US regulators plan to tighten safety rules for ingredients added to food products under the so-called Generally Recognised as Safe (GRAS) principle.
The US Department of Health and Human Services (HSS) described the proposed measure as a “landmark action”, along with efforts to “establish a stronger scientific foundation for future nutrition policy”.
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HSS said in a statement yesterday (10 August) that the proposal would require food manufacturers to notify the Food and Drug Administration (FDA) when adding a “substance” to food products to ensure it complies with GRAS.
“Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to reach their own conclusions that certain substances are generally recognised as safe under the conditions of their intended use,” according to the statement.
“Although the FDA has long operated voluntary notification programmes, companies have not been required to notify the agency when making these determinations.”
Meanwhile, HHS said that, together with the US Department of Agriculture (USDA), it has sent the federal government’s first proposed definition of ultra-processed foods (UPFs) for final review.
No details were provided on the contents of the proposed definition amid a long awaited explanation of UPFs as a guide for the US food industry.
HHS said the draft was shaped by input from various stakeholders, including industry, consumer organisations, researchers, and the public.
It pointed to studies linking a high intake of UPFs with chronic diseases such as type-2 diabetes and heart disease.
However, the lack of a “standardised” definition has made it harder to keep research consistent across the federal government, HSS added.
Robert F. Kennedy, Jr., the secretary of HHS, said: “Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children.”
In terms of GRAS, the FDA aims to “modernise” the existing framework by “significantly improving transparency”, according to the HHS.
For substances already being used on the market through industry self-GRAS conclusions, the proposal would create a “time-limited streamlined submission pathway”, the statement added.
That process would allow manufacturers to submit information to the FDA on existing uses.
HHS said that would help the agency target post-market safety evaluations while avoiding unnecessary regulatory burdens.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Kyle Diamantas, the acting commissioner of the FDA, said.
TD Cowen analyst Robert Moskow had a positive view of the proposed GRAS changes, saying the new rules are “relatively accommodative to the food industry given that it only asks for notification rather than pre-market approval or retroactive review of existing self-affirmed GRAS additives”.
Moskow added in a follow-up research note: “The new rule does not eliminate self-affirmation or require a pre-market FDA approval of new additives.
“As such we do not expect food companies to incur materially higher costs or delays to comply. Manufacturers will continue to rely on third-party safety and toxicology reviews to substantiate their self-affirmations.”
