FDA’s recently proposed rule to require companies to notify it when they determine a new food ingredient is Generally Recognized As Safe (GRAS) would impose additional requirements on the food and beverage industry, but it also could dramatically increase FDA’s workload, raising questions about whether the agency has the staff and resources to carry them out.
At least 1,000 substances in the food supply have never been submitted to FDA, according to an estimate from the consultancy Manatt. It explains that under a 1958 amendment to the Federal Food, Drug, and Cosmetic Act, companies can introduce substances without FDA authorization if qualified experts determine they are generally recognized as safe (GRAS) under their intended conditions of use.
By contrast, it says, companies have voluntarily notified FDA of more than 1,200 ingredients that they have determined are GRAS.
The gap between the two has fueled criticism from public health advocates, HHS Secretary Robert F Kennedy Jr’s Make America Health Again movement and other stakeholders, including the Center For Science in the Public Interest, which argues the exemption allows the introduction of “new ingredients without FDA review – endangering public health and leaving consumers in the dark about what’s in their food.”
FDA’s proposal to move GRAS notifications from voluntary to mandatory addresses the information gap – but only halfway. Whether FDA has the legal authority to require the notifications, and whether it has the staff and resources to process what could be a surge in submissions, remain unresolved. For the food and beverage industry, that leaves a basic question: What will the new GRAS regime look like if the proposal becomes final?
Does FDA have the resources to review an influx of GRAS notifications?
FDA estimates the cost of the proposed rule would be approximately $89.6 million, but could stretch up to $210 million. Annualized costs could be about $10.5 million, with a high estimate of $24.6 million.
It justifies the expense by saying the proposed rule would give it additional information to “ensure GRAS conclusions have a scientific basis” and “appropriate documentation.”
It adds this would “help strengthen public confidence in FDA’s ability to oversee the safety of the US supply.”
But how the agency will review the notifications in a timely fashion or use the data is unclear.
“This proposed rule form would lead to significant extra work for FDA” if finalized in or near its proposed form, notes Nathan Brown a partner on the food and beverage team at the law firm Akin.
Brown said FDA expects the mandatory regime to increase the number of draft notices, potentially prompting the agency to use an additional 90-day extension to its review period.
In addition, he said, “a substantial one-time inflow of information about food additives and substances that are already in commerce” will hit the agency via the “streamlined pathway” indicated in the proposed rule for self-determined GRAS ingredients for which the agency was not previously notified.
“It is not clear where the resources or staffing would come from” to cover this extra work, he said.
This would be a concern about any proposal of this magnitude, but it is especially pointed given FDA lost between 3,850 to 4,300 employees since the start of President Donald Trump’s second term in January 2025. Under the Department of Government Efficiency (DOGE) initiatives and Kennedy’s leadership at HHS, the agency carried out sweeping cuts that heavily impacted reviewers in food safety among other areas.
One option could be for FDA to delay the implementation deadline, hypothesized Brown, who said this was a strategy that he has seen as a former FDA employee.
“When there are changes this significant, as implementation deadlines approach, FDA is also confronted with a decision about whether to extend those deadlines. Sometimes that is because industry needs more time, and FDA may exercise enforcement discretion, but other times, it is because the agency needs more time,” he said. “So, the question in this proposal is: Are these timeframes realistic?”
How will FDA use the additional information?
Regardless, the influx of information could alter FDA’s food safety approach. But how remains unclear.
Brown acknowledged the “the proposal would give FDA dramatically more substance-specific and use-specific information, particularly about substances already on the market. But then also going forward, the question is what the agency will do with that really large increase in information, and how will they prioritize reviews because they already have resource limitations as it is that dictate where the food program focuses its compliance efforts, as well as its policy making and other decision-making.”
He also asked, “What are they going to do with the potentially vastly more information they have about food substances? What will their risk-based approach be in that new reality?”
These are important questions for stakeholders to consider as they draft their comments on the proposed rule, which are due Dec. 11, he said.