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The U.S. Food and Drug Administration (FDA) is proposing mandatory — rather than voluntary — notification when food companies determine that ingredients they add to food are “generally recognized as safe,” or GRAS.
The move, announced last month by the Trump administration, comes as a growing number of food ingredients are being developed using synthetic biology.
The agency said the proposed change would give regulators and the public more information about what is being added to the food supply and help the FDA identify potentially unsafe uses.
“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 said during a press briefing.
The FDA will accept public comments on the proposal for 120 days.
The proposal would not require the FDA to approve every GRAS ingredient before it reaches consumers. Companies would continue to make the initial determination that a substance qualifies as GRAS, but they would have to notify the FDA and provide supporting information.
The proposed change comes as food manufacturers increasingly use precision fermentation, a form of synthetic biology that uses genetically engineered microorganisms to produce specific proteins, fats, enzymes and other substances.
Some companies are using the technology to produce plant-based proteins designed to replicate conventional animal foods, including dairy and egg proteins.
Several precision-fermented ingredients have received “FDA has no questions” letters under the existing GRAS notification system.
The technology has raised questions about what consumers are actually eating, how those ingredients are evaluated and whether existing regulatory requirements provide enough information about the food.
‘Children should not become the post-marketing safety study’
Little is known about the long-term effects on children of regularly consuming foods containing synthetic biology-derived ingredients, as long-term data are limited.
Dr. Michelle Perro, a pediatrician and author who studies children’s health, said she is skeptical.
“My greatest concern as a pediatrician is not that we have proven these foods are harmful to children,” Perro said. “My concern is precisely the opposite: We do not have adequate evidence demonstrating the long-term safety of repeated consumption of many of these newly manufactured food ingredients during childhood.”
Perro said children may be particularly sensitive to dietary exposures because their immune, metabolic and other biological systems are still developing.
“Children are not simply smaller adults,” she said. “Their immune systems, intestinal microbiome, nervous systems, endocrine systems and metabolic pathways are developing rapidly. Exposures occurring during these developmental windows can have consequences that would not necessarily be predicted by short-term testing in adults.”
Children need adequate protein, fats, vitamins and minerals for growth and development. Replacing conventional food with genetically modified organisms (GMO) or lab-grown ingredients can alter the nutritional composition of the final product.
For example, producing one protein found in milk does not re-create milk.
Cow’s milk is a complex combination of proteins, fats, carbohydrates, minerals and other compounds. A product containing certain ingredients may reproduce one component or function of milk without reproducing its complete nutritional composition.
Perro said that difference warrants more research, particularly when products could become routine parts of children’s diets.
“The appropriate scientific position is neither ‘these products are definitely dangerous’ nor ‘the technology is safe because the intended protein resembles a natural protein,’” she said. “The appropriate position is: Show us the data.”
Perro said she would like to see independent testing to determine exactly what these foods contain, including any unintended proteins or other substances they may produce.
She also wants testing to determine if they could cause allergic or immune reactions, along with studies on toxicity, effects on gut microbiome, child development and children’s health over the long term.
“Children should not become the post-marketing safety study,” she said.
What is precision fermentation?
Precision fermentation differs from traditional fermentation used to make foods such as yogurt, bread and sauerkraut.
In precision fermentation, microorganisms such as yeast or fungi are genetically engineered to produce a particular substance. The microorganism is grown in fermentation tanks, and the desired substance is then harvested and purified for use in food.
One example is beta-lactoglobulin, a major whey protein found in cow’s milk. Companies can engineer microorganisms to produce a version of the protein without obtaining it directly from an animal.
The technology is promoted as a way to create specific food components at scale while reducing dependence on livestock. Supporters point to potential benefits involving cost, efficiency, sustainability and the ability to produce proteins with predictable functional characteristics.
But the technology used to manufacture an ingredient can create something new even when the intended molecule resembles one humans have consumed for generations.
A 2026 study published in Scientific Reports analyzed a commercially available “synbio milk” product using the fungus Trichoderma reesei.
The researchers found substantial differences between the product and conventional cow’s milk. Of 69 nutritional compounds identified in bovine milk, only seven were detected in the synthetic-biology product, and generally in smaller amounts.
The study does not conclude that the product is toxic or that the unidentified compounds are dangerous. Rather, the researchers said the findings demonstrate a need for additional testing to determine any health risks.
“Therefore, comprehensive toxicity and allergenicity testing are needed to assess the safety of synbio milk for human consumption,” the researchers concluded.
‘Precision-fermented milk protein can still be a milk allergen’
For a child with a milk allergy, “animal-free” does not necessarily mean “free of milk allergens.”
A precision-fermented dairy protein can still trigger a milk allergy even if no animal was used to produce it. The FDA’s GRAS database includes multiple notifications for beta-lactoglobulin for use in milk substitutes and other foods.
“A precision-fermented milk protein can still be a milk allergen,” Perro said.
She also raised questions about the manufacturing organism and purification process, including the possibility of residual proteins, metabolites and other compounds generated during fermentation.
“Regulators and researchers have identified potential safety issues involving host cell proteins and other remnants, microbial contaminants, unintended metabolites, toxins, chemical residues and unintended biological activity,” Perro said.
Food-safety authorities have raised concerns about whether consumers can recognize potential allergens when the technology used to make an ingredient is not obvious from the food’s label.
Britain’s Food Standards Agency warned in June that allergens for precision-fermented foods need to be clearly labeled. The agency cited precision-fermented dairy alternatives as an example.
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Did the FDA go far enough?
The FDA proposal would not mean every synthetic-biology food receives a separate FDA safety determination before reaching consumers.
That frustrates some food-safety advocates, who say mandatory notification does not go far enough.
Alexis Baden-Mayer, writing in a Substack commentary, stated that the proposal would allow companies to continue using the GRAS designation rather than obtaining traditional premarket approval for food additives.
Baden-Mayer wrote:
“GRAS is a failed process that lets companies claim that new synthetic Frankenfoods are exempt from pre-market safety testing. Under the loophole, all a company has to do is decide, on its own, that its novel ingredient is GRAS.
“As things stand now, the company doesn’t even have to tell the FDA it has done so. This means we have no way to find out what new synthetic Frankenfoods are entering the food supply or what the risks of eating them might be.”
Baden-Mayer argued that recent action by U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and the proposal would not create the systemic change she wants to see in the food system.
“He isn’t doing anything to close it or even tighten it up,” Baden-Mayer wrote.
HHS and the FDA did not respond to a request for comment.
The FDA said GRAS substances can be exempt from food-additive requirements when they meet the applicable legal standard for safety based on scientific procedures supported by evidence.
The FDA’s proposed GRAS rule comes as the Trump administration’s Make America Healthy Again (MAHA) agenda has placed greater emphasis on food ingredients and food safety.
Additionally, the FDA announced it was completing its first federal definition of ultraprocessed food, which advocates believe could expedite closer analysis and food transparency. The definition was not disclosed.
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