally Recognised as Safe”. The designation allows certain substances to be excluded from the formal food-additive approval process when their safety is generally recognised by qualified experts based on scientific evidence or longstanding safe use.
The FDA has allowed companies to independently determine GRAS status since the late 1990s. The agency's current notification system is voluntary, although the FDA strongly encourages companies to submit notices.
That system has drawn criticism from consumer advocates, who argue that companies can introduce ingredients into foods without independent FDA review or public notification.
In the US, thousands of substances are used as food additives, including preservatives, thickeners and other ingredients used in food production and packaging.
FDA Review Could Take Up to 180 Days
Under the proposed system, the FDA would be expected to review a new ingredient submission within 180 days.
If regulators identify safety concerns, they could seek additional information from manufacturers or ask companies to delay introducing an ingredient while the concerns are examined.
The proposal would therefore give the FDA more information about ingredients entering the food supply without replacing the GRAS system with mandatory premarket approval for every new substance.
Federal Definition of Ultra-Processed Food Moves Forward
In a separate development, the FDA said it has completed work on the federal government's first definition of ultra-processed food.
The agency has submitted the proposed definition to the White House for further review but has not released the details or proposed language.
A federal definition could provide a common standard for research and future policy discussions surrounding highly processed foods.
The FDA and USDA previously began work toward a uniform federal definition, with the agencies seeking information on the characteristics and criteria that should be used.
Why Ultra-Processed Foods Are Under Scrutiny
Ultra-processed foods generally involve industrial processing and may contain additives, colours, preservatives or other ingredients not commonly used in home kitchens.
Common examples include sugary cereals, sodas, chips and frozen pizzas.
Health advocates have called for greater scrutiny of such foods because of their association in scientific research with several chronic health conditions. However, defining the category remains challenging because some highly processed foods, including certain whole-grain breads, yogurts and granolas, can also have nutritional benefits.
A formal government definition could eventually help shape federal research, dietary policy and potential labelling discussions.
Food Policy Remains a Priority
Neither of Monday's announcements is expected to immediately change what Americans eat.
However, both initiatives are priorities for Health Secretary Robert F. Kennedy Jr., who has pledged to address artificial colours, additives and other ingredients as part of the administration's broader food and health agenda.
The FDA's proposed GRAS notification rule and the pending ultra-processed food definition represent separate steps, but both could increase federal oversight and transparency around the ingredients and processing methods used in packaged foods.
(The above story first appeared on LatestLY on Aug 10, 2026 11:56 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).
