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 foodImproving textureThickening productsMaintaining colourEnhancing flavourProcessing and packagingThe 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 ingred
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